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Comparison

Adverse Events

NCT00615901

NCT00829166

the primary trial recorded many more seizures than the secondary trial, despite having less than one tenth the number of patients in its total cohort.

Contradiction

{'Clinical Trial ID': 'NCT00615901', 'Intervention': ['INTERVENTION 1: ', ' Cohort A (CMF at 14 Day Intervals)', ' This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim for a cohort of 38 patients. A safety analysis will then be performed.', ' cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically confirmed adenocarcinoma of the breast confirmed at MSKCC within 3 months of enrollment. Patients with inflammatory breast cancer are not eligible for the study. Pathology will be assessed in the standard fashion. Results of HER-2/neu, estrogen receptor, and progesterone receptor are required for study entry.', ' The patient cannot be Her-2/neu over-expressing either by immunohistochemistry or FISH as per hospital laboratory standard whether institutional or outside laboratory.', ' Patients must be > than or equal to 18 years of age', ' Patients must have a Karnofsky score of > than or equal to 80', ' Patients may have received hormonal therapy for the purpose of chemoprevention but must be willing to discontinue at least 24 hours prior to enrollment and while participating in this trial.', ' Patients will have completed their definitive breast surgery (mastectomy or breast conserving surgery)', ' Patients must be ready to begin therapy within 84 days from the final surgical procedure required to treat their primary tumor', ' Patients must be stage I-II', ' Absolute neutrophil count (ANC) > than or equal to 1500/µL and platelet count > than or equal to 100,000/µL', ' Total bilirubin must be < than or equal to 1.1 mg/dL or within normal institutional limits if outside MSKCC. Transaminases (SGOT/AST and/or SGPT/ALT) may be up to < than or equal to 92.5 U/L or < than or equal to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is < than or equal to ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < than or equal to ULN.', ' Serum creatinine must be within 0.6-1.3 mg/dL or within normal institutional limits if outside MSKCC.', ' Patients must be willing to discontinue sex hormonal therapy e.g., birth control pills, ovarian hormonal replacement therapy, etc., prior to enrollment. Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.', ' Patients must give written, informed consent indicating their understanding and willingness to participate in the study.', ' Brachytherapy after lumpectomy is permitted.', 'Exclusion Criteria:', ' Stage III-IV breast cancer', ' Prior chemotherapy or radiation therapy is excluded except for brachytherapy.Radiation for patients on this protocol will be given, if indicated, after the completion of chemotherapy.', ' Pregnant or lactating patients', ' Patients with a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer. Patients with other non-mammary malignancies must have been disease-free for at least five years.', ' Patients with unstable angina, congestive heart failure, current use of digitalis, betablockers, or calcium blockers for therapy of congestive heart failure, arrhythmia requiring medical therapy, or with a history of a myocardial infarction within 12 months.', ' Patients with a psychiatric illness that would prevent them from understanding the nature of the investigational therapy and complying with protocol requirements.', ' Patients with concurrent medical conditions, which, in the judgment of the investigator, would make them inappropriate candidates for study enrollment', ' Patients with active, unresolved infections', ' Patients that have known sensitivity to E. coli derived proteins, PEG-filgrastim, filgrastim, or any component products.', ' Patients must be Her 2/neu non-over-expressing.'], 'Results': ['Outcome Measurement: ', ' The Number of Patients Who Completed 8 Cycles.', ' the study regimen is deemed feasible and tolerable for patients with ANC > 1.5 on day 1 of treatment for all 8 cycles and absence of grade 3 or higher non-hematologic toxicity, excluding alopecia, nausea/vomiting and bone pain We will also evaluate the total number of days needed to complete all 8 cycles.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Cohort A (CMF at 14 Day Intervals)', ' Arm/Group Description: This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim for a cohort of 38 patients. A safety analysis will then be performed.', ' cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.', ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: participants 29'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/38 (5.26%)', ' Febrile neutropenia 0/38 (0.00%)', ' Abdominal pain 1/38 (2.63%)', ' Skin infection 0/38 (0.00%)', ' Seizure 1/38 (2.63%)']}

{'Clinical Trial ID': 'NCT00829166', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine', ' Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.', 'INTERVENTION 2: ', ' Lapatinib + Capecitabine', ' Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.'], 'Eligibility': ['Inclusion Criteria:', ' HER2 status must be prospectively, centrally tested and be HER2-positive based on central laboratory assay results', ' Histologically or cytologically confirmed invasive breast cancer', ' Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both a taxane, alone or in combination with another agent, and trastuzumab, alone or in combination with another agent', ' Documented progression (which occur during or after most recent treatment or within 6 months after completing of adjuvant therapy) of incurable, unresectable, locally advanced or metastatic breast cancer, defined by the investigator', ' Measurable and/or nonmeasurable disease; participants with central nervous system-only disease are excluded', ' Cardiac ejection fraction greater than or equal to (>/=) 50 percent (%) by either echocardiogram or multi-gated acquisition scan', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception; contraception use should continue for the duration of the study treatment and for at least 6 months after the last dose of study treatment', 'Exclusion Criteria:', ' History of treatment with trastuzumab emtansine', ' Prior treatment with lapatinib or capecitabine', ' Peripheral neuropathy of Grade >/= 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0', ' History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above', ' History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to randomization except hormone therapy, which could be given up to 7 days prior to randomization; recovery of treatment-related toxicity consistent with other eligibility criteria', ' History of radiation therapy within 14 days of randomization', ' Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as any history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) of randomization', ' History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment', ' History of myocardial infarction or unstable angina within 6 months of randomization', ' Current dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy', ' Current severe, uncontrolled systemic disease (for example, clinically significant cardiovascular, pulmonary, or metabolic disease)', ' Pregnancy or lactation', ' Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus', ' Presence of conditions that could affect gastrointestinal absorption: Malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis', ' History of intolerance (such as Grade 3-4 infusion reaction) to trastuzumab', ' Known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase deficiency', ' Current treatment with sorivudine or its chemically related analogs, such as brivudine'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)', ' PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported.', ' Time frame: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine', ' Arm/Group Description: Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.', ' Overall Number of Participants Analyzed: 495', ' Measure Type: Number', ' Unit of Measure: percentage of participants 53.5', 'Results 2: ', ' Arm/Group Title: Lapatinib + Capecitabine', ' Arm/Group Description: Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.', ' Overall Number of Participants Analyzed: 496', ' Measure Type: Number', ' Unit of Measure: percentage of participants 61.3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 92/490 (18.78%)', ' Anaemia * 1/490 (0.20%)', ' Anaemia of malignant disease * 0/490 (0.00%)', ' Febrile neutropenia * 0/490 (0.00%)', ' Neutropenia * 0/490 (0.00%)', ' Thrombocytopenia * 4/490 (0.82%)', ' Angina pectoris * 0/490 (0.00%)', ' Atrial fibrillation * 1/490 (0.20%)', ' Cardiomyopathy * 1/490 (0.20%)', ' Coronary artery disease * 0/490 (0.00%)', ' Pericardial effusion * 0/490 (0.00%)', 'Adverse Events 2:', ' Total: 99/488 (20.29%)', ' Anaemia * 1/488 (0.20%)', ' Anaemia of malignant disease * 1/488 (0.20%)', ' Febrile neutropenia * 2/488 (0.41%)', ' Neutropenia * 1/488 (0.20%)', ' Thrombocytopenia * 1/488 (0.20%)', ' Angina pectoris * 1/488 (0.20%)', ' Atrial fibrillation * 0/488 (0.00%)', ' Cardiomyopathy * 0/488 (0.00%)', ' Coronary artery disease * 1/488 (0.20%)', ' Pericardial effusion * 2/488 (0.41%)']}

a70cc8e5-0ef5-4045-8fec-d9e7503b5e6e

Comparison

Results

NCT00390455

NCT00558103

In both the secondary trial and the primary trial the test cohorts produced better results than the control groups.

Entailment

{'Clinical Trial ID': 'NCT00390455', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Lapatinib)', ' Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.', 'INTERVENTION 2: ', ' Arm II (Placebo)', ' Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.'], 'Eligibility': ['Inclusion Criteria:', ' Histologic, pathologic or cytologic diagnosis of cancer of the female breast in either primary or metastatic setting; histological documentation of metastatic/recurrent disease is not required if there is unequivocal clinical evidence for recurrence', ' Stage IV breast cancer (using American Joint Committee on Cancer [AJCC] criteria, 6th edition), or locally advanced (stage III) breast cancer not considered amenable to curative therapy', ' Patients with symptomatic brain metastases or other symptomatic central nervous system (CNS) metastases are not eligible for the study; no screening studies are required among asymptomatic patients; patients with previously treated brain metastases, who are free of symptoms referable to CNS disease and who are > 3 months from treatment for brain metastases are eligible', " Tumors (as determined on pathology from either primary or metastatic sites) must be potentially sensitive to endocrine therapy, defined as expressing estrogen receptor (ER) and/or progesterone receptor (PgR) as determined immunohistochemical methods according to the local institution's standard protocol, >= 1% cells will be considered to be positive", ' The protocol has been amended to permit tumors with any HER2 status, though a determination of HER2 status must have been made; patients will be considered to be eligible if HER2 expression is documented by one of the following methods:', ' Immunohistochemistry (IHC) 0 (i.e., negative), 1+, 2+, or 3+ levels of expression, or', ' Gene amplification (fluorescent in situ hybridization [FISH]) positive or negative', ' Patients must have at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2.0 cm with conventional techniques or as >= 1.0 cm with spiral computed tomography (CT) scan', ' Exception: Patients with lytic or blastic bone metastases as their only site of disease will be eligible for the study even though these patients are not considered to have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria; these patients will be evaluable for time to progression, but not response', ' Patients with all other lesions, including small lesions (longest diameter < 2.0 cm with conventional techniques or < 1.0 cm with spiral CT scan) and truly non-measurable lesions including those listed below are not eligible', ' Lesions that are considered non-measurable include the following:', ' Bone lesions (women with bone lesions will be eligible as described above)', ' Leptomeningeal disease', ' Ascites', ' Pleural/pericardial effusion', ' Inflammatory breast cancer', ' Lymphangitis cutis/pulmonitis', ' Abdominal masses that are not confirmed and followed by imaging techniques', ' Cystic lesions', ' Patients must have had one or two prior endocrine treatments for breast cancer in either the adjuvant or metastatic setting, exclusive of treatment-related amenorrhea or ovarian suppression; sequential use of two different third-generation aromatase inhibitors is considered "one" treatment; it is not required that tumors be resistant to such treatments; for example:', ' A patient with de novo metastatic breast cancer who had never received endocrine therapy is not eligible;', ' A patient who received adjuvant tamoxifen and subsequent therapy with an aromatase inhibitor (adjuvant or metastatic) is eligible;', ' A patient who received an aromatase inhibitor in either the adjuvant or metastatic setting, and who discontinued therapy after several months because of side effects, is eligible;', ' A patient who received an aromatase inhibitor in the adjuvant setting is eligible, regardless of whether they did or did not receive tamoxifen at some point;', ' A patient who received adjuvant tamoxifen, and subsequently a nonsteroidal aromatase inhibitor and a steroidal aromatase inhibitor for advanced breast cancer in the adjuvant or metastatic setting is eligible;', ' A patient who received adjuvant tamoxifen, and then a nonsteroidal aromatase inhibitor and subsequently megesterol acetate for advanced breast cancer is not eligible', ' Tumors potentially sensitive to endocrine therapy, defined as >= 3 months of prior endocrine therapy without disease progression in the adjuvant or metastatic setting', ' Patients must have had prior treatment in either the adjuvant or metastatic setting with a commercially available third-generation aromatase inhibitor (i.e. anastrozole, exemestane, or letrozole); it is not required that tumors be resistant to such therapies', ' Patients may have received up to one prior chemotherapy regimen for stage IV breast cancer; prior chemotherapy in the adjuvant and/or neoadjuvant setting is permitted; patients must have finished chemotherapy at least 1 week prior to starting protocol based treatment', ' Patients may have received prior trastuzumab therapy for stage IV breast cancer, in combination with up to one chemotherapy and/or endocrine therapy regimen, but that must have concluded at least 3 weeks prior to starting protocol-based therapy; prior trastuzumab therapy in the adjuvant and/or neoadjuvant setting is permitted, but must have concluded at least 3 weeks prior to starting protocol-based therapy', ' Prior therapy with commercially available inhibitor of EGFR (including but not limited to gefitinib, erlotinib, lapatinib or cetuximab) or experimental inhibitors of EGFR is prohibited', ' Patients may have initiated bisphosphonate therapy prior to study entry; such patients will have bone lesions considered evaluable for progression but not for response', ' Prior fulvestrant therapy is prohibited', ' Patients receiving a gonadotropin-releasing hormone (GnRH) agonist for ovarian suppression must remain on such therapy throughout the course of protocol treatment; patients must discontinue other endocrine treatments, including systemic hormone-replacement therapy and intravaginal estrogens prior to study entry; patients must have concluded radiation therapy prior to study entry; patients must be at least 1 week from prior chemotherapy or 3 weeks from prior trastuzumab therapy, with adequate recovery of bone marrow function and performance status', ' Patients must be postmenopausal women, defined as a woman fulfilling any of the following criteria:', ' Age >= 60 years; or', ' Age >= 45 years with an intact uterus and amenorrhea for 12 months or more; or', ' History of bilateral oophorectomy; or', ' Follicle stimulating hormone (FSH) levels within postmenopausal range according to the ranges established by the testing facility; or', ' Treatment with a GnRH agonist for ovarian suppression for at least 3 consecutive months prior to study registration, and remaining on such therapy throughout the course of protocol treatment', ' Women who are pregnant or nursing are not eligible for the study; clinicians should advise patients that there are no data for the safety of lapatinib or fulvestrant among pregnant patients, nor data on the impact of these agents on fertility or pregnancy', ' Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-2', ' Absence of pending visceral crisis, in the opinion of the treating physician', ' Absence of acquired or inherited bleeding disorder', ' Absence of need for therapeutic systemic anticoagulation (defined as maintaining international normalized ratio [INR] > 1.6); patients may take low-dose warfarin or aspirin (or equivalent) for maintenance of central venous catheter patency', ' Granulocytes >= 1,000/μl', ' Platelet count >= 100,000/μl', ' Creatinine =< 2 mg/dl', " Total bilirubin =< 1.5 x upper limits of normal (ULN) unless due to Gilbert's syndrome", ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN without liver metastases; =< 5 x ULN with liver metastases', ' INR =< 1.6', ' Left ventricular ejection fraction (LVEF) within institutional limits of normal'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per RECIST criteria).', ' Time frame: Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years', 'Results 1: ', ' Arm/Group Title: Arm I (Lapatinib)', ' Arm/Group Description: Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.', ' Overall Number of Participants Analyzed: 146', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.7 (3.7 to 5.7)', 'Results 2: ', ' Arm/Group Title: Arm II (Placebo)', ' Arm/Group Description: Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.', ' Overall Number of Participants Analyzed: 145', ' Median (95% Confidence Interval)', ' Unit of Measure: months 3.8 (3.8 to 5.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/141 (8.51%)', ' Cardiac pain 1/141 (0.71%)', ' Constipation 1/141 (0.71%)', ' Diarrhea 7/141 (4.96%)', ' Gastrointestinal disorder 0/141 (0.00%)', ' Nausea 5/141 (3.55%)', ' Vomiting 2/141 (1.42%)', ' Chest pain 1/141 (0.71%)', ' Disease progression 1/141 (0.71%)', ' Fatigue 8/141 (5.67%)', ' Gait abnormal 0/141 (0.00%)', ' Injection site reaction 1/141 (0.71%)', ' Pain 1/141 (0.71%)', 'Adverse Events 2:', ' Total: 14/137 (10.22%)', ' Cardiac pain 1/137 (0.73%)', ' Constipation 2/137 (1.46%)', ' Diarrhea 4/137 (2.92%)', ' Gastrointestinal disorder 1/137 (0.73%)', ' Nausea 3/137 (2.19%)', ' Vomiting 1/137 (0.73%)', ' Chest pain 1/137 (0.73%)', ' Disease progression 0/137 (0.00%)', ' Fatigue 5/137 (3.65%)', ' Gait abnormal 1/137 (0.73%)', ' Injection site reaction 0/137 (0.00%)', ' Pain 2/137 (1.46%)']}

{'Clinical Trial ID': 'NCT00558103', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo', ' Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).', 'INTERVENTION 2: ', ' Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg', ' Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.'], 'Eligibility': ['Inclusion criteria:', ' Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact patient eligibility is provided in the pazopanib IB and lapatinib prescribing information (or the lapatinib IB).', ' For Cohort 1 of this study, eligible patients met inclusion criteria outlined in the original version of the protocol and protocol amendment 1.', ' For Cohort 2 of this study, eligible patients must meet all of the following criteria:', ' Patients must have evaluable Inflammatory Breast Cancer (IBC) substantiated by all of the following prior to randomization:', ' History of invasive breast cancer documented by a biopsy and accompanying pathology report', ' Current photographs* (global view and close-up views of all skin lesions) submitted at screening demonstrating unequivocal evidence of IBC as determined by either the medical monitor alone or in consultation with one or more of the study Principal Investigators.', " All patients must have photography at screening. Canfield Scientific Inc. will provide centralized monitoring, tracking, and collection of patients' photographs throughout the study. Screening photographs must be uploaded to the Canfield Scientific Inc website and approved by Canfield Scientific Inc, as the central photography vendor. The photographs, along with the completed Inflammatory Breast Cancer Skin Assessment Tool (IBSAT), must be reviewed and approved by GSK before a patient can be randomized. Sites should allow a minimum of 3 business days for this process. Sites submitting quality photographs and IBSATs on a regular basis will receive an exemption from this requirement for future patients.", ' Patients with secondary IBC are eligible.', ' Measurable lesions (cutaneous or radiographic) may be in the field of prior standard or palliative radiation therapy; however, there must be at least a 4 week period between the last radiation treatment and the baseline scan documenting disease status for the lesion to be measurable. If the irradiated lesion is the only site of disease, documented progression of the irradiated lesion is required.', ' Disease progression or relapse following treatment for invasive breast cancer, which must have included a chemotherapy regimen. In regions where trastuzumab is available with no barriers to access*, patients must have received prior trastuzumab in addition to chemotherapy in order to be eligible. * (Barriers to access may include financial considerations.)', ' Unequivocal ErbB2 overexpressing breast cancer, defined as 3+ staining by immunohistochemistry (IHC), or 2+ staining by IHC in conjunction with ErbB2 gene amplification by FISH/CISH, or ErbB2 gene amplification by FISH/CISH alone (in subjects whose tumor blocks were not assessed by IHC). ErbB2 gene amplification is defined by: > six (6) ErbB2 gene copies/nucleus for test systems without an internal control probe or an ErbB2/CEP 17 ratio of more than 2.2.', ' Sites must submit a copy of the laboratory report demonstrating unequivocal ErbB2 overexpression, if testing performed at a local laboratory, with the screening worksheet. Archived tumor must be provided for all patients for ErbB2 FISH testing by the central laboratory. Patients will remain on study based on local ErbB2 expression results. If archived tumor is not available, a biopsy must be obtained at screening and sent to TMD Laboratories for ErbB2 FISH testing.', " - Patients must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up. Procedures conducted as part of the patient's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.", ' Note: Informed consent may be obtained prior to the protocol-specified screening window (i.e. Day -14 to Day -1).', ' Females age 18 years, except in Tunisia. In Tunisia, patients must be 20 years to be eligible for this study.', ' Adequate organ function as defined below:', ' System (Laboratory Values)', ' Hematologic:Absolute neutrophil count (ANC)( 1.5 X 10^9/L)Hemoglobin1( 9 g/dL)Platelets( 100 X 10^9/L)International normalized ratio (INR)( 1.2 X upper limit of normal (ULN))Partial thromboplastin time (PTT)( 1.2 X ULN)', ' Hepatic:Total bilirubin2 ( 1.5 X upper limit of normal (ULN))AST and ALT( 2.5 X ULN)', ' Renal:Serum Creatinine ( 1.5 mg/dL)Or, if serum creatinine >1.5 mg/dL,', ' Calculated creatinine clearance( 50 mL/min)', ' Urine Protein to Creatinine Ratio(<1)', ' Patients may not have had a transfusion within 7 days of screening assessment.', ' Exception: Patients with elevated bilirubin levels due to Gilberts syndrome are eligible.', ' Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive or where MUGA scans are the accepted standard. Patients with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure are not eligible.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.', ' A female is eligible to enter and participate in this study if she is of:', ' Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:', ' A hysterectomy', ' A bilateral oophorectomy (ovariectomy)', ' A bilateral tubal ligation', ' Is post-menopausal', ' Patients not using hormone replacement therapy (HRT) must have experienced total cessation of menses for 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40 mIU/mL and an estradiol value < 40pg/mL (<140 pmol/L).', ' Patients must discontinue HRT prior to study enrollment due to the potential for inhibition of CYP enzymes that metabolize estrogens and progestins (See Section 8). For most forms of HRT, at least 2-4 weeks must elapse between the cessation of HRT and determination of menopausal status; length of this interval depends on the type and dosage of HRT. If a female patient is determined not to be post-menopausal, they must use adequate contraception, as defined immediately below.', ' Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, has used adequate contraception since the pregnancy test and agrees to use adequate contraception as described below. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:', ' An intrauterine device with a documented failure rate of less than 1% per year.', " Vasectomized partner who is sterile prior to the female patient's entry and is the sole sexual partner for that female.", ' Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product.', ' Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).', ' Note: Oral contraceptives are not reliable due to potential drug drug interactions.', ' Female patients who are lactating should discontinue nursing prior to the first dose of investigational product and should refrain from nursing throughout the treatment period and for 14 days following the last dose of investigational product.', ' - French patients: In France, a patient will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.', 'Exclusion Criteria:', ' Patients meeting any of the following criteria must not be enrolled in the study:', ' Treatment in the 14 days prior to randomization with any cancer therapy (tumor embolization, chemotherapy, immunotherapy, biological therapy, or hormonal therapy) or treatment with mitomycin within 6 weeks prior to randomization. Such treatment may not be resumed or begun after study entry. Note: Patients receiving LH-RH analogue therapy prior to the study may continue to receive LH-RH analogues for the duration of study participation. Bisphosphonates are permitted if started prior to Day 1.', ' Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity (with the exception of alopecia).', ' Prior lapatinib therapy or other Her2/ErbB2 targeted therapy (except trastuzumab).', ' Prior therapy with an anti-VEGF antibody or other VEGF/VEGF-R targeted therapy.', ' Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.', ' Use of any prohibited medication within the timeframes listed in Section 8.1.3', ' History of another malignancy.', ' Note: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible. If subject previously had breast cancer, it must have been HER2+ with either 3+ overexpression by IHC or unequivocal HER2 gene amplification by FISH or CISH.', ' History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 2 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases.', ' Clinically significant gastrointestinal abnormalities that may increase the risk for GI bleeding including, but not limited to:', ' Active peptic ulcer disease', ' Known intraluminal metastatic lesion/s with suspected bleeding', ' Inflammatory bowel disease', ' Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation', ' History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.', ' Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but limited to:', ' Malabsorption syndrome', ' Major resection of the stomach or small bowel.', ' Presence of uncontrolled infection.', ' Prolongation of corrected QT interval (QTc) > 480 msecs.', ' History of any one or more of the following cardiovascular conditions within the past 6 months:', ' Cardiac angioplasty or stenting', ' Myocardial infarction', ' Unstable angina', ' Arterial thrombosis', ' Symptomatic peripheral vascular disease', ' Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) (see Section 15.9 Appendix 9 for description).', ' Poorly controlled hypertension [defined as systolic blood pressure (SBP) of 140mmHg or diastolic blood pressure (DBP) of 90mmHg].', " Note: Initiation or adjustment of antihypertensive medication(s) is permitted during the screening period, in order to control a patient's BP prior to randomization. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour. The mean SBP / DBP values from each blood pressure assessment must be < 140/90mmHg in order for a patient to be eligible for the study. See Section 6.2 and Section 6.4.2 for details on blood pressure control and reassessment prior to study enrollment.", ' History of cerebrovascular accident, including TIA, pulmonary embolism or deep venous thrombosis (DVT).', ' Prior major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (other than ulcers due to inflammatory breast cancer).', ' Evidence of active bleeding or bleeding diathesis.', ' Hemoptysis within 6 weeks prior to first dose of investigational product.', ' Known endobronchial lesions or involvement of large pulmonary vessels by tumor.', " Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety, provision of informed consent, or compliance to study procedures.", ' Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or lapatinib.', " Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)."], 'Results': ['Outcome Measurement: ', ' Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions', ' RECIST-based response assessment was done at Weeks (Wks) 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, CR is the disappearance of all target and non-target lesions; PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.', ' Time frame: Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks', 'Results 1: ', ' Arm/Group Title: Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo', ' Arm/Group Description: Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).', ' Overall Number of Participants Analyzed: 38', ' Measure Type: Number', ' Unit of Measure: participants 11', 'Results 2: ', ' Arm/Group Title: Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg', ' Arm/Group Description: Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.', ' Overall Number of Participants Analyzed: 38', ' Measure Type: Number', ' Unit of Measure: participants 17'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/38 (15.79%)', ' Neutropenia 1/38 (2.63%)', ' Sinus tachycardia 0/38 (0.00%)', ' Bradycardia 0/38 (0.00%)', ' Cardiopulmonary failure 0/38 (0.00%)', ' Vomiting 1/38 (2.63%)', ' Diarrhea 0/38 (0.00%)', ' Nausea 1/38 (2.63%)', ' Abdominal pain 0/38 (0.00%)', ' Pancreatitis 0/38 (0.00%)', ' Sudden death 1/38 (2.63%)', ' Fatigue 0/38 (0.00%)', ' Asthenia 0/38 (0.00%)', ' Hepatotoxicity 0/38 (0.00%)', 'Adverse Events 2:', ' Total: 14/38 (36.84%)', ' Neutropenia 1/38 (2.63%)', ' Sinus tachycardia 0/38 (0.00%)', ' Bradycardia 0/38 (0.00%)', ' Cardiopulmonary failure 0/38 (0.00%)', ' Vomiting 2/38 (5.26%)', ' Diarrhea 2/38 (5.26%)', ' Nausea 0/38 (0.00%)', ' Abdominal pain 0/38 (0.00%)', ' Pancreatitis 0/38 (0.00%)', ' Sudden death 1/38 (2.63%)', ' Fatigue 0/38 (0.00%)', ' Asthenia 0/38 (0.00%)', ' Hepatotoxicity 1/38 (2.63%)']}

e852619c-312a-470f-8b77-149e79f69a3f

Single

Adverse Events

NCT00003830

The most common adverse event in both cohorts of the primary trial was Anaphylaxis, which affected more than 10 patients in total.

Contradiction

{'Clinical Trial ID': 'NCT00003830', 'Intervention': ['INTERVENTION 1: ', ' Arm I:Sentinel Node Resection+Conventional Axillary Dissection', ' Sentinel node resection immediately followed by axillary dissection', ' conventional surgery: Sentinel node resection immediately followed by axillary dissection.', 'INTERVENTION 2: ', ' Arm II: Sentinel Node Resection Followed by Node Examination', ' Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.', ' Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Resectable invasive adenocarcinoma of the breast, confirmed by 1 of the following:', ' Histologically confirmed by core or open biopsy', ' Confirmed by fine needle aspiration cytology AND positive clinical breast examination and ultrasound or mammography', ' Clinically negative lymph nodes', ' No positive ipsilateral axillary lymph nodes', ' No prior removal of ipsilateral axillary lymph nodes', ' No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven nonmalignant by biopsy', " No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude", ' Tethering or dimpling of the skin or nipple inversion allowed', ' No bilateral malignancy or mass in the opposite breast that is suspicious for malignancy, unless proven nonmalignant by biopsy', ' No diffuse tumors or multiple malignant tumors in different quadrants of the breast', ' No other prior breast malignancy except lobular carcinoma in situ', ' No prior or concurrent breast implants', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age:', ' 18 years and older', ' Sex:', ' Female', ' Menopausal status:', ' Not specified', 'Performance status:', ' Not specified', ' Life expectancy:', ' At least 10 years (excluding diagnosis of cancer)', ' Hematopoietic:', ' Not specified', ' Hepatic:', ' No hepatic systemic disease', ' Renal:', ' No renal systemic disease', ' Cardiovascular:', ' No cardiovascular systemic disease', ' Other:', ' No prior malignancy within past 5 years except:', ' Effectively treated squamous cell or basal cell skin cancer', ' Surgically treated carcinoma in situ of the cervix', ' Surgically treated lobular carcinoma in situ of the ipsilateral or contralateral breast', ' No concurrent psychiatric or addictive disorder', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy:', ' No prior immunotherapy for this cancer', ' Chemotherapy:', ' No prior chemotherapy for this cancer, including neoadjuvant chemotherapy', ' Endocrine therapy:', ' No prior hormonal therapy for this cancer', ' Radiotherapy:', ' No prior radiotherapy for this cancer', ' Surgery:', ' See Disease Characteristics', ' No prior breast reduction surgery', ' Prior excisional biopsy or lumpectomy allowed'], 'Results': ['Outcome Measurement: ', ' Morbidity - Number of Participants With Residual Shoulder Abduction Deficit', ' Morbidity as measured by residual shoulder abduction deficit. Shoulder Abduction Deficit definition: Shoulder range of motion decreased by greater than or equal to 10% as compared with that measured prior to surgery.', ' Time frame: Before and after surgery (within 30 days of randomization)', 'Results 1: ', ' Arm/Group Title: Arm I:Sentinel Node Resection+Conventional Axillary Dissection', ' Arm/Group Description: Sentinel node resection immediately followed by axillary dissection', ' conventional surgery: Sentinel node resection immediately followed by axillary dissection.', ' Overall Number of Participants Analyzed: 1449', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 276 19.0%', 'Results 2: ', ' Arm/Group Title: Arm II: Sentinel Node Resection Followed by Node Examination', ' Arm/Group Description: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.', ' Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.', ' Overall Number of Participants Analyzed: 1519', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 200 13.2%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/2788 (0.32%)', ' Anaphylaxis 5/2788 (0.18%)', ' Infections and infestations - Other, specify 2/2788 (0.07%)', ' Nervous system disorders - Other, specify 0/2788 (0.00%)', ' Respiratory, thoracic and mediastinal disorders - Other, specify 1/2788 (0.04%)', ' Thromboembolic event 1/2788 (0.04%)', 'Adverse Events 2:', ' Total: 8/2800 (0.29%)', ' Anaphylaxis 5/2800 (0.18%)', ' Infections and infestations - Other, specify 0/2800 (0.00%)', ' Nervous system disorders - Other, specify 1/2800 (0.04%)', ' Respiratory, thoracic and mediastinal disorders - Other, specify 1/2800 (0.04%)', ' Thromboembolic event 2/2800 (0.07%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

27160f45-e4cb-48be-8cf2-c23ced4578c0

Comparison

Eligibility

NCT00754325

NCT00399529

the secondary trial and the primary trial both accept patients with HER-2/neu-overexpressing adenocarcinoma of the breast.

Entailment

{'Clinical Trial ID': 'NCT00754325', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant and Dasatinib', ' Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.', ' Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.', ' Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years', 'INTERVENTION 2: ', ' Fulvestrant', ' Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.', ' Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.'], 'Eligibility': ['For more information regarding Bristol-Myers Squibb (BMS) clinical trial participation, please visit www.BMSStudyConnect.com.', 'Inclusion Criteria:', ' Histologically confirmed hormone receptor positive (HR+) [(estrogen receptor (ER+) and/or progesterone receptors(PgR+)] breast cancer according to immunohistochemistry (IHC)', ' Measureable or evaluable-only disease', ' human epidermal growth factor receptor 2+ (HER2+) or HER2- breast cancer', ' Males and females 18 years of age', ' Females are post menopausal or surgically sterile', ' Recurrent or progressive advanced breast cancer (locally-advanced or metastatic), that has progressed: (a) during or within 12 months after completion of adjuvant Aromatase Inhibitor (AI) treatment OR (b) during AI treatment in advanced setting (metastatic therapy)', 'Exclusion Criteria:', ' Pregnant or breast feeding', ' >1 chemotherapy regimen for advanced disease', ' Pleural or pericardial effusion', ' Serious cardiac condition'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Disease Progression (PD) or Death', ' This endpoint evaluated the progression free survival (PFS) of participants amongst the total evaluable population. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Participants with no recorded post-baseline tumor assessment had PFS censored at the day of randomization. Participants lost to follow-up were censored at the last date of contact. Participants that had not progressed or died had PFS censored at the date of last follow-up.', ' Time frame: Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)', 'Results 1: ', ' Arm/Group Title: Fulvestrant and Dasatinib', ' Arm/Group Description: Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.', ' Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.', ' Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: participants 35', 'Results 2: ', ' Arm/Group Title: Fulvestrant', ' Arm/Group Description: Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.', ' Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: participants 40'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/50 (28.00%)', ' Angina Pectoris 0/50 (0.00%)', ' Hypertension 1/50 (2.00%)', ' Coagulation Time Increased 0/50 (0.00%)', ' Bowel Obstruction 1/50 (2.00%)', ' Dehydration 0/50 (0.00%)', ' Diarrhea 1/50 (2.00%)', ' Nausea 3/50 (6.00%)', ' Nausea and Vomiting 0/50 (0.00%)', ' Obstruction Bowel 2/50 (4.00%)', ' Vomiting 3/50 (6.00%)', ' Weakness Generalized 0/50 (0.00%)', ' Cholecystitis 1/50 (2.00%)', 'Adverse Events 2:', ' Total: 11/49 (22.45%)', ' Angina Pectoris 1/49 (2.04%)', ' Hypertension 0/49 (0.00%)', ' Coagulation Time Increased 1/49 (2.04%)', ' Bowel Obstruction 0/49 (0.00%)', ' Dehydration 1/49 (2.04%)', ' Diarrhea 0/49 (0.00%)', ' Nausea 0/49 (0.00%)', ' Nausea and Vomiting 1/49 (2.04%)', ' Obstruction Bowel 0/49 (0.00%)', ' Vomiting 0/49 (0.00%)', ' Weakness Generalized 1/49 (2.04%)', ' Cholecystitis 0/49 (0.00%)']}

{'Clinical Trial ID': 'NCT00399529', 'Intervention': ['INTERVENTION 1: ', ' Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide', ' Allogeneic GM-CSF-secreting breast cancer vaccine : the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.', ' Cyclophosphamide : 300 mg/m^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study', ' Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously'], 'Eligibility': ['Inclusion Criteria:', ' Patients with histologically confirmed HER-2/neu-overexpressing adenocarcinoma of the breast; this is defined as HER-2+ by immunohistochemistry (IHC) 3+ staining or Fluorescence In-Situ Hybridization (FISH). Prior adjuvant Trastuzumab therapy is permitted. Patients must not be eligible for therapy of known curative potential for metastatic breast cancer if it is identified during the course of the study.', ' Patients may have measurable or evaluable disease.', ' Stable central nervous system (CNS) disease that has been adequately treated and is not under active treatment allowed.', ' Age 18 years or older.', ' Able to give informed consent.', ' Patients with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.', ' No systemic oral steroids administered within 28 days prior to initiating treatment on protocol. Topical, ocular, and nasal steroids are allowed, as are those applied to mucus membranes.', " No prior or currently active autoimmune disease requiring management with systemic immunosuppression. This includes inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia or immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, sarcoidosis, or other rheumatologic disease. Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable.", ' Not pregnant, and on appropriate birth control if of child-bearing potential.', ' No history of other malignancies within the prior five years (excluding a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancer, and superficial bladder cancer).', ' Adequate bone marrow reserve with absolute neutrophil count (ANC) > 1000 and platelets > 100,000.', ' Adequate renal function with serum creatinine < 2.0.', " Adequate hepatic reserve with serum bilirubin < 2.0, aspartate transaminase (AST) and alanine aminotransferase (ALT) < 2X the upper limit of normal, and alkaline phosphatase < 5X the upper limit of normal. Serum bilirubin > 2.0 is acceptable in the setting of known Gilbert's syndrome.", ' Adequate cardiac reserve with a cardiac ejection fraction within the lower limit of facility normal by MUGA, or 45% by echocardiogram.', ' No active major medical or psychosocial problems that could be complicated by study participation.', ' HIV negative.', 'Exclusion Criteria:', ' No histologic documentation of breast adenocarcinoma.', ' Breast adenocarcinoma that is not amplified for HER-2/neu gene expression by at least 2-fold by FISH analysis, or that is less than IHC 3+ when FISH negative.', ' Cardiac dysfunction documented by an ejection fraction less than the lower limit of the facility normal by multi-gated acquisition (MUGA) scan, or 45% by echocardiogram.', ' Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest.', ' History of autoimmune disease as detailed above.', ' Systemic oral corticosteroid treatment within 28 days prior to initiating treatment on study.', ' Uncontrolled medical problems.', ' Evidence of active acute or chronic infection.', ' Chemotherapy, radiation therapy, or biologic therapy (except Trastuzumab) within 28 days prior to initiating treatment on study. Hormonal therapy and supportive therapy with bisphosphonates will be allowed.', ' Participation in an investigational new drug trial within 28 days prior to initiating treatment on study.', ' Pregnant or breast feeding.', ' Hepatic, renal, or bone marrow dysfunction as detailed above.', ' Concurrent malignancy or history of other malignancy within the last five years except as noted above.', ' Corn allergy.', ' Known severe hypersensitivity to Trastuzumab (excluding mild to moderate infusion reactions that are easily managed and do not recur).'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adverse Events', ' Safety is measured as the number of patients that experienced adverse events related to study drug.', ' Time frame: From first dose through 30 days after last dose of study drug, up to 9 months', 'Results 1: ', ' Arm/Group Title: Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide', ' Arm/Group Description: Allogeneic GM-CSF-secreting breast cancer vaccine : the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.', ' Cyclophosphamide : 300 mg/m^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study', ' Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Fatigue: 8 40.0%', ' Urticaria: 7 35.0%', ' Pruritus: 6 30.0%', ' Fever: 5 25.0%', ' Flu-like symptoms: 4 20.0%', ' Lymphadenopathy: 4 20.0%', ' Abdominal pain: 3 15.0%', ' Rash: 3 15.0%', ' Malaise: 3 15.0%', ' Chills: 3 15.0%', ' Dizziness: 2 10.0%', ' Anorexia: 1 5.0%', ' Erythema: 1 5.0%', ' Headache: 1 5.0%', ' Nausea: 1 5.0%', ' Arm pain: 1 5.0%', ' Cancer site pain: 1 5.0%', ' Leg pain: 1 5.0%', ' Groin tightness: 1 5.0%', ' Erythema at vaccine sites: 20 100.0%', ' Pruritus at vaccine sites: 20 100.0%', ' Induration at vaccine sites: 20 100.0%', ' Pain at vaccine sties: 17 85.0%', ' Rash at vaccine sites: 7 35.0%', ' Blister at vaccine sites: 5 25.0%', ' Hyperpigmentation at vaccine sites: 4 20.0%', ' Bruising at vaccine sites: 3 15.0%', ' Edema at vaccine sites: 2 10.0%', 'Vaccine site flare: 2 10.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/20 (5.00%)', ' Urticaria *1/20 (5.00%)']}

e4b65e9f-10f6-4424-95d2-837e29587a63

Single

Eligibility

NCT01127373

Patients with T1N2M0, T2N1M0, T3N1M1 and TxN1M0 tumors are eliglbe for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01127373', 'Intervention': ['INTERVENTION 1: ', ' Radiation Therapy Via Multi-beam IMRT', ' This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.', ' Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.', ' BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.'], 'Eligibility': ['Inclusion Criteria:', ' Female gender', ' Age 18 years', ' An invasive primary breast cancer of any histology arising from breast parenchyma', ' Patient must be status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection', ' Pathologic confirmation of metastatic disease in at least one regional lymph node. Regional lymph nodes are defined as the ipsilateral axillary lymph nodes, ipsilateral supraclavicular lymph nodes, and ipsilateral internal mammary lymph nodes. Thus, any T stage is allowed as long as the N stage is 1 and M stage is 0.', ' Patient signed study-specific consent form.', 'Exclusion Criteria:', ' Patients with distant metastasis.', ' Patients who are pregnant or breastfeeding.', ' Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.', ' Time between initial diagnosis of breast cancer and start of radiation therapy exceeds 13 months.', " Estimated life expectancy judged to be less than one year by patient's treating radiation oncologist.", ' Prior radiation therapy to the ipsilateral or contralateral breast or thorax.', ' Primary breast cancer is a lymphoma or sarcoma histology.', ' Patients with a history of non-skin malignancy <5 years prior to the diagnosis of breast cancer.', ' Patients requiring radiation to the bilateral breasts.'], 'Results': ['Outcome Measurement: ', ' Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification', ' The purpose of this pilot study is to assess the feasibility of utilizing multi-beam IMRT in the adjuvant treatment of the breast and regional lymph nodes of women with node-positive breast cancer requiring coverage of the internal mammary lymph nodes. A feasibility rate of at least 90% is required, ie, treatment can be successfully planned and delivered for at least 90% of the patients.', ' Time frame: 5 weeks', 'Results 1: ', ' Arm/Group Title: Radiation Therapy Via Multi-beam IMRT', ' Arm/Group Description: This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.', ' Multi-Beam Intensity-Modulated Radiation Therapy: IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.', ' BreastQ questionnaire-: MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.', ' Overall Number of Participants Analyzed: 116', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Discontinued IMRT due to disease progression: 1 0.9%', ' Completed IMRT: 111 95.7%', ' Ineligible: 4 3.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/116 (8.62%)', ' Death not assoc w CTCAE term-Disease prog NOS 1/116 (0.86%)', ' Fever (in the absence of neutropenia) 1/116 (0.86%)', ' Pain - Chest/thorax NOS 1/116 (0.86%)', ' Breast Infection 1/116 (0.86%)', ' Back Pain 1/116 (0.86%)', ' Muscle weakness - Whole body/general 1/116 (0.86%)', ' Pain - Back 1/116 (0.86%)', ' Dysarthria 1/116 (0.86%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

68f6f3db-0bfb-4e03-8e2f-92ae5d0f55a1

Single

Results

NCT01432886

One of the patients in cohort 2 of the primary trial experienced neutropenia persisting for more than 7 days.

Contradiction

{'Clinical Trial ID': 'NCT01432886', 'Intervention': ['INTERVENTION 1: ', ' E7389 With Weekly Trastuzumab', ' Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.', 'INTERVENTION 2: ', ' E7389 With Tri-weekly Trastuzumab', ' Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.'], 'Eligibility': ['Inclusion Criteria', ' Females aged greater than or equal to 20 years and less than 75 years at the time of informed consent.', ' Histologically or cytologically confirmed with breast cancer', ' Score 3+ by immunohistochemistry (IHC) or HER2 positive by Fluorescence in Situ Hybridization (FISH) method', ' Subjects who meet any of the following criteria:', ' Evidence of recurrence during adjuvant chemotherapy with trastuzumab and taxane', ' Evidence of recurrence within 6 months after adjuvant chemotherapy with trastuzumab and taxane', ' Experienced prior chemotherapy including trastuzumab and taxane for advanced or recurrent breast cancer', ' Adequate organ function', ' Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) is 0 or 1', ' Subjects who have submitted written informed consent for study entry', ' Exclusion Criteria', ' Subjects with known brain metastasis accompanied by clinical symptoms or requiring active treatment', ' Subjects with severe active infection requiring active treatment', ' Subjects with large pleural effusions, ascites, or pericardial effusions requiring drainage.', ' Hypersensitivity to trastuzumab, halicondrin B or halicondrin B chemical derivatives', ' Known positive for human immunodeficiency virus (HIV) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV) by serum test.', ' Subjects who are pregnant (positive B-hCG test) or breastfeeding', ' Subjects judged to be ineligible for this study by the principal investigator or sub-investigator.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicity (DLT)', ' For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.', ' Time frame: Up to 3 weeks', 'Results 1: ', ' Arm/Group Title: E7389 With Weekly Trastuzumab', ' Arm/Group Description: Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: Participants 0', 'Results 2: ', ' Arm/Group Title: E7389 With Tri-weekly Trastuzumab', ' Arm/Group Description: Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: Participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 0/6 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

7796fe1b-1952-4339-90f3-47b051ebe927

Comparison

Adverse Events

NCT01086605

NCT00570921

the primary trial and the secondary trial do not record any of the same adverse events.

Entailment

{'Clinical Trial ID': 'NCT01086605', 'Intervention': ['INTERVENTION 1: ', ' Arm I/Group A (Pixantrone IV Day 1)', ' Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Arm II/Group B (Pixantrone IV Days 1, 8, and 15)', ' Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Registration and Randomization - Inclusion Criteria', ' Women or men', ' 18 years of age', ' Histologically or cytologically confirmed adenocarcinoma of the breast and clinical evidence of metastatic breast cancer.', ' Pre-treatment requirements:', ' 4.1. Must have been previously treated in neoadjuvant, adjuvant or metastatic setting with anthracycline and/or taxane.', ' 4.2. Must have received 2-3 prior chemotherapy treatment regimens NOTE: If NO prior (neo)adjuvant chemotherapy, patient must have received a minimum of 2 prior chemotherapy regimens in the metastatic setting.', ' 4.2.1 NOTE: If prior (neo)adjuvant chemotherapy HAS been given, patient must have received at least 1 prior chemotherapy regimen in the metastatic setting.', ' 4.3. Prior hormonal therapy allowed in the neo-adjuvant, adjuvant, or metastatic setting.', ' Unlimited prior hormonal therapy is allowed.', ' Patients must have measurable disease as defined in the protocol.', ' Negative pregnancy test done 7 days prior to registration, for women of childbearing potential only.', ' The following laboratory values obtained 15 days prior to registration.', ' 7.1 Hemoglobin 10.0g/dL', ' 7.2 ANC 1500/mm^3', ' 7.3 Platelet count 100,000/mL', ' 7.4 Total bilirubin 1.5 x ULN)', ' 7.5 SGOT (AST) and SGPT (ALT) 5 x ULN', ' 7.6 Serum creatinine 1.5 x ULN', ' LVEF 50% and EKG within institutional normal limits completed 22 days prior to registration.', ' ECOG Performance Status (PS) of 0, 1 or 2.', ' Life expectancy >3 months', ' Ability to complete questionnaire(s) by themselves or with assistance.', ' Patient has provided written informed consent', ' Willingness to return to NCCTG enrolling institution for follow-up.', ' Registration and Randomization - Exclusion Criteria', ' Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.', ' 1.1 Pregnant women', ' 1.2 Nursing women', ' 1.3 Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician)', ' Stage III or IV invasive cancer (other than breast cancer) in 3 years prior to registration (with the exception of non-melanoma skin cancer).', ' HER2 positive breast cancer (3+ by IHC or FISH amplified) breast cancer by ASCO/CAP guidelines', ' Has already received lifetime cumulative treatment with doxorubicin equivalent to >400 mg/m2.', ' >3 prior chemotherapy regimens for breast cancer.', ' 5.1 NOTE: This number includes (neo)adjuvant chemotherapy, if given. If (neo)adjuvant chemotherapy HAS been given it counts as one (1) regimen.', ' Major surgery, chemotherapy, or immunologic therapy 3 weeks prior to registration.', ' 6.1 NOTE: If patient has received prior treatment with bevacizumab, treatment on this trial should not begin until 4 weeks after the last dose of bevacizumab.', ' Radiotherapy 4 weeks prior to registration, except if to a non-target lesion only.', ' 7.1 Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.', ' 7.2 If patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting.', ' 7.3 Acute adverse events from radiation must have resolved to Grade 1 (according to current version of NCI CTCAE).', ' Evidence of active brain metastasis including leptomeningeal involvement.', ' 8.1 CNS metastasis controlled by prior surgery and/or radiotherapy is allowed. To be considered controlled, there must be at least 2 months of no symptoms or evidence of progression prior to study entry and corticosteroid therapy given to control brain edema must have been discontinued.', ' Uncontrolled hypertension (blood pressure [BP] >160/90mmHg on 2 occasions at least 5 minutes apart). (Patients who have recently started or adjusted anti-hypertensive medications are eligible providing that BP is <140/90mmHg on any new regimen for 3 different observations in 14 days.).', ' Clinically significant cardiovascular or cerebrovascular disease, including any history of the following at any time prior to registration:', ' 10.1 Myocardial infarction', ' 10.2 Unstable angina pectoris', ' 10.3 New York Heart Association (NYHA) Class II or greater congestive heart failure', ' 10.4. Uncontrolled or clinically significant cardiac arrhythmia (patients with controlled atrial fibrillation are eligible)', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.', ' Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.', ' History of allergy or hypersensitivity to drug product excipients or agents chemically similar to pixantrone.', ' Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered.', ' 14.1 Patient may not enroll in such clinical trials while participating in this study.', ' Exception may be granted for trials related to symptom management (Cancer Control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this trial.'], 'Results': ['Outcome Measurement: ', ' Proportion of Confirmed Tumor Responses (Complete or Partial Response)', ' The proportion of confirmed responses will be estimated by the number of women who achieve a CR or PR on two consecutive evaluations at least 6-8 weeks apart depending on the dose level. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients at each dose level. Confidence intervals for the true success proportion at each dose level will be calculated according to the approach of Duffy and Santner. Response will be evaluated in this study using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1); Complete Response (CR): Disappearance of all non-nodal target lesions, each target lymph node must have reduction in short axis to <1.0 cm. and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axis of the target lymph nodes taking as reference the Baseline Sum of Diameters.', ' Time frame: Up to 5 years', 'Results 1: ', ' Arm/Group Title: Arm I/Group A (Pixantrone IV Day 1)', ' Arm/Group Description: Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 24', ' Measure Type: Number', ' Unit of Measure: proportion 0.08 (0.01 to 0.27)', 'Results 2: ', ' Arm/Group Title: Arm II/Group B (Pixantrone IV Days 1, 8, and 15)', ' Arm/Group Description: Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 22', ' Measure Type: Number', ' Unit of Measure: proportion 0.05 (0 to 0.24)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/24 (12.50%)', ' Disseminated intravascular coagulation 0/24 (0.00%)', ' Death NOS 0/24 (0.00%)', ' Edema limbs 0/24 (0.00%)', ' Fatigue 0/24 (0.00%)', ' Hepatic failure 1/24 (4.17%)', ' Alanine aminotransferase increased 1/24 (4.17%)', ' Aspartate aminotransferase increased 1/24 (4.17%)', ' Blood bilirubin increased 0/24 (0.00%)', ' Ejection fraction decreased 1/24 (4.17%)', 'Adverse Events 2:', ' Total: 9/22 (40.91%)', ' Disseminated intravascular coagulation 1/22 (4.55%)', ' Death NOS 1/22 (4.55%)', ' Edema limbs 1/22 (4.55%)', ' Fatigue 1/22 (4.55%)', ' Hepatic failure 0/22 (0.00%)', ' Alanine aminotransferase increased 0/22 (0.00%)', ' Aspartate aminotransferase increased 1/22 (4.55%)', ' Blood bilirubin increased 1/22 (4.55%)', ' Ejection fraction decreased 1/22 (4.55%)']}

{'Clinical Trial ID': 'NCT00570921', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant + Everolimus', ' Fulvestrant + Everolimus', ' Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses-one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal status, defined as any one of the following criteria: Documented history of bilateral oophorectomy, Age 60 years or more, OR Age 45 to 59 and satisfying one or more of the following criteria: Amenorrhea for at least 12 months and intact uterus OR Amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) concentration - within postmenopausal range including: Patients who have had a hysterectomy or Patients who have received hormone replacement', ' Patients must have histologically confirmed invasive breast cancer', ' Metastatic or locally advanced disease', ' Patients must have estrogen receptor and/or progesterone receptor positive disease', ' Measurable or evaluable disease', ' Failure of aromatase inhibitor therapy within the previous 6 months. Patients who received prior tamoxifen are eligible to enroll', ' Prior aromatase inhibitor therapy or other endocrine therapy must be discontinued at least 1 week prior to enrollment and any toxicity from such therapy must have reverted to grade I or less at the time of enrollment', ' Patients must not have received chemotherapy, radiation therapy, or had surgery within 4 weeks prior to enrollment and any toxicity from such therapy must have recovered to grade 1 or less prior to enrollment', ' Patients must not have received either of the study medications previously', ' WHO performance status of 0, 1, or 2', ' Adequate organ function defined as follows: Adequate renal function, defined by a serum creatinine within the upper limits of normal, Adequate liver function, defined by a bilirubin of < 1.5 the upper limit of normal (ULN) and aspartate aminotransferase (AST), alanine aminotransferase (ALT) of 2.5 times the ULN, Adequate bone marrow function, defined as an absolute neutrophil count (ANC) 1.5 x 109/L, platelet count (PLT) >100,000/ul, Hb >9 gm/dl, international normalized ratio (INR) <1.3, and because fulvestrant is administered intramuscularly, it should not be used in patients with bleeding diatheses, thrombocytopenia or in patients on anticoagulants', ' Patients will be asked to provide a tumor paraffin block if available', ' Ability to understand and sign a written informed consent for participation in the trial', 'Exclusion Criteria:', ' Known severe hypersensitivity to everolimus (or similar drugs) or any of the excipients of this product', ' Premenopausal status', ' Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ', ' Patients with brain metastasis or leptomeningeal involvement', ' Patients with malignant pleural effusion or ascites only disease', ' Rapidly progressive visceral disease', ' WHO performance status of 3 or 4', ' As judged by the investigator, uncontrolled intercurrent illness including, but not limited to: Ongoing or active infection, Symptomatic congestive heart failure, Unstable angina pectoris or significant cardiac arrhythmia, Psychiatric illness/social situations that would limit compliance with study requirements, Severely impaired lung function such as severe chronic obstructive pulmonary disease (COPD) or interstitial lung disease, a known forced expiratory volume at one second (FEV1) of < 1.5 liters, or dyspnea of grade III or greater, Uncontrolled diabetes as defined by a fasting blood sugar (FBS) of > 1.5 ULM, Known liver disease such as cirrhosis or chronic hepatitis, Known HIV positivity, OR known condition causing malabsorption', ' Chronic treatment with systemic steroids or other immunosuppressive agents', ' Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period', ' Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial', ' Prior treatment with an mTOR inhibitor', ' Treatment with a non-approved or investigational drug within 30 days or 5 half-lives of the drug, whichever is greater, before Day 1 of study treatment', ' In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that would preclude intramuscular injections', ' History of hypersensitivity to castor oil'], 'Results': ['Outcome Measurement: ', ' Time to Progression', ' [Not Specified]', ' Time frame: Duration of time start of treatment to time of documented progression or death', 'Results 1: ', ' Arm/Group Title: Fulvestrant + Everolimus', ' Arm/Group Description: Fulvestrant + Everolimus', ' Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses-one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that.', ' Overall Number of Participants Analyzed: 31', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.4 (1.9 to 12.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/33 (15.15%)', ' Left Ventricular Thrombus * 1/33 (3.03%)', ' Nausea * 1/33 (3.03%)', ' Acute Cholecystitis * 1/33 (3.03%)', ' Renal Failure * 1/33 (3.03%)', ' Pneumonia * 1/33 (3.03%)']}

c7df7b38-068b-48a8-b805-b8ebb3e854e6

Single

Eligibility

NCT00945061

patients with Multi-focal breast cancer cannot be accepted for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00945061', 'Intervention': ['INTERVENTION 1: ', ' Intraoperative Radiation Therapy', ' Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.', 'INTERVENTION 2: ', ' Intracavitary Balloon Brachytherapy', ' Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.'], 'Eligibility': ['Inclusion Criteria:', " Patients' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.", ' Lesion size 3 cm treated with a tylectomy and whole breast irradiation (with or without tumor bed boost)', ' Unifocal breast cancer recurrence', ' Negative resection margins with at least a 2 mm margin from invasive and in situ cancer or a negative re-excision', ' Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered first and chemotherapy must begin no earlier than two weeks following completion of radiation.', ' Signed study-specific informed consent prior to study entry.', 'Exclusion Criteria:', ' Patients with distant metastatic disease', ' Patients with invasive lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or nonepithelial breast malignancies such as lymphoma or sarcoma.', ' Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.', ' Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25% of the invasive tumor is Ductal carcinoma in situ (DCIS) and DCIS present in adjacent breast tissue. Presence of an EIC increases the chance of local recurrence, and as such, one might not be a candidate for repeat breast conservation.', " Patients with Paget's disease of the nipple.", ' Patients with skin involvement.', ' Patients with collagen vascular disorders, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.', ' Patients with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.', ' Other malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study.', ' Patients who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.', ' Patients with known BReast CAncer gene (BRCA)1/BRCA 2 mutations.'], 'Results': ['Outcome Measurement: ', ' Ipsilateral Breast Tumor Recurrence Rates', ' Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.', ' Time frame: 1 month after radiation therapy (RT)', 'Results 1: ', ' Arm/Group Title: Intraoperative Radiation Therapy', ' Arm/Group Description: Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0', 'Results 2: ', ' Arm/Group Title: Intracavitary Balloon Brachytherapy', ' Arm/Group Description: Patients undergo partial breast irradiation delivered as MammoSite brachytherapy consisting of 10 fractions over 5 days.', ' Overall Number of Participants Analyzed: 1', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/12 (0.00%)', 'Adverse Events 2:', ' Total: ']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

39227bbb-0e26-4ba0-94a7-762376541889

Comparison

Intervention

NCT03283553

NCT02679755

the primary trial and the secondary trial have a different number of cohorts.

Contradiction

{'Clinical Trial ID': 'NCT03283553', 'Intervention': ['INTERVENTION 1: ', ' Multicomponent Intervention', " 1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.", 'INTERVENTION 2: ', ' Usual Care', ' Care as usual with the medical oncologist.'], 'Eligibility': ['Inclusion Criteria:', ' Medical oncology patient: Established patient of participating medical oncologist greater than 18 years of age, have a diagnosis of early stage or advanced breast cancer, are receiving active systemic therapy (in the form of IV adjuvant systemic therapy if early stage), are English speaking, able to provide informed consent themselves, and identify a family member who they would like to include in their care.', ' Care partner: Family member (e.g. spouse, adult child, parent, adult sibling or other relative) or unpaid friend who regularly accompanies patient to medical oncology visits.', ' Medical oncology provider: Practicing medical oncology provider at a participating clinic who provides care to patients with breast cancer.', 'Exclusion Criteria:', ' Medical oncology patients: Younger than 18 years, pregnant, not being treated for breast cancer, do not attend medical oncology visits with family member or unpaid friend or unwilling for their family member or unpaid friend to be contacted.', ' Care partner: Paid non-family member who accompanies patient to visits.'], 'Results': ['Outcome Measurement: ', ' Between-group Differences in Patient Complete Illness Understanding at 9-months', ' Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life. We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.', ' Time frame: 9 months', 'Results 1: ', ' Arm/Group Title: Multicomponent Intervention', " Arm/Group Description: 1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.", ' Overall Number of Participants Analyzed: 63', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Illness Understanding at 9-Months: 42 66.7%', ' Not Complete Illness Understanding at 9-Months: 21 33.3%', 'Results 2: ', ' Arm/Group Title: Usual Care', ' Arm/Group Description: Care as usual with the medical oncologist.', ' Overall Number of Participants Analyzed: 55', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Illness Understanding at 9-Months: 38 69.1%', ' Not Complete Illness Understanding at 9-Months: 17 30.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/69 (0.00%)', 'Adverse Events 2:', ' Total: 0/63 (0.00%)']}

{'Clinical Trial ID': 'NCT02679755', 'Intervention': ['INTERVENTION 1: ', ' Palbociclib+Letrozole India Cohort', ' Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information', 'INTERVENTION 2: ', ' Palbociclib+Letrozole Australia Cohort', ' Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information'], 'Eligibility': ['Inclusion Criteria:', ' Post-menopausal women (>=18 years of age) with proven diagnosis of advanced carcinoma of the breast (ER(+) and/or PgR(+) and HER2(-)) who are appropriate for letrozole therapy (in the first-line advanced/metastatic disease setting).', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2.', ' Adequate bone marrow, liver, and renal function.', 'Exclusion Criteria:', ' Prior treatment with any CDK inhibitor .', ' QTc >480 msec; history of QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.', ' High cardiovascular risk, including, but not limited to myocardial infarction, severe/unstable angina, severe cardiac dysrhythmias, and symptomatic pulmonary embolism in the past 6 months of enrollment.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Treatment-Emergent Adverse Events (All Causalities)', ' An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as treatment emergent adverse events (TEAEs). AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.', ' Time frame: Baseline up to 28 days after last dose of study treatment, an average of 14 months', 'Results 1: ', ' Arm/Group Title: Palbociclib+Letrozole India Cohort', ' Arm/Group Description: Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information', ' Overall Number of Participants Analyzed: 100', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Participants with adverse events: 92 92.0%', ' Participants with serious adverse events: 18 18.0%', ' Participants with grade 3 or 4 adverse events: 69 69.0%', ' Participants with grade 5 adverse events: 3 3.0%', ' Participants discontinued due to adverse events: 2 2.0%', 'Results 2: ', ' Arm/Group Title: Palbociclib+Letrozole Australia Cohort', ' Arm/Group Description: Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information', ' Overall Number of Participants Analyzed: 152', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Participants with adverse events: 152 100.0%', ' Participants with serious adverse events: 45 29.6%', ' Participants with grade 3 or 4 adverse events: 124 81.6%', ' Participants with grade 5 adverse events: 7 4.6%', ' Participants discontinued due to adverse events: 9 5.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/100 (18.00%)', ' Anaemia * 4/100 (4.00%)', ' Febrile neutropenia * 3/100 (3.00%)', ' Neutropenia * 1/100 (1.00%)', ' Pancytopenia * 0/100 (0.00%)', ' Thrombocytopenia * 1/100 (1.00%)', ' Acute coronary syndrome * 1/100 (1.00%)', ' Stress cardiomyopathy * 0/100 (0.00%)', ' Abdominal pain * 0/100 (0.00%)', ' Abdominal pain upper * 0/100 (0.00%)', ' Ascites * 1/100 (1.00%)', 'Adverse Events 2:', ' Total: 45/152 (29.61%)', ' Anaemia * 0/152 (0.00%)', ' Febrile neutropenia * 3/152 (1.97%)', ' Neutropenia * 1/152 (0.66%)', ' Pancytopenia * 1/152 (0.66%)', ' Thrombocytopenia * 0/152 (0.00%)', ' Acute coronary syndrome * 0/152 (0.00%)', ' Stress cardiomyopathy * 1/152 (0.66%)', ' Abdominal pain * 2/152 (1.32%)', ' Abdominal pain upper * 2/152 (1.32%)', ' Ascites * 0/152 (0.00%)']}

fdb7afc0-ef7e-44bf-bfe3-5252fa8b0106

Single

Eligibility

NCT02321527

Patients with invasive breast cancer with a diameter of more than 70mm are included in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT02321527', 'Intervention': ['INTERVENTION 1: ', ' CEUS Sentinel Lymph Node Imaging + Guided Biopsy', ' Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.'], 'Eligibility': ['Inclusion Criteria:', ' 18 years or older.', ' Ipsilateral biopsy-proven invasive breast cancer <5 cm in maximal dimension by Ultrasound or Mammography.', ' No abnormal axillary nodes identified on grayscale AUS, or abnormal nodes with benign subsequent FNA biopsy.', 'Exclusion Criteria:', ' Pregnant or nursing women', ' Prior SLN dissection', ' Neoadjuvant chemotherapy.', ' Prior axillary lymph node surgery.', ' Prior history of ipsilateral breast cancer.', 'Known or suspected: Cardiac shunts', 'Known or suspected: hypersensitivity to perflutren, blood, blood products or albumin', 'Known or suspected: hypersensitivity to a prior OPTISON administration'], 'Results': ['Outcome Measurement: ', ' Number of Breast Cancer Participants With Sentinel Lymph Nodes (SLN) Identification Using the CEUS Technique', ' Following the Microbubble CEUS of ipsilateral axillary nodes, needle biopsy and I-125 seed placement, a single node/participant (biopsied node) will be included in the statistical evaluation. The technique determined as technically feasible if an enhancing node is visualized in at least 90% of the subjects and 80% concordance is achieved between imaging-guided biopsy and final surgical histopathology. If no enhancement is identified, the overlying skin will be massaged, and re-injection of contrast will be employed up to three times. If no contrast enhancement in lymphatics is observed, the case will be reported as a failure of the CEUS technique.', 'Time frame: 1 day', 'Results 1: ', ' Arm/Group Title: CEUS Sentinel Lymph Node Imaging + Guided Biopsy', ' Arm/Group Description: Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 20 95.2%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/21 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

fd15ddaf-1abc-4551-a5b3-08217b975e36

Comparison

Results

NCT00054132

NCT01421017

As the primary trial and the secondary trial use very similar outcome metrics, we can easily compare and contrast across their results.

Contradiction

{'Clinical Trial ID': 'NCT00054132', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Erlotinib Hydrochloride, Bevacizumab)', ' Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed carcinoma of the breast with metastatic (stage IV) disease that is currently stable or progressing after therapy', ' Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan', ' Patients must have either stable disease or disease progression on or after therapy with one or two conventional chemotherapy regimens for the treatment of metastatic (stage IV) breast cancer', ' Prior treatment with high-dose chemotherapy and autologous stem cell/bone marrow transplantation is allowed, and is considered one prior regimen when administered for metastatic disease', ' There is no restriction for the number of prior hormonal therapies or immunotherapies', ' If human epidermal growth factor receptor 2 (Her2)/neu-positive (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescence in situ hybridization [FISH]), prior therapy with trastuzumab required', ' Any number of prior regimens of chemotherapy and/or hormonal therapy are allowed in the adjuvant setting, and do not count towards prior therapy when determining eligibility for this trial', ' Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)', ' Life expectancy of greater than 3 months', ' Leukocytes >= 3,000/ul', ' Absolute neutrophil count >= 1,000/ul', ' Platelets >= 75,000/ul', ' Total bilirubin within normal institutional limits', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT[) =< 2.5 X institutional upper limit of normal', ' Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min for patients with creatinine levels outside institutional normal using the Cockcroft-Gault formula', ' Women of childbearing potential must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately', ' Patients must have breast cancer tissue available as either paraffin blocks or unstained slides for planned correlative science sub study', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Patients who have had chemotherapy, radiotherapy immunotherapy or investigational therapy within 3 weeks prior to starting treatment (6 weeks for nitrosoureas or mitomycin C), or hormonal therapy within 2 weeks prior to starting treatment', ' Patients may not be receiving any other investigational agents', ' History or evidence upon physical examination of central nervous system (CNS) disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke); all subjects must have a baseline CT or magnetic resonance imaging (MRI) of the head', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774 or bevacizumab', ' Prior treatment with kinase insert domain receptor (KDR) inhibitors (e.g. vascular endothelial growth factor [VEGF] Trap, Su5416, Su6668, ZD6474, PTK757, IMC-1CII)', ' Prior treatment with EGFR targeting therapies (e.g. ZD1839 or C225)', ' Major surgery, open biopsy or significant traumatic injury occurring within 28 days prior to treatment; this does not apply to indwelling catheters, which require an interval of at least 24 hours between placement of the catheter and treatment with bevacizumab', ' Current or recent (within 10 days prior to treatment) use of full-dose oral or parenteral anticoagulants or thrombolytic agents (except as required to maintain patency of preexisting, permanent indwelling IV catheters; for subjects receiving warfarin, international normalized ratio [INR] should be < 1.5)', ' Chronic daily treatment with aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit the platelet function (e.g. cyclooxygenase [COX]-1 inhibitors)', ' Presence of bleeding diathesis or coagulopathy', ' Cumulative anthracycline and anthracenedione exposure as follows: doxorubicin > 450 mg/m^2; epirubicin > 700 mg/m^2; liposomal doxorubicin > 550 mg/m^2; mitoxantrone > 140 mg/m^2', ' Proteinuria at baseline; subjects unexpectedly discovered to have >= 1+ proteinuria should undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate =< 500 mg protein/ 24 hours to allow participation in the study', ' Cardiac ejection fraction (multigated acquisition scan [MUGA] or echocardiogram) less than the local institution lower limit of normal', " Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjögren's syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test)", ' Serious, non-healing wound, ulcer, or bone fracture', ' Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease within 1 year prior to day 0', ' Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, or prior surgical procedures affecting absorption', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with OSI-774', ' Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study', ' Patients with recent (within 6 months) arterial thrombotic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, myocardial infarction (MI), or clinically significant peripheral artery disease'], 'Results': ['Outcome Measurement: ', ' Level of EGFR Expression', ' Estimated at the end of the trial Immunoreactivity will be evaluated qualitatively with regard to intensity as follows: Measured on a scale, ranging from 0-3+ 0=negative (no immunoreactivity)', '1+ - 3+ = positive:', ' faint immunoreactivity (weak staining)', ' intense immunoreactivity (strong staining) Immunohistochemical studies will be performed on the tumor specimen to correlate the anti-tumor efficacy of OSI-774 and bevacizumab with pre-treatment molecular characteristics.', ' Time frame: Up to 12 years', 'Results 1: ', ' Arm/Group Title: Treatment (Erlotinib Hydrochloride, Bevacizumab)', ' Arm/Group Description: Patients receive erlotinib hydrochloride PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 38', ' Measure Type: Number', ' Unit of Measure: participants EGFR 0: 24', 'EGFR 1+: 8', 'EGFR 2+: 4', ' EGFR 3+: 0', ' Insufficient tumor tissue: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/38 (15.79%)', ' Diarrhea 1/38 (2.63%)', ' General disorders and administration site conditions-other, specify 2/38 (5.26%)', ' Pain, other 1/38 (2.63%)', ' Dehydration 1/38 (2.63%)', ' Peripheral motor neuropathy 1/38 (2.63%)', ' Dyspnea 1/38 (2.63%)', ' Pleural effusion 1/38 (2.63%)', ' Skin ulceration 1/38 (2.63%)', ' Thrombosis 1/38 (2.63%)']}

{'Clinical Trial ID': 'NCT01421017', 'Intervention': ['INTERVENTION 1: ', ' IMQ+RT', ' This arm has been closed as of 6/4/2014.', ' Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)', ' Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.', ' Week 9: response assessment', ' Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.', ' Radiation', 'Imiquimod', 'INTERVENTION 2: ', ' CTX/IMQ/RT', ' Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion', ' Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)', ' Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.', ' Week 9: response assessment', ' Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.', ' Radiation', ' Imiquimod', 'Cyclophosphamide'], 'Eligibility': ['Inclusion Criteria:', ' Patients with biopsy-confirmed breast cancer.', ' Patients with at least measurable skin metastases and distant, measurable metastases (outside of skin) by Response Evaluation Criteria in Solid Tumors (RECIST). For patients without distant measurable metastases, an area of the skin metastases designated to not receive local therapy can be substituted. Patients with multiple (>= 2) metastatic sites (skin involvement not required), with at least one site measurable by RECIST, will be eligible for the CTX/RT cohort.', ' Age >= 18 years.', ' Eastern Cooperative Oncology Group performance status 0-2.', ' Patients must agree to tumor fine-needle aspiration required by protocol.', ' Concurrent systemic cancer therapy (hormones, biologics or chemotherapy) can be continued if distant metastases are non-responsive (i.e. no complete response or partial response) on that regimen for >= 8 weeks as assessed by the investigator.', ' Patients must have adequate organ and bone marrow function as defined below:', ' absolute neutrophil count >= 1,300/microliter', ' hemoglobin >= 9.0 grams/deciliter', ' platelets >= 75,000/microliter', ' total bilirubin =< 1.5 X institutional upper limit of normal', ' AST (aspartate aminotransferase) =< 2.5 X institutional upper limit of normal', ' ALT (alanine aminotransferase) =< 2.5 X institutional upper limit of normal', ' creatinine =< 2 X institutional upper limit of normal if patient has chronic renal insufficiency and creatinine has been stable for > 4 months)', ' Informed consent.', 'Exclusion Criteria:', ' Brain metastases unless resected or irradiated and stable >= 4 weeks.', ' Concurrent treatment with other investigational agents.', ' Patients who have received any local therapy (radiotherapy, high-potency corticosteroids, intralesional therapy, laser therapy or surgery) other than biopsy to the target area within 4 weeks prior to first dosing of study agent.', ' Patients who have received hyperthermia to the target area within 10 weeks prior to first dosing of study agent.', ' Patients with an uncontrolled bleeding disorder.', ' Patients (with skin metastases only) who will be therapeutically anticoagulated with heparins or coumadin at the time of the biopsy (they are eligible if anticoagulation can be held prior to biopsy as per investigator). Patients on aspirin and other platelet agents are eligible.', ' Patients with known immunodeficiency or receiving immunosuppressive therapies.', ' History of allergic reactions to imiquimod or its excipients.', ' Uncontrolled intercurrent medical illness or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnancy or lactation.', ' Women of childbearing potential not using a medically acceptable means of contraception.'], 'Results': ['Outcome Measurement: ', ' Systemic Tumor Response Rates (Complete Response+Partial Response)', ' The systemic tumor response refers to the response at the time of best overall response. The response criteria are specially adapted from Response Evaluation Criteria in Solid Tumor for Immunotherapies (Wolchok, et al., 2009).', ' Time frame: 9 weeks from the start of the treatment of RT', 'Results 1: ', ' Arm/Group Title: IMQ+RT', ' Arm/Group Description: This arm has been closed as of 6/4/2014.', ' Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)', ' Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.', ' Week 9: response assessment', ' Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.', ' Radiation', ' Imiquimod', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: proportion of tumors .25 (.06 to .57)', 'Results 2: ', ' Arm/Group Title: CTX/IMQ/RT', ' Arm/Group Description: Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion', ' Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)', ' Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.', ' Week 9: response assessment', ' Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.', ' Radiation', ' Imiquimod', ' Cyclophosphamide', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: proportion of tumors .083 (.002 to .38)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/12 (16.67%)', ' Blurred Vision *0/12 (0.00%)', ' Breast Pain *1/12 (8.33%)', ' Fever *1/12 (8.33%)', ' Tumor Pain *2/12 (16.67%)', ' Headache *0/12 (0.00%)', ' Pain in extremity *0/12 (0.00%)', ' Breast Infection *1/12 (8.33%)', ' Skin Infection *1/12 (8.33%)', ' Neosplasms Benign *1/12 (8.33%)', ' Dysarthria *0/12 (0.00%)', ' Pleural Effusion *0/12 (0.00%)', 'Adverse Events 2:', ' Total: 3/12 (25.00%)', ' Blurred Vision *0/12 (0.00%)', ' Breast Pain *0/12 (0.00%)', ' Fever *0/12 (0.00%)', ' Tumor Pain *0/12 (0.00%)', ' Headache *1/12 (8.33%)', ' Pain in extremity *1/12 (8.33%)', ' Breast Infection *0/12 (0.00%)', ' Skin Infection *1/12 (8.33%)', ' Neosplasms Benign *0/12 (0.00%)', ' Dysarthria *1/12 (8.33%)', ' Pleural Effusion *1/12 (8.33%)']}

067f4671-0720-4980-a0fa-8d01d31daa9a

Comparison

Adverse Events

NCT02366130

NCT01262027

the primary trial reported more than 10 times the number of patients experiencing adverse events as the secondary trial .

Contradiction

{'Clinical Trial ID': 'NCT02366130', 'Intervention': ['INTERVENTION 1: ', ' Ra-223 Dichloride + Denosumab', ' Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.', ' Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.', ' A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.', ' Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.', ' Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.', ' Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.'], 'Eligibility': ['Inclusion Criteria:', ' Stage IV breast cancer with metastases to the bone and/or bone marrow.', ' Pathological or radiographically confirmation of metastases to the bone and/or bone marrow. (The definition of radiologic diagnosis of bone metastasis is based on typical and highly reliable imaging findings in studies such as bone scan (new or multiple TC99m positive lesions), PET/CT (new or multiple FRG positive lesions), and MRI (typical T1w replacement, T2w positive and T1 plus contrast media positive) for bone metastasis with 2 or more lesions. If the bone metastasis is highly suspected or not well defined by imaging, bone biopsy is necessary for confirmation.)', ' Visible uptake in at least one lesion on bone scanning prior to radium therapy.', ' No limit in number of prior hormonal agents in metastatic breast cancer; only one prior chemotherapy is allowed in metastatic setting. Anti-HER2 targeting therapy, CDK4/6 inhibitor, other targeted therapy (e.g., mTOR or PI3K inhibitor) in combination with hormonal treatment will be counted as one hormonal agent. Any anti-HER2 targeting therapy in combination with chemotherapy will not be counted as one additional treatment.', ' Breast tumors with hormone receptor positive disease (ER+/PR+, ER+/PR- regardless of HER2 status).', ' ECOG performance score of 0, 1.', ' Age =/> 18 years.', ' All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF).', ' Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 6 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.', ' Acceptable hematology and serum biochemistry screening values: White Blood Cell Count (WBC) =/> 3,000/mm3 Absolute Neutrophil Count (ANC) =/> 1,500/mm3 Platelet (PLT) count =/> 100,000/mm3 Hemoglobin (HGB) =/> 10 g/dl Total bilirubin level </=2.0 x institutional upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) </= 3.0 x ULN Creatinine </= 1.5 x ULN', ' Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.', 'Exclusion Criteria:', ' Following breast cancer disease conditions are not eligible: A) Single Bone Lesion. B)Two or more visceral metastasis C) Single visceral lesion < 2cm without any laboratory changes or clinical symptoms due to the metastatic lesion is permitted. D)Presence of brain metastases E) Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). T F) Impending fracture, spinal cord compression, and/or potentially unstable compression fracture of vertebral body with possibility of cord compression. G) Life expectancy severely limited by concomitant illness (less than 12 months). H) Concurrent external beam radiation therapy to non target lesion is permitted.', ' Following prior treatments are not eligible. A) Use of any investigational agent within 30 days preceding enrollment. B) Treatment with cytotoxic chemotherapy within previous 4 weeks C) Failure to achieve </= Grade 2 AE resolution from cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted). D) Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Ra-223 dichloride) for the treatment of bony metastases.', " Following medical conditions are not eligible. A) Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer or cervical dysplasia) B) Any other serious illness or medical condition, such as but not limited to: Any infection =/> National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2. C) Cardiac failure New York Heart Association (NYHA) III or IV. D) Crohn's disease or ulcerative colitis-Bone marrow dysplasia or Myelodysplastic syndrome.", ' Women who are pregnant or breast-feeding. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.', " Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.", ' Major surgery within 30 days prior to start of study drug.', ' Excluded therapies and medications, previous and concomitant: A) Concurrent anti-cancer therapy (chemotherapy, surgery, immunotherapy, biologic therapy, anti-HER 2 targeting therapies, or tumor embolization) other than Ra 223 dichloride. Concurrent external beam radiation therapy is permitted.B) Prior use of Ra-223 dichloride. C) Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form).'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Disease Control Rate at 9 Months', ' Disease control rate is defined as the rate of the patients at that time with clinically complete or partial response or stable disease.', ' Time frame: 9 months from receiving the first dose of Radium-223', 'Results 1: ', ' Arm/Group Title: Ra-223 Dichloride + Denosumab', ' Arm/Group Description: Ra-223 dichloride 55 kBq/kg administered as a bolus intravenous (IV) injection (over 1 minute) through a secure in-dwelling catheter on day 1 of the study and then every four weeks thereafter for 6 cycles.', ' Denosumab 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.', ' A single hormonal agent (ie, Tamoxifen or Aromatase Inhibitor or Fulvestrant) administered daily while on study. Physician to decide what type of hormone therapy participant will receive.', ' Ra-223 dichloride: 55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.', ' Denosumab: 120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.', ' Hormone Therapy: A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 35 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 28/36 (77.78%)', ' Lymphocytopenia 210/36 (27.78%)', ' Neutropenia 29/36 (25.00%)', ' Anemia 26/36 (16.67%)', ' Thrombocytopenia 24/36 (11.11%)', ' Hyperglycemia 27/36 (19.44%)', ' Nausea 213/36 (36.11%)', ' Diarrhea 211/36 (30.56%)', ' Fatigue 215/36 (41.67%)', ' Flu-like symptoms 26/36 (16.67%)', ' Hot Flashes 25/36 (13.89%)', ' AST/ALT elevation 211/36 (30.56%)', ' Arthralgia 24/36 (11.11%)']}

{'Clinical Trial ID': 'NCT01262027', 'Intervention': ['INTERVENTION 1: ', ' Dovitinib', ' Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Patients have histological confirmation of breast carcinoma with a clinical diagnosis of IBC based on presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d orange), with or without an underlying palpable mass involving the majority of the skin of the breast. Pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis.', ' Patients have stage IV disease with local or distant relapse', ' Patients have negative HER2 expression by IHC (defined as 0 or1+), or fluorescence in situ hybridization (FISH). If HER2 is 2+, negative HER2 expression must be confirmed by FISH.', ' Patients are able to swallow and retain oral medication.', ' Patients have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.', ' Patients have received two or more standard chemotherapies for metastatic disease and have relapsed.', ' Patients have ability and willingness to sign written informed consent.', ' Patients are 18 years of age or older.', ' Female patients of childbearing potential (A female not free from menses > 2 years or not surgically sterilized) must be willing to use highly effective contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study. Highly effective contraception, defined as male condom with spermicide, diaphragm with spermicide, intra-uterine device. Highly effective contraception must be used by both sexes during the study and must be continued for 8 weeks after the end of study treatment. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.', ' Female patients of childbearing potential must have negative serum pregnancy test </=14 days prior to starting study treatment.', ' If Patients have been treated with anti-vascular endothelial growth factor (VEGF) agents, such as Bevacizumab, last dose must be > 4 weeks.', ' Patients have biopsy tissue of the metastatic disease (including chest wall or regional nodes) available (paraffin blocks or up to 20 unstained slides), if no biopsy tissue available, a biopsy (or thoracentesis if patient has pleural effusion only) of the metastatic disease will be performed to confirm the diagnoses.', ' Serum total bilirubin must be within Upper Limited Normal (T. Bilirubin upper limit of normal (ULN)=1.0 mg/dl)', ' AST and ALT must be < 2.5 x ULN(with or without liver metastases).', 'Exclusion Criteria:', ' Patients are receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, radiation therapy and biological therapy) while taking study medication.', ' Cirrhosis of liver, or known hepatitis B or C infection have hepatic impairment Child-Pugh Score of B or worse.', ' Absolute neutrophil count (ANC) < 1.5', ' Patients have an active infection and require IV or oral antibiotics.', ' Impaired cardiac function or clinically significant cardiac diseases, including any of the following: a) History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation; b) Clinically significant resting bradycardia (< 50 beats per minute); c) left ventricular ejection fraction (LVEF) assessed by 2-D echocardiogram (ECHO) < 50% or lower limit of normal (which ever is higher) or multiple gated acquisition scan (MUGA) < 45% or lower limit of normal (which ever is higher). d) Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE); e) Uncontrolled hypertension defined by an SBP>150 and/or a diastolic blood pressure (DBP)>100 mm Hg with or without anti-hypertensive medication.', ' History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug.', ' Patients have a concurrent disease or condition that would make them inappropriate for study participation, or any serious medical disorder that would interfere with patients safety.', ' Patients with only locally or regionally confined disease without evidence of metastatic disease.'], 'Results': ['Outcome Measurement: ', ' Overall Response (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants', ' Number of participants experiencing CR, PR or SD as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Response is anyone who experiences SD, CR or PR in first 6 months. CR: Disappearance clinical evidence active tumor by evaluation, mammogram & ultrasound. No symptoms or evidence of residual invasive tumor, including no residual tumor in axillary lymph nodes. PR: 50%/> decrease for minimum 4 weeks in measurable lesion determined by product of perpendicular diameters of lesion. Every lesion should not regress to qualify as PR; however, if lesion progresses or if new lesions appear, response cannot be classified as PR. Minor Response [MR]: Decreases in tumor masses insufficient to qualify as partial remission, i.e. <50%. SD: Between MR & PD. PD: Increase 25% measured lesion from baseline. New lesions constitutes increasing disease. Mixed responses consid', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Dovitinib', ' Arm/Group Description: Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.', ' Overall Number of Participants Analyzed: 19', ' Measure Type: Number', ' Unit of Measure: participants Complete Response (CR): 0', ' Partial Response (PR): 0', ' Stable Disease (SD): 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/22 (4.55%)', ' Blood bilirubin increased 1/22 (4.55%)', ' Alkaline phosphatase increased 1/22 (4.55%)']}

026e7eb7-37fd-4aae-b74f-dacf905db262

Single

Eligibility

NCT02878057

Patients that are fully active and able to carry on all pre-disease performance without restriction are excluded from the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT02878057', 'Intervention': ['INTERVENTION 1: ', ' Advanced Breast Cancer', ' Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)', ' Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)'], 'Eligibility': ['Inclusion Criteria:', ' HER-2 negative advanced breast cancer with chest wall metastasis confirmed by histology or cytological examination (patients who have received anthracyclines and/or paclitaxel in adjuvant chemotherapy).', ' Patients with recurrence or metastasis who have received no more than two lines of chemotherapy.', ' If hormone receptor is positive, endocrine therapy must have been performed for the patients with recurrence or metastasis, or the recurrence or metastasis occurred in less than two years of endocrine therapy.', ' 18 years old.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.', ' A life expectancy of more than 3 months.', ' At least one measurable site of disease confirmed by CT or MRI according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was required.', ' If the target lesions are lymph nodes, the short diameter is required to be less than 1.5cm and the target lesions are not suitable for surgical treatment; target lesions have not been in radiotherapy or recurred in the radiation field.', ' Baseline blood routine examination in accordance with the following criteria: neutrophil counts more than 1.5*109/L; platelet counts greater than 100*109/L; hemoglobin greater than 9 g/dL (blood transfusion is allowed to achieve or maintain the index)', ' Liver function in accordance with the following criteria: total bilirubin less than 1.5 times the upper limit of normal value; aspartate aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5 times the upper limit of normal value, less than 5 times the upper limit of normal value in patients with liver metastases.', ' Renal function in accordance with the following criteria: serum creatinine less than 1.25 times the upper limit of normal value, or the creatinine clearance rate calculated greater than 50 mL/min;', ' Women with fertility are willing to take contraceptive measures in the trial: when seven days before the drug delivery of serum or urine pregnancy test negative.', 'Exclusion Criteria:', ' receiving radiation therapy 28 days before enrolled. Radiotherapy before enrollment to relieve the metastatic bone pain is allowed, but medullary bone radiated should not exceed 30% of the total amount;', ' symptomatic central nervous system metastases;', ' current or recent (30 days before enrollment) use of another study drug or being involved in another clinical study;', ' Other malignant tumors that have occurred within 5 years (except for the cured or well-controlled cervical carcinoma in situ, skin squamous cell carcinoma, or skin basal cell carcinoma);', ' With hypertension and the blood pressure cannot be reduced to the normal range through antihypertensive drug treatment (systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg).', ' With grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval more than or equal to 450 ms for men, more than or equal to 470 ms for female);', ' according to the criteria of NYHA, cardiac insufficiency of grade III and IV or left ventricular ejection fraction (LVEF) less than 50% revealed by echocardiography;', ' abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 times the ULN), with bleeding tendency or under thrombolysis or anticoagulation therapy;', ' within 3 months before enrollment, clinically significant bleeding symptoms occur, or having obvious bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, occult blood + + and above in baseline period, or suffering from vasculitis, et al;', ' within 4 months before enrollment receiving major surgery or getting severe traumatic injury, fracture or ulcer;', ' having factors that affect the absorption of the oral drugs obviously, such as the inability to swallow, chronic diarrhea and intestinal obstruction, et al;', ' urine routine test with urinary protein more than ++, or 24 hour urinary protein more than 1.0 g;', ' with symptomatic serous cavity effusion, which needs to be surgically managed (including pleural effusion, ascites, pericardial effusion);', ' with other possible conditions that can affect the clinical research or evaluation of the results judged by the researchers.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', ' Time frame: evaluation per 2 cycles (8 weeks), up to 6 months;From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months', 'Results 1: ', ' Arm/Group Title: Advanced Breast Cancer', ' Arm/Group Description: Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)', ' Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)', ' Overall Number of Participants Analyzed: 26', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.9 (2.1 to 8.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/30 (40.00%)', ' Hypertension *2/30 (6.67%)', ' Fatigue *1/30 (3.33%)', ' Bilirubin increased *2/30 (6.67%)', ' Transaminase increased *1/30 (3.33%)', ' proteinuria *6/30 (20.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

a79fc503-215f-40d4-9cc1-e101cec3a9c9

Single

Results

NCT00191269

the primary trial measured the Number of Participants With Disease Progression (PD) or Death, to evaluate the performance of its interventions.

Contradiction

{'Clinical Trial ID': 'NCT00191269', 'Intervention': ['INTERVENTION 1: ', ' Dose Level 1', ' Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.', 'INTERVENTION 2: ', ' Dose Level 2', ' Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically and/or cytologically confirmed breast cancer', ' Received prior chemotherapy for metastatic breast cancer with anthracycline and taxane regimen', ' To have at least one measurable region', ' PS: 0-1', ' To have adequate organ function (bone marrow, liver and renal function)', 'Exclusion Criteria:', ' To have Interstitial pneumonia or pulmonary fibrosis', ' To have inflammatory carcinoma', ' Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery', ' To have brain metastasis with symptom', ' To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)'], 'Results': ['Outcome Measurement: ', ' Tumor Response', ' Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.', ' Time frame: baseline to measured progressive disease', 'Results 1: ', ' Arm/Group Title: Dose Level 1', ' Arm/Group Description: Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 0', ' Partial Response: 0', ' Long Stable Disease: 1', ' Stable Disease: 1', ' Progressive Disease: 2', 'Not Evaluable: 2', 'Results 2: ', ' Arm/Group Title: Dose Level 2', ' Arm/Group Description: Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.', ' Overall Number of Participants Analyzed: 62', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 1', ' Partial Response: 4', ' Long Stable Disease: 4', ' Stable Disease: 16', ' Progressive Disease: 32', 'Not Evaluable: 5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1', ' Cardiac failure acute 0/6 (0.00%)', ' Cataract 0/6 (0.00%)', ' Cellulitis 1/6 (16.67%)', ' Infection 0/6 (0.00%)', ' Blood lactate dehydrogenase increased 0/6 (0.00%)', ' Anorexia 0/6 (0.00%)', ' Femur fracture 0/6 (0.00%)', ' Brain oedema 0/6 (0.00%)', ' Dyspnoea 1/6 (16.67%)', ' Acute respiratory failure 0/6 (0.00%)', ' Catheterisation venous 0/6 (0.00%)', " Raynaud's phenomenon 0/6 (0.00%)", 'Adverse Events 2:', ' Total: 10', ' Cardiac failure acute 1/62 (1.61%)', ' Cataract 1/62 (1.61%)', ' Cellulitis 1/62 (1.61%)', ' Infection 1/62 (1.61%)', ' Blood lactate dehydrogenase increased 1/62 (1.61%)', ' Anorexia 1/62 (1.61%)', ' Femur fracture 1/62 (1.61%)', ' Brain oedema 1/62 (1.61%)', ' Dyspnoea 0/62 (0.00%)', ' Acute respiratory failure 1/62 (1.61%)', ' Catheterisation venous 2/62 (3.23%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

ee5f95d0-3824-4ce4-bf58-1ecd3ce4e7ee

Comparison

Adverse Events

NCT00574587

NCT00777049

There were no cases of cardiac tamponade in the primary trial or the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00574587', 'Intervention': ['INTERVENTION 1: ', ' Stratum A: VR-Paclitaxel-Trastuzumab', ' Stratum A: Vorinostat 200 (Dose Level 1) or 300 mg (Dose level 2) by mouth on days 1-3 plus weekly paclitaxel 80 mg x 12 weeks and trastuzumab 4 mg/kg, then 2 mg/kg x 12 weeks, followed by doxorubicin 60 mg/m2 -cyclophosphamide 600 mg/m2 every 2 weeks x 8 weeks, followed by surgery', 'INTERVENTION 2: ', ' Stratum B: VR-Paclitaxel-Trastuzumab', ' Stratum B: 300 mg by mouth on days 1-3 plus weekly paclitaxel 80 mg x 12 weeks and trastuzumab 4 mg/kg, then 2 mg/kg x 12 weeks, followed by doxorubicin 60 mg/m2 -cyclophosphamide 600 mg/m2 every 2 weeks x 8 weeks, followed by surgery'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed adenocarcinoma of the breast associated with the following stages: IIB, IIIA, IIIB or IIIC.', ' Tumor must be Her2/neu positive', ' No prior chemotherapy, radiation or definitive therapeutic surgery', 'Exclusion Criteria:', ' May not be receiving any other investigational agents', ' Uncontrolled intercurrent illness'], 'Results': ['Outcome Measurement: ', ' Recommended Phase II Dose of Vorinostat in Combination With Weekly Paclitaxel/Trastuzumab', ' Dose limiting toxicity in cycle 1', ' Time frame: 3 weeks', 'Results 1: ', ' Arm/Group Title: Stratum A: VR-Paclitaxel-Trastuzumab', ' Arm/Group Description: Stratum A: Vorinostat 200 (Dose Level 1) or 300 mg (Dose level 2) by mouth on days 1-3 plus weekly paclitaxel 80 mg x 12 weeks and trastuzumab 4 mg/kg, then 2 mg/kg x 12 weeks, followed by doxorubicin 60 mg/m2 -cyclophosphamide 600 mg/m2 every 2 weeks x 8 weeks, followed by surgery', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: mg 300', 'Results 2: ', ' Arm/Group Title: Stratum B: VR-Paclitaxel-Trastuzumab', ' Arm/Group Description: Stratum B: 300 mg by mouth on days 1-3 plus weekly paclitaxel 80 mg x 12 weeks and trastuzumab 4 mg/kg, then 2 mg/kg x 12 weeks, followed by doxorubicin 60 mg/m2 -cyclophosphamide 600 mg/m2 every 2 weeks x 8 weeks, followed by surgery', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: mg 300'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', ' cardiac tamponade 0/3 (0.00%)', ' congestive heart failure 0/3 (0.00%)', ' pulmonary emobolism 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 2/23 (8.70%)', ' cardiac tamponade 0/23 (0.00%)', ' congestive heart failure 1/23 (4.35%)', ' pulmonary emobolism 1/23 (4.35%)']}

{'Clinical Trial ID': 'NCT00777049', 'Intervention': ['INTERVENTION 1: ', ' ER+ and/or PgR+ (Arm I)', ' Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg', 'INTERVENTION 2: ', ' ER- and PgR- (Arm II)', ' Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent obtained prior to any study-related procedures', ' Women 18 years old', ' Patients with an ECOG performance status of 2 assessed within 2 weeks (14 days) prior to registration', ' Histologically or cytologically confirmed breast cancer with locally recurrent or radiological evidence of metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.', ' Measurable disease per RECIST (Response Evaluation Criteria in Solid Tumor) guidelines', ' HER2-negative patients by local laboratory testing (IHC 0 or 1+ staining, IHC 2+ staining but in situ hybridization negative, or in situ hybridization negative).', ' ER and PgR testing from a local laboratory is required prior to patient registration', ' For Arm I: at least two lines of prior endocrine therapy (in adjuvant and/or metastatic settings) are required. Up to two prior cytotoxic chemotherapies are allowed in the metastatic setting (prior adjuvant and neoadjuvant chemotherapy is allowed).', ' For Arm II: up to 2 prior cytotoxic chemotherapy regimens for treatment of metastatic or locally recurrent breast cancer are allowed.', ' Complete radiological tumor measurement within 4 weeks (28 days) prior to registration:', ' Chest: CT scan with intravenous contrast if the contrast is not medically contraindicated or MRI', ' Abdomen: CT scan with intravenous or oral contrast if the contrast is not medically contraindicated or MRI', ' Brain: CT scan or MRI', ' Bone: Whole body Bone Scintigraphy', ' Patients must meet the following laboratory criteria within 2 weeks (14 days) prior to registration:', ' Hematology', ' Neutrophil count of > 1200/mm3', ' Platelet count of > 100,000/mm3', ' Hemoglobin 90 g/L', ' Biochemistry', ' AST/SGOT and ALT/SGPT 2.5 x upper limit of normal (ULN) or 5.0 x ULN if the transaminase elevation is due to disease involvement', ' Serum bilirubin 1.5 x ULN', ' Serum creatinine 1.5 x ULN or 24-hour creatinine clearance 50 mL/min', ' Serum potassium, sodium, magnesium, phosphorus, and calcium within normal limits for the institution', ' Serum albumin LLN or 30g/L', ' Clinically euthyroid function (TSH and free T4). (Patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism).', ' LVEF assessment (2-D echocardiogram or MUGA scan) performed within 6 weeks prior to registration, showing a LVEF value > 50%', ' Electrocardiogram performed within 1 week prior to registration (details about findings on the Electrocardiogram that are not acceptable for participating in the study are reported in the Exclusion criteria section)', ' Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to registration and agree to appropriate method of pregnancy prevention.', ' Patient should have an archival tumor sample available for confirmation of HER2, Estrogen and Progesterone status by the central lab.', 'Exclusion Criteria:', ' Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer', ' Patients who need valproic acid for any other medical condition during the study or within 5 days prior to first panobinostat treatment', ' Patients who have received prior systemic anti-cancer therapy (cytotoxic chemotherapy, endocrine therapy, targeted therapy, monoclonal antibody or biologic therapy) or investigational agent within the last 4 weeks prior to registration (6 weeks for nitrosoureas and mitomycin; 2 weeks for capecitabine)', ' Patients who have received prior radiotherapy to 25% of the bone marrow within the last 4 weeks prior to registration; local radiotherapy is allowed however all recently irradiated lesions should not be included in the measurable disease assessment.', ' Patients who have received prior investigational agents within the last 4 weeks prior to registration', ' Patients with unresolved diarrhea CTCAE grade 1', ' Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat', ' History of cardiac dysfunction including any one of the following:', ' Complete left bundle branch block or obligate use of a cardiac pacemaker or congenital long QT syndrome or history or presence of ventricular tachyarrhythmias or clinically significant resting bradycardia (<50 beats per minute) or QTcF > 450 msec on screening ECG or right bundle branch block and left anterior hemiblock (bifascicular block)', ' Presence of unstable atrial fibrillation (ventricular response rate >100 bpm). Patients with stable atrial fibrillation are allowed in the study provided they do not meet the other cardiac exclusion criteria', ' Previous history angina pectoris or acute MI within 6 months of registration', ' Congestive Heart Failure (New York Heart Association functional classification III-IV)', ' History of unexplained syncope', ' Other clinically significant heart disease (e.g. cardiomyopathy, cardiac artery disease, uncontrolled hypertension, or history of poor compliance with an antihypertensive regimen)', ' Family history of long QT syndrome, unexplained syncope or unexplained sudden death', ' Acute or chronic liver or renal disease', ' Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes mellitus, active untreated or uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease including dyspnoea at rest from any cause) that could cause unacceptable safety risks or compromise compliance with the protocol', ' Concomitant use of drugs with a risk of causing torsades de pointes where such treatments cannot be discontinued or switched to a different medication prior to starting study drug', ' Brain metastases, unless patient randomized on study at least 90 days from completion of brain radiotherapy and / or surgery without radiologic or functional evidence of progressive brain metastases, and off corticosteroids above the dose of 7.5 mg prednisone or equivalent; No concurrent radiotherapy for brain metastasis is allowed', ' Clinically significant third space fluid accumulation', ' Concurrent biphosphonates unless if initiated prior to study entry (at least 4 weeks before patient registration)', ' Pregnant (i.e., positive beta-human chorionic gonadotropin test) or breast feeding patient', ' Unable to swallow oral medications', ' Not willing to use a double barrier method of non-hormonal birth control. Contraception must be used during the study and for 30 days after last dose of study treatment.', ' Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (as Determined by Investigator): the Percentage of Patients Assigned to a Treatment Arm With a Confirmed Best Response of CR or PR.', ' The assessment of overall response (OR) is based on the response of target lesion, of non-target lesion, and on presence of new lesions (RECIST criteria version 1.0 using imaging techniques; as per investigator assessment).', ' Time frame: 6 years and 2 months', 'Results 1: ', ' Arm/Group Title: ER+ and/or PgR+ (Arm I)', ' Arm/Group Description: Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 0', ' Partial Response: 1', ' Stable Disease / Incompete Response: 13', ' Progressive Disease: 14', 'Missing: 5', 'Results 2: ', ' Arm/Group Title: ER- and PgR- (Arm II)', ' Arm/Group Description: Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 1', ' Partial Response: 0', ' Stable Disease / Incompete Response: 4', ' Progressive Disease: 14', 'Missing: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/32 (37.50%)', ' Anaemia 0/32 (0.00%)', ' Neutropenia 1/32 (3.13%)', ' Thrombocytopenia 4/32 (12.50%)', ' Atrial fibrillation 1/32 (3.13%)', ' Cardiac failure congestive 1/32 (3.13%)', ' Myocardial ischaemia 1/32 (3.13%)', ' Abdominal discomfort 0/32 (0.00%)', ' Ascites 1/32 (3.13%)', ' Constipation 0/32 (0.00%)', ' Rectal haemorrhage 1/32 (3.13%)', ' Vomiting 1/32 (3.13%)', ' Fatigue 1/32 (3.13%)', 'Adverse Events 2:', ' Total: 8/20 (40.00%)', ' Anaemia 1/20 (5.00%)', ' Neutropenia 0/20 (0.00%)', ' Thrombocytopenia 1/20 (5.00%)', ' Atrial fibrillation 0/20 (0.00%)', ' Cardiac failure congestive 0/20 (0.00%)', ' Myocardial ischaemia 0/20 (0.00%)', ' Abdominal discomfort 1/20 (5.00%)', ' Ascites 0/20 (0.00%)', ' Constipation 2/20 (10.00%)', ' Rectal haemorrhage 0/20 (0.00%)', ' Vomiting 0/20 (0.00%)', ' Fatigue 0/20 (0.00%)']}

7a9fa9d8-8b71-4df3-918f-0f8e8ecb4b0a

Comparison

Intervention

NCT03592121

NCT01439711

Unlike the secondary trial, the primary trial does not specify a specific dosage or frequency for its intervention.

Entailment

{'Clinical Trial ID': 'NCT03592121', 'Intervention': ['INTERVENTION 1: ', ' AB-101', ' Apply to both nipple/areola regions approximately 1 hour prior to sexual activity', ' AB-101: Apply approximately 1 hour prior to sexual activity', 'INTERVENTION 2: ', ' Placebo', ' Apply to both nipple/areola regions approximately 1 hour prior to sexual activity', ' Placebo: Apply approximately 1 hour prior to sexual activity'], 'Eligibility': ['Inclusion Criteria:', ' Female breast cancer survivor', ' Age: 18 to 70', ' First diagnosed with Stage I or II breast cancer', ' Have had breast surgery: nipple sparring mastectomy or lumpectomy', ' At least 3 years post surgery', ' Nipple neuropathy post breast surgery (change in Llikeart scale >= 3 between pre and post surgery)', ' Baseline nipple sensitivity <=5 (likeartLikert scale)', ' QoL-BC (>=7)', ' Delayed orgasm (CTCAE v4.0) Grade 2', ' One of the following: Delayed orgasm (CTCAE v4.0) Grade 2 and/or Vaginal dryness (CTCAE v4.0) Grade 2 or 3', ' Able to give informed consent', ' Currently in a monogamous heterosexual relationship for at least 12 months', ' Sexually active within the last 30 days', ' Willing to engage in sexual activity at least once a month during the duration of the study', ' Willing to use on a regular basis a web based form system to record sexual events i.e., have access to the Internet', ' Willing to use an adequate method of birth control', ' Able to comply with the study requirements for 8 consecutive weeks', ' Able to give informed consent', 'Exclusion Criteria:', ' Previous adverse event to alpha 1 agonists (oral, nasal, topical, or ocular) or drugs in this class', ' Currently pregnant', ' Nursing within the last 6 months prior to beginning the study', ' History of cardiovascular or cerebrovascular disease, e.g., heart attack, disease of the arteries of the heart, partial heart block, rapid ventricular heartbeat, slow heartbeat, chronic heart failure, severe hardening of the arteries, blood clot in an artery', ' Actively being treated for breast cancer', ' Changes in chronic medication for oncology, cardiology, or endocrinology in past 12 months', ' Uncontrolled or severe hypertension', ' Decreased oxygen in the tissues or blood', ' Active inflammation of the liver', ' Acute inflammation of the pancreas', ' Overactive thyroid gland', ' Acidosis', ' Diabetes', ' Spinal cord injury', ' Nipple dermatitis', ' Regional complex pain syndrome', ' Use of any hypertensive drugs', ' Use of MAO inhibitors', ' Subjects assigned to interventional drug arm and failed to report an increase >=2 from baseline in nipple sensitivity (likert scale) during phase I', ' In partners: sexual dysfunction or erectile dysfunction', ' Currently enrolled in any other medical study or has been enrolled in any medical study in the past 30 days', ' Nipple dermatitis', ' Regional complex pain syndrome', ' Unable to provide consent or make allotted clinical visits'], 'Results': ['Outcome Measurement: ', ' Change in Delayed Orgasm Grade', ' Change in Delayed Orgasm Grade (CTCAE v4.0 - Common Terminology of Adverse Events) CTCAE v4.0 is the NIH Common Terminology of Adverse Events v4.0', ' Delayed Orgasm is defined as: A disorder characterized by sexual dysfunction characterized by a delay in climax.', ' This is a binary grading system:', ' Grade 0:Delay in achieving orgasm not adversely affecting relationship Grade 1:Delay in achieving orgasm adversely affecting relationship', ' Time frame: [baseline, week 8]', 'Results 1: ', ' Arm/Group Title: AB-101', ' Arm/Group Description: Apply to both nipple/areola regions approximately 1 hour prior to sexual activity', ' AB-101: Apply approximately 1 hour prior to sexual activity', ' Overall Number of Participants Analyzed: 3', ' Mean (Standard Deviation)', ' Unit of Measure: Grade -0.33 (0.58)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Apply to both nipple/areola regions approximately 1 hour prior to sexual activity', ' Placebo: Apply approximately 1 hour prior to sexual activity', ' Overall Number of Participants Analyzed: 0', ' Mean (Standard Deviation)', ' Unit of Measure: Grade '], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 0/0']}

{'Clinical Trial ID': 'NCT01439711', 'Intervention': ['INTERVENTION 1: ', ' Letrozole + MRI', ' Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.'], 'Eligibility': ['Eligibility Criteria:', ' Histologic documentation: Pathologic confirmation of ductal carcinoma in situ (DCIS) of the female breast without invasive cancer, with diagnosis rendered on core biopsy only, completed within 60 days before registration. Patients diagnosed with DCIS on the basis of surgical biopsy are not eligible for this study.', ' Patients with microinvasion on diagnostic core biopsy, defined as tumor 1 mm in greatest dimension, will be allowed to participate.', ' All patients must have a clip placed, either at the time of the diagnostic biopsy or at the time of the baseline MRI prior to the start of treatment.', ' Tissue samples: Patient has diagnostic tissue available for correlative studies.', ' Clinical stage: Tis or T1mi N0, M0', " Hormone receptor status: DCIS must express estrogen and/or progesterone receptor, as determined by immunohistochemical methods on the diagnostic pathology sample, according to the local institution's standard protocol. Greater than or equal to 1% cells will be considered to be positive.", ' Menopausal status: Patients must be postmenopausal defined as:', ' Age 55 years and one year or more of amenorrhea', ' Age < 55 years and one year or more amenorrhea, with an estradiol assay < 20pg/ml', ' Surgical menopause with bilateral oophorectomy (at least 28 days must elapse from surgery to time of study registration)', ' The use of GnRH analogs to achieve post menopausal status is not allowed.', ' Prior treatment:', ' No prior surgical excision in the index breast for current DCIS diagnosis of DCIS', ' Any exogenous hormone therapy must be completed 4 weeks prior to registration', ' Any patients with a history of tamoxifen or raloxifene use within two years of current DCIS diagnosis are not eligible', ' No prior neoadjuvant/adjuvant therapy for current DCIS diagnosis', ' Contraindication to MRI: No contraindications to breast MRI', 'Measurable disease: Mammographic extent of calcifications must be accurately measurable in at least one dimension with each lesion 1 cm and 7 cm', ' DCIS must be visible on MRI based on central review.', ' Patients with palpable DCIS or adenopathy are not eligible to participate.', ' Patients with multifocal or bilateral disease are eligible.', ' History of osteoporosis: Women diagnosed with osteoporosis may participate in this trial provided they are receiving appropriate therapy or if they have declined therapy.', ' Age: Patients 18 years of age', 'Performance Status: ECOG performance status 0 or 1', ' Pregnancy/nursing status: Not pregnant or nursing', ' Required Initial Laboratory Values:', ' ANC 1,000/μL', ' Platelet count 100,000/μL', ' Serum creatinine 1.7 mg/dL', ' Bilirubin 2.0 mg/dL', ' AST/ALT 2.5 times upper limit of normal', ' Serum estradiol level assay < 20 pg/mL *Required for patients < 55 years of age and one year or more of amenorrhea'], 'Results': ['Outcome Measurement: ', ' Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 3 (V3)', ' Mean total MRI FTV change from baseline to month 3 (V3): For patients with more than one measureable lesion on the MRI, the sum over all measureable lesions on the MRI was calculated at each time point. V3 was calculated by subtracting the total MRI FTV measured (i.e. the sum over all lesions present with MRI FTV measurements) at 3 months from the total MRI FTV measured at baseline. For V3 the raw change in the volume will be calculated for each patient and a mean and 95% confidence interval will be constructed using two-sided t-tests.', ' Time frame: up to 3 months from start of treatment', 'Results 1: ', ' Arm/Group Title: Letrozole + MRI', ' Arm/Group Description: Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.', ' Overall Number of Participants Analyzed: 68', ' Mean (95% Confidence Interval)', ' Unit of Measure: cubic centimeters -1.93 (-2.87 to -0.98)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/90 (2.22%)', ' Heart failure 1/90 (1.11%)', ' Restrictive cardiomyopathy 1/90 (1.11%)', ' Fever 1/90 (1.11%)', ' Hypokalemia 1/90 (1.11%)', ' Arthralgia 1/90 (1.11%)', ' Myalgia 1/90 (1.11%)', ' Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify 1/90 (1.11%)', ' Hypertension 2/90 (2.22%)']}

ccb703ea-df18-451b-8db8-ed0e510a4c0f

Single

Adverse Events

NCT00284180

Across both cohorts of the primary trial a total of two patients had low levels of oxygen in their body tissues.

Entailment

{'Clinical Trial ID': 'NCT00284180', 'Intervention': ['INTERVENTION 1: ', ' Vinflunine', ' Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days', 'INTERVENTION 2: ', ' Vinflunine/Trastuzumab', ' Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle of vinflunine/trastuzumab, the dose of vinflunine could be escalated to 320 mg/m2'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed breast cancer with metastatic disease. Patients without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.', ' The human epidermal growth factor receptor 2 (HER2) status of the tumor will be used to stratify patients. Tumors that are HER2 FISH+ will receive vinflunine and trastuzumab. Patients with tumors which are HER2 FISH negative or if the HER2 status is unknown/not performed will remain on study and will receive single agent vinflunine.', ' Patients must have measurable disease not directly irradiated as per RECIST criteria.', ' Measurable disease- is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.', ' Prior Therapy: Patients must not have received prior chemotherapy in the metastatic breast setting. Patients who have not received prior anthracyclines or taxanes should be considered for these agents. Patients may have received prior chemotherapy and/or hormonal therapy for early stage breast cancer. The chemotherapy regimen may have included an anthracycline and/or a taxane as long as it has been > 6 months since completion of the regimen. Adjuvant trastuzumab is allowed. Patients may have received prior radiation therapy in either the metastatic or early stage setting as long as <25% of the bone marrow has been treated. Prior radiation to the whole pelvis is not allowed. Radiation therapy must be completed at least 7 days prior to study registration, and all radiation related toxicities must be resolved to grade 1 before patient is eligible for study inclusion. Patients may have received any number of hormonal therapies in the neo-adjuvant, adjuvant or metastatic setting.', ' Age >18 years.', ' Life expectancy of > 6 months.', ' Eastern Cooperative Oncology Group (ECOG) performance status <2.', ' Patients must have normal organ and marrow function. Laboratory tests should be completed within 14 days prior to starting study treatment. Only for patients who will be receiving trastuzumab, a left ventricular ejection fraction (LVEF) may be determined by either echocardiography or multigated acquisition (MUGA) scan, and should be obtained within 4 weeks prior to starting study treatment.', ' Fertility/reproduction. Patients must not be pregnant, expect to become pregnant or conceive a child from time of first signing study consent until at least 12 weeks after last dose of study treatment.', ' Exclusion Criteria', ' Patients who have received prior vinca alkaloid chemotherapy are not eligible unless treatment was completed > 5 years ago.', ' Patients in which the HER2 status is unknown or is FISH negative will not receive trastuzumab but are eligible for treatment with single agent vinflunine.', ' Patients that have received prior chemotherapy for metastatic breast cancer.', ' Patients receiving trastuzumab must have received a cumulative dose of doxorubicin less than 360mg/m2, and/or an epirubicin cumulative dose less than 720mg/m2 for study entry.', ' Patients with known leptomeningeal carcinomatosis are excluded from this clinical trial', ' History of grade 3 or 4 allergic reactions attributed to trastuzumab.', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnant women are excluded from this study', ' History of other non-breast cancer malignancy except for carcinoma in situ of the cervix or non-melanoma skin cancer, or in patients with greater than a 5-year disease free interval from a prior malignancy.', ' Patients who have received prior chemotherapy for early stage breast cancer with the completion of the regimen being < 6 months will not be eligible.'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: Vinflunine', ' Arm/Group Description: Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days', ' Overall Number of Participants Analyzed: 11', ' Measure Type: Number', ' Unit of Measure: percentage of participants 9 (0.23 to 41.26)', 'Results 2: ', ' Arm/Group Title: Vinflunine/Trastuzumab', ' Arm/Group Description: Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle of vinflunine/trastuzumab, the dose of vinflunine could be escalated to 320 mg/m2', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: percentage of participants 33 (14.59 to 56.97)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/11 (45.45%)', ' Diabetes insipidus [1]1/11 (9.09%)', ' Nausea 0/11 (0.00%)', ' Ileus 1/11 (9.09%)', ' Dehydration 1/11 (9.09%)', ' Vomiting 0/11 (0.00%)', ' Pain NOS [2]2/11 (18.18%)', ' Pain - abdomen 0/11 (0.00%)', ' Fracture [3]0/11 (0.00%)', ' Progressive Disease 1/11 (9.09%)', ' CNS Ischemia 1/11 (9.09%)', ' Respiratory Failure 0/11 (0.00%)', ' Hypoxia 1/11 (9.09%)', 'Adverse Events 2:', ' Total: 8/21 (38.10%)', ' Diabetes insipidus [1]0/21 (0.00%)', ' Nausea 1/21 (4.76%)', ' Ileus 0/21 (0.00%)', ' Dehydration 1/21 (4.76%)', ' Vomiting 1/21 (4.76%)', ' Pain NOS [2]0/21 (0.00%)', ' Pain - abdomen 1/21 (4.76%)', ' Fracture [3]1/21 (4.76%)', ' Progressive Disease 1/21 (4.76%)', ' CNS Ischemia 1/21 (4.76%)', ' Respiratory Failure 1/21 (4.76%)', ' Hypoxia 1/21 (4.76%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

56cd4492-3884-4b2a-a000-7c859d86f6f5

Single

Adverse Events

NCT01492101

less than 1% of either cohort of the primary trial was effect by either Pancytopenia or Coagulopathy.

Entailment

{'Clinical Trial ID': 'NCT01492101', 'Intervention': ['INTERVENTION 1: ', ' NKTR-102', ' NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.', 'INTERVENTION 2: ', " Physician's Treatment of Choice", " Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:", ' eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel'], 'Eligibility': ['Inclusion Criteria (major highlights):', ' Patient is an adult female with histologically or cytologically confirmed carcinoma of the breast for whom single-agent cytotoxic chemotherapy is indicated', ' Patient can have either measurable or non-measurable disease by RECIST.', ' Patient has received prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with an anthracycline, a taxane and capecitabine', ' Patient has minimum of 2 and a maximum of 5 prior cytotoxic chemotherapy regimens with the last dose administered within 6 months. A minimum of two chemotherapy regimens had to be for locally recurrent and/or metastatic disease. All therapy received prior to a diagnosis of metastatic disease (eg, neoadjuvant, adjuvant or repeated adjuvant therapy following a second resection) is counted as one regimen.', ' Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.', ' Adequate hematopoietic, liver and kidney functions.', ' Exclusion Criteria (major highlights):', ' Patient with chemotherapy within 21 days, radiotherapy within 14 days, biological therapy with 14 days, hormonal therapy within 7 days and investigational therapy within 21 days prior to randomization.', ' Patient with any major surgery within 28 days prior to randomization.', ' Patient with concurrent use of biologic agents for the treatment of cancer including antibodies or any investigational agent(s).', ' Patient with prior treatment for cancer with a camptothecin derivative.', ' Patient with chronic or acute GI disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care to control diarrhea in the 28 days prior to randomization.', ' Patient received pharmacotherapy for hepatitis B or C, tuberculosis or HIV.', ' Patient with known cirrhosis diagnosed with Child-PUGH Class A or higher liver disease.', ' Patient with prior malignancy (other than breast cancer) except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 5 years prior to randomization.', ' Patient requiring daily use of oxygen supplementation in the 28 days prior to randomization.', ' Patients with significant cardiovascular impairment.'], 'Results': ['Outcome Measurement: ', ' Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population', ' Duration of OS was defined as the time from the date of randomisation to the date of death due to any cause. Subjects were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. OS was determined using the ITT population which included all subjects randomized into 1 of the 2 treatment arms. Subjects who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Subjects who did not have any follow-up since the date of randomization were censored at the date of randomization.', ' Time frame: 36 Months', 'Results 1: ', ' Arm/Group Title: NKTR-102', ' Arm/Group Description: NKTR-102: 145 mg/m2 NKTR-102 will be delivered q21day as a 90 minute intravenous (IV) infusion on day 1 of each treatment cycle.', ' Overall Number of Participants Analyzed: 429', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 12.4 (11.0 to 13.6)', 'Results 2: ', " Arm/Group Title: Physician's Treatment of Choice", " Arm/Group Description: Treatment of Physician's Choice (TPC): One of the following Treatment of Physician Choice will be administered per standard of care:", ' eribulin ixabepilone vinorelbine gemcitabine paclitaxel docetaxel or nab-paclitaxel', ' Overall Number of Participants Analyzed: 423', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 10.3 (9.0 to 11.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 128/425 (30.12%)', ' Febrile neutropenia *2/425 (0.47%)', ' Anaemia *2/425 (0.47%)', ' Pancytopenia *2/425 (0.47%)', ' Coagulopathy *1/425 (0.24%)', ' Idiopathic thrombocytopenic purpura *0/425 (0.00%)', ' Microangiopathic haemolytic anaemia *1/425 (0.24%)', ' Neutropenia *0/425 (0.00%)', ' Pericardial effusion *1/425 (0.24%)', ' Acute coronary syndrome *1/425 (0.24%)', 'Adverse Events 2:', ' Total: 129/406 (31.77%)', ' Febrile neutropenia *6/406 (1.48%)', ' Anaemia *0/406 (0.00%)', ' Pancytopenia *0/406 (0.00%)', ' Coagulopathy *0/406 (0.00%)', ' Idiopathic thrombocytopenic purpura *1/406 (0.25%)', ' Microangiopathic haemolytic anaemia *0/406 (0.00%)', ' Neutropenia *1/406 (0.25%)', ' Pericardial effusion *1/406 (0.25%)', ' Acute coronary syndrome *0/406 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

08b79e0d-5e97-45fb-ac83-0096b56f714b

Single

Results

NCT01466270

The the primary trial placebo group had a over 10% higher mean retention than the donepezil hydrochloride PO QD group.

Contradiction

{'Clinical Trial ID': 'NCT01466270', 'Intervention': ['INTERVENTION 1: ', ' Arm I', ' Patients receive donepezil hydrochloride PO QD.', ' donepezil hydrochloride: Given PO', 'INTERVENTION 2: ', ' Arm II', ' Patients receive placebo PO QD.', 'Placebo: Given PO'], 'Eligibility': ['INCLUSION CRITERIA:', ' Adults >18 years old.', ' Female with history of invasive breast cancer', ' Must have completed adjuvant chemotherapy between 1 and 5 years prior to registration', ' Received at least 4 cycles of cytotoxic chemotherapy', ' Documentation of prior chemotherapy', ' Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study registration and continue for the duration of the study (9 months)', ' Karnofsky Performance Status must be > 60 or ECOG 0-2.', ' Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted. Patient will be asked to list any that have been taken within the last 3 days on the recent medication sheet.', ' Patients must be able to give informed consent to participate in the study, including signing the consent form.', ' Self-reported cognitive disruption (FACT-Cog Version 3 Perceived Cognitive Impairments sub-score of < 63)', ' Negative serum pregnancy test within 10 days prior to registration for women of child-bearing potential.', 'EXCLUSION CRITERIA:', ' Evidence or suspected recurrent or metastatic disease', " History of dementia, Alzheimer's disease, multi-infarct dementia or CVA (history of transient ischemic attack (TIA is allowed)", ' Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drugs.are not allowed. For patients who have used these medications they must not have used them within 4 weeks prior to registration.', ' Patients may not currently be taking Ketoconazole or Quinidine', ' Hypersensitivity to donepezil.', ' Use of investigational medications within the last 30 days.', ' Prior brain metastasis', ' Traumatic brain injury, multiple sclerosis or recent myocardial infarction', ' History of schizophrenia, psychosis or substance abuse', ' Untreated current severe depression. (Currently treated depression is permitted if treatment is stable.)', ' Acute severe fatigue, chronic fatigue syndrome or fibromyalgia.', ' History of hepatic or renal dysfunction or disease', ' Pregnant women are excluded from this study. The effects of donepezil on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because donepezil is known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.', ' It is unknown whether donepezil is excreted in breast milk, for this reason women who are currently breast-feeding are not eligible for this study.'], 'Results': ['Outcome Measurement: ', ' Retention', ' Retention is the percentage of participants who stay in the study for 24 weeks.', ' Time frame: 24 Weeks', 'Results 1: ', ' Arm/Group Title: Arm I', ' Arm/Group Description: Patients receive donepezil hydrochloride PO QD.', ' donepezil hydrochloride: Given PO', ' Overall Number of Participants Analyzed: 31', ' Mean (Standard Error)', ' Unit of Measure: percentage of participants 71.0 (8.3)', 'Results 2: ', ' Arm/Group Title: Arm II', ' Arm/Group Description: Patients receive placebo PO QD.', ' Placebo: Given PO', ' Overall Number of Participants Analyzed: 31', ' Mean (Standard Error)', ' Unit of Measure: percentage of participants 80.7 (7.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/28 (7.14%)', ' Insomnia 2/28 (7.14%)', ' Pain: Chest Wall 0/28 (0.00%)', ' Muscle Cramps 0/28 (0.00%)', ' Headache 1/28 (3.57%)', 'Adverse Events 2:', ' Total: 1/30 (3.33%)', ' Insomnia 0/30 (0.00%)', ' Pain: Chest Wall 1/30 (3.33%)', ' Muscle Cramps 1/30 (3.33%)', ' Headache 0/30 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

c524ecf2-1ca6-4a9a-bedf-f0709124fa1b

Comparison

Results

NCT00798135

NCT01209195

the primary trial and the secondary trial both investigate Pharmacokinetics Itraconazole 500mg QD.

Contradiction

{'Clinical Trial ID': 'NCT00798135', 'Intervention': ['INTERVENTION 1: ', ' Itraconazole', ' oral itraconazole 200mg a day until disease progression or unacceptable toxicities.'], 'Eligibility': ['Inclusion Criteria:', ' - Patients must have a pathologically confirmed diagnosis of invasive carcinoma of the breast. - Patients must carry a diagnosis of metastatic breast cancer. - Patients must be able to swallow oral medications. - Patients with HER 2+ tumors must have received trastuzumab in the past and may have had lapatinib. - Patients must have an ECOG performance status of 0-1. - Patients must be informed of the investigational nature of the study and must sign and give written informed consent. - Patients must have recovered to grade <1 from all acute toxicity of previous therapy for breast cancer with the exception of alopecia. - Adequate hematologic and hepatic function: 1)Absolute neutrophil count >= 1,500 mm3 2) Platelet count >= 100,000 mm3 3) Bilirubin <= 1.5mg/dL x ULN 4) AST and/or ALT <= 2 x ULN (< 5 x ULN in presence of known liver metastasis). - Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and must practice an effective method of birth control. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should also practice an effective method of birth control. - All WOCBP MUST have a negative serum or urine pregnancy test within 4 weeks prior to the start of study drug administration.', 'Exclusion Criteria:', ' Use of the following concomitant medications within 14 days of starting protocol therapy is prohibited: Cisapride, dofetilide, ergot derivatives, levomethadyl, lovastatin, midazolam, pimozide, quinidine, simvastatin, or triazolam.', ' Patients who are taking alprazolam (Xanax) are excluded from the trial.', ' Patients must not have an active infection requiring the use of intravenous antibiotics. The use of oral antibiotics is allowed.', ' Hypersensitivity to itraconazole, any component of the formulation, or to other azoles.', ' Patients with uncontrolled CNS metastasis are excluded. If patients have CNS metastasis they must have completed brain radiation at least 2 weeks prior to registration and must be off steroids for CNS metastasis.', ' Known preexisting congestive heart failure or left ventricular dysfunction. Patients with risk factors (ex. uncontrolled hypertension with BP >160/90) for cardiac dysfunction but no preexisting diagnosis of congestive heart failure or left ventricular dysfunction will have a screening EKG prior to enrollment. Subsequently, those patients with an abnormal EKG, as judged by the treating physician, will be excluded from the study.'], 'Results': ['Outcome Measurement: ', ' Pharmacokinetics (PK) of Oral Itraconazole', ' To determine the pharmacokinetics (PK) of oral itraconazole in patients with MBC by measuring mean trough plasma levels at steady state at weeks 2 and 4.', ' Time frame: pre-dose at Weeks 2 and 4', 'Results 1: ', ' Arm/Group Title: Itraconazole', ' Arm/Group Description: oral itraconazole 200mg a day until disease progression or unacceptable toxicities.', ' Overall Number of Participants Analyzed: 12', ' Mean (Standard Deviation)', ' Unit of Measure: ng/mL Week 2 Intraconazole Concentration: 230.7 (216.8)', ' Week 4 Intraconazole Concentration: 305.8 (334.8)', ' Week 2 6-OH Itraconazole Concentration: 454.8 (429.3)', ' Week 4 6-OH Itraconazole Concentration: 501.6 (502.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/13 (23.08%)', ' NAUSEA *1/13 (7.69%)', ' PAIN - ABDOMEN NOS *1/13 (7.69%)', ' VOMITING *1/13 (7.69%)', ' HEMORRHAGE, GI - UPPER GI NOS *1/13 (7.69%)', ' PAIN - BACK *1/13 (7.69%)', ' MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER *1/13 (7.69%)', ' PLEURAL EFFUSION (NON-MALIGNANT) *1/13 (7.69%)', ' THROMBOSIS/THROMBUS/EMBOLISM *1/13 (7.69%)']}

{'Clinical Trial ID': 'NCT01209195', 'Intervention': ['INTERVENTION 1: ', ' Part 1: Dose Escalation: Cohort 1', ' MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV', 'INTERVENTION 2: ', ' Part 1: Dose Escalation: Cohort 2', ' MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV', ' Paclitaxel - 80mg/m2 weekly IV'], 'Eligibility': ['Inclusion Criteria:', ' Cytological or histological confirmation of locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or endometrial cancer; OR, cytological or histological confirmation of locally advanced /metastatic Her2 non-overexpressing breast cancer', ' Eighteen years of age or above', ' Candidates for chemotherapy', ' Able to understand and sign an informed consent (or have a legal representative who is able to do so)', ' Measurable disease according to RECIST v1.1', ' ECOG Performance Score (PS) of 2', ' Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-121', 'Exclusion Criteria:', ' Prior radiation therapy to >25% of bone marrow-bearing areas', ' Evidence of any other active malignancy', ' Active infection or fever> 38.5°C during screening visits or on the first scheduled day of dosing', ' Symptomatic CNS disease', ' Known hypersensitivity to any of the components of MM-121 or who have had hypersensitivity reactions to fully human monoclonal antibodies', ' Received treatment, within 30 days prior to the first scheduled day of dosing, with any investigational agents that have not received regulatory approval for any indication or disease state', ' Pregnant or breast feeding'], 'Results': ['Outcome Measurement: ', ' Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT)', ' To establish the safety of escalating doses of MM-121 in combination with paclitaxel in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.', ' Time frame: From date of first dose to 30 days after termination, the longest 163 weeks', 'Results 1: ', ' Arm/Group Title: Part 1: Dose Escalation: Cohort 1', ' Arm/Group Description: MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: participants reporting DLTs 0', 'Results 2: ', ' Arm/Group Title: Part 1: Dose Escalation: Cohort 2', ' Arm/Group Description: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV', ' Paclitaxel - 80mg/m2 weekly IV', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants reporting DLTs 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/10 (40.00%)', ' SMALL INTESTINAL OBSTRUCTION * [1]3/10 (30.00%)', ' INTESTINAL OBSTRUCTION * [1]1/10 (10.00%)', ' INTESTINAL PERFORATION * [1]1/10 (10.00%)', ' ABDOMINAL PAIN * [1]0/10 (0.00%)', ' DIARRHOEA * [1]0/10 (0.00%)', ' GASTRITIS * [1]0/10 (0.00%)', ' PEPTIC ULCER * [1]0/10 (0.00%)', ' DEATH * [1]1/10 (10.00%)', ' DISEASE PROGRESSION * [1]0/10 (0.00%)', 'Adverse Events 2:', ' Total: 12/31 (38.71%)', ' SMALL INTESTINAL OBSTRUCTION * [1]0/31 (0.00%)', ' INTESTINAL OBSTRUCTION * [1]0/31 (0.00%)', ' INTESTINAL PERFORATION * [1]0/31 (0.00%)', ' ABDOMINAL PAIN * [1]1/31 (3.23%)', ' DIARRHOEA * [1]1/31 (3.23%)', ' GASTRITIS * [1]1/31 (3.23%)', ' PEPTIC ULCER * [1]1/31 (3.23%)', ' DEATH * [1]0/31 (0.00%)', ' DISEASE PROGRESSION * [1]3/31 (9.68%)', ' FATIGUE * [1]2/31 (6.45%)']}

6d549a9b-47bf-4369-962b-2759cfd7051e

Comparison

Eligibility

NCT00703326

NCT00274768

Participants with HER2- primary breast tumors, confirmed by fluorescence in-situ hybridization are eligible for the secondary trial and the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00703326', 'Intervention': ['INTERVENTION 1: ', ' Ramucirumab (IMC-1121B) + Docetaxel', ' Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.', ' Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.', 'INTERVENTION 2: ', ' Placebo + Docetaxel', ' Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.', ' Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Participant is able to provide signed informed consent', ' Participant is female and 18 years of age or older if required by local laws or regulations', ' Participant has histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent. Every effort should be made to make paraffin-embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis', ' Participant has measurable and/or non-measurable disease', " Participants' primary and/or metastatic tumor is human epidermal growth factor receptor 2 (HER2)-negative by fluorescence in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or 0, 1+ overexpression by immunohistochemistry (IHC)", ' Participant has not received prior chemotherapy for metastatic or locally-recurrent and inoperable breast cancer', ' Participant completed (neo) adjuvant taxane therapy at least 6 months prior to randomization', ' Participant completed (neo) adjuvant biologic therapy at least 6 weeks prior to randomization', ' Participant completed all prior radiotherapy with curative intent 3 weeks prior to randomization', ' Participant may have received prior hormonal therapy for breast cancer in the (neo) adjuvant and/or the metastatic setting 2 weeks prior to randomization', " Participant's left ventricular ejection fraction is within normal institutional ranges", ' Participant has resolution to grade 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI-CTCAE v 3.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy which must have resolved to grade 2', ' Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1', ' Participant is amenable to compliance with protocol schedules and testing', ' Participant has adequate hematological functions [absolute neutrophil count (ANC) 1500 cells/microliter (mcL), hemoglobin 9 grams/deciliter (g/dL), and platelets 100,000 cells/mcL and 850,000 cells/mcL]', ' Participant has adequate hepatic function [bilirubin within normal limits (WNL), aspartate transaminase (AST) and alanine transaminase (ALT) 2.5 times the upper limit of normal (ULN), or 5.0 times the ULN if the transaminase elevation is due to liver metastases, and alkaline phosphatase 5.0 times the ULN]', ' Participant has serum creatinine 1.5 x ULN. If serum creatinine > 1.5 x ULN the calculated creatinine clearance should be > 40 milliliters/minute (mL/min)', " Participant's urinary protein is 1+ on dipstick or routine urinalysis (UA); if urine protein 2+, a 24-hour urine collection must demonstrate < 1000 milligrams (mg) of protein in 24 hours to allow participation in the study", ' Participant must have adequate coagulation function as defined by international normalized ratio (INR) 1.5 and a partial thromboplastin time (PTT) 1.5 X ULN if not receiving anticoagulation therapy. Participants on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin and if on warfarin must have a INR between 2 and 3 and have no active bleeding (defined as within 14 days of randomization) or pathological condition that carries a high risk of bleeding (such as, tumor involving major vessels or known varices)', ' Women of childbearing potential must implement adequate contraception in the opinion of the investigator', ' Participant has not received prior biologic therapy for metastatic or locally recurrent and inoperable breast cancer', 'Exclusion Criteria:', ' Participant has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that she has been disease free for > 3 years', ' Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80', ' Participant has a known sensitivity to agents of similar biologic composition as ramucirumab or other agents that specifically target vascular endothelial growth factor (VEGF)', ' Participant has a history of chronic diarrheal disease within 6 months prior to randomization', ' Participant has received irradiation to a major bone marrow area as defined as > 25% of bone marrow (such as, pelvic or abdominal radiation) within 30 days prior to randomization', ' Participant has participated in clinical trials of experimental agents within 4 weeks prior to randomization', ' Participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders', ' Participant has active, high risk bleeding (such as, via gastric ulcers or gastric varices) within 14 days prior to randomization', ' Participant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy', ' Participant has uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator', ' Participant has brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease', ' Participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness', ' Participant has pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.', ' Participant is pregnant or lactating'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS was defined as time from randomization until the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter of target lesions taking as reference the smallest sum longest diameter since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who neither progressed nor died were censored the day of their last radiographic tumor assessment if available or date of randomization if no post initiation radiographic assessment was available. If death or PD occurred after 2 missing radiographic visits, censoring occurred at date of the last radiographic visit prior to the missed visits. The symptomatic/clinical disease progression (deterioration) without documented radiologic progression did not constitute progression.', ' Time frame: Randomization to disease progression or death or until data cutoff of 31 Mar 2013 (up to 56 months)', 'Results 1: ', ' Arm/Group Title: Ramucirumab (IMC-1121B) + Docetaxel', ' Arm/Group Description: Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.', ' Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m ) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 759', ' Median (95% Confidence Interval)', ' Unit of Measure: months 9.5 (8.3 to 9.8)', 'Results 2: ', ' Arm/Group Title: Placebo + Docetaxel', ' Arm/Group Description: Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.', ' Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m ) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 385', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.2 (7.1 to 8.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 285/752 (37.90%)', ' Anaemia 2/752 (0.27%)', ' Disseminated intravascular coagulation 2/752 (0.27%)', ' Febrile neutropenia 51/752 (6.78%)', ' Neutropenia 47/752 (6.25%)', ' Thrombocytopenia 2/752 (0.27%)', ' Atrial fibrillation 1/752 (0.13%)', ' Atrial flutter 0/752 (0.00%)', ' Cardiac failure congestive 1/752 (0.13%)', ' Left ventricular dysfunction 0/752 (0.00%)', 'Adverse Events 2:', ' Total: 117/382 (30.63%)', ' Anaemia 3/382 (0.79%)', ' Disseminated intravascular coagulation 0/382 (0.00%)', ' Febrile neutropenia 11/382 (2.88%)', ' Neutropenia 20/382 (5.24%)', ' Thrombocytopenia 0/382 (0.00%)', ' Atrial fibrillation 1/382 (0.26%)', ' Atrial flutter 1/382 (0.26%)', ' Cardiac failure congestive 0/382 (0.00%)', ' Left ventricular dysfunction 1/382 (0.26%)']}

{'Clinical Trial ID': 'NCT00274768', 'Intervention': ['INTERVENTION 1: ', ' Capecitabine', ' The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast', ' Evidence of metastatic involvement (stage IV disease)', ' Patients must have measurable disease', ' At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)', ' Treated brain metastases (surgery or radiation therapy) allowed if clinically stable', ' Patients with leptomeningeal disease are ineligible', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2', ' Male or female', ' Menopausal status not specified', ' Absolute neutrophil count (ANC) 1,500/mm^3', ' Platelet count 100,000/mm^3', ' Creatinine clearance > 50 mL/min', ' Fertile patients must use effective contraception', ' No history of another severe and/or life-threatening medical disease', ' No other active primary malignancy', ' Not pregnant or nursing', ' Negative pregnancy test', ' Patients with asymptomatic HIV infection are eligible', ' Liver dysfunction score 9', ' No pre-existing liver disease (i.e., cirrhosis or active viral hepatitis)', ' No active gastrointestinal malabsorption illness', ' No clinically significant cardiac disease, including the following:', ' Congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication, or myocardial infarction within the past six months', ' No prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency', ' No history of uncontrolled seizures or central nervous system disorders', ' No significant history of noncompliance to medical regimens', ' No clinically significant psychiatric disability that would preclude study compliance', ' PRIOR CONCURRENT THERAPY:', ' No previous capecitabine', ' Up to 3 prior cytotoxic regimens allowed for metastatic disease', ' Prior noncytotoxic therapy allowed (e.g., hormonal treatment or trastuzumab)', ' No other concurrent therapies intended to treat the primary condition including chemotherapy, biologic agents, or immunotherapy', ' No concurrent anti-estrogen therapy, radiation therapy, or investigational systemic therapy', ' No other concurrent investigational drugs', ' No concurrent use of the following drugs: warfarin for full anticoagulation, cimetidine, or azidothymidine (AZT)', ' Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed', ' At least 4 weeks since prior sorivudine or brivudine', ' Concurrent use of bisphosphonates allowed if initiated before beginning study therapy', ' Concurrent use of megestrol acetate suspension as an appetite stimulant allowed'], 'Results': ['Outcome Measurement: ', ' Response Rate', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', ' Time frame: Participants were followed to progression, evaluated every 12 weeks', 'Results 1: ', ' Arm/Group Title: Capecitabine', ' Arm/Group Description: The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: participants 21'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/26 (7.69%)', ' Death [1]2/26 (7.69%)']}

596f20cf-299d-40a3-881a-cdd49bcb21f6

Single

Adverse Events

NCT03066947

At least one patient in the primary trial suffered from Gastroesophageal reflux disease.

Entailment

{'Clinical Trial ID': 'NCT03066947', 'Intervention': ['INTERVENTION 1: ', ' SV-BR-1-GM Monotherapy', ' Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites ~2 and ~4 days after SV-BR-1-GM inoculation', ' SV-BR-1-GM: See above', ' Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells', ' Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response'], 'Eligibility': ['Inclusion Criteria:', ' 1. Have histological confirmation of breast cancer with recurrent and/or metastatic lesions via investigational site.', ' Patients with new or progressive breast cancer metastatic to brain will be eligible provided:', ' There is no need for steroids and patients have not had steroids at least 2 weeks', ' No individual tumor size is >50 mm3', ' ECOG status <3', ' Tumor is not impinging on Middle Cerebral Artery/speech-motor strip', ' If surgically debulked, must be healed from surgery and at least 3 weeks have elapsed since general anesthesia', ' Patients consent to MRI studies at 3-4 week intervals until evidence of tumor regression on at least 2 imaging studies. In no case, will the interval between MRI studies be longer than 3 months. MRI study may be introduced at any time should the patients develop new or clearly worsening symptoms and/or introduction of steroids', ' 2. Have evidence of persistent, recurrent, or progressive disease for which there is no known or established treatment available with curative intent, after failing at least one course of community standard systemic treatment with chemotherapy (and endocrine therapy if appropriate)', ' 3. Be 18 years of age or older and female', ' 4. Have expected survival of at least 4 months', ' 5. Have adequate performance status (ECOG 0-2)', ' 6. Patients may be maintained on hormonal therapy provided there is clear evidence of tumor progression', ' 7. Have provided written informed consent.', 'Exclusion Criteria:', ' Concurrent or recent chemotherapy (within 3 weeks), XRT within 3 weeks, may have had immunotherapy in the past (off within 3 weeks), or general anesthesia/major surgery (within 3 weeks). Patients must have recovered from all known or expected toxicities from previous treatment and passed a treatment-free "washout" period of 3 weeks before starting this program (8 weeks for persons receiving nitrosourea or mitomycin).', ' History of clinical hypersensitivity to GM-CSF, Interferon-alpha-2b (Merck), yeast, beef, or to any components used in the preparation of the experimental vaccine.', ' BUN >30 and a creatinine >2.', ' Absolute granulocyte count < 1000; platelets <100,000.', ' Bilirubin >2.0; alkaline phosphatase >5x upper limit of normal (ULN); ALT/AST >2x ULN.', ' Proteinuria >1+ on urinalysis or >1 gm/24hr.', ' Left ventricular ejection fraction (LVEF as determined by cardiac echo or MUGA scan) below the normal limits of the institutions specific testing range. This assessment may be repeated once at the discretion of the Investigator with the approval of the Sponsor.', ' New York Heart Association stage 3 or 4 cardiac disease.', ' A pleural effusion of moderate severity or worse.', ' Any woman of childbearing potential, unless she:', ' Agrees to take measures to avoid becoming pregnant during the study and', ' Has a negative serum pregnancy test within 7 days prior to starting treatment.', ' Women who are pregnant or nursing.', ' Patients with concurrent second malignancy. Persons with previous malignancies effectively treated and not requiring treatment for >24 months are eligible, provided there is unambiguous documentation that current local recurrence or metastatic site represents recurrence of the primary breast malignancy.', ' Patients who are HIV positive (by self-report) or have clinical or laboratory features indicative of AIDS.', ' 14. Patients who require systemic steroids at a dose equivalent of >10 mg/day of prednisone. Beta-blocker therapy, while not exclusionary, is discouraged and alternatives should be sought if possible. The beta-blocker might compromise use of epinephrine for the rare possibility of anaphylaxis. Anticoagulants must be approved by the Investigator with notification of the Sponsor.', ' Patients who are on treatment for rheumatological or autoimmune disease unless approved by the Investigator in consultation with the Sponsor (e.g., as for replacement therapy for autoimmune thyroiditis or diabetes).', ' Patients with severe psychiatric (i.e. schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the PI.', ' Male breast cancer patients.', ' Patients may not be on a concurrent clinical trial, unless approved by PI.'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]', ' To evaluate the number of patients with toxicity events while on SV-BR-1-GM, as defined by the Common Terminology Criteria for Adverse Events (CTCAE)', ' Time frame: Through study completion, an average of 1 year', 'Results 1: ', ' Arm/Group Title: SV-BR-1-GM Monotherapy', ' Arm/Group Description: Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites ~2 and ~4 days after SV-BR-1-GM inoculation', ' SV-BR-1-GM: See above', ' Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells', ' Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response', ' Overall Number of Participants Analyzed: 24', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Patients with Adverse Events: 24 100.0%', ' Erythema injection site: 11 45.8%', ' Pruritis injection site: 8 33.3%', ' Induration injection site: 7 29.2%', ' Fatigue: 6 25.0%', ' Nausea: 6 25.0%', ' Constipation: 5 20.8%', ' Abdominal pain: 4 16.7%', ' Flu like symptoms: 4 16.7%', ' Diarrhea: 3 12.5%', ' GGTP increased: 3 12.5%', ' Injection site reaction: 3 12.5%', ' Urinary Tract Infection: 3 12.5%', ' Vomiting: 3 12.5%', ' Abdominal distension: 2 8.3%', ' Alkaline Phosphatase Increased: 2 8.3%', ' ALT Increased: 2 8.3%', ' Anorexia: 2 8.3%', ' AST Increased: 2 8.3%', ' Back Pain: 2 8.3%', ' Chills: 2 8.3%', 'Decreased appetite: 2 8.3%', ' Dehydration: 2 8.3%', ' Dizziness: 2 8.3%', ' Erythema Multiforme: 2 8.3%', ' Glucose increased: 2 8.3%', ' Hematocrit Decreased: 2 8.3%', ' Hypercalcemia: 2 8.3%', ' Lymphocytes Decreased: 2 8.3%', ' Myalgia: 2 8.3%', ' Pleural Effusion: 2 8.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/24 (33.33%)', ' Restrictive Cardiomyopathy * 21/24 (4.17%)', ' Palpitations * 21/24 (4.17%)', ' GERD * 21/24 (4.17%)', ' Fever * 21/24 (4.17%)', ' Sepsis * 1/24 (4.17%)', ' Urinary Tract Infection * 21/24 (4.17%)', ' Influenza A * 21/24 (4.17%)', ' Dehydration * 21/24 (4.17%)', ' Hyponatremia * 21/24 (4.17%)', ' Worsening of Hypercalcemia * 21/24 (4.17%)', ' Bone Pain * 21/24 (4.17%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

78ae19aa-6e26-4f9a-b381-cd77d92e4ecb

Comparison

Eligibility

NCT00418028

NCT00293540

Sam has recently received a liver transplant, he is not eligible for the primary trial, but is eligible for the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00418028', 'Intervention': ['INTERVENTION 1: ', ' Arm A (Cint)', ' Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.', 'INTERVENTION 2: ', ' Arm B (Ccont)', ' Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.'], 'Eligibility': ['Inclusion Criteria', ' Patients diagnosed with metastatic breast cancer', ' Patients that either have received previous treatment with anthracyclines and/or taxanes or not (either as advance or in metastatic disease).', ' The patient is ambulatory with a functional ECOG < 2 status (see Appendix 2).', ' Patient presents, at least one lesion measurable according to RECIST criteria (see Appendix 3)', ' Patients with a life expectancy of at least 3 months.', ' Patients that agree to and are able to fulfill the requirements of the whole protocol through the whole study.', 'Exclusion criteria:', ' Patients that have previously shown unexpected severe reactions to therapy with fluoropyrimidines or with a known sensitivity to 5-fluorouracile.', ' Patients previously treated with capecitabine.', ' Patients with organ transplants.', ' Other diseases or severe affections:', ' Patients with previous convulsions, central nervous system diseases or psychiatric diseases, including dementia, that the investigator might consider clinically significant and which adversely affect therapeutic compliance.', ' Patients with severe intellectual impairment, unable to carry out basic daily routines and established depression.', ' Clinical significant cardiac disease (e. g. . congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not fully controlled with medication) or myocardial infarction within the last 12 months.', ' Severe renal impairment (baseline creatinine clearance < 30 ml/min)', ' Patients with signs of metastasis in the CNS. Patients with a history of uncontrolled convulsions, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded.', ' Patients with an active infection.', ' Patients with a history of other neoplasias during the previous five years, except for basal cell skin cancer or cervical cancer in situ, both cured.', ' Patients showing the following laboratory values:', ' Neutrophil count < 555 x 109/l', ' Platelet count< 100 x 109/l', ' Serum creatinine > 1,5 x upper normality limit', ' seric bilirubin > 2,0 x upper normality limit', ' ALAT, ASAT > 2,5 x upper normality limit or > 5 x upper normality limit in case of liver metastases', ' Alkaline phosphatase > 2,5 x upper normality limit > 5 x upper normality limit in case of liver metastases o > 10 x upper normality limit in case of bone metastases.', ' Patients under radiotherapy four weeks prior to the initiation of the study treatment, or under previous radiotherapy on the marker lesions be measured during the study (new marker lesions that appear in previously irradiated areas are accepted) or patients who are receiving programmed radiotherapy.', ' Patients under major surgery within 4 weeks prior to study treatment or who have not completely recovered from the effects of major surgery.', ' Patients who lack upper gastrointestinal tract physical integrity or with malabsorption syndrome.', ' Patients who have received more than two cycles of chemotherapy for the metastatic disease.', ' Patients Her2 + per FISH ó +++ Immunohistochemistry'], 'Results': ['Outcome Measurement: ', ' Time to Progression', ' Time to Progression (TTP) is defined as the time (in months) from the moment the patient starts the study treatment to the date of progressive disease. That is, a patient has an event is she progresses or dies due to progressive disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).', ' Time frame: After 1 year from the treatment start day.', 'Results 1: ', ' Arm/Group Title: Arm A (Cint)', ' Arm/Group Description: Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.', ' Overall Number of Participants Analyzed: 72', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.68 (6.55 to 11.05)', 'Results 2: ', ' Arm/Group Title: Arm B (Ccont)', ' Arm/Group Description: Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.', ' Overall Number of Participants Analyzed: 84', ' Median (95% Confidence Interval)', ' Unit of Measure: months 6.84 (6.02 to 8.06)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/95 (13.68%)', ' Neutrophils/granulocytes (ANC/AGC)1/95 (1.05%)', ' Ventricular arrhythmia1/95 (1.05%)', ' Diarrhea6/95 (6.32%)', ' Obstruction1/95 (1.05%)', ' Mucositis/stomatitis1/95 (1.05%)', ' Febrile neutropenia2/95 (2.11%)', ' Infection with unknown ANC0/95 (0.00%)', ' Dizziness1/95 (1.05%)', ' Renal failure0/95 (0.00%)', 'Adverse Events 2:', ' Total: 4/97 (4.12%)', ' Neutrophils/granulocytes (ANC/AGC)1/97 (1.03%)', ' Ventricular arrhythmia0/97 (0.00%)', ' Diarrhea0/97 (0.00%)', ' Obstruction0/97 (0.00%)', ' Mucositis/stomatitis0/97 (0.00%)', ' Febrile neutropenia0/97 (0.00%)', ' Infection with unknown ANC1/97 (1.03%)', ' Dizziness0/97 (0.00%)', ' Renal failure1/97 (1.03%)']}

{'Clinical Trial ID': 'NCT00293540', 'Intervention': ['INTERVENTION 1: ', ' A Mid-luteal Surgery', '[Not Specified]', 'INTERVENTION 2: ', ' B Mid-follicular Surgery', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' Estrogen receptor or progesterone receptor positive breast cancer', ' Premenopausal with regular menstrual cycles', 'Exclusion Criteria:', ' Current oral contraceptives'], 'Results': ['Outcome Measurement: ', ' Overall Survival', ' Assess whether patients who undergo surgical oophorectomy in the history-estimated mid-luteal phase of their menstrual cycles survive longer than patients who undergo this surgery in the history-estimated mid-follicular phase of their menstrual cycles.', ' Time frame: Up to 9 years', 'Results 1: ', ' Arm/Group Title: A Mid-luteal Surgery', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 115', ' Median (95% Confidence Interval)', ' Unit of Measure: years 2.14 (1.53 to 2.67)', 'Results 2: ', ' Arm/Group Title: B Mid-follicular Surgery', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 119', ' Median (95% Confidence Interval)', ' Unit of Measure: years 2.00 (1.61 to 2.31)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/115 (0.00%)', ' Deep vein thrombosis * [1]0/115 (0.00%)', 'Adverse Events 2:', ' Total: 1/119 (0.84%)', ' Deep vein thrombosis * [1]1/119 (0.84%)']}

1d4f9f95-6f97-4054-9dd8-fe78aa5fc685

Single

Intervention

NCT01781299

all subjects in the primary trial must undergo a minor surgery.

Entailment

{'Clinical Trial ID': 'NCT01781299', 'Intervention': ['INTERVENTION 1: ', ' AlloDerm RTU', ' Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.', 'AlloDerm RTU', 'INTERVENTION 2: ', ' SurgiMend PRS', ' Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.', 'SurgiMend PRS'], 'Eligibility': ['Inclusion Criteria:', " Subject's with ability to provide informed consent.", ' Subjects greater than 18 years old', ' Subjects to undergo an immediate tissue expander reconstruction following mastectomy; and', ' Subjects who are, in the opinion of the Investigator, able to understand the study, comply with the study design and are willing to return to the clinic for all the research required follow-up visits.', 'Exclusion Criteria:', ' Subjects less than 18 years of age', " Subjects that based on surgeon's discretion cannot be effectively reconstructed with the use of ADM product", ' Pregnancy', 'Bovine allergy'], 'Results': ['Outcome Measurement: ', ' Complication Rates', ' To determine the complication rate for tissue expander breast reconstruction patients using SurgiMend PRS and AlloDerm RTU ADM products. Time points include: After first procedure: 10-14 days, then 2, 4, 6, and 10 weeks after drain removal; After second procedure: 1-2 weeks, 6 weeks, 1 year, and 3 years.', ' Time frame: 3 years', 'Results 1: ', ' Arm/Group Title: AlloDerm RTU', ' Arm/Group Description: Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.', ' AlloDerm RTU', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 4 100.0%', 'Results 2: ', ' Arm/Group Title: SurgiMend PRS', ' Arm/Group Description: Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.', ' SurgiMend PRS', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 3 75.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/4 (0.00%)', 'Adverse Events 2:', ' Total: 0/5 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

d4b2d877-34af-4944-84f7-046e22c2854e

Single

Results

NCT00119262

cohorts 1 and 2 of the primary trial recorded a different number of patients that suffered from Congestive Heart Failure.

Contradiction

{'Clinical Trial ID': 'NCT00119262', 'Intervention': ['INTERVENTION 1: ', ' Arm A (ddBAC > BT > B)', ' Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab', 'INTERVENTION 2: ', ' Arm B (ddAC > BT > B)', ' Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed adenocarcinoma of the breast with involvement of at least one axillary or internal mammary lymph node on routine histologic examination with hematoxylin and eosin staining; NOTE: patients with axillary or internal mammary node involvement only demonstrated by immunohistochemistry are not eligible', ' Patients must have completed definitive breast surgery including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy, lumpectomy and axillary dissection, or lumpectomy and sentinel node biopsy; NOTE: axillary dissection is strongly encouraged in patients with lymph node involvement identified on sentinel node biopsy', ' Margins of lumpectomy or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ (DCIS); patients with resection margins positive for lobular carcinoma in situ (LCIS) are eligible', ' (ARM A ONLY) Interval between last surgery for breast cancer (lumpectomy, mastectomy, sentinel node biopsy, axillary dissection or re-excision of lumpectomy margins) and D1 must be > 28 days and =< 84 days', ' ECOG performance status of 0-2', ' Absolute neutrophil count >= 1000/mm^3', ' Platelet count >= 100,000/mm^3', ' Total bilirubin =< 1.5 mg/dL', ' AST =< 2 upper limit of normal', ' Serum creatinine =< 1.5 mg/dL', ' Urine protein: creatinine ratio < 1.0', ' PT INR =< 1.5', ' PTT =< 1.5 x normal', ' LVEF >= institutional limits of normal by MUGA or ECHO', " Prior to registration the investigator must specify if radiation is planned; patients who have undergone a lumpectomy must receive radiation; post-mastectomy radiation is at the investigator's discretion", ' Patients with HER2+ (3+ by IHC or FISH+) breast cancer are not eligible and should be treated with a trastuzumab-based adjuvant therapy', ' Patients with synchronous bilateral breast cancer (diagnosed within one month) are eligible if the higher TMN stage tumor meets the eligibility criteria for this trial', ' Patients must not have clinical evidence of inflammatory disease or fixed axillary nodes (N2) at diagnosis', ' Patients must not have received prior cytotoxic chemotherapy, hormonal therapy or radiation for this breast cancer; prior treatment with an anthracycline, anthracenedione or taxane for any condition is not allowed; NOTE: prior use of tamoxifen for chemoprevention is allowed but must be discontinued at study entry; similarly prior raloxifene use is allowed but must be discontinued at study entry', ' Patients must not have had a major surgical procedure within 4 weeks of entry; NOTE: non-operative biopsy or placement of a vascular access device is not considered a major surgery', ' Patients must not have clinically significant cardiovascular disease including:', ' New York Heart Association (NYHA) grade II or greater congestive heart failure', ' Grade II or greater peripheral vascular disease', ' Uncontrolled hypertension defined as SBP > 160 or DBP > 90', ' Any prior history of cerebrovascular disease including TIA or stroke', ' Patients must not require therapeutic anticoagulation; patients with a history of deep venous thrombosis or pulmonary embolism are not eligible; NOTE: prophylactic use of anticoagulants to maintain patency of a vascular assess device is permitted', ' Patients may not require regular use of aspirin (daily for >= 10 days at doses of > 325 mg/day) or regular therapeutic doses of other nonsteroidal anti-inflammatory agents known to inhibit platelet function; additionally, patients using any of the following drugs known to inhibit platelet function are not eligible: dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and cilostazol (Pletal); NOTE: regular use of Cox-2 inhibitors is permitted; NOTE: low-dose aspirin is permitted', ' Patients must not have a non-healing wound or fracture; patients with an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months are excluded', ' Patients must not have hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products or other recombinant human antibodies', ' Patients who have experienced myocardial infarction or unstable angina within 12 months are excluded', ' Patients who have had experienced an arterial thrombotic event within 12 months are excluded', ' Patients must not have uncontrolled or clinical significant arrhythmia', ' Women must not be pregnant or breast-feeding due to the potential harmful effects of bevacizumab on the developing fetus; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy', ' Women of childbearing potential and sexually active males are required to use an accepted and effective method of contraception while on study and for at least 3-4 months after the last dose of bevacizumab'], 'Results': ['Outcome Measurement: ', ' Congestive Heart Failure Rate', ' Clinical congestive heart failure includes patients with symptomatic decline in LVEF to at or below the lower limit of normal (LLN), or symptomatic diastolic dysfunction. 223 treated patients were included in the analysis.', ' Time frame: assessed on day 1 of cycles 5, 9, 17 and 25, and at end of treatment, then every 3 months for <2 years and every 6 months for 2-3 years from study entry', 'Results 1: ', ' Arm/Group Title: Arm A (ddBAC > BT > B)', ' Arm/Group Description: Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab', ' Overall Number of Participants Analyzed: 103', ' Measure Type: Number', ' Unit of Measure: percentage of participants 2.9 (0.6 to 8.3)', 'Results 2: ', ' Arm/Group Title: Arm B (ddAC > BT > B)', ' Arm/Group Description: Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab', ' Overall Number of Participants Analyzed: 120', ' Measure Type: Number', ' Unit of Measure: percentage of participants 2.5 (0.5 to 7.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 71/103 (68.93%)', ' Anemia 1/103 (0.97%)', ' Hemolysis 1/103 (0.97%)', ' Febrile neutropenia 4/103 (3.88%)', ' Cardiac-Ischemia 1/103 (0.97%)', ' Left ventricular diastolic dysfunction 1/103 (0.97%)', ' Left ventricular systolic dysfunction 4/103 (3.88%)', ' Diarrhea w/o prior colostomy 2/103 (1.94%)', ' Muco/stomatitis (symptom), oral cavity 3/103 (2.91%)', 'Adverse Events 2:', ' Total: 65/120 (54.17%)', ' Anemia 4/120 (3.33%)', ' Hemolysis 0/120 (0.00%)', ' Febrile neutropenia 5/120 (4.17%)', ' Cardiac-Ischemia 0/120 (0.00%)', ' Left ventricular diastolic dysfunction 2/120 (1.67%)', ' Left ventricular systolic dysfunction 4/120 (3.33%)', ' Diarrhea w/o prior colostomy 0/120 (0.00%)', ' Muco/stomatitis (symptom), oral cavity 3/120 (2.50%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

d3ca3729-2795-4cd5-9968-666781d17fac

Single

Adverse Events

NCT01752907

There were 0 observed cases of Tibia or Fibula fractures in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01752907', 'Intervention': ['INTERVENTION 1: ', ' General Education DVD', ' Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.', 'INTERVENTION 2: ', ' Bone Pain Education DVD', ' Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.'], 'Eligibility': ['Inclusion Criteria', ' Age 18 years or over', ' Eastern cooperative oncology group (ECOG) performance status 0-2', ' Female with newly diagnosed, not previously treated with chemotherapy, stage I-III breast cancer', ' Planning to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy', ' Medically eligible to safely receive adjuvant or neoadjuvant chemotherapy and pegfilgrastim as determined by the investigator', ' Planning to receive prophylaxis with pegfilgrastim starting in the first cycle and continuing throughout each chemotherapy cycle of the study period', ' Has provided informed consent', " Able to understand the content of the DVD material, in investigator's opinion", ' Able to read and understand English', ' Exclusion Criteria', ' Planning to receive weekly chemotherapy', ' Chronic use of oral non-steroidal anti-inflammatory drugs (NSAIDs) or oral antihistamines with the following exception:', ' - Chronic oral aspirin use for cardiovascular-related indications', ' Ongoing chronic pain, or other painful conditions requiring treatment (including immediate post-operative treatment of surgical or procedural-associated pain) as determined by the investigator', ' Chronic oral steroid use. Premedication related to the administration of taxanes, and use of anti-emetics is allowed, per usual clinical practice.', ' Prior chemotherapy treatment for cancer within 5 years of current breast cancer diagnosis', ' Prior use of granulocyte-colony stimulating factor (G-CSF)', ' Currently enrolled in, or less than 30 days since ending, another clinical trial which includes language directing G-CSF (filgrastim, pegfilgrastim, other) or granulocyte-macrophage colony stimulating factor (GM-CSF) (sargramostim) use', ' Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes a blinded treatment or blinded treatment arm (whether or not the subject is randomized to the blinded arm)', ' Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes the use of any agent not currently considered to be standard therapy for the adjuvant or neoadjuvant treatment of stage I-III breast cancer based on National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Breast Cancer', ' Currently enrolled in, or less than 30 days since ending, any pain intervention study'], 'Results': ['Outcome Measurement: ', ' Maximum Patient-reported Bone Pain in Cycle 1', ' Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.', ' Time frame: Days 1 to 5 during cycle 1.', 'Results 1: ', ' Arm/Group Title: General Education DVD', ' Arm/Group Description: Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.', ' Overall Number of Participants Analyzed: 149', ' Mean (Standard Error)', ' Unit of Measure: units on a scale 3.2 (0.2)', 'Results 2: ', ' Arm/Group Title: Bone Pain Education DVD', ' Arm/Group Description: Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.', ' Overall Number of Participants Analyzed: 151', ' Mean (Standard Error)', ' Unit of Measure: units on a scale 3.5 (0.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/149 (10.74%)', ' Anaemia 0/149 (0.00%)', ' Febrile neutropenia 7/149 (4.70%)', ' Neutropenia 1/149 (0.67%)', ' Pancytopenia 1/149 (0.67%)', ' Atrial fibrillation 2/149 (1.34%)', ' Cardiac failure congestive 0/149 (0.00%)', ' Abdominal pain 0/149 (0.00%)', ' Diarrhoea 2/149 (1.34%)', ' Dyspepsia 0/149 (0.00%)', ' Gastritis haemorrhagic 0/149 (0.00%)', ' Nausea 2/149 (1.34%)', 'Adverse Events 2:', ' Total: 20/151 (13.25%)', ' Anaemia 1/151 (0.66%)', ' Febrile neutropenia 4/151 (2.65%)', ' Neutropenia 2/151 (1.32%)', ' Pancytopenia 0/151 (0.00%)', ' Atrial fibrillation 0/151 (0.00%)', ' Cardiac failure congestive 1/151 (0.66%)', ' Abdominal pain 1/151 (0.66%)', ' Diarrhoea 3/151 (1.99%)', ' Dyspepsia 1/151 (0.66%)', ' Gastritis haemorrhagic 1/151 (0.66%)', ' Nausea 1/151 (0.66%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

fb85a3a5-b9a1-48f4-84f3-2e2307e2f104

Comparison

Adverse Events

NCT01901146

NCT00209092

Cohort 1 of the primary trial recorded the same number of instances of Neutropenic fever as Cohort 1 of the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT01901146', 'Intervention': ['INTERVENTION 1: ', ' ABP 980', ' Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.', 'INTERVENTION 2: ', ' Trastuzumab', ' Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Females 18 years of age', ' Histologically confirmed invasive breast cancer', ' Planning for surgical resection of breast tumor and sentinel node or axillary lymph node resection', ' Planning neoadjuvant chemotherapy', ' HER2 positive disease', ' Measurable disease in the breast after diagnostic biopsy, defined as longest diameter 2.0 cm', ' Known estrogen receptor (ER) and progesterone receptor (PR) hormone receptor status at study entry', ' Normal bone marrow function', ' Normal hepatic function', ' Normal renal function', ' Subjects must sign an Institutional Review Board/Ethics Committee (IRB/EC)-approved informed consent form before any study specific procedures', ' Inclusion Criteria for Randomization:', ' Left ventricular ejection fraction (LVEF) of 55% by 2D echocardiogram', ' Complete all 4 cycles of run-in chemotherapy', 'Exclusion Criteria:', ' Bilateral breast cancer', ' Presence of known metastases', ' Received prior treatment, including chemotherapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer', ' Other concomitant active malignancy or history of malignancy in the past 5 years except treated basal cell carcinoma of the skin or carcinoma in situ of the cervix', ' Pre-existing clinically significant ( grade 2) peripheral neuropathy', ' Any history of documented or current congestive heart failure, current high-risk uncontrolled arrhythmias, current angina pectoris requiring a medicinal product, current clinically significant valvular disease, current evidence of transmural infarction on electrocardiogram (ECG), or current poorly controlled hypertension', ' Severe dyspnea at rest requiring supplementary oxygen therapy', ' History of positivity for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV)', ' Recent infection requiring a course of systemic anti-infectives that were completed 14 days before enrollment (with the exception of uncomplicated urinary tract infection)', ' Woman of childbearing potential who is pregnant or is breast feeding', ' Woman of childbearing potential who is not consenting to use highly effective methods of birth control (eg, true abstinence [periodic abstinence (eg calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception], sterilization, or other non-hormonal forms of contraception) during treatment and for at least 7 months after the last administration of the protocol specified treatment', ' Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study', ' Other investigational procedures while participating in this study are excluded', ' Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products, trastuzumab, murine proteins, or to any of the excipients', ' Subject previously has enrolled and/or has been randomized in this study', ' Subject likely to not be available to complete all protocol required study visits or procedures', ' History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With a Pathologic Complete Response', ' Pathologic complete response (pCR) was defined as the absence of invasive tumor cells in the breast tissue and in axillary lymph nodes, regardless of residual ductal carcinoma in situ (DCIS).', ' Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.', ' Time frame: 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase', 'Results 1: ', ' Arm/Group Title: ABP 980', ' Arm/Group Description: Participants received ABP 980 at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m paclitaxel Q3W for 4 cycles.', ' Overall Number of Participants Analyzed: 358', ' Measure Type: Number', ' Unit of Measure: percentage of participants 48.0', 'Results 2: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: Participants received trastuzumab at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m paclitaxel Q3W for 4 cycles.', ' Overall Number of Participants Analyzed: 338', ' Measure Type: Number', ' Unit of Measure: percentage of participants 40.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/364 (4.95%)', ' Febrile neutropenia 3/364 (0.82%)', ' Atrial fibrillation 1/364 (0.27%)', ' Cardio-respiratory arrest 1/364 (0.27%)', ' Sinus bradycardia 1/364 (0.27%)', ' Ventricular extrasystoles 0/364 (0.00%)', ' Enterocolitis 0/364 (0.00%)', ' Faecaloma 0/364 (0.00%)', ' Gastric ulcer perforation 0/364 (0.00%)', ' Gastrointestinal toxicity 0/364 (0.00%)', ' Pancreatitis acute 0/364 (0.00%)', 'Adverse Events 2:', ' Total: 5/361 (1.39%)', ' Febrile neutropenia 0/361 (0.00%)', ' Atrial fibrillation 0/361 (0.00%)', ' Cardio-respiratory arrest 0/361 (0.00%)', ' Sinus bradycardia 0/361 (0.00%)', ' Ventricular extrasystoles 0/361 (0.00%)', ' Enterocolitis 0/361 (0.00%)', ' Faecaloma 0/361 (0.00%)', ' Gastric ulcer perforation 0/361 (0.00%)', ' Gastrointestinal toxicity 1/361 (0.28%)', ' Pancreatitis acute 0/361 (0.00%)']}

{'Clinical Trial ID': 'NCT00209092', 'Intervention': ['INTERVENTION 1: ', ' Arm A:Sequential Therapy', ' Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).', 'INTERVENTION 2: ', ' Arm B:Concurrent Therapy', ' Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed breast carcinoma.', ' Early stage breast cancer (stage 1, 2, 3).', ' No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.', ' 18 years of age or older.', ' Final eligibility for a clinical trial is determined by the health professionals conducting the trial.', 'Exclusion Criteria:', ' Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.', ' Major surgery within 28 days of study entry.', ' Evidence of central nervous system (CNS) metastases.', ' Final eligibility for a clinical trial is determined by the health professionals conducting the trial.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.', ' Pathologic complete response (pCR): Absence of invasive breast cancer in the breast.', ' Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignant disease)+partial response(PR-reduction by at least 30%)', ' Stable disease (SD): No decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions.', ' Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Arm A:Sequential Therapy', ' Arm/Group Description: Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: participants Pathologic Complete Response-Overall population: 2', ' Overall Clinical Response: 15', ' Stable disease: 3', ' Progressive Disease: 7', 'Results 2: ', ' Arm/Group Title: Arm B:Concurrent Therapy', ' Arm/Group Description: Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: participants Pathologic Complete Response-Overall population: 3', ' Overall Clinical Response: 23', ' Stable disease: 1', ' Progressive Disease: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/25 (24.00%)', ' Neutropenia *3/25 (12.00%)', ' Anemia *0/25 (0.00%)', ' Febrile Neutropenia *0/25 (0.00%)', ' Chest Pain *0/25 (0.00%)', ' Diarrhea *1/25 (4.00%)', ' Fatigue *1/25 (4.00%)', ' Liver Tests *0/25 (0.00%)', ' Neuropathy *0/25 (0.00%)', ' Syncope *0/25 (0.00%)', ' Hand and Foot Syndrome *1/25 (4.00%)', 'Adverse Events 2:', ' Total: 11/26 (42.31%)', ' Neutropenia *3/26 (11.54%)', ' Anemia *1/26 (3.85%)', ' Febrile Neutropenia *1/26 (3.85%)', ' Chest Pain *1/26 (3.85%)', ' Diarrhea *1/26 (3.85%)', ' Fatigue *0/26 (0.00%)', ' Liver Tests *1/26 (3.85%)', ' Neuropathy *1/26 (3.85%)', ' Syncope *1/26 (3.85%)', ' Hand and Foot Syndrome *1/26 (3.85%)']}

b98c7a50-ed79-41ff-9733-fff143f630be

Comparison

Intervention

NCT02203565

NCT00194779

laboratory biomarker analysis is used in the secondary trial and the primary trial.

Entailment

{'Clinical Trial ID': 'NCT02203565', 'Intervention': ['INTERVENTION 1: ', " Supportive Care (Dakin's Solution, Radiation Therapy)", " Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.", " Dakin's solution: Applied topically", ' radiation therapy: Undergo radiation therapy', ' questionnaire administration: Ancillary studies', ' laboratory biomarker analysis: Optional correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Women with breast cancer who plan to undergo radiation therapy to the breast or chest wall', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Women with scleroderma or discoid lupus', ' Women with inflammatory breast cancer as evidenced by clinical assessment', ' Women with breast cancer involving the skin', ' Women who have undergone prior radiotherapy to the chest wall and/or breast'], 'Results': ['Outcome Measurement: ', ' Percent of Women Who Develop Grade 3 or 4 Radiation Dermatitis (as Defined by the Stanford Radiation Dermatitis Scoring System) During a Course of Radiation Therapy', ' Stanford Radiation Dermatitis Scoring System:', ' Grade Clinical finding', ' 0 No skin change', ' 1 Faint, barely detectable erythema 2 Follicular rash, hyperpigmentation, evolving erythema 3 Dry desquamation, brisk erythema 4 Moist desquamation 5 Bleeding, ulceration, and/or infection', ' Time frame: Baseline to up to 6 weeks after completion of therapy', 'Results 1: ', " Arm/Group Title: Supportive Care (Dakin's Solution, Radiation Therapy)", " Arm/Group Description: Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.", " Dakin's solution: Applied topically", ' radiation therapy: Undergo radiation therapy', ' questionnaire administration: Ancillary studies', ' laboratory biomarker analysis: Optional correlative studies', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 6 42.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/20 (15.00%)', ' Dermatitis radiation 3/20 (15.00%)']}

{'Clinical Trial ID': 'NCT00194779', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Neoadjuvant Therapy, Adjuvant Therapy)', ' See Detailed Description.', ' doxorubicin hydrochloride: Given IV', ' cyclophosphamide: Given PO', ' paclitaxel: Given IV', ' filgrastim: Given SC', ' capecitabine: Given PO', ' methotrexate: Given IV', ' vinorelbine tartrate: Given IV', ' needle biopsy: Correlative studies', ' therapeutic conventional surgery: Undergo definitive breast surgery', ' immunohistochemistry staining method: Correlative studies', ' trastuzumab: Given IV', ' tamoxifen citrate: Given PO', ' letrozole: Given PO', ' laboratory biomarker analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Have known tumor HER-2/neu expression; if determination is "intermediate" by immunohistochemistry, fluorescent in situ hybridization (FISH) must be performed; protocol therapy is determined by HER-2/neu result', ' Have histologically confirmed, operable breast cancer that is either:', ' Hormone receptor (estrogen receptor [ER] or progesterone receptor [PR]) positive and HER2/neu positive or', ' ER/PR negative', ' Have radiographically measurable breast cancer > 1cm (Operable lesions are T1c-T3 and N0-N2a; histologic confirmation should be by core needle biopsy only)', ' Be chemotherapy naïve', ' Eastern Cooperative Oncology Group (ECOG) performance status of =< 2', ' Absolute neutrophil count (ANC) >= 1,500', ' Platelet count >= 100,000', ' Serum creatinine =< 1.5 x international upper limit of normal (IULN)', ' Bilirubin < 2.0', ' Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvate transaminase (SGPT) =< 2 x IULN', ' Alkaline phosphatase =< 2 x IULN', ' Have staging studies and tumor assessment prior to registration; staging studies include physical exam with bidimensional tumor measurements and mammography, ultrasound, or magnetic resonance imaging (MRI) to assess tumor volume; sentinel lymph node dissection or axillary needle biopsy must be completed prior to enrollment; MRI and positron emission tomography (PET) (fluorodeoxyglucose [FDG], methoxyisobutylisonitrile [MIBI] and fluoroestradiol [FES]) imaging will be done before enrollment if clinically indicated to assess tumor volume or may be done within the first month of study participation on another institutional protocol', ' Patients with clinically apparent cardiac disease, or history of same, are not eligible; patients who are >= 60 years of age or who have a history of hypertension must have an echocardiogram or multi gated acquisition scan (MUGA) prior to enrollment; patients with breast cancer that is HER-2/neu positive who will receive herceptin (trastuzumab) must have an echocardiogram or MUGA scan; the left ventricular ejection fraction (LVEF) must be within the institutional normal range; if LVEF is > 75%, the investigator should consider having the LVEF reviewed or repeating the MUGA prior to registration', ' Women of childbearing potential must have a negative pregnancy test within seven days prior to registration', ' Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures', 'Exclusion Criteria:', ' Primary tumor =< 1 cm, not measurable; inflammatory disease', ' Pregnant or lactating; woman of childbearing potential with either a positive or no pregnancy test at baseline are excluded; postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential; patients must agree to continue contraception for 30 days from the date of the last study drug administration; woman of childbearing potential not using a reliable and appropriate contraceptive method are excluded', ' Evidence of distant metastatic disease', ' Prior chemotherapy or hormonal therapy for breast cancer', ' Except for the following no other malignancy is allowed: synchronous ipsilateral breast cancer of the same subtype (ER/PR, HER-2/neu), adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other stage I or II cancer from which the patient has been disease free for at least 5 years', ' Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil', ' Previous enrollment in an investigational drug study within the past four weeks', ' History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance with oral drug intake', ' Patients with cardiac disease that would preclude the use of Adriamycin, Taxol or Herceptin are not eligible', ' Active cardiac disease:', ' Angina pectoris that requires the use of antianginal medication', ' Cardiac arrhythmia requiring medication', ' Severe conduction abnormality', ' Clinically significant valvular disease', ' Cardiomegaly on chest x-ray', ' Ventricular hypertrophy on electrocardiogram (EKG)', ' Uncontrolled hypertension, (diastolic greater than 100 mm/Hg or systolic > 200 mm/hg)', ' Current use of digitalis or beta blockers for congestive heart failure (CHF)', ' Clinically significant pericardial effusion', ' History of cardiac disease:', ' Myocardial infarction documented as a clinical diagnosis or by EKG or any other test', ' Documented congestive heart failure', ' Documented cardiomyopathy', ' Documented arrhythmia or cardiac valvular disease that requires medication or is medically significant', ' Major surgery within 4 weeks of the start of study treatment without complete recovery', ' Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome', ' Known, existing uncontrolled coagulopathy', ' Unwillingness to give written informed consent', ' Unwillingness to participate or inability to comply with the protocol for the duration of the study'], 'Results': ['Outcome Measurement: ', ' Combined Rate of Microscopic pCR and Macroscopic Pathologic Complete Response (mCR)', ' Microscopic pCR: No evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection. mCR: The examining pathologist cannot identify gross residual tumor mass in the surgical specimen. This differs from a pCR where the specimen must also be negative for invasive tumor by microscopy. For this study, we are using a definition of mCR that will make the trial more translatable to other institutions. For this study, mCR will be defined as no focus of invasive cancer >= 1 cm.', ' Count of participants with either a pCR or mCR.', ' Time frame: Up to 16 weeks', 'Results 1: ', ' Arm/Group Title: Treatment (Neoadjuvant Therapy, Adjuvant Therapy)', ' Arm/Group Description: See Detailed Description.', ' doxorubicin hydrochloride: Given IV', ' cyclophosphamide: Given PO', ' paclitaxel: Given IV', ' filgrastim: Given SC', ' capecitabine: Given PO', ' methotrexate: Given IV', ' vinorelbine tartrate: Given IV', ' needle biopsy: Correlative studies', ' therapeutic conventional surgery: Undergo definitive breast surgery', ' immunohistochemistry staining method: Correlative studies', ' trastuzumab: Given IV', ' tamoxifen citrate: Given PO', ' letrozole: Given PO', ' laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 29 69.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/50 (16.00%)', ' Febrile Neutropenia1/50 (2.00%)', ' Death1/50 (2.00%)', ' Neutropenia5/50 (10.00%)']}

47aa5686-75af-4ed8-b4ff-715b458ce40a

Comparison

Intervention

NCT00077376

NCT01256008

the primary trial investigates a novel chemotherapy treatment, whereas the secondary trial is testing a type of psychological therapy.

Entailment

{'Clinical Trial ID': 'NCT00077376', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab/Ixabepilone/Carboplatin', ' During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.', ' After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Patients with histologically confirmed adenocarcinoma of the breast which is metastatic and is known to overexpress HER2/neu who have received no prior chemotherapy for metastatic breast cancer; prior hormonal therapy for metastatic disease is allowed; NOTE: for this protocol, HER2 overexpression will be defined as 3+ HER2 positivity as measured by immunohistochemistry using the HercepTest (DAKO) or HER2 gene amplification as measured by fluorescent in-situ hybridization (FISH, e.g. Vysis); representative diagnostic tissue must be submitted for central diagnostic review', ' Patients must not be pregnant or breast feeding because of the teratogenic potential of these drugs; it is recommended that all females of childbearing potential have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective non-hormonal method of contraception', ' Patients must have at least one objective measurable disease parameter; baseline measurements and evaluations using RECIST criteria guidelines must be obtained within 4 weeks prior to registration to the study; NOTE: all areas of disease should be recorded and followed', ' Patients must have an ECOG performance status of 0 or 1', ' Patients must be disease free of prior malignancy for >= 5 years with the exception of curatively treated basal cell carcinoma or squamous cell carcinomas of the skin or carcinoma in situ of the cervix', ' Patients must not have a history of untreated brain metastasis or brain metastasis currently undergoing radiation; patients with brain metastasis representing the sole site of disease are not eligible for this study; patients with previously treated brain metastasis who have responded to brain radiotherapy and/or surgery and continue in response are eligible provided the brain is not the only site of measurable disease', ' Patients must not have peripheral neuropathy of any grade', ' Patients must not have a history of prior severe (grade 3 or 4) hypersensitivity reaction to a drug formulated in polyoxyethylated castor oil (Cremophor EL)', ' Patients must have left ventricular ejection fraction by MUGA scan or echocardiogram that is at or above the lower institutional limits of normal obtained within 6 weeks prior to registration', ' Patients must not have a history of New York Heart Association class 3 or 4 heart failure', ' Serum creatinine =< 1.5 mg/dl', ' Granulocytes >= 1500/mm^3', ' Platelets >= 100,000/mm^3', ' SGOT(AST) and SGPT(ALT) =< 1.5 x upper limit of normal (unless liver is involved by tumor, in which case SGOT(AST) and SGPT(ALT) can be =< 2.0 x upper limit of normal)', ' Patients must have no history of prior therapy with trastuzumab (Herceptin), Ixabepilone (BMS-247550) or carboplatin for metastatic disease; patients who develop metastatic disease =< 6 months after completing adjuvant trastuzumab (Herceptin), paclitaxel, docetaxel, carboplatin, or Ixabepilone (BMS-247550) are considered to have had prior therapy for metastatic disease and are excluded from study participation', ' Patients must not have received a cumulative dose of doxorubicin of greater than 360 mg/m^2 or epirubicin of greater than 640 mg/m^2', ' Concurrent use of hormonal therapy is not permitted; concurrent radiation therapy is not permitted; hormonal therapy must have been discontinued >= 1 week prior to registration; radiation therapy must have been completed >= 2 weeks prior to registration', ' Patients may have had prior radiation therapy, but the previously irradiated tumors cannot be used to assess a clinical response; patients will not be eligible if they do not have other areas of measurable disease; an exception will be given for patients who have had tumor recurrence in an area that received adjuvant radiation treatments, such as the axilla or chest wall'], 'Results': ['Outcome Measurement: ', ' Objective Response for HER2+ Patients (Best Objective Response a Patient Has Ever Experienced on Study)', ' To assess objective response, it is necessary to estimate the overall tumor burden at baseline to which subsequent measurements will be compared. The same method of assessment and the same technique should be used to characterize each lesion at baseline and during follow-up.', ' The best overall response based on RECIST is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration. The best response was determined based on the tumor responses in target and nontarget lesions, with or without new lesions. To be assigned a status of complete or partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 8 weeks.', ' Time frame: Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years', 'Results 1: ', ' Arm/Group Title: Trastuzumab/Ixabepilone/Carboplatin', ' Arm/Group Description: During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.', ' After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity.', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: Participants Complete Response: 3', ' Partial Response: 13', ' No Change/ Stable: 10', ' Progression: 11', 'Unevaluable: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 39/59 (66.10%)', ' Anemia 7/59 (11.86%)', ' Hematologic-other 1/59 (1.69%)', ' Diarrhea w/o prior colostomy 4/59 (6.78%)', ' Nausea 4/59 (6.78%)', ' Vomiting 2/59 (3.39%)', ' Abdomen, pain 1/59 (1.69%)', ' Fatigue 7/59 (11.86%)', ' Death NOS 1/59 (1.69%)', ' Allergic reaction 2/59 (3.39%)', ' Infection with Grade 0-2 neutrophils, urinary tract 2/59 (3.39%)', ' Leukopenia 19/59 (32.20%)']}

{'Clinical Trial ID': 'NCT01256008', 'Intervention': ['INTERVENTION 1: ', ' Stage 1 Clinical Management', ' The group will receive clinical management treatment only each session.', ' Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.', ' Following are major elements:', ' Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.', 'INTERVENTION 2: ', ' Stage 1 CBT', ' The experimental group will receive CBT each session.', " CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."], 'Eligibility': ['Inclusion Criteria:', ' Age: 20-65 years;', ' Pathologically diagnosed breast cancer patients, with the diagnosis from at least 2 comprehensive clinical attending physicians, in line with clinical diagnosis of breast cancer;', ' A week after breast cancer surgery;', ' With complaints and symptoms of depression or anxiety', ' HAMD-17 8 points or / and HAMA 8 points;', " Have some reading comprehension skills (could complete the self-rating scale independently or with others' help);", ' Informed consent', 'Exclusion Criteria:', ' Previous diagnosis of mental disorder or Bipolar Disorder; alcohol and drug abusing history;', ' Use antidepressants, antipsychotics or accept any form of psychological treatment, or participation in other clinical trials in the last month', ' Patients with cardiovascular disease, liver and kidney dysfunction and other serious diseases;', ' Hearing, visual or understanding impairment;', ' Severe depression, suicidal tendencies;', " Can not or will not comply with clinical treatment programs based on the physicians' judgment", ' Exit criteria:', ' Persons with poor compliance during the trial period;', ' Persons whose depression increased during the trial period, has serious suicidal tendencies and requires urgent intervention;', ' Persons who are believed have other circumstances and should be suspended by Physicians'], 'Results': ['Outcome Measurement: ', ' Hamilton Depression Rating Scale (HAMD-17)', ' The scale(HAMD-17) is used to assessed the depression symptoms of patients.', ' The scale range is 0-53.Higher value represents a worse outcome.', ' The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week', ' Time frame: baseline,2 w,4 w,8 w,12 w,16 w,24 w', 'Results 1: ', ' Arm/Group Title: Stage 1 Clinical Management', ' Arm/Group Description: The group will receive clinical management treatment only each session.', ' Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.', ' Following are major elements:', ' Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.', ' Overall Number of Participants Analyzed: 98', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale baseline: 11.52 (3.789)', ' 2W: 10.23 (3.207)', ' 4W: 9.80 (3.056)', ' 8W: 8.71 (3.601)', ' 12W: 8.01 (3.200)', ' 16W: 7.42 (3.019)', ' 24W: 7.01 (3.317)', 'Results 2: ', ' Arm/Group Title: Stage 1 CBT', ' Arm/Group Description: The experimental group will receive CBT each session.', " CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention.", ' Overall Number of Participants Analyzed: 98', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale baseline: 13.31 (5.090)', ' 2W: 11.72 (4.976)', ' 4W: 9.72 (4.835)', ' 8W: 7.80 (4.440)', ' 12W: 5.71 (3.979)', ' 16W: 5.13 (4.108)', ' 24W: 4.45 (3.875)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/98 (0.00%)', 'Adverse Events 2:', ' Total: 0/98 (0.00%)']}

e89fdc93-d624-4ba7-aa64-574a278e982b

Single

Adverse Events

NCT00871858

1 patient in cohort 1 of the primary trial was diagnosed with a Clear cell renal cell carcinoma.

Contradiction

{'Clinical Trial ID': 'NCT00871858', 'Intervention': ['INTERVENTION 1: ', ' Arm A (ANA)', ' Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.', ' anastrozole: Given orally', 'INTERVENTION 2: ', ' Arm B (FULV)', ' Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.', ' fulvestrant: Given intramuscularly'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:', ' SBR grade I-II disease (patients < 65 years of age)', ' SBR grade I-III disease (patients > 65 years of age)', ' T2 (2-5 cm), T3, or T4B, and N0-1 disease', ' No metastatic disease', ' Breast lesion not amenable to breast-conserving resection', ' No inflammatory breast cancer', ' No prior breast cancer', ' Hormone receptor status:', ' Estrogen receptor- and/or progesterone receptor-positive', ' PATIENT CHARACTERISTICS:', ' Postmenopausal', ' No other cancer within the past 5 years except for adequately treated skin carcinoma or carcinoma in situ of the cervix', ' No contraindication to anti-hormonal treatment', ' No psychological, familial, social, or geographical reasons that would preclude follow up', ' PRIOR CONCURRENT THERAPY:', ' At least 8 days since prior hormone replacement therapy', ' No concurrent anti-vitamin K treatment'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR) Determined by Clinical Palpation', ' Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.', ' Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Arm A (ANA)', ' Arm/Group Description: Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.', ' anastrozole: Given orally', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Number', ' Unit of Measure: percentage of participants 58.9 (45.0 to 71.9)', 'Results 2: ', ' Arm/Group Title: Arm B (FULV)', ' Arm/Group Description: Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.', ' fulvestrant: Given intramuscularly', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: percentage of participants 53.8 (39.5 to 67.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/60 (3.33%)', ' Bronchial infection 0/60 (0.00%)', ' Ankle fracture 1/60 (1.67%)', ' Clear cell kidney cancer 0/60 (0.00%)', ' Programmed peritoneal dialysis 1/60 (1.67%)', ' Endometrial atrophy 0/60 (0.00%)', 'Adverse Events 2:', ' Total: 3/58 (5.17%)', ' Bronchial infection 1/58 (1.72%)', ' Ankle fracture 0/58 (0.00%)', ' Clear cell kidney cancer 1/58 (1.72%)', ' Programmed peritoneal dialysis 0/58 (0.00%)', ' Endometrial atrophy 1/58 (1.72%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

1739541a-2d3f-4a13-b956-769a1cbed4d7

Single

Adverse Events

NCT02187744

One patient in the primary trial suffered from sepsis, due to the presence of an implanted device.

Entailment

{'Clinical Trial ID': 'NCT02187744', 'Intervention': ['INTERVENTION 1: ', ' PF-05280014', ' Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.', 'INTERVENTION 2: ', ' Trastuzumab-EU', ' Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed HER2 overexpressing invasive breast cancer.', ' Plan for definitive surgical resection of breast tumor (i.e., lumpectomy or mastectomy, and sentinel node (SN) biopsy or axillary lymph node dissection (ALND).', ' Plan for neoadjuvant chemotherapy.', ' Measurable disease in the breast after diagnostic biopsy, defined as longest diameter 2.0 cm.', 'Exclusion Criteria:', ' Bilateral breast cancer.', ' Inflammatory breast cancer.', ' Presence of known distant metastases.', ' Received prior treatment, including chemotherapy, endocrine therapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Steady State Drug Concentration Ctrough (Cycle 6 Pre-dose) >20 µg/mL at Cycle 5.', ' The percentage of participants with Cycle 5 Ctrough (Cycle 6 pre-dose) >20 μg/mL in each treatment group, the denominator being the number of participants in the per protocol population for each treatment group.', ' Time frame: Cycle 5', 'Results 1: ', ' Arm/Group Title: PF-05280014', ' Arm/Group Description: Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.', ' Overall Number of Participants Analyzed: 101', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 92.1 (85.0 to 96.5)', 'Results 2: ', ' Arm/Group Title: Trastuzumab-EU', ' Arm/Group Description: Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.', ' Overall Number of Participants Analyzed: 89', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 93.3 (85.9 to 97.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/113 (6.19%)', ' Febrile neutropenia 1/113 (0.88%)', ' Neutropenia 1/113 (0.88%)', ' Anaemia 0/113 (0.00%)', ' Pancytopenia 1/113 (0.88%)', ' Proctitis 1/113 (0.88%)', ' Device related sepsis 1/113 (0.88%)', ' Gastrointestinal infection 0/113 (0.00%)', ' Injection site abscess 1/113 (0.88%)', ' Tooth infection 0/113 (0.00%)', ' Hip fracture 0/113 (0.00%)', ' Blood creatinine increased 1/113 (0.88%)', 'Adverse Events 2:', ' Total: 6/112 (5.36%)', ' Febrile neutropenia 2/112 (1.79%)', ' Neutropenia 1/112 (0.89%)', ' Anaemia 1/112 (0.89%)', ' Pancytopenia 0/112 (0.00%)', ' Proctitis 0/112 (0.00%)', ' Device related sepsis 0/112 (0.00%)', ' Gastrointestinal infection 1/112 (0.89%)', ' Injection site abscess 0/112 (0.00%)', ' Tooth infection 1/112 (0.89%)', ' Hip fracture 1/112 (0.89%)', ' Blood creatinine increased 0/112 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

c8f401a0-5e7d-4fd9-b31e-0866c9bee6a9

Single

Intervention

NCT02312622

Both cohorts of the primary trial receive identical interventions; Pegylated Irinotecan Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days , the differences between the cohorts is the type of cancers that patients are diagnosed with, cohort 1 is NSCLC, whereas cohort 2 is mBC and the number of cycles for each cohort, 1 for cohort 1 and 4 for cohort 2.

Contradiction

{'Clinical Trial ID': 'NCT02312622', 'Intervention': ['INTERVENTION 1: ', ' Cohort A - Pegylated Irinotecan to Treat NSCLC', ' Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.', ' Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)', 'INTERVENTION 2: ', ' Cohort C - Pegylated Irinotecan to Treat mBC', ' Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.', ' Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)'], 'Eligibility': ['Inclusion Criteria:', ' At least 18 years of age.', ' Life expectancy of 3 months or longer.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.', ' Advanced or refractory cancer, consisting of', ' Metastatic breast cancer (mBC) for which single-agent cytotoxic chemotherapy is indicated. OR', ' Histologically-proven metastatic lung cancer:', ' Non-small cell lung cancer (NSCLC) as Stage IV disease or recurrent metastatic disease [per lung cancer tumor, node and metastasis (TNM) classification system, 7th ed] (Cohort A) OR', ' Small cell lung cancer (SCLC) as extensive stage or recurrent metastatic disease (cohort B), including tumors with mixed small cell and non-small cell elements.', ' Prior chemotherapy (at least one of the following):', ' At least one line of prior systemic chemotherapy', ' At least one line of prior targeted treatment for metastatic disease Adjuvant systemic chemotherapy within prior 6 months Prior treatment for metastatic breast cancer (mBC) must have included taxane-based regimen', ' Prior chemotherapy, including other investigational therapy, has been completed prior to initiation of study treatment, according to the following:', ' 2 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered on a daily or weekly schedule', ' 3 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered every 2 weeks', ' 4 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered every 3 weeks Previously received at least one CNS directed treatment (such as surgery or radiation) OR not be eligible for CNS stereotactic radiosurgery Measurable CNS disease, either previously untreated (not counting systemic therapy), or progressed following previous radiation treatment. Lesions that have progressed after prior radiosurgery should not be selected as measurable disease if they are suspected of being radionecrosis.', ' The following measurement criteria are required, as visualized by contrast-enhanced MRI with slice thickness of 1.5 mm, unless absence of contrast or thicker slices is specifically authorized by Protocol Director. Measurements do not include tumor edema.', ' At least one CNS tumor measuring 10 mm in longest diameter, OR', ' At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two additional CNS tumors measuring 3 mm in longest diameter, for which the sum of the longest diameters is 10 mm. Additional tumors are not exclusionary.', ' Adequate organ function as evidenced by:', ' Absolute neutrophil count (ANC) 1.5 x 10e9/L without G-CSF (filgrastim, pegfilgrastim, or equivalent) support within 7 days', ' Hemoglobin (Hgb) 9.0 g/dL (90 g/L) without blood transfusion within 7 days', ' Platelet count 100 x 10e9/L without platelet transfusion within 7 days', " Bilirubin 1.5 X upper limit of normal (ULN), except for patients with documented history of Gilbert's disease who may have DIRECT bilirubin 1.5 X ULN", ' Alanine aminotransferase (ALT) 2.5 X ULN, except 5 X ULN for patients with liver metastases', ' Aspartate aminotransferase (AST) 2.5 X ULN, except 5 X ULN for patients with liver metastases', ' Serum creatinine 1.5 X ULN; or calculated creatinine clearance 50 mL/min (using Cockcroft-Gault formula), or measured creatinine clearance 50 mL/min.', 'Exclusion Criteria:', ' Previous treatment with a camptothecin derivative (eg, irinotecan, topotecan, and investigational agents including but not limited to exatecan, rubitecan, gimatecan, karenitecin, SN38 investigational agents, EZN 2208, SN 2310, and AR 67) is not allowed', ' Patients may not have a known history of leptomeningeal disease, as diagnosed by positive CSF cytology, unless prospective permission for enrollment is granted from the sponsor and the PI', ' Patients may not have had major surgery or radiotherapy (therapeutic and/or palliative) within 14 days prior to initiation of study treatment, including CNS-directed radiation therapy. Minor procedures, such as tumor biopsy, thoracentesis, or intravenous catheter placement are allowed with no waiting period', ' Patients may not have the following co morbid disease or concurrent illness:', ' Chronic or acute gastrointestinal (GI) disorders resulting in diarrhea of any severity grade; patients may not use chronic anti-diarrheal supportive care (more than 3 days/week) to control diarrhea in the 28 days prior to first dose of investigational drug. (exception: anti-diarrheal medications used to control symptoms from a medication that will be discontinued prior to study are allowed with a 7 day washout before study therapy, for example loperamide for erlotinib-associated diarrhea)', ' Known cirrhosis, defined as Child Pugh class A or higher liver disease', ' Other active malignancy, except for non melanoma skin cancer and carcinoma in situ (of the cervix or bladder)', ' Any other severe/uncontrolled inter current illness or significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation', ' Patients may not have a known allergy or hypersensitivity to any of the components of the investigational therapy, including polyethylene glycol (PEG) or topoisomerase inhibitors', ' Patients may not be receiving the following medications at the time of first dose of investigational drug:', ' Pharmacotherapy for known hepatitis B or C, tuberculosis, or human immunodeficiency virus (HIV)', ' Any of the following enzyme inducing anti epileptic medications (EIAEDs): phenytoin, carbamazepine, oxcarbazepine, phenobarbital', ' Other chemotherapy, hormonal therapy, immunotherapy, other investigational agents, or biologic agents for the treatment of cancer except for bisphosphonates or denosumab', ' Pregnant or nursing patients will be excluded from the study'], 'Results': ['Outcome Measurement: ', ' Central Nervous System (CNS) Disease Control Rate (Cohort A and C)', ' Central nervous system (CNS) disease control (DC) is defined as a complete response (CR); partial response (PR); or stable disease (SD). The outcome is reported as the number and percentage of participants who achieve DC, a number without dispersion.', ' Response criteria are as follows. Note that any lesion less than 10 mm in longest diameter (LD) is considered unchanged unless there is a 3 mm change in the sum of the LDs.', ' CR = Disappearance of all target lesions, sustained for 4 weeks with no new lesions; clinical condition stable or improved', ' PR = 30% decrease in target lesion LD and no new lesions, sustained for 4 weeks; clinical condition stable or improved', ' PD (progressive disease) = Any of 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration', ' SD = Neither PR or PD', ' Time frame: At 12 weeks', 'Results 1: ', ' Arm/Group Title: Cohort A - Pegylated Irinotecan to Treat NSCLC', ' Arm/Group Description: Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.', ' Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m as monotherapy once every 21 days (1 cycle)', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 16.7%', 'Results 2: ', ' Arm/Group Title: Cohort C - Pegylated Irinotecan to Treat mBC', ' Arm/Group Description: Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.', ' Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m as monotherapy once every 21 days (1 cycle)', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 16.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/12 (100.00%)', ' Febrile neutropenia 0/12 (0.00%)', ' Pericardial tamponade 1/12 (8.33%)', ' Pericardial Effusion 1/12 (8.33%)', ' Diarrhea 0/12 (0.00%)', ' Non-cardiac chest pain 1/12 (8.33%)', ' Sepsis 0/12 (0.00%)', ' Respiratory infection 1/12 (8.33%)', ' Septic Shock 0/12 (0.00%)', ' Spinal fracture 0/12 (0.00%)', ' Dehydration 2/12 (16.67%)', ' Disease progression 1/12 (8.33%)', 'Adverse Events 2:', ' Total: 3/3 (100.00%)', ' Febrile neutropenia 2/3 (66.67%)', ' Pericardial tamponade 0/3 (0.00%)', ' Pericardial Effusion 0/3 (0.00%)', ' Diarrhea 1/3 (33.33%)', ' Non-cardiac chest pain 0/3 (0.00%)', ' Sepsis 1/3 (33.33%)', ' Respiratory infection 0/3 (0.00%)', ' Septic Shock 1/3 (33.33%)', ' Spinal fracture 0/3 (0.00%)', ' Dehydration 1/3 (33.33%)', ' Disease progression 0/3 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

206fc00c-2c34-42bc-8fca-44be696e03c9

Single

Results

NCT00393939

Median (95% Confidence Interval) Progression-Free Survival (PFS) was over a year higher for patients in the Trastuzumab + Sunitinib group of the primary trial than for the Docetaxel group.

Contradiction

{'Clinical Trial ID': 'NCT00393939', 'Intervention': ['INTERVENTION 1: ', ' Docetaxel + Sunitinib', ' Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).', 'INTERVENTION 2: ', ' Docetaxel', ' Docetaxel 100 mg/m^2 every 3 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Breast cancer with evidence of unresectable locally recurrent, or metastatic disease', ' Her-2 negative tumors', 'Exclusion Criteria:', ' Patients for whom docetaxel is contraindicated', ' Clinical presentation of inflammatory carcinoma with no other measurable disease'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS defined as time from date of randomization to date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.4.', ' Time frame: Baseline up to Month 33', 'Results 1: ', ' Arm/Group Title: Docetaxel + Sunitinib', ' Arm/Group Description: Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).', ' Overall Number of Participants Analyzed: 296', ' Median (95% Confidence Interval)', ' Unit of Measure: months Independent radiology assessment: 8.6 (8.2 to 10.3)', " Investigator's assessment: 8.2 (7.3 to 8.6)", 'Results 2: ', ' Arm/Group Title: Docetaxel', ' Arm/Group Description: Docetaxel 100 mg/m^2 every 3 weeks', ' Overall Number of Participants Analyzed: 297', ' Median (95% Confidence Interval)', ' Unit of Measure: months Independent radiology assessment: 8.3 (7.7 to 9.6)', " Investigator's assessment: 6.9 (6.5 to 7.3)"], 'Adverse Events': ['Adverse Events 1:', ' Total: 112/295 (37.97%)', ' Anaemia 4/295 (1.36%)', ' Febrile neutropenia 20/295 (6.78%)', ' Leukopenia 5/295 (1.69%)', ' Lymphatic disorder 1/295 (0.34%)', ' Neutropenia 11/295 (3.73%)', ' Thrombocytopenia 1/295 (0.34%)', ' Angina pectoris 0/295 (0.00%)', ' Atrial fibrillation 1/295 (0.34%)', ' Atrioventricular block 1/295 (0.34%)', ' Cardiac arrest 1/295 (0.34%)', ' Cardiac disorder 1/295 (0.34%)', 'Adverse Events 2:', ' Total: 79/293 (26.96%)', ' Anaemia 2/293 (0.68%)', ' Febrile neutropenia 13/293 (4.44%)', ' Leukopenia 7/293 (2.39%)', ' Lymphatic disorder 0/293 (0.00%)', ' Neutropenia 16/293 (5.46%)', ' Thrombocytopenia 0/293 (0.00%)', ' Angina pectoris 1/293 (0.34%)', ' Atrial fibrillation 0/293 (0.00%)', ' Atrioventricular block 0/293 (0.00%)', ' Cardiac arrest 0/293 (0.00%)', ' Cardiac disorder 0/293 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

4a6d7f07-27b5-4281-b59c-f1c77dbd6e2d

Single

Eligibility

NCT00581256

Patients with left-sided breast cancer and an ECOG between 1-2 are excluded from the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00581256', 'Intervention': ['INTERVENTION 1: ', ' IMRT', ' Best Delivery-optimized radiotherapy technique (IMRT)', ' IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume.', 'INTERVENTION 2: ', ' 3DRT', ' Best 3-dimensional standard PWTF technique', ' 3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease'], 'Eligibility': ['Inclusion Criteria:', ' Eligibility Criteria', ' Breast cancer diagnosis: Patients must have histologically confirmed adenocarcinoma of the breast requiring comprehensive loco-regional irradiation that includes treatment to the intact breast/chest wall, supraclavicular (SCV), infraclavicular nodes (ICV), and internal mammary nodes (IMN).', ' Patients must have pathologic T 1, 2, 3 or 4, N 1, 2, or 3 Stage II or III disease as defined by the AJCC Staging System, 6th edition. Patients who do not undergo axillary staging but are at risk for nodal involvement may also be treated.', ' All patients must have left-sided breast cancer.', ' Both men and women are eligible.', ' Patients must be adults (18 years of age or older)', ' For women of child-bearing age, effective contraception must be used. A written statement must be obtained that the patient is not pregnant. If there is any question of pregnancy at time of therapeutic RT or at time of each SPECT-CT scan, a pregnancy test will be done to confirm the patient is not pregnant.', ' Performance status should be 0-2 by ECOG criteria.', ' Patients that have received prior RT may be enrolled on the present study if the new breast lesion can be treated with no overlap of RT fields.', ' Patients must be aware of the neoplastic nature of her/his disease.', ' Patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with the Institutional Review Board (IRB) of the University of Michigan and federal guidelines.', " Patients' blood tests should indicate they are able to tolerate radiotherapy. Tests must be done within 28 days of registration:", ' CBC with differential and platelet count (Hemoglobin > 8.0 g/dl; wbc > 2000/mm3; absolute neutrophil count > 1000/mm3; platelet count > 75,000/mm3.', 'Exclusion Criteria:', ' Patients who are pregnant or are nursing are excluded.', ' Pathologically node negative breast cancer unless treated with neo-adjuvant chemotherapy.', ' Performance status > 2 by ECOG criteria', ' Patients who are unable to lie on their back and raise their arm above their head in the treatment planning position for radiotherapy', ' Patients with a clinically unstable medical condition', ' Patients with a life-threatening disease state', ' History or suspicion of serious life-threatening allergic reaction to Tc-99m imaging agents.', ' Patients that have had breast-conservation surgery with positive margins or any patient with negative margins with a tumor positive for an extensive intraductal component.', ' Patients that are not able to use the ABC device.'], 'Results': ['Outcome Measurement: ', ' The Number of Participants With a Significant Increase in Perfusion Defects (PD)', " To compare the extent of new myocardial perfusion defects following breast cancer radiotherapy using the best standard 3-D radiotherapy technique, partially wide tangent fields, versus the best optimized technique. Perfusion defects (PD) were assessed by comparing normalized perfusion distributions against our institution's normal polar map databases for the left anterior descending artery (LAD) using thresholds of 2.5-SD (standard deviation) and 1.5-SD below the normal mean. On the basis of interest variability, a PD increase greater than 5% or 10% was considered significant for 2.5- and 1.5-SD thresholds, respectively.", 'Time frame: 1 Year', 'Results 1: ', ' Arm/Group Title: IMRT', ' Arm/Group Description: Best Delivery-optimized radiotherapy technique (IMRT)', ' IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume.', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: participants 2.5 SD and PD increase >5%: 1', ' 1.5 SD and PD increase >10%: 3', 'Results 2: ', ' Arm/Group Title: 3DRT', ' Arm/Group Description: Best 3-dimensional standard PWTF technique', ' 3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: participants 2.5 SD and PD increase >5%: 2', ' 1.5 SD and PD increase >10%: 5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/28 (3.57%)', ' Infection with normal ANC or Grade 1 or 2 neutrophils [1]1/28 (3.57%)', 'Adverse Events 2:', ' Total: 0/26 (0.00%)', ' Infection with normal ANC or Grade 1 or 2 neutrophils [1]0/26 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

83cef795-d4a8-486c-8ac1-34a9acee9672

Comparison

Adverse Events

NCT00127933

NCT00191789

the primary trial recorded one patient with a catheter-related complication, whereas in the secondary trial none where observed.

Entailment

{'Clinical Trial ID': 'NCT00127933', 'Intervention': ['INTERVENTION 1: ', ' HER2-Neu Negative', ' Dose and route per treatment cycle (Q3W):', ' Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1', ' HER2-neu negative: capecitabine + docetaxel', ' Duration: Four 3-week treatment cycles', 'INTERVENTION 2: ', ' HER2-Neu Positive', ' Dose and route per treatment cycle (Q3W):', ' Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly', ' HER2-neu positive: capecitabine + docetaxel + trastuzumab', ' Duration: Four 3-week treatment cycles'], 'Eligibility': ['Inclusion Criteria:', ' women >=18 years of age;', ' newly diagnosed;', ' infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer.', 'Exclusion Criteria:', ' evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes;', ' previous systemic or local primary treatment.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery', ' Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate.', ' Time frame: at the time of definitive surgery; after four 3-week cycles (3-4 months)', 'Results 1: ', ' Arm/Group Title: HER2-Neu Negative', ' Arm/Group Description: Dose and route per treatment cycle (Q3W):', ' Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1', ' HER2-neu negative: capecitabine + docetaxel', ' Duration: Four 3-week treatment cycles', ' Overall Number of Participants Analyzed: 101', ' Measure Type: Number', ' Unit of Measure: percentage of participants 15.8 (9.7 to 25.4)', 'Results 2: ', ' Arm/Group Title: HER2-Neu Positive', ' Arm/Group Description: Dose and route per treatment cycle (Q3W):', ' Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly', ' HER2-neu positive: capecitabine + docetaxel + trastuzumab', ' Duration: Four 3-week treatment cycles', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: percentage of participants 50.0 (31.9 to 71.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/122 (12.30%)', ' febrile neutropenia 4/122 (3.28%)', ' Neutropenia 0/122 (0.00%)', ' Angina unstable 1/122 (0.82%)', ' Coronary artery disease 1/122 (0.82%)', ' Myocardial infarction 1/122 (0.82%)', ' Diarrhoea 2/122 (1.64%)', ' Colitis 1/122 (0.82%)', ' Pyrexia 2/122 (1.64%)', ' Chest pain 1/122 (0.82%)', ' Pneumonia 1/122 (0.82%)', ' Catheter site cellulitis 1/122 (0.82%)', 'Adverse Events 2:', ' Total: 7/34 (20.59%)', ' febrile neutropenia 1/34 (2.94%)', ' Neutropenia 1/34 (2.94%)', ' Angina unstable 0/34 (0.00%)', ' Coronary artery disease 0/34 (0.00%)', ' Myocardial infarction 0/34 (0.00%)', ' Diarrhoea 0/34 (0.00%)', ' Colitis 0/34 (0.00%)', ' Pyrexia 0/34 (0.00%)', ' Chest pain 0/34 (0.00%)', ' Pneumonia 1/34 (2.94%)', ' Catheter site cellulitis 0/34 (0.00%)', ' Infection 1/34 (2.94%)']}

{'Clinical Trial ID': 'NCT00191789', 'Intervention': ['INTERVENTION 1: ', ' Gemcitabine+Doxorubicin+Cisplatin+Surgery', ' Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).', ' Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of breast carcinoma', ' No previous chemotherapy, with bidimensionally measurable locally advanced disease', ' Adequate performance status (Karnofsky Performance Status [KPS] greater than or equal to 70), bone marrow reserves, hepatic, cardiac and renal functions.', 'Exclusion Criteria:', ' Inflammatory breast cancer', ' Pregnancy and Breast-feeding', ' Serious concomitant disorder or infection', ' Previous cancer within the last 5 years or a second primary malignancy.'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Pathological Complete Response (Pathological Complete Response Rate)', ' Complete pathological response: No invasive tumor cells identified from sections from site of previous cancer. Require evidence corroborating prior presence of invasive cancer, which requires detection of abnormal fibroelastic breast stroma devoid of normal lobular units and contains foamy macrophages with moderate numbers of fibroblasts and mononuclear inflammatory cells. Presence of nondescript collagenised lobules or breast fibrous tissue is not evidence that tumor site has been adequately sampled and macroscopic assessment and sampling is needed until original neoplastic stroma identified.', ' Time frame: tumor assessment at baseline and during surgery after eight 21-day treatment cycles', 'Results 1: ', ' Arm/Group Title: Gemcitabine+Doxorubicin+Cisplatin+Surgery', ' Arm/Group Description: Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).', ' Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.', ' Overall Number of Participants Analyzed: 65', ' Measure Type: Number', ' Unit of Measure: participants 13'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/65 (26.15%)', ' Febrile neutropenia 3/65 (4.62%)', ' Neutropenia 2/65 (3.08%)', ' Pancytopenia 1/65 (1.54%)', ' Thrombocytopenia 1/65 (1.54%)', ' Cardiac arrest 2/65 (3.08%)', ' Myocardial infarction 1/65 (1.54%)', ' Diarrhoea 5/65 (7.69%)', ' Stomatitis 1/65 (1.54%)', ' Vomiting 2/65 (3.08%)', ' Fatigue 1/65 (1.54%)', ' Jaundice 1/65 (1.54%)', ' Neutropenic infection 2/65 (3.08%)']}

b3cee7a6-cec1-4676-974d-7cfb3ccd9919

Comparison

Eligibility

NCT00944047

NCT00228943

Patients with HER2 positive tumors are excluded from the primary trial, but may be included in the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT00944047', 'Intervention': ['INTERVENTION 1: ', ' Intervention Arm', ' Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery', ' nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks', ' trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks', ' Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles', ' cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)', ' Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.', ' - Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.', ' Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.', ' -All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.'], 'Eligibility': ['Inclusion Criteria:', ' Female patient 18 years of age', ' Histologically proven stage II or III adenocarcinoma of the breast', ' Must be candidate for neoadjuvant treatment (Tumor size 2 cm, T2, T3, T4 and/or clinical N1 or N2).', ' HER-2/neu 1+ or 2+ by immunohistochemistry', ' Must have operable tumor.', ' Performance status of 2 or better per SWOG criteria', ' LVEF 55% by echocardiogram performed within 4 weeks prior to treatment initiation', ' If patient of childbearing potential, pregnancy test is negative', ' Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial.', ' Adequate bone marrow function: ANC > 1500/mm3, platelet count > 100,000/mm3, and hemoglobin > 9 g/dL', ' Adequate kidney function: serum creatinine of < 1.5mg/dl and/or creatinine clearance of > 60 mL/min', ' Adequate hepatic function: transaminases < 2.5 x upper limit of normal and total bilirubin < 1.5 mg/dL', ' Must be informed of the investigational nature of the study and must sign an informed consent in accordance with the institutional rules.', ' Pretreatment lab values must be performed within 14 days of patient registration, and other baseline studies (with the exception of mammogram) must be performed within 30 days of patient registration.', 'EXCLUSION CRITERIA:', ' Patient with metastatic breast cancer.', ' Women with tumors that are HER-2 neu 0+ or 3+ by immunohistochemistry', ' Women with HER 2 FISH amplified tumors (FISH ratio >2.2)', ' Patients who have had prior endocrine therapy for > 4 weeks or chemotherapy for this breast cancer will be excluded.', ' Locally advanced, inoperable tumors will be excluded.', ' The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications.', ' History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias', ' Ejection fraction < 55%', ' Pregnancy or lactation', ' Patients with inadequate laboratory values (as defined above) are excluded from study.', ' Patients with NCI common toxicity criteria (CTC) grade 2 or greater peripheral neuropathy are excluded from study.', ' Patients with active infection are excluded from study.', ' Patients with concomitant or previous malignancies within the last 5 years, are excluded from the study. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).', ' Patients with emotional limitations are excluded from study.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response', ' [Not Specified]', ' Time frame: 22 weeks', 'Results 1: ', ' Arm/Group Title: Intervention Arm', ' Arm/Group Description: Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery', ' nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks', ' trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks', ' Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles', ' cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)', ' Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.', ' - Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.', ' Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.', ' -All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Number', ' Unit of Measure: percentage of participants 26'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/32 (15.63%)', ' Pain * 1/32 (3.13%)', ' Febrile neutropenia * 2/32 (6.25%)', ' Pneumonia * 1/32 (3.13%)', ' Syncope * 1/32 (3.13%)']}

{'Clinical Trial ID': 'NCT00228943', 'Intervention': ['INTERVENTION 1: ', ' Full Strength Acute Tryptophan Depletion', '[Not Specified]', 'INTERVENTION 2: ', ' Half-Strength Tryptophan Depletion - Control', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' At least 18 years of age', ' Willing and able to provide informed consent', ' Reporting daily hot flashes', ' Able to read, write, and speak English', ' Postmenopausal to limit sample variability (> 12 months amenorrhea)', ' Greater then 1 month but < 5 years post-treatment (surgery, radiation, chemotherapy) for non-metastatic breast cancer.', ' These criteria allow inclusion of women successfully treated for recurrent breast cancer since there is no known reason to exclude them. Menopausal status is assessed using self-reports due to problems in reliably measuring follicle-stimulating hormone levels and estradiol in tamoxifen users.', 'Exclusion Criteria:', ' Exclusion criteria are current depression, history of migraines or hepatitis, abnormal chemistry profile (e.g., sodium, potassium, glucose), or a positive urine drug screen for illegal substances.'], 'Results': ['Outcome Measurement: ', ' Serum Tryptophan Levels', ' Mean serum tryptophan levels (blood draw) at the end of the nadir period.', ' Time frame: baseline, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours', 'Results 1: ', ' Arm/Group Title: Full Strength Acute Tryptophan Depletion', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 24', ' Mean (Standard Deviation)', ' Unit of Measure: nmol/ml 0.0034 (.0027)', 'Results 2: ', ' Arm/Group Title: Half-Strength Tryptophan Depletion - Control', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 23', ' Mean (Standard Deviation)', ' Unit of Measure: nmol/ml 0.02 (0.02)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}

007de11b-4265-4695-b18e-e0d6909a347a

Comparison

Intervention

NCT01869764

NCT02556632

Every participant in the secondary trial and the primary trial undergoes Laboratory Biomarker Analysis and completes a Questionnaire.

Contradiction

{'Clinical Trial ID': 'NCT01869764', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Omega-3 Fatty Acid)', ' Patients receive omega-3 fatty acid PO daily for 7-14 days.', 'omega-3 fatty acid: Given PO', ' laboratory biomarker analysis: Correlative studies', 'INTERVENTION 2: ', ' Arm II (Placebo)', ' Patients receive placebo PO daily for 7-14 days.', ' placebo: Given PO', ' laboratory biomarker analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Newly diagnosed stage I to III breast cancer and carcinoma in situ (including lobular carcinoma in situ [LCIS] and ductal carcinoma in situ [DCIS])', ' Breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment', ' Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved written informed consent document', ' Tumor measures at least 1 centimeter on imaging or physical exam', 'Exclusion Criteria:', ' Any patient with surgery scheduled < 7days after biopsy', ' Patients who are unable to refrain from the use of any NSAID or full-dose acetylsalicylic acid (ASA)-containing NSAID while taking study drug', ' Patients who will receive neoadjuvant chemotherapy are not eligible', ' Patients who are currently taking omega-3 fatty acids, as they are unable to be randomized to placebo', ' Patients who have previously taken omega-3 fatty acid within 1 month prior to study enrollment', ' Patients with an allergy or known hypersensitivity to fish'], 'Results': ['Outcome Measurement: ', ' PUFA Levels in Normal and Metastatic Breast Tissue', ' Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3', ' Time frame: At time of surgery', 'Results 1: ', ' Arm/Group Title: Arm I (Omega-3 Fatty Acid)', ' Arm/Group Description: Patients receive omega-3 fatty acid PO daily for 7-14 days.', 'omega-3 fatty acid: Given PO', ' laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 22', ' Mean (Standard Deviation)', ' Unit of Measure: ug/ml Normal breast tissue 18:2 n-6: 22 participants', ' 60.986 (40.392)', ' Normal breast tissue 18:3 n-3: 22 participants', ' 3.232 (2.289)', ' Normal breast tissue 20:2 n-6: 22 participants', ' 1.104 (0.96)', ' Normal breast tissue 20:4 n-6: 22 participants', ' 2.221 (1.349)', ' Normal breast tissue 20:3 n-3: 22 participants', ' 0.049 (0.107)', ' Normal breast tissue 20:5 n-3: 22 participants', ' 0.027 (0.128)', ' Normal breast tissue 22:6 n-3: 22 participants', ' 0.095 (0.443)', ' Normal breast tissue n-3: 22 participants', ' 3.402 (2.572)', ' Normal breast tissue n-6: 22 participants', ' 3.421 (2.085)', ' Normal breast tissue n3/n-6 ratio: 21 participants', ' 0.948 (0.468)', ' Malignant breast tissue 18:2 n-6: 22 participants', ' 44.137 (44.544)', ' Malignant breast 18:3 n-3: 22 participants', ' 1.943 (2.162)', ' Malignant breast 20:2 n-6: 22 participants', ' 0.889 (0.886)', ' Malignant breast 20:4 n-6: 22 participants', ' 3.208 (1.948)', ' Malignant breast 20:3 n-3: 22 participants', ' 0.034 (0.087)', ' Malignant breast 20:5 n-3: 22 participants', ' 0.2 (0.665)', ' Malignant breast 22:6 n-3: 22 participants', ' 0 (0)', ' Malignant breast n-3: 22 participants', ' 2.178 (2.41)', ' Malignant breast n-6: 22 participants', ' 48.233 (46.105)', ' Malignant breast n-3/n-6 ratio: 22 participants', ' 0.029 (0.031)', ' Differences in PUFA level 18:2 n-6: 22 participants', ' -16.85 (51.043)', ' Differences in PUFA level 18:3 n-3: 22 participants', ' -1.289 (2.784)', ' Differences in PUFA level 20:2 n-6: 22 participants', ' -0.215 (0.866)', ' Differences in PUFA level 20:4 n-6: 22 participants', ' 0.986 (1.595)', ' Differences in PUFA level 20:3 n-3: 22 participants', ' -0.015 (0.105)', ' Differences in PUFA level 20:5 n-3: 22 participants', ' 0.173 (0.545)', ' Differences in PUFA level 22:6 n-3: 22 participants', ' -0.095 (0.443)', ' Difference in PUFA level n-3: 22 participants', ' -1.224 (2.794)', ' Difference in PUFA level in n-6: 22 participants', ' 44.812 (45.463)', ' Difference in n-3/n-6 ratio: 21 participants', ' -0.92 (0.45)', 'Results 2: ', ' Arm/Group Title: Arm II (Placebo)', ' Arm/Group Description: Patients receive placebo PO daily for 7-14 days.', ' placebo: Given PO', ' laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 19', ' Mean (Standard Deviation)', ' Unit of Measure: ug/ml Normal breast tissue 18:2 n-6: 19 participants', ' 72.762 (50.742)', ' Normal breast tissue 18:3 n-3: 19 participants', ' 3.505 (2.041)', ' Normal breast tissue 20:2 n-6: 19 participants', ' 1.008 (0.724)', ' Normal breast tissue 20:4 n-6: 19 participants', ' 2.342 (1.445)', ' Normal breast tissue 20:3 n-3: 19 participants', ' 0.038 (0.085)', ' Normal breast tissue 20:5 n-3: 19 participants', ' 0.034 (0.147)', ' Normal breast tissue 22:6 n-3: 19 participants', ' 0.061 (0.264)', ' Normal breast tissue n-3: 19 participants', ' 3.64 (2.24)', ' Normal breast tissue n-6: 19 participants', ' 3.413 (1.962)', ' Normal breast tissue n3/n-6 ratio: 19 participants', ' 1.102 (0.438)', ' Malignant breast tissue 18:2 n-6: 19 participants', ' 33.735 (31.548)', ' Malignant breast 18:3 n-3: 19 participants', ' 1.356 (1.465)', ' Malignant breast 20:2 n-6: 19 participants', ' 0.601 (0.657)', ' Malignant breast 20:4 n-6: 19 participants', ' 2.248 (1.744)', ' Malignant breast 20:3 n-3: 19 participants', ' 0 (0)', ' Malignant breast 20:5 n-3: 19 participants', ' 0 (0)', ' Malignant breast 22:6 n-3: 19 participants', ' 0 (0)', ' Malignant breast n-3: 19 participants', ' 1.357 (1.466)', ' Malignant breast n-6: 19 participants', ' 36.586 (32.856)', ' Malignant breast n-3/n-6 ratio: 19 participants', ' 0.032 (0.016)', ' Differences in PUFA level 18:2 n-6: 19 participants', ' -39.027 (38.697)', ' Differences in PUFA level 18:3 n-3: 19 participants', ' -2.149 (1.935)', ' Differences in PUFA level 20:2 n-6: 19 participants', ' -0.407 (0.514)', ' Differences in PUFA level 20:4 n-6: 19 participants', ' -0.094 (1.589)', ' Differences in PUFA level 20:3 n-3: 19 participants', ' -0.038 (0.085)', ' Differences in PUFA level 20:5 n-3: 19 participants', ' -0.034 (0.147)', ' Differences in PUFA level 22:6 n-3: 19 participants', ' -0.061 (0.264)', ' Difference in PUFA level n-3: 19 participants', ' -2.282 (2.127)', ' Difference in PUFA level in n-6: 19 participants', ' 33.173 (31.836)', ' Difference in n-3/n-6 ratio: 19 participants', ' -1.07 (0.438)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/28 (0.00%)', 'Adverse Events 2:', ' Total: ']}

{'Clinical Trial ID': 'NCT02556632', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Curcumin-based Gel)', ' Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.', 'Curcumin-based Gel: Applied topically', ' Laboratory Biomarker Analysis: Correlative studies', ' Questionnaire Administration: Ancillary studies', 'INTERVENTION 2: ', ' Arm II (HPR Plus)', ' Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.', ' Dermatologic Complications Management: Apply HPR Plus topically', ' Laboratory Biomarker Analysis: Correlative studies', ' Questionnaire Administration: Ancillary studies'], 'Eligibility': ['Inclusion Criteria:', ' Subjects with a diagnosis of non-inflammatory breast cancer or carcinoma in situ', ' Subjects must be prescribed and scheduled for "conventional fractionated" RT without concurrent chemotherapy; bolus and intensity modulated radiation therapy (IMRT) are permitted; lymph node irradiation (i.e., internal mammary nodes, supraclavicular nodes, axillary nodes, etc) as part of their prescribed radiation therapy are permitted; conventional fractionated radiation therapy regimens eligible for study are described below:', ' Minimal (min) total dose: whole breast: 44 gray (Gy); breast boost: 10 Gy; tumor bed = whole breast +/- boost: 50.0 Gy; lymph nodes: 45 Gy', ' Maximal (max) total dose: whole breast: 50.4 Gy; breast boost: 20 Gy; tumor bed = whole breast +/- boost: 66.0 Gy; lymph nodes: 50.4 Gy', ' Min dose per fraction: whole breast: 1.8 Gy; breast boost: 2.0 Gy; tumor bed = whole breast +/- boost: 1.8 Gy; lymph nodes: 1.8 Gy', ' Max dose per fraction: whole breast: 2.0 Gy; breast boost: 2.0 Gy; tumor bed = whole breast +/- boost: 2.0 Gy; lymph nodes: 2.0 Gy', 'Min # of fractions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole breast +/- boost: 25 Gy; lymph nodes: 25 Gy', 'Max # of fractions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole breast +/- boost: 36 Gy; lymph nodes: 28 Gy', ' Min # of sessions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole breast +/- boost: 25 Gy; lymph nodes: 25 Gy', ' Max # of sessions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole breast +/- boost: 36 Gy; lymph nodes: 28 Gy', ' Subjects may or may not have had surgery (lumpectomy or mastectomy) prior to RT; (NOTE: surgery is not required for eligibility)', ' Subjects may have had chemotherapy prior to radiation; a minimum of two weeks is required between end of chemotherapy and start of RT', ' Subjects may be currently prescribed hormone treatment or Herceptin therapy', ' Subjects must be able to read, speak, and understand English', ' Subjects must have the ability to understand and the willingness to sign a written informed consent document', ' Subjects must agree to not use any other topical agents on skin in the radiation treatment area during the course of this trial; subjects should only use topical agents for the study (i.e., topical intervention or standard care agents) supplied by the study personnel and/or treating physician', 'Exclusion Criteria:', ' Pregnant females are ineligible; all subjects of childbearing potential will be asked if they are pregnant or could be pregnant; the patient must respond "no" to continue with radiation and to participate in this clinical study', ' Subjects with bilateral breast cancer are not eligible', ' Subjects receiving the short-course fractionation radiation therapy (i.e., 16 sessions or 20 sessions at 2.4 to 2.6 Gy fractions per session, with or without boost)', ' Subject is currently on anti-EGFR (human epidermal growth factor receptor) therapy, such as Iressa (gefitinib) or Erbitux (cetuximab, C225)', ' Previous radiation to the chest or breast', ' Subjects with breast reconstruction prior to RT', ' Previous diagnosis of radiosensitivity disorder (i.e., ataxia telangiectasia)', ' Previous diagnosis of collagen vascular disorder or vasculitis', ' Presence of unhealed surgical wounds in chest or breast region and/or breast infection', ' Current daily application of a prescribed topical product to the skin within the RT area for an unrelated skin condition that cannot be discontinued during the participation in this clinical trial', ' Presence of any active dermatological issues in radiation treatment area (i.e., fungal skin infection, dermatitis, psoriasis plaques, etc)'], 'Results': ['Outcome Measurement: ', ' Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration)', ' The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions at the end of RT.', ' The RDS score ranges from 0-4 with higher scores indicating worse outcome.', ' Time frame: Baseline up to 1 week post radiation therapy', 'Results 1: ', ' Arm/Group Title: Arm I (Curcumin-based Gel)', ' Arm/Group Description: Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.', 'Curcumin-based Gel: Applied topically', ' Laboratory Biomarker Analysis: Correlative studies', ' Questionnaire Administration: Ancillary studies', ' Overall Number of Participants Analyzed: 59', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 2.68 (0.74)', 'Results 2: ', ' Arm/Group Title: Arm II (HPR Plus)', ' Arm/Group Description: Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.', ' Dermatologic Complications Management: Apply HPR Plus topically', ' Laboratory Biomarker Analysis: Correlative studies', ' Questionnaire Administration: Ancillary studies', ' Overall Number of Participants Analyzed: 59', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 2.64 (0.74)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/64 (4.69%)', ' Heart Failure * 0/64 (0.00%)', ' Radiation Dermatitis * 3/64 (4.69%)', ' Headache * 0/64 (0.00%)', ' Pleuritic pain * 0/64 (0.00%)', ' Dermatitis * 1/64 (1.56%)', 'Adverse Events 2:', ' Total: 2/65 (3.08%)', ' Heart Failure * 1/65 (1.54%)', ' Radiation Dermatitis * 1/65 (1.54%)', ' Headache * 0/65 (0.00%)', ' Pleuritic pain * 1/65 (1.54%)', ' Dermatitis * 0/65 (0.00%)']}

ce621235-b584-439b-bb11-ab2fa04c3195

Comparison

Intervention

NCT01646346

NCT03283553

the secondary trial and the primary trial both use irradiation techniques in their studies.

Contradiction

{'Clinical Trial ID': 'NCT01646346', 'Intervention': ['INTERVENTION 1: ', ' 4D Conformal Image-Guided Partial Breast RT', ' This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.', ' 4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days.'], 'Eligibility': ['Inclusion Criteria:', ' The patient must consent to be in the study and must have a signed an approved consent form conforming with institutional guidelines.', ' Patient must be > 50 years old.', ' The patient should have a life expectancy of at least two years with a karnofsky performance status > 70.', ' The patient must have stage 0 or I breast cancer.', ' On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.', ' Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (>2mm, DCIS and invasive). Re-excision of surgical margins is permitted.', ' Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 2 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 2 cm or less.)', ' Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is NOT required for patients with DCIS.', ' The patient must have simulation within 8 weeks/56 days of the final surgery for their breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure).', ' Patients with a history of non-ipsilateral breast malignancies are eligible if they have been disease-free for 2 or more years prior to enrollment. Patients with the following cancers are eligible even if diagnosed and treated within the past 2 years: carcinoma in situ of the cervix, colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.', ' Chemotherapy is permitted if planned for 2 weeks after radiation.', ' Urine pregnancy test must be performed and be negative on all women younger than 60 who have not had a tubal ligation, oophorectomy, or hysterectomy.', ' Separate incisions for the lumpectomy and sentinel node biopsy should be present. Use of only one incision will typically result in a contiguous cavity with the tumor bed and the sentinel node sampling, and inability of the radiation oncologist to delineate the tumor bed from the sentinel node bed.', ' The patient must have a cavity which is able to be targeted with external beam APBI, either through surgical clip placement, or CVS 3 or higher. The cavity to whole breast ratio must be 30% or less.', 'Exclusion Criteria:', ' Men are not eligible for this study as men are not breast conservation candidates.', ' T0, T2 (> 2.0 cm), T3, node positive, stage III or IV breast cancer.', ' Any positive axillary nodes.', ' Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor.', ' Suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign.', ' Non-epithelial breast malignancies such as sarcoma or lymphoma.', ' Proven multicentric carcinoma in more than one quadrant or separated by more than 2 centimeters.', " Paget's disease of the nipple.", ' History of invasive breast cancer or DCIS in the same breast.', ' Surgical margins that cannot be microscopically assessed or are less then 2 mm.', ' Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.', ' Pregnancy or lactation at the time of proposed radiation. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.', ' Psychiatric or addictive disorders or other conditions that, in the opinion of the treating physician, would preclude the patient from meeting the study requirements.', ' Patients with coexisting medical conditions in whom life expectancy is < 2 years.', ' Patients with skin involvement, regardless of tumor size.'], 'Results': ['Outcome Measurement: ', ' Patients With Reduction in Incidental Radiation', ' Patients were assessed to determine if there was a reduction in breast radiation V50 less than 45% and V100 less than 23.5%.', 'Time frame: 5 day', 'Results 1: ', ' Arm/Group Title: 4D Conformal Image-Guided Partial Breast RT', ' Arm/Group Description: This is a single arm trial designed to look at the results in women treated with partial breast irradiation twice daily for 5 days.', ' 4D Conformal Image-Guided Partial Breast RT: External beam partial breast radiation to target a portion of the breast twice a day for 5 days.', ' Overall Number of Participants Analyzed: 46', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 46 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/46 (0.00%)']}

{'Clinical Trial ID': 'NCT03283553', 'Intervention': ['INTERVENTION 1: ', ' Multicomponent Intervention', " 1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.", 'INTERVENTION 2: ', ' Usual Care', ' Care as usual with the medical oncologist.'], 'Eligibility': ['Inclusion Criteria:', ' Medical oncology patient: Established patient of participating medical oncologist greater than 18 years of age, have a diagnosis of early stage or advanced breast cancer, are receiving active systemic therapy (in the form of IV adjuvant systemic therapy if early stage), are English speaking, able to provide informed consent themselves, and identify a family member who they would like to include in their care.', ' Care partner: Family member (e.g. spouse, adult child, parent, adult sibling or other relative) or unpaid friend who regularly accompanies patient to medical oncology visits.', ' Medical oncology provider: Practicing medical oncology provider at a participating clinic who provides care to patients with breast cancer.', 'Exclusion Criteria:', ' Medical oncology patients: Younger than 18 years, pregnant, not being treated for breast cancer, do not attend medical oncology visits with family member or unpaid friend or unwilling for their family member or unpaid friend to be contacted.', ' Care partner: Paid non-family member who accompanies patient to visits.'], 'Results': ['Outcome Measurement: ', ' Between-group Differences in Patient Complete Illness Understanding at 9-months', ' Illness understanding was measured by 4 questions regarding knowledge that is considered to be essential to making informed treatment decisions in serious illness, including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease state, and 4.) expectation of duration of life. We summed responses to each item (coded 1 or 0 to reflect the presence or absence of understanding), yielding a score ranging from 0 to 4. Participants with perfect scores reflecting complete illness understanding (4 of 4 correct responses) were compared to all others.', ' Time frame: 9 months', 'Results 1: ', ' Arm/Group Title: Multicomponent Intervention', " Arm/Group Description: 1.) A one-page paper-pencil agenda setting checklist completed immediately before a regularly scheduled medical oncology visit to elicit and align patient and companion perspectives regarding issues to discuss with the provider, and to stimulate discussion about the role of the companion in the visit, 2.) facilitated registration for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to doctor's electronic visit notes.", ' Overall Number of Participants Analyzed: 63', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Illness Understanding at 9-Months: 42 66.7%', ' Not Complete Illness Understanding at 9-Months: 21 33.3%', 'Results 2: ', ' Arm/Group Title: Usual Care', ' Arm/Group Description: Care as usual with the medical oncologist.', ' Overall Number of Participants Analyzed: 55', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Illness Understanding at 9-Months: 38 69.1%', ' Not Complete Illness Understanding at 9-Months: 17 30.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/69 (0.00%)', 'Adverse Events 2:', ' Total: 0/63 (0.00%)']}

f358f023-2393-44eb-9535-3f0e1851318d

Single

Intervention

NCT00470301

Every patient in the primary trial is given tipifarnib PO, along with paclitaxel, doxorubicin hydrochloride and acyclophosphamide IV.

Entailment

{'Clinical Trial ID': 'NCT00470301', 'Intervention': ['INTERVENTION 1: ', ' Arm I', ' See Detailed Description', ' tipifarnib: Given orally', ' paclitaxel: Given IV', ' doxorubicin hydrochloride: Given IV', ' cyclophosphamide: Given IV', ' pegfilgrastim: Given SC', ' conventional surgery: surgical procedures performed on patients', ' axillary lymph node dissection: correlative study'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed adenocarcinoma of the breast; clinical stage IIB, IIIA, IIIB, or IIIC disease', ' At least 1 week since prior tamoxifen or other selective estrogen receptor modulator for prevention or for other indications (e.g., osteoporosis or prior ductal carcinoma in situ)', ' HER-2/neu-negative by immunohistochemistry or fluorescence in situ hybridization (FISH)', ' Hormone receptor status:', ' Estrogen and/or progesterone receptor-positive* [Note: *Patients enrolled on the phase I portion of the trial may have estrogen and progesterone receptor-negative disease]', ' Normal organ function including:', ' WBC >= 3,000/mm^3', ' Absolute neutrophil count >= 1,500/mm^3', ' Platelet count >= 100,000/mm^3', ' Bilirubin normal', ' AST and ALT =< 2.5 times upper limit of normal', ' LVEF normal by echocardiogram or nuclear scan', ' Creatinine normal OR Creatinine clearance >= 60 mL/min', ' FEV1 >= 1 L* and DLCO >= 50%* [Note: *Only if baseline CT scan of chest shows parenchymal lung disease OR there is a history of chronic obstructive or other pulmonary disease]', ' No prior chemotherapy, radiotherapy, or definitive therapeutic surgery (e.g., mastectomy, lumpectomy, or axillary dissection) for this cancer but prior sentinel lymph node biopsy for this malignancy allowed', ' No prior adjuvant chemotherapy for a previous breast malignancy', ' No concurrent combination antiretroviral therapy for HIV-positive patients', ' No other concurrent investigational agents', ' No other concurrent anticancer agents or therapies', ' ECOG performance status 0-1', ' Fertile patients must use effective contraception', 'Exclusion criteria:', ' No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix', ' No history of allergic reactions attributed to compounds of similar chemical or biological composition to tipifarnib or other study drugs (e.g., imidazoles or quinolones)', ' No other uncontrolled illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would preclude study compliance', ' Not pregnant or nursing'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response Rate (pCR)', ' An increase in the breast pCR from 15% (anticipated for chemotherapy alone) to 35% would be considered promising.', ' Time frame: Up to 5 years', 'Results 1: ', ' Arm/Group Title: Arm I', ' Arm/Group Description: See Detailed Description', ' tipifarnib: Given orally', ' paclitaxel: Given IV', ' doxorubicin hydrochloride: Given IV', ' cyclophosphamide: Given IV', ' pegfilgrastim: Given SC', ' conventional surgery: surgical procedures performed on patients', ' axillary lymph node dissection: correlative study', ' Overall Number of Participants Analyzed: 55', ' Measure Type: Number', ' Unit of Measure: participants 33 (7 to 36)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/60 (21.67%)', ' Neutropenia 13/60 (21.67%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

0e963b25-0d2b-4fc6-89c6-1eb068bc092e

Single

Results

NCT00733408

There was just under 8 weeks difference in Progression-free Survival between the minimum and maximum PFS in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00733408', 'Intervention': ['INTERVENTION 1: ', ' Tx (Chemo, MoAb, and Enzyme Inhibitor)', ' INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.', ' MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.', ' paclitaxel albumin-stabilized nanoparticle formulation: Given IV', ' bevacizumab: Given IV', ' erlotinib hydrochloride: Given PO'], 'Eligibility': ['Inclusion Criteria:', ' Have histologically confirmed invasive breast cancer that is estrogen receptor (ER) negative (=< 10%), progesterone receptor (PR) negative (=< 10%) and human epidermal growth factor receptor 2 (HER2) normal (=< 10% of cells) by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)', ' Be receiving first-line therapy for metastatic disease', ' Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria; X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; X-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration', ' OR non-measurable disease only, with rising serum cancer antigen (CA)15-3 or CA 27.29 or carcinoembryonic antigen (CEA) documented by two consecutive measurements taken at least 14 days apart with the most recent measurement being within 42 days prior to registration; the second CA 15-3 or CA 27.29 or CEA value must have at least a 20% increase over the first and for CA 15-3 or CA 27.29 be greater than or equal to 40 units/mL or for CEA be greater than or equal to 4 ng/mL', ' Subjects with brain metastases as their first site of disease recurrence may be eligible if treated by definitive radiation (stereotactic radiosurgery or whole brain) with clinically controlled neurologic symptoms for a period of 21 days prior to study treatment', ' Bilirubin =< 1.5 mg/dL', ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis', ' Alkaline phosphatase =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis', ' Platelets > 100,000 cells/mm^3', ' Hemoglobin > 9.0 g/dL', ' Absolute neutrophil count (ANC) >= 1,500 cells/mm^3', ' Creatinine =< 1.5 mg/dL is recommended; however, institutional norms are acceptable', ' If of childbearing potential must have a negative pregnancy test and use an effective method to avoid pregnancy for the duration of the trial and for at least 6 months after completion of study therapy', ' Pre-existing peripheral neuropathy, if present, must be < grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)', ' Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional standards and federal guidelines', 'Exclusion Criteria:', ' Recurrent disease within 12 months after completion of adjuvant chemotherapy containing a weekly taxane', ' Central nervous system (CNS) metastases that are symptomatic and/or requiring steroids', ' Pre-existing nephritic syndrome', ' Serious intercurrent medical or psychiatric illness including serious active infection', ' Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)', ' Any prior history of hypertensive crisis or hypertensive encephalopathy', ' New York Heart Association (NYHA) grade II or greater congestive heart failure', ' History of myocardial infarction or unstable angina within 6 months prior to study enrollment', ' History of stroke or transient ischemic attack within 6 months prior to study enrollment', ' Significant vascular disease (e.g., aortic aneurysm, aortic dissection)', ' Symptomatic peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study', ' Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment', ' Serious, non-healing wound, ulcer, or bone fracture', ' Proteinuria at screening as demonstrated by either:', ' Urine protein:creatinine (UPC) ratio >= 1.0 at screening OR', ' Urine dipstick for proteinuria > 2+ (patients discovered to have > 2+ proteinuria on dipstick urinalysis at baseline must have a UPC ratio done that is < 1.0 to be eligible; if the UPC ratio is >= 1.0 then the patient should undergo a 24-hour urine collection which must demonstrate =< 1 g of protein in 24 hours for the patient to be eligible)', ' Known hypersensitivity to any component of bevacizumab or to nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation)'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier survival curves will be used. A 95% confidence interval for the median PFS will be calculated. A lower bound greater than 8 months would be strong evidence that Nab-Paclitaxel- bevacizumab induction therapy followed by bevacizumab-erlotinib hydrochloride maintenance therapy is superior to paclitaxel and bevacizumab. However, a median PFS of 13 months or greater (regardless of whether the 95% confidence interval for the median extends below 8 months) could also indicate promising results.', ' Time frame: Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 8 years', 'Results 1: ', ' Arm/Group Title: Tx (Chemo, MoAb, and Enzyme Inhibitor)', ' Arm/Group Description: INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.', ' MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.', ' paclitaxel albumin-stabilized nanoparticle formulation: Given IV', ' bevacizumab: Given IV', ' erlotinib hydrochloride: Given PO', ' Overall Number of Participants Analyzed: 55', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.1 (7.2 to 11.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/55 (9.09%)', ' Infection 2/55 (3.64%)', ' Pain * 1/55 (1.82%)', ' Muscle Weakness * 1/55 (1.82%)', ' Dyspnea 1/55 (1.82%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

390b08d3-e147-47f9-82d7-0643b8d5c8ae

Comparison

Intervention

NCT00994279

NCT00545077

Between both the primary trial and the secondary trial Bevacizumab is only administered to patients in cohort 2 of the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00994279', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: Yoga Intervention', ' Yoga Intervention', ' Yoga: Yoga sessions', 'INTERVENTION 2: ', ' Arm 2: Educational Wellness Group', ' Educational Wellness Group', ' Education: Educational Wellness Group'], 'Eligibility': ['Inclusion Criteria:', ' Women will be eligible if they are:', ' Scheduled to begin chemotherapy treatment within 3 weeks of study registration, or able to start Yoga/Wellness sessions prior to second chemotherapy treatment.', ' 18 years of age.', ' Physically able to attend yoga classes (simply meaning that they can physically make it to the intervention session and are able to sit on a chair or lie on the floor) (ECOG Performance Status rating 0-2; Zubrod et al., 1960).', ' Diagnosed with breast cancer Stages I-III.', ' Chemotherapy is anticipated to continue during the 10 weeks of the study intervention.', ' 2-8 weeks post-completion of breast surgery (unless receiving neoadjuvant chemotherapy).', ' Ability to understand and the willingness to sign a written informed consent document.', 'Exclusion Criteria:', ' Have practiced yoga on a regular basis (at least once a week) within the past 4 weeks to recruit women who are not already regularly practicing yoga. Given that the benefits of yoga are likely more immediate than long-term, however, we will enroll women who have previously had a yoga practice.', ' Are being treated with surgery and/or radiation therapy and/or hormonal treatment only and/or Herceptin therapy only (no chemotherapy).', ' Anticipate undergoing surgery related to their breast cancer or receipt of radiation therapy during the study period.', ' Have regularly engaged in moderate (activity that makes you breathe somewhat harder than normal; may include carrying light loads, bicycling at a regular pace, fast walking, tennis, easy swimming, or popular or folk dancing) or vigorous (activity that causes heavy breathing, sweating, rapid fatigue; it can only be sustained for very short periods of time, like running or swimming strongly) physical activity at least 3-5 days per week (on average) within the past 4 weeks.', ' Pregnant women will not be excluded from this study because the study intervention(s) pose no risk of potential for teratogenic or abortifacient effects. In fact, gentle yoga practice is quite safe for pregnant women and poses can be slightly modified, if needed. The anticipated number of pregnant women eligible to enroll is minimal.'], 'Results': ['Outcome Measurement: ', ' Retention', ' Proportion of participants completing the 10 week study', ' Time frame: 10 weeks', 'Results 1: ', ' Arm/Group Title: Arm 1: Yoga Intervention', ' Arm/Group Description: Yoga Intervention', ' Yoga: Yoga sessions', ' Overall Number of Participants Analyzed: 22', ' Measure Type: Number', ' Unit of Measure: percentage of participants 82 (60 to 95)', 'Results 2: ', ' Arm/Group Title: Arm 2: Educational Wellness Group', ' Arm/Group Description: Educational Wellness Group', ' Education: Educational Wellness Group', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Number', ' Unit of Measure: percentage of participants 89 (65 to 99)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/21 (4.76%)', ' Febrile Neutropenia 0/21 (0.00%)', ' Heart Failure 1/21 (4.76%)', 'Adverse Events 2:', ' Total: 1/17 (5.88%)', ' Febrile Neutropenia 1/17 (5.88%)', ' Heart Failure 0/17 (0.00%)']}

{'Clinical Trial ID': 'NCT00545077', 'Intervention': ['INTERVENTION 1: ', ' Arm A: Endocrine Therapy (ET)', ' Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.', ' Letrozole', 'Fulvestrant', 'INTERVENTION 2: ', ' Arm B: ET With Bevacizumab (ET-B)', ' Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg i.v. on day 1 every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.', ' Letrozole', ' Bevacizumab', 'Fulvestrant'], 'Eligibility': ['Inclusion Criteria:', ' Before starting the specific protocol procedures, the written informed consent must be obtained and documented.', ' Women 18 years.', ' Capacity to comply with all the protocol requirements.', ' Functional Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.', ' Life expectancy 24 weeks.', ' Histologically confirmed breast adenocarcinoma, with measurable or non-measurable, locally advanced or metastatic (stage IV) disease. In the event that the patient only has locally advanced disease, she will not be able to undergo curative local treatment. Patients with metastasis confined to the bone can be chosen, but the disease must be confirmed by radiology, CT scan or Nuclear magnetic resonance (NMR) if there is any doubt after a single bone scan.', ' Patients with HER2-negative disease evaluated by Immunohistochemistry (IHC) and Fluorescence in situ hybridization (FISH)/Chromogenic in situ hybridisation (CISH) (IHC 0 or 1+, or 2+ and negative FISH). Patients with 3+ by IHC cannot be chosen regardless of the FISH/CISH status and those with positive FISH/CISH (> 2 amplifications) cannot be chosen either, regardless of the IHC findings.', ' Positive hormone receptors (estrogen receptor [ER] and/or progesterone receptor [PgR]) evaluated by a local or central laboratory, according to the criteria of the participating institution.', ' Patients who are candidates for receiving first-line treatment with letrozole.', ' Patients may have received (neo)adjuvant chemotherapy, provided that the last dose of the latter was received at least 12 months before randomization. Patients must be recovered from toxicity.', ' The patients are allowed to have received adjuvant radiotherapy, provided that it was completed at least 6 weeks before randomization and the patient has recovered from the reversible acute effects of the radiation. The previous administration of radiotherapy to palliate the pain of bone metastases is authorized, provided that:', ' Not more than 30% of bone marrow has been irradiated.', ' The patient has recovered from the reversible acute effects of the radiation.', ' The patient has at least one metastatic location which has not been irradiated and which may be evaluated for progression, or a clear progression of the bone disease has been objectified after the end of the palliative radiotherapy.', ' The patients may have received any kind of previous (neo)adjuvant hormone therapy provided that they are considered to be candidates for first-line hormonotherapy with either letrozole or fulvestrant.', ' The treatment with bisphosphonates is allowed and recommended for patients with bone metastases. Whenever it is possible, the treatment should be started before or within the 4 weeks of starting the study therapy. The patients starting treatment with bisphosphonates must be carefully evaluated so that they do not mask the progression of the disease.', ' In the patients with heart failure risk (e.g. previously treated with > 360mg/m2 of doxorubicin or equivalent doses of other anthracyclines), the Left Ventricular Ejection Fraction (LVEF) must be determined by means of an echocardiogram or radionuclide ventriculography (MUGA), and it must t be > the lower limit of normal.', 'Exclusion Criteria:', " Evolutionary disease requiring an immediate treatment with cytotoxic chemotherapy according to the investigator's judgment.", ' Patients with locally advanced breast cancer who are expected to undergo surgery or curative radiotherapy.', ' Previous chemotherapy or hormonotherapy for the metastatic disease. Patients may have received neoadjuvant chemotherapy or neoadjuvant hormonotherapy with curative intention as a part or as an alternative to an adjuvant treatment. For the previous neoadjuvant hormonotherapy the same premises than for the adjuvant hormonotherapy are valid.', ' Previous therapy with anti-vascular endothelial growth factor (VEGF) or VEGF Receptor (VEGFR) tyrosine-kinase inhibitors.', ' History of another pathology that may affect the development of the protocol or the interpretation of results. It is considered that patients who have suffered from a skin carcinoma that is not melanoma, cervical carcinoma in situ or another neoplasia treated with a curative intention and with a disease-free interval exceeding 5 years can be chosen.', ' Evidence of central nervous system (CNS) metastasis. A CT scan or brain NMR must be done within the 4 weeks before the randomization in case of suspecting brain metastasis.', ' History or evidence in the physical or neurological examination of CNS pathology unrelated to cancer unless it is suitable treated with standard therapy (e.g. uncontrolled convulsions).', ' History of peripheral neuropathy National Cancer Institute (NCI) CTCAE grade >2 at the time of randomization.', ' Patients subjected to major surgical procedures, open biopsies or those having significant trauma injuries within the 28 days prior to randomization, or patients who are expected to undergo a major surgical procedure that must necessarily be performed within the course of the study.', ' Minor surgical procedures in the 7 days prior to randomization.', ' Unsuitable bone marrow supply: absolute neutrophil count (ANC) < 1.5 x 109/L, platelets < 100 x 109/L or Hb < 10 g/dL.', ' Impaired liver function: total bilirubin total > 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) > 2.5 x ULN (> 5 x ULN in patients with liver metastases).', ' Impaired kidney function:', ' Serum creatinine > 2.0 mg/dL or 177 µmol/L.', ' Proteinuria determined by reactive strip > 2+. A 24h determination of proteins in urine will be requested for the patients with > 2+ in the baseline analysis and must have a protein figure < 1 g/24 h.', ' Chronic treatment with oral corticoids (dose > 10 mg/day of methylprednisolone or equivalent): the use of inhaled corticoids is allowed.', ' Chronic treatment with acetylsalicylic acid (> 325 mg/day) or clopidogrel (> 75 mg/day).', ' Uncontrolled arterial hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant cardiovascular disease: for example cerebrovascular accident (CVA) (in the 6 months prior to randomization), coronaropathy or history of acute mycardial infarction (AMI) in the last 6 months, unstable angina, congestive heart failure of grade > II of the New York Heart Association (NYHA) or severe heart arrhythmias which are not controlled with medication or which can potentially interfere with the study treatment.', ' History or evidence of hemorrhagic diathesis or coagulopathy with bleeding risk.', ' History of abdominal fistula, gastrointestinal perforation or intra-abdominal abcess in the 6 months prior to randomization.', ' Active infection requiring i.v. antibiotics at the time of randomization.', ' Unhealed wounds, active peptic ulcer, esophageal varices.', " Any other disease, psychological or metabolic alteration, found in the physical or laboratory examination, providing reasonable indications for suspecting a disease or complaint for which the use of any of the study drugs are contraindicated, or which may affect the patient's compliance with the routine procedures of the study or which places the patient at a high risk of experiencing complications related to the treatment.", ' Current or recent (within 30 days prior to that start of the study treatment) treatment with another drug under investigation or participation in another investigation study.', ' Known hypersensitivity to any of the study drugs or their components.', ' Hypersensitivity to the products of Chinese hamster ovary cells or to other human or humanized recombinant antibodies.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' PFS was defined as the time elapsed from randomization until the date in which the progression of the disease or the death for any reason (whichever occurs first) is documented.', ' Time frame: Up to 2 years', 'Results 1: ', ' Arm/Group Title: Arm A: Endocrine Therapy (ET)', ' Arm/Group Description: Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.', ' Letrozole', ' Fulvestrant', ' Overall Number of Participants Analyzed: 184', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 14.4 (11.4 to 17.5)', 'Results 2: ', ' Arm/Group Title: Arm B: ET With Bevacizumab (ET-B)', ' Arm/Group Description: Endocrine treatment consisting of either letrozole or fulvestrant. Patients will be randomized to receive bevacizumab 15mg/kg i.v. on day 1 every 3 weeks plus endocrine treatment or endocrine treatment as a single agent. The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent.', ' Letrozole', ' Bevacizumab', ' Fulvestrant', ' Overall Number of Participants Analyzed: 190', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 19.3 (16.5 to 22.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/184 (11.41%)', ' Lymphangitis 0/184 (0.00%)', ' Angina pectoris 0/184 (0.00%)', ' Cardiac infarction 0/184 (0.00%)', ' Heart failure 0/184 (0.00%)', ' Infarction 0/184 (0.00%)', ' Acute pancreatitis 0/184 (0.00%)', ' Anal fistula 0/184 (0.00%)', ' Colitis 1/184 (0.54%)', ' Diarrhoea 0/184 (0.00%)', ' Diverticulitis 0/184 (0.00%)', ' Hemorrhoids 0/184 (0.00%)', 'Adverse Events 2:', ' Total: 64/190 (33.68%)', ' Lymphangitis 1/190 (0.53%)', ' Angina pectoris 1/190 (0.53%)', ' Cardiac infarction 1/190 (0.53%)', ' Heart failure 1/190 (0.53%)', ' Infarction 1/190 (0.53%)', ' Acute pancreatitis 1/190 (0.53%)', ' Anal fistula 1/190 (0.53%)', ' Colitis 0/190 (0.00%)', ' Diarrhoea 2/190 (1.05%)', ' Diverticulitis 1/190 (0.53%)', ' Hemorrhoids 1/190 (0.53%)']}

2570cb04-4edd-48c9-b634-9f2e086469de

Single

Results

NCT00270894

60 patients in the primary trial were able to Complete at least 85% of the Planned Dose on Schedule.

Contradiction

{'Clinical Trial ID': 'NCT00270894', 'Intervention': ['INTERVENTION 1: ', ' Neoadjuvant Therapy', ' Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.'], 'Eligibility': ['Inclusion Criteria:', ' Non-pregnant females =/> 18 years of age', ' Non-inflammatory breast cancer stage IIA - IIIC or high risk node negative', ' Core biopsy of breast demonstrating invasive cancer and documented ER/PgR receptor status', ' Normal cardiac function and adequate hematologic function', ' Human epidermal growth factor receptor 2 protein (HER2) positive', ' No evidence of metastatic disease', ' ECOG Performance Status 0 - 1', ' Women of childbearing potential must agree to using effective contraception while on treatment and for at least 3 months post-treatment', 'Exclusion Criteria:', ' Treated with other investigational drugs within 30 days', ' Uncontrolled intercurrent disease or active infection', ' Known sensitivity to e. coli-derived proteins or polysorbate 80', ' Psychiatric illness or social situation that would limit study compliance', ' Pre-existing peripheral neuropathy > Grade 1', ' Cancer within 5 years of screening with the exception of surgically cured nonmelanomatous skin cancer; in-situ carcinoma of the cervix; or in-situ carcinoma of the breast', ' Bilateral synchronous breast cancer', ' Inflammatory breast cancer', ' Women who are pregnant or breast feeding'], 'Results': ['Outcome Measurement: ', ' Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule', ' Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with > 85% of the protocol-specified dose.', ' Time frame: From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)', 'Results 1: ', ' Arm/Group Title: Neoadjuvant Therapy', ' Arm/Group Description: Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Number', ' Unit of Measure: percentage of participants 60'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/30 (13.33%)', ' Congestive heart failure * 1/30 (3.33%)', ' Pneumonia * 1/30 (3.33%)', ' Medical Error * 1/30 (3.33%)', ' Interstitial lung disease * 1/30 (3.33%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

f6a7e279-b923-45e3-8ad5-e81e17c0a682

Comparison

Eligibility

NCT02511730

NCT00193206

Patients with prior chemotherapy are eligible for the primary trial, but excluded from the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT02511730', 'Intervention': ['INTERVENTION 1: ', ' FFDM Plus DBT', ' Breast Images with FFDM and DBT', ' FFDM Plus DBT: Fujifilm Aspire Cristalle System', 'INTERVENTION 2: ', ' FFDM', ' Breast Images with FFDM alone', ' FFDM: Fujifilm Aspire Cristalle System'], 'Eligibility': ['Inclusion Criteria:', ' Female subjects participating in FMSU004A protocol with known clinical status', 'Exclusion Criteria:', ' Subjects with unknown clinical status not participating in FMSU004A protocol.'], 'Results': ['Outcome Measurement: ', ' Compare Per Subject Area Under Curve (AUC): FFDM Only vs DBT Plus FFDM', " Breast AUC performance metrics to determine if FFDM plus DBT improved cancer detection rate, requiring correct lesion localization. Statistician to estimate AUCs for each reader in each review condition (FFDM read in conjunction with FFDM plus DBT read) based on their Probability of Malignancy (POM) scores. POM scores will require correct lesion localization, such that in a case with cancer if the reader recorded one or more findings in the case but none of them are determined by the truther to match the location(s) of any proven malignancies, a POM score of 0 will be assigned to the case. Statistician to provide graphical representations of each reader's ROC curve for each review condition. For each reader the difference between the AUC for the FFDM read in conjunction with the FFDM plus DBT will be presented. Statistician to perform MRMC comparison of AUC's between FFDM read in conjunction with FFDM plus DBT using the MRMC method of Dorfman, Berbaum & Metz (1992).", ' Time frame: 1 month', 'Results 1: ', ' Arm/Group Title: FFDM Plus DBT', ' Arm/Group Description: Breast Images with FFDM and DBT', ' FFDM Plus DBT: Fujifilm Aspire Cristalle System', ' Overall Number of Participants Analyzed: 100', ' Mean (Standard Error)', ' Unit of Measure: Probability 100 (0.812)', 'Results 2: ', ' Arm/Group Title: FFDM', ' Arm/Group Description: Breast Images with FFDM alone', ' FFDM: Fujifilm Aspire Cristalle System', ' Overall Number of Participants Analyzed: 100', ' Mean (Standard Error)', ' Unit of Measure: Probability 100 (0.780)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/100 (0.00%)', 'Adverse Events 2:', ' Total: 0/100 (0.00%)']}

{'Clinical Trial ID': 'NCT00193206', 'Intervention': ['INTERVENTION 1: ', ' Intervention', ' Systemic Therapy', ' ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles', ' Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles', ' Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles'], 'Eligibility': ['Inclusion Criteria:', ' To be included in this study, you must meet the following criteria:', ' Locally advanced/inflammatory adenocarcinoma of the breast', ' 18 years of age or older', ' Normal heart function', ' Able to perform activities of daily living with minimal assistance', ' No prior chemotherapy for breast cancer', ' Adequate bone marrow, liver and kidney function', ' No evidence or history of significant cardiovascular abnormalities', ' Sentinel node or axillary dissection', ' Sign an informed consent form', 'Exclusion Criteria:', ' You cannot participate in this study if any of the following apply to you:', ' Pregnant or breast feeding', ' History of heart disease with congestive heart failure', ' Heart attack within the previous 6 months', ' Prior chemotherapy or hormone therapy for breast cancer', ' History of active uncontrolled infection', ' Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response', ' For the purpose of this study, a pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0) and axillary lymph nodes (pN0), gross or microscopic, in the sample removed at the time of surgical resection. Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: Intervention', ' Arm/Group Description: Systemic Therapy', ' ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles', ' Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles', ' Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles', ' Overall Number of Participants Analyzed: 116', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 23 19.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/123 (17.89%)', ' Cardiac Ischemia/Infarction [1]1/123 (0.81%)', ' Pain - Chest 2/123 (1.63%)', ' Dehydration 2/123 (1.63%)', ' Death [2]1/123 (0.81%)', ' Weakness 1/123 (0.81%)', ' Pain - Liver 1/123 (0.81%)', ' Infection - Skin [3]3/123 (2.44%)', ' Infection - Gastrointestinal [4]1/123 (0.81%)', ' Infection - Vein [5]2/123 (1.63%)', ' Infection - Pneumonia 1/123 (0.81%)']}

3d82851c-f302-4988-bd78-232583e04e96

Single

Intervention

NCT01819233

All the primary trial participants have the same number of calories in their diets throughout the duration of the study.

Contradiction

{'Clinical Trial ID': 'NCT01819233', 'Intervention': ['INTERVENTION 1: ', ' Behavioral Dietary Intervention', ' Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.', ' Behavioral dietary intervention: Receive caloric restricted dietary intervention', ' Therapeutic conventional surgery: Undergo definitive lumpectomy', ' Radiation therapy: Undergo radiation therapy', ' Counseling intervention: Receive dietary counseling', ' Quality-of-life assessment: Ancillary studies'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically proven diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancer', ' Ability to have breast conservation as determined by the judgment of the radiation oncologist, for which the radiation oncologist has determined that he or she will only treat the whole breast and not regional lymph nodes', ' The patient must be female', ' Age >= 18', ' If multifocal breast cancer, then it must be able to be resected through a single lumpectomy incision', ' Appropriate stage for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup:', ' History/physical examination, including breast exam and documentation of weight and Karnofsky performance status of 80-100% for at least 60 days prior to study entry', ' Ipsilateral mammogram within 6 months prior to study entry', ' Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry', ' Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy', ' Patient must capable of and provide study specific informed consent prior to study entry', ' Body mass index (BMI) >= 21', ' Weight >= 100 lbs', ' No prior history of non-breast malignancies in the past 2 years unless it was a non-melanomatous skin lesion or carcinoma in situ of the cervix', ' Patient must not have any of the following severe, active co-morbidity, defined as follows:', ' Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months', ' Transmural myocardial infarction within the last 6 months', ' Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration', ' Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration', ' Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol', ' Acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) positive based upon current Centers for Disease and Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol; the need to exclude patients with AIDS or HIV from this protocol is necessary because anti-retrovirals may alter patient metabolism', ' Patient must not have active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash', ' No prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields', ' Patient may not have any active gastrointestinal/malabsorption disorder at the discretion of the Principal Investigator', ' Inflammatory bowel disease', ' Celiac disease', ' Chronic pancreatitis', ' Chronic diarrhea or vomiting', ' Active eating disorder', ' Creatinine < 1.7', ' Not currently taking steroids', ' No currently active pituitary secreting tumors up to physician discretion', ' No history of or current active drug/alcohol dependence', ' No patients being decisionally impaired', 'Exclusion Criteria:', ' Patient is not a candidate for breast conservation', ' Patient is male', ' Age < 18 years', ' Patient requires regional lymph node irradiation therapy', ' Patient has evidence of distant metastases', ' Karnofsky performance status less than 80% within 60 days prior to study', ' Ipsilateral mammogram done greater than 6 months prior to study', ' Women of childbearing potential with a positive serum beta human chorionic gonadotropin (hCG)', ' Patient has a history of dementia, psychosis or other disorder affecting their mental status to the point where they cannot consent or comply with study guidelines', ' BMI < 21', ' Weight < 100 lbs', ' Weight loss >= 10% in the last 3 months (mos)', ' Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 2 years prior to registration', ' Two or more breast cancers not resectable through a single lumpectomy incision', ' Non-epithelial breast malignancies such as sarcoma or lymphoma', ' Prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields', ' Severe, active co-morbidity, defined as follows:', ' Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months', ' Transmural myocardial infarction within the last 6 months', ' Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration', ' Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration', ' Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol', ' Acquired immune deficiency syndrome (AIDS) or HIV positive based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol; the need to exclude patients with AIDS or HIV from this protocol is necessary because anti-retrovirals may alter patient metabolism', ' Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash', ' Active gastrointestinal/malabsorption disorder at the discretion of the Principal Investigator', ' Inflammatory bowel disease', ' Celiac disease', ' Chronic pancreatitis', ' Chronic diarrhea or vomiting', ' Active eating disorder', ' Creatinine >= 1.7', ' Current use of steroids', ' Pituitary secreting tumors up to physician discretion', ' Active drug/alcohol dependence or abuse history', ' Decisionally impaired patients'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Are Adherent to the Diet Restriction', ' Computed along with a 95% exact confidence interval. Exact binomial test (with a one-sided alpha of 0.05) will be used to test whether adherence is greater than 60%.', ' Time frame: Up to week 12', 'Results 1: ', ' Arm/Group Title: Behavioral Dietary Intervention', ' Arm/Group Description: Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.', ' Behavioral dietary intervention: Receive caloric restricted dietary intervention', ' Therapeutic conventional surgery: Undergo definitive lumpectomy', ' Radiation therapy: Undergo radiation therapy', ' Counseling intervention: Receive dietary counseling', ' Quality-of-life assessment: Ancillary studies', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Number', ' Unit of Measure: participants 28 [1] (NA to 74.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/38 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

5c9f5916-37d3-4f6f-977b-be70204cf57c

Comparison

Intervention

NCT01156987

NCT02234479

Participants in the primary trial are assigned an intervention depending on their cancer diagnosis, whereas in the secondary trial the interventions are randomly assigned.

Entailment

{'Clinical Trial ID': 'NCT01156987', 'Intervention': ['INTERVENTION 1: ', ' Healthy Volunteers', ' Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.', ' Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:', ' an IV line is placed by nurse,', ' patient is placed in the 4 T MRI scanner at CMRR,', ' initial scout images and manual linear shims are adjusted,', ' Pre-contrast SWIFT T1 weighted images and T1 map are obtained,', ' continuous SWIFT acquisition begins immediately before contrast injection,', ' contrast injection,', ' continuous SWIFT acquisition continues for 12 min after contrast,', ' late enhancement images may also be obtained.', ' 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods.', 'INTERVENTION 2: ', ' Breast Cancer Patients', ' Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.', ' Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:', ' an IV line is placed by nurse,', ' patient is placed in the 4 T MRI scanner at CMRR,', ' initial scout images and manual linear shims are adjusted,', ' Pre-contrast SWIFT T1 weighted images and T1 map are obtained,', ' continuous SWIFT acquisition begins immediately before contrast injection,', ' contrast injection,', ' continuous SWIFT acquisition continues for 12 min after contrast,', ' late enhancement images may also be obtained.', ' 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar'], 'Eligibility': ['Inclusion Criteria:', ' Women with a clinically or mammographically identified suspicious breast mass that is likely to be biopsied or surgically removed.', 'Exclusion Criteria:', ' Pregnancy', ' Ferromagnetic implants', ' History of shotgun wounds and shrapnel', ' Obesity (>250 pounds)', ' Cardiac pacemaker', ' Incompatible implanted medical device', ' Severe claustrophobia', ' Major surgeries with potential of ferromagnetic implants', ' Severe asthma and allergies', ' i-STAT system, a handheld blood analyzer (I-STAT) creatinine test, estimated glomerular filtration rate (GFR) <30', ' Metallic object (greater than 2 cm in length) in the breast', ' Metallic ink tatoo within 20 cm of the breast (approximately 8 inches)'], 'Results': ['Outcome Measurement: ', ' Lesions', ' Number of lesions detected', ' Time frame: at time of read by two radiologiests, compared to biopsy within 7 days.', 'Results 1: ', ' Arm/Group Title: Healthy Volunteers', ' Arm/Group Description: Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.', ' Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:', ' an IV line is placed by nurse,', ' patient is placed in the 4 T MRI scanner at CMRR,', ' initial scout images and manual linear shims are adjusted,', ' Pre-contrast SWIFT T1 weighted images and T1 map are obtained,', ' continuous SWIFT acquisition begins immediately before contrast injection,', ' contrast injection,', ' continuous SWIFT acquisition continues for 12 min after contrast,', ' late enhancement images may also be obtained.', ' 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods.', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Number', ' Unit of Measure: lesions 0', 'Results 2: ', ' Arm/Group Title: Breast Cancer Patients', ' Arm/Group Description: Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.', ' Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:', ' an IV line is placed by nurse,', ' patient is placed in the 4 T MRI scanner at CMRR,', ' initial scout images and manual linear shims are adjusted,', ' Pre-contrast SWIFT T1 weighted images and T1 map are obtained,', ' continuous SWIFT acquisition begins immediately before contrast injection,', ' contrast injection,', ' continuous SWIFT acquisition continues for 12 min after contrast,', ' late enhancement images may also be obtained.', ' 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar', ' Overall Number of Participants Analyzed: 23', ' Measure Type: Number', ' Unit of Measure: lesions 12'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/8 (0.00%)', 'Adverse Events 2:', ' Total: 0/23 (0.00%)']}

{'Clinical Trial ID': 'NCT02234479', 'Intervention': ['INTERVENTION 1: ', ' Hydrophor (Group A)', ' Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.', ' Hydrophor (Group A): Rehydrates dry, chapped or chafed skin', 'May be used alone as a skin lubricant or protectant', 'INTERVENTION 2: ', ' MediHoney (Group B)', ' Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.', " MediHoney (Group B): It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:", ' Maintain a balanced environment for healing.', ' Aids in reducing dermatitis.', ' Reduce affected area pH.2-3'], 'Eligibility': ['Inclusion Criteria:', ' Breast cancer treated with either lumpectomy or mastectomy (with or without reconstruction).', ' The patient must be female.', ' Radiation therapy planned to whole breast/chestwall area (can include lymph node radiation; conventional 3D radiation, IMRT/IGRT, and hypofractionation are all allowed).', ' Age 18 years old.', 'Exclusion Criteria:', ' Previous radiation therapy to chest area that would result in overlapping radiation fields.', ' Wound care issues.', ' Patients undergoing concurrent cytotoxic chemotherapy and radiation therapy (concurrent Herceptin and/or tamoxifen/aromatase inhibitors and RT is allowed).', ' Patients receiving HDR (savi or mammosite) brachytherapy treatments.', ' Patients with an allergy and/or sensitivity to Hydrophor, honey, and/or Medihoney.', ' Immunocompromised status.', ' Age < 18 years old.'], 'Results': ['Outcome Measurement: ', ' Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy', ' The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It is hoped that the outcome of this pilot study will provide evidence supporting the use of Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary data to expand this study to larger, federally funded research (R01) looking at the beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in several disease settings.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Hydrophor (Group A)', ' Arm/Group Description: Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.', ' Hydrophor (Group A): Rehydrates dry, chapped or chafed skin', 'May be used alone as a skin lubricant or protectant', ' Overall Number of Participants Analyzed: 16', ' Measure Type: Number', ' Unit of Measure: participants radiation dermatitis: 15', ' hyperpigmentation: 15', 'Results 2: ', ' Arm/Group Title: MediHoney (Group B)', ' Arm/Group Description: Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.', " MediHoney (Group B): It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:", ' Maintain a balanced environment for healing.', ' Aids in reducing dermatitis.', ' Reduce affected area pH.2-3', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Number', ' Unit of Measure: participants radiation dermatitis: 15', ' hyperpigmentation: 15'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/16 (0.00%)', 'Adverse Events 2:', ' Total: ']}

0c5f2498-4c10-4e51-8915-d86b37b08156

Single

Adverse Events

NCT00545688

There were no patients with paranasal sinus reactions, or Left ventricular dysfunction in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00545688', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab+Docetaxel', ' Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.', ' Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.', 'INTERVENTION 2: ', ' Trastuzumab+Pertuzumab+Docetaxel', ' Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.', ' Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.'], 'Eligibility': ['Inclusion Criteria:', ' female patients, >=18 years of age;', ' locally advanced, inflammatory or early stage invasive breast cancer;', ' HER2 positive (HER2+++ by IHC or FISH/CISH+).', 'Exclusion Criteria:', ' metastatic disease (Stage IV) or bilateral breast cancer;', ' previous anticancer therapy or radiotherapy for any malignancy;', ' other malignancy, other than cancer in situ of the cervix, or basal cell cancer;', ' insulin-dependent diabetes;', ' clinically relevant cardiovascular disease.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Achieving Pathological Complete Response (pCR)', ' pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders', ' Time frame: Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)', 'Results 1: ', ' Arm/Group Title: Trastuzumab+Docetaxel', ' Arm/Group Description: Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.', ' Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.', ' Overall Number of Participants Analyzed: 107', ' Measure Type: Number', ' Unit of Measure: percentage of participants 29.0 (20.6 to 38.5)', 'Results 2: ', ' Arm/Group Title: Trastuzumab+Pertuzumab+Docetaxel', ' Arm/Group Description: Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.', ' Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.', ' Overall Number of Participants Analyzed: 107', ' Measure Type: Number', ' Unit of Measure: percentage of participants 45.8 (36.1 to 55.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/107 (19.63%)', ' Febrile neutropenia * 10/107 (9.35%)', ' Neutropenia * 1/107 (0.93%)', ' Left ventricular dysfunction * 0/107 (0.00%)', ' Angina pectoris * 0/107 (0.00%)', ' Cardiac failure congestive * 0/107 (0.00%)', ' Diarrhoea * 2/107 (1.87%)', ' Abdominal strangulated hernia * 0/107 (0.00%)', ' Duodenal ulcer haemorrhage * 0/107 (0.00%)', ' Pyrexia * 1/107 (0.93%)', 'Adverse Events 2:', ' Total: 22/107 (20.56%)', ' Febrile neutropenia * 8/107 (7.48%)', ' Neutropenia * 6/107 (5.61%)', ' Left ventricular dysfunction * 3/107 (2.80%)', ' Angina pectoris * 1/107 (0.93%)', ' Cardiac failure congestive * 0/107 (0.00%)', ' Diarrhoea * 0/107 (0.00%)', ' Abdominal strangulated hernia * 1/107 (0.93%)', ' Duodenal ulcer haemorrhage * 0/107 (0.00%)', ' Pyrexia * 1/107 (0.93%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

c54dc963-671a-4384-8b1f-d8058a832131

Single

Adverse Events

NCT02340221

A total of 32 patients in the primary trial had Diarrhoea.

Entailment

{'Clinical Trial ID': 'NCT02340221', 'Intervention': ['INTERVENTION 1: ', ' Placebo+Fulvestrant', ' Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.', 'INTERVENTION 2: ', ' Taselisib+Fulvestrant', ' Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen receptor (ER) positive breast cancer', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Participants for whom endocrine therapy (example [e.g.], fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study', ' Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer', ' Radiologic/objective evidence of breast cancer recurrence or progression while on or within 12 months of the end of adjuvant treatment with an aromatase inhibitor (AI), or progression while on or within 1 month of the end of prior AI treatment for locally advanced or metastatic breast cancer', ' Measurable disease via Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) or non-measurable, evaluable disease with at least one evaluable bone lesion via RECIST v1.1', ' Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue for oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutation testing', ' A valid cobas PIK3CA mutation result by central testing is required', ' Adequate hematologic and end-organ function within 28 days prior to treatment initiation', 'Exclusion Criteria:', ' Human epidermal growth factor receptor 2 (HER2)-positive disease by local laboratory testing (immunohistochemistry 3 positive [IHC 3+] staining or in situ hybridization positive)', ' Prior treatment with fulvestrant', ' Prior treatment with a phosphatidylinositol 3-kinase (PI3K) inhibitor, mammalian target of rapamycin (mTOR) inhibitor (e.g. everolimus), or protein kinase B (AKT) inhibitor', ' Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1', ' Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1', ' All acute treatment-related toxicity must have resolved to Grade less than or equal to (</=) 1 or be deemed stable by the Investigator', ' Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen for metastatic breast cancer', ' Concurrent hormone replacement therapy', ' Known untreated or active central nervous system (CNS) metastases', ' Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications', ' History of inflammatory bowel disease or active bowel inflammation', ' Clinically significant cardiac or pulmonary dysfunction', ' Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B or C virus'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)', ' PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.', ' Time frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)', 'Results 1: ', ' Arm/Group Title: Placebo+Fulvestrant', ' Arm/Group Description: Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.', ' Overall Number of Participants Analyzed: 176', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.39 (3.68 to 7.29)', 'Results 2: ', ' Arm/Group Title: Taselisib+Fulvestrant', ' Arm/Group Description: Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.', ' Overall Number of Participants Analyzed: 340', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.43 (7.26 to 9.07)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/213 (8.92%)', ' Pancytopenia 0/213 (0.00%)', ' Anaemia 1/213 (0.47%)', ' Atrial fibrillation 0/213 (0.00%)', ' Cardiac failure congestive 0/213 (0.00%)', ' Myocardial infarction 0/213 (0.00%)', ' Supraventricular tachycardia 0/213 (0.00%)', ' Diarrhoea 0/213 (0.00%)', ' Colitis 0/213 (0.00%)', ' Vomiting 1/213 (0.47%)', ' Nausea 1/213 (0.47%)', ' Enterocolitis 0/213 (0.00%)', 'Adverse Events 2:', ' Total: 133/416 (31.97%)', ' Pancytopenia 1/416 (0.24%)', ' Anaemia 0/416 (0.00%)', ' Atrial fibrillation 2/416 (0.48%)', ' Cardiac failure congestive 1/416 (0.24%)', ' Myocardial infarction 1/416 (0.24%)', ' Supraventricular tachycardia 1/416 (0.24%)', ' Diarrhoea 32/416 (7.69%)', ' Colitis 14/416 (3.37%)', ' Vomiting 4/416 (0.96%)', ' Nausea 3/416 (0.72%)', ' Enterocolitis 2/416 (0.48%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

a4c62782-9f4c-4cf5-96b3-eb8e9098a3b4

Single

Adverse Events

NCT00014222

Cohort one of the primary trial reported 2/680 patients experiecing eye-related adverse events, whereas cohort two recorded none.

Entailment

{'Clinical Trial ID': 'NCT00014222', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: CEF', ' 6 cycles - q 28 days (6 months) - Cyclophosphamide 75 mg/m2 - po - Days 1-14 - Epirubicin 60 mg/m2 - IV - Days 1 and 8 - 5 Fluorouracil: 500mg/m2 - IV - Days 1 and 8 + Continuous Antibiotic Prophylaxis with Cotrimoxazole 960 mg (i.e.2x480 mg tablets) po-bid or Ciprofloxacin 500 mg - po-bid', ' cyclophosphamide: 75, 600 and 830 mg/m2', ' epirubicin hydrochloride: 60 mg/m2', ' fluorouracil: 500mg/m2', 'INTERVENTION 2: ', ' Arm 2: EC/T', ' 6 cycles - q 14 days (3 months) - Epirubicin 120 mg/m2 - IV - Day 1 - Cyclophosphamide 830 mg/m2 - IV - Day 1 - Filgrastim 5μg/kg/d - SC - Days 2 - 13 + Epoetin Alfa 40,000 IU - SC - once weekly (to begin within 1 week after start of protocol therapy as needed) 21 days from last administration of EC (EC/T) 4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 - 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion', ' epoetin alfa: 40,000 IU', ' filgrastim: 5 mg/kg/d - days 2-13', ' cyclophosphamide: 75, 600 and 830 mg/m2', ' doxorubicin hydrochloride: 60 mg/m2', ' paclitaxel: 175 mg/m2'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed adenocarcinoma of the breast that is potentially curable', ' T0-4 (dermal involvement on pathology assessment only), N0-2, M0', ' No clinical T4 disease', ' Previously treated with one of the following:', ' Total mastectomy and level II axillary node dissection', ' Partial mastectomy and level II axillary node dissection with planned breast radiotherapy after completion of adjuvant chemotherapy regimen*', ' Patients with a positive sentinel node biopsy must undergo level II axillary node dissection or sufficient nodal sampling', ' If microscopic residual in situ or invasive disease is present at total or partial mastectomy margins, planned radiotherapy must also include a boost to the tumor bed', ' No residual tumor in the axilla after dissection', ' Axillary node positive', ' Negative nodes allowed if the tumor is 1 cm and 1 or more of the following criteria defining high-risk node-negative disease are met:', ' Histological grade III or,', ' Estrogen receptor negative or,', ' Lymphatic/vascular invasion', ' Hormone receptor status:', ' Estrogen receptor status known', ' PATIENT CHARACTERISTICS:', ' Age:', ' 60 and under', ' Sex:', ' Female', ' Menopausal status:', ' Pre- or postmenopausal', 'Performance status:', ' ECOG 0-2', ' Life expectancy:', ' At least 5 years', ' Hematopoietic:', ' WBC 3,000/mm^3', ' Platelet count 100,000/mm^3', ' Hepatic:', ' Bilirubin 1.5 times upper limit of normal (ULN)', ' Renal:', ' Creatinine 1.5 times ULN', ' Cardiovascular:', ' LVEF limit of normal by MUGA or echocardiogram', ' No arrhythmia requiring ongoing treatment', ' No congestive heart failure', ' No documented coronary artery disease', ' Other:', ' No other malignancy except:', ' Adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix', ' Ductal or lobular carcinoma in situ that has been curatively treated by surgery alone', ' Other prior malignancies (except breast cancer) curatively treated more than 5 years prior to study entry', ' No serious underlying medical illness or psychiatric or addictive disorder that would preclude study compliance', ' No known hypersensitivity to E. coli-derived products, mammalian-cell derived products, or any study agents', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective non-hormonal contraception', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy:', ' No prior immunotherapy for breast cancer', ' No concurrent pegfilgrastim or darbepoetin alfa (Arm II)', ' Allowed on arms 1 and 3 if medically necessary', ' Chemotherapy:', ' No prior chemotherapy for breast cancer', ' Endocrine therapy:', ' No prior hormonal therapy for breast cancer', ' No concurrent hormone replacement therapy', ' No concurrent selective estrogen-receptor modulators (e.g., raloxifene for the treatment or prevention of osteoporosis)', ' No concurrent oral contraceptives (i.e., birth control pills)', ' No other concurrent aromatase inhibitors', ' Radiotherapy:', ' See Disease Characteristics', ' No prior radiotherapy for breast cancer', ' Surgery:', ' See Disease Characteristics', ' No more than 12 weeks since prior total or partial mastectomy (including re-excision of margins)', ' Other:', ' At least 30 days since prior investigational drugs', ' No other concurrent investigational drugs', ' Concurrent bisphosphonates for the treatment or prevention of osteoporosis allowed'], 'Results': ['Outcome Measurement: ', ' Disease Free Survival', ' Disease free survival was defined as the time from randomization to the time of recurrence of the primary disease. Local or nodal recurrence and metastatic disease were considered a recurrence of the primary tumour. Patients who had contralateral breast cancer or a second primary malignancy, or died from some cause other than disease were censored as relapse-free at the time of death. Patients who had not relapsed were censored at longest follow-up or at non-breast cancer death. As required, adjudication was used to assess reports of recurrence.', ' Time frame: 13 years', 'Results 1: ', ' Arm/Group Title: Arm 1: CEF', ' Arm/Group Description: 6 cycles - q 28 days (6 months) - Cyclophosphamide 75 mg/m2 - po - Days 1-14 - Epirubicin 60 mg/m2 - IV - Days 1 and 8 - 5 Fluorouracil: 500mg/m2 - IV - Days 1 and 8 + Continuous Antibiotic Prophylaxis with Cotrimoxazole 960 mg (i.e.2x480 mg tablets) po-bid or Ciprofloxacin 500 mg - po-bid', ' cyclophosphamide: 75, 600 and 830 mg/m2', ' epirubicin hydrochloride: 60 mg/m2', ' fluorouracil: 500mg/m2', ' Overall Number of Participants Analyzed: 701', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Disease Recurrence: 141 20.1%', ' No recurrence: 560 79.9%', 'Results 2: ', ' Arm/Group Title: Arm 2: EC/T', ' Arm/Group Description: 6 cycles - q 14 days (3 months) - Epirubicin 120 mg/m2 - IV - Day 1 - Cyclophosphamide 830 mg/m2 - IV - Day 1 - Filgrastim 5μg/kg/d - SC - Days 2 - 13 + Epoetin Alfa 40,000 IU - SC - once weekly (to begin within 1 week after start of protocol therapy as needed) 21 days from last administration of EC (EC/T) 4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 - 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion', ' epoetin alfa: 40,000 IU', ' filgrastim: 5 mg/kg/d - days 2-13', ' cyclophosphamide: 75, 600 and 830 mg/m2', ' doxorubicin hydrochloride: 60 mg/m2', ' paclitaxel: 175 mg/m2', ' Overall Number of Participants Analyzed: 701', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Disease Recurrence: 135 19.3%', ' No recurrence: 566 80.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 83/680 (12.21%)', ' Hemoglobin 11/680 (1.62%)', ' Transfusion: Platelets 0/680 (0.00%)', ' Transfusion: pRBCs 0/680 (0.00%)', ' Febrile neutropenia 49/680 (7.21%)', ' Edema 1/680 (0.15%)', ' Ischemia/infarction 0/680 (0.00%)', ' Palpitations 0/680 (0.00%)', ' Pericardial effusion 0/680 (0.00%)', ' Keratitis 1/680 (0.15%)', ' Double vision 1/680 (0.15%)', ' Colitis 1/680 (0.15%)', 'Adverse Events 2:', ' Total: 86/688 (12.50%)', ' Hemoglobin 15/688 (2.18%)', ' Transfusion: Platelets 1/688 (0.15%)', ' Transfusion: pRBCs 1/688 (0.15%)', ' Febrile neutropenia 41/688 (5.96%)', ' Edema 0/688 (0.00%)', ' Ischemia/infarction 0/688 (0.00%)', ' Palpitations 1/688 (0.15%)', ' Pericardial effusion 1/688 (0.15%)', ' Keratitis 0/688 (0.00%)', ' Double vision 0/688 (0.00%)', ' Colitis 0/688 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

91adb350-ab20-41a6-944d-c13b55cf33f2

Comparison

Results

NCT02038010

NCT00764322

Neither the primary trial or the secondary trial are measuring Dose Limiting Toxicity of BYL719 in Combination With T-DM1.

Contradiction

{'Clinical Trial ID': 'NCT02038010', 'Intervention': ['INTERVENTION 1: ', ' Cohort -1 (250mg BYL719, 3.6mg/kg T-DM1)', ' Patients receive 250 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' PI3K inhibitor BYL719: Given PO', ' Ado-trastuzumab emtansine: Given IV', ' Pharmacological study: Correlative studies', ' Laboratory biomarker analysis: Optional correlative studies', 'INTERVENTION 2: ', ' Cohort 1 (300mg BYL719, 3.6mg/kg T-DM1)', ' Patients receive 300 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' PI3K inhibitor BYL719: Given PO', ' Ado-trastuzumab emtansine: Given IV', ' Pharmacological study: Correlative studies', ' Laboratory biomarker analysis: Optional correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically-confirmed HER2-positive breast cancer that is locally advanced or metastatic (stage 4); ideally this should be from biopsy of the metastatic disease; however if this is not available, histologic confirmation from the primary tumor is acceptable', ' Patients must have had progression on a trastuzumab and taxane-based chemotherapy regimen during or after treatment for locally advanced or metastatic disease or within 6 months after treatment for early-stage HER2-positive disease documented by one of the following results using Food and Drug Administration (FDA)-approved testing methods:', ' Fluorescence in situ hybridization (FISH)-positive (with an amplification ratio >= 2.0 indicating positive status) and/or', ' Immunohistochemistry (IHC) 3 + by local laboratory assessment', ' Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2', ' Patients must have a life expectancy >= 90 days', ' Patients must have baseline laboratory tests within the following parameters at least 4 weeks (28 days) prior to registration:', ' Hemoglobin > 8 g/dL (which may be reached by transfusion)', ' Platelet count >= 100 x 10^9/L (no transfusion allowed within 2 weeks)', ' Absolute neutrophil count (ANC) >= 1.5 x 10^9/L without growth factor support', ' Serum bilirubin =< 1.5 x upper limit of normal (ULN)', ' Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and/or alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) =< 2.5 x upper limit of normal (ULN) or =< 5 x ULN if liver metastases are present', ' Serum creatinine =< 1.5 x ULN or calculated or directly measured creatinine clearance (CrCl) >= 50% LLN (lower limit of normal)', ' Fasting plasma glucose (FPG) < 140 mg/dL/7.8 mmol/L', ' Patients with child-bearing potential must have a negative urine pregnancy test within 7 days prior to registration', ' Patients must have a baseline electrocardiogram (ECG) showing QT interval =< 460 msec within 14 days prior to registration', ' Patients must provide written informed consent prior to any registration on study', ' Patients must be willing and able to comply with scheduled visits, treatment plan and laboratory tests', ' Patient must be able to swallow and retain oral medication', 'Exclusion Criteria:', ' Patients with prior sensitivity or intolerance to PI3K inhibitors are not eligible for participation', ' Patients with a history of grade >= 3 hypersensitivity reaction to trastuzumab, OR grade >= 1 with the most recent trastuzumab infusion before study entry, OR continued requirement for prolonged trastuzumab infusions to prevent hypersensitivity reactions are not eligible for participation', ' Patients with a history of intolerance to trastuzumab and/or adverse events related to trastuzumab that resulted in trastuzumab being permanently discontinued are not eligible for participation', ' Patients who have received prior treatment with T-DM1 are not eligible for participation', ' Patients who have received prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy, hormonal therapy) within 2 weeks prior to registration are not eligible for participation', ' Patients with central nervous system (CNS) involvement may participate if the patient meets all of the following criteria:', ' At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment', ' Clinically stable with respect to the CNS tumor at the time of screening', ' Not receiving steroid therapy', ' Not receiving enzyme inducing anti-epileptic medications that were started for brain metastases', ' Patients who have received radiotherapy =< 4 weeks prior to registration, with the exception of palliative radiotherapy, who have not recovered from side effects of such therapy to baseline or grade =< 1 and/or from whom >= 30% of the bone marrow was irradiated are not eligible for participation', ' Patients who have undergone major surgery =< 4 weeks prior to registration or who have not recovered from side effects of such procedure are not eligible for participation', ' Patients with clinically significant cardiac disease or impaired cardiac function are not eligible for participation; this includes patients with:', ' Congestive heart failure (CHF) requiring treatment (New York Heart Association [NYHA] grade >= 2)', ' Left ventricular ejection fraction (LVEF) < 50% as determined by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO)', ' Uncontrolled arterial hypertension defined by blood pressure > 140/100 mm Hg at rest (average of 3 consecutive readings)', ' History or current evidence of unstable, clinically significant cardiac arrhythmias or patients that require medications with a narrow therapeutic window, atrial fibrillation and/or conduction abnormality (e.g. congenital long QT syndrome, high-grade/complete atrioventricular [AV]-blockage)', ' Acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft [CABG], coronary angioplasty, or stenting), < 3 months prior to screening', ' QT interval adjusted according to Fridericia (QTcF) > 460 msec on screening ECG', ' Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting plasma glucose (FPG) >= 140 mg/dL/7.8 mmol/L, or history of documented steroid-induced diabetes mellitus are not eligible for participation', " Patients exhibiting any other condition that would, in the Investigator's judgment, preclude patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures are not eligible for participation; this might include, but is not limited to, infection/inflammation, intestinal obstruction, and/or social/psychological complications", ' Patients with impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral BYL719 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) are not eligible for participation', ' Patients who are currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes (TdP) AND are unable to discontinue this medication or switch to a different medication prior to beginning study treatment are not eligible for participation', ' Patients with a history of another malignancy within 2 years prior to registration are not eligible for participation; NOTE: the exceptions to this include cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix', ' Patients receiving therapeutic doses of warfarin are not eligible for participation; NOTE: Patients with a need for therapeutic anticoagulation should be given low molecular weight heparin or other non-warfarin product', ' Pregnant or nursing (lactating) women are not eligible for participation; NOTE: Pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL)', ' Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, are not eligible for participation UNLESS they agree to use highly effective methods of contraception during dosing and for 5 weeks after study drugs discontinuation; highly effective contraception methods include:', ' Total abstinence (when this is in line with the preferred and usual lifestyle of the subject); periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception', ' Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 5 weeks before receiving study treatment. In case of oophorectomy alone, the reproductive status of the woman must have been confirmed by follow up hormone level assessment', ' Male sterilization (at least 6 months prior to screening); for female subjects on the study the vasectomized male partner should be the sole partner for that subject', ' Combination of the following:', ' Placement of an intrauterine device (IUD) or intrauterine system (IUS)', ' Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository', ' NOTE: Oral contraceptives (OC), injected or implanted hormonal methods are not allowed as the sole method of contraception, as BYL719 has not been characterized with respect to its potential to interfere with the PK and/or the effectiveness of OCs'], 'Results': ['Outcome Measurement: ', ' Dose Limiting Toxicity (DLT) of Dose-escalating BYL719 in Combination With T-DM1', " DLTs of BYL719 in combination with T-DM1 will be assessed using National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (except for hyperglycemia). A DLT is described any grade 3 or higher, clinically significant toxicity (excluding alopecia) experienced during the first 21 days following first dose of BYL719 that is determined to be at least possibly related to study medication. Lower grades may also be considered DLTs if they lead to a dose interruption of more than 7 consecutive days of BYL719. In general adverse events (AEs) will be graded according to the following:", ' Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE', ' Time frame: The 1st 21 days (Cycle 1) of treatment', 'Results 1: ', ' Arm/Group Title: Cohort -1 (250mg BYL719, 3.6mg/kg T-DM1)', ' Arm/Group Description: Patients receive 250 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' PI3K inhibitor BYL719: Given PO', ' Ado-trastuzumab emtansine: Given IV', ' Pharmacological study: Correlative studies', ' Laboratory biomarker analysis: Optional correlative studies', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Thrombocytopenia: 0 0.0%', 'Rash Maculopapular: 0 0.0%', 'Results 2: ', ' Arm/Group Title: Cohort 1 (300mg BYL719, 3.6mg/kg T-DM1)', ' Arm/Group Description: Patients receive 300 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' PI3K inhibitor BYL719: Given PO', ' Ado-trastuzumab emtansine: Given IV', ' Pharmacological study: Correlative studies', ' Laboratory biomarker analysis: Optional correlative studies', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Thrombocytopenia: 1 20.0%', 'Rash Maculopapular: 2 40.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/11 (27.27%)', ' Acute pancreatitis [1]1/11 (9.09%)', ' Wound Infection 0/11 (0.00%)', ' Elevated Fasting Plasma 1/11 (9.09%)', ' Tumor pain 0/11 (0.00%)', ' Delirium 0/11 (0.00%)', ' Death due to Respiratory Failure 0/11 (0.00%)', ' Epistaxis 1/11 (9.09%)', ' Hypoxemia 1/11 (9.09%)', ' Pain of skin 0/11 (0.00%)', 'Adverse Events 2:', ' Total: 3/6 (50.00%)', ' Acute pancreatitis [1]0/6 (0.00%)', ' Wound Infection 1/6 (16.67%)', ' Elevated Fasting Plasma 0/6 (0.00%)', ' Tumor pain 1/6 (16.67%)', ' Delirium 1/6 (16.67%)', ' Death due to Respiratory Failure 1/6 (16.67%)', ' Epistaxis 0/6 (0.00%)', ' Hypoxemia 0/6 (0.00%)', ' Pain of skin 1/6 (16.67%)']}

{'Clinical Trial ID': 'NCT00764322', 'Intervention': ['INTERVENTION 1: ', ' Ultra-rapid Metabolizers', ' Those with the highest transformation of the CYP2D6 genotype to allelic activity', 'INTERVENTION 2: ', ' Extensive Metabolizers', ' Those with the most normal transformation of the CYP2D6 genotype to allelic activity'], 'Eligibility': ['Inclusion:', ' Histologically confirmed invasive carcinoma of the breast or ductal breast carcinoma in situ Has been receiving tamoxifen citrate at a dose of 20 mg/day for at least 4 months either for the treatment of invasive or non-invasive carcinoma of the breast or for breast cancer recurrence prevention', ' Expected duration of tamoxifen citrate treatment at least 6 months Hormone receptor status not specified Concurrent participation in non-treatment studies allowed provided it will not interfere with participation in this study Menopausal status not specified Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy 6 months Absolute Neutrophil Count (ANC) 1.0 x 10^9/L Platelet count 100 x 10^9/L Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 2.5 times Upper Limit of Normal (ULN) Total bilirubin 2.5 times ULN Creatinine clearance 50 mL/min Fertile patients must use effective contraception', ' PRIOR CONCURRENT THERAPY:', ' No limitations to number of prior therapies', ' No limitations for prior radiotherapy', ' More than 14 days since prior and no other concurrent investigational agent', ' Exclusion:', ' Not pregnant or nursing No active, serious infection or medical or psychiatric illness likely to preclude study participation No psychiatric conditions that would preclude study compliance or informed consent No history of venous thromboembolism, transient ischemic attack, or cerebral vascular accident No history of allergic reaction to tamoxifen citrate or any of its reagents No concurrent coumadin', ' No concurrent medications known to inhibit CYP2D6, including any of the following:', ' Amiodarone', ' Haloperidol', ' Indinavir', ' Ritonavir', ' Quinidine', ' No concurrent selective serotonin reuptake inhibitors, except the following:', ' Venlafaxine', 'Citalopram'], 'Results': ['Outcome Measurement: ', ' Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes', ' Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline and after 4 months of treatment; The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.', ' Time frame: 4 months', 'Results 1: ', ' Arm/Group Title: Ultra-rapid Metabolizers', ' Arm/Group Description: Those with the highest transformation of the CYP2D6 genotype to allelic activity', ' Overall Number of Participants Analyzed: 5', ' Mean (Standard Deviation)', ' Unit of Measure: ng/mL Baseline endoxifen concentration: 5 participants', ' 8.4 (4.59)', ' 4-Month endoxifen concentration: 4 participants', ' 15.35 (5.48)', 'Results 2: ', ' Arm/Group Title: Extensive Metabolizers', ' Arm/Group Description: Those with the most normal transformation of the CYP2D6 genotype to allelic activity', ' Overall Number of Participants Analyzed: 119', ' Mean (Standard Deviation)', ' Unit of Measure: ng/mL Baseline endoxifen concentration: 119 participants', ' 10.00 (6.00)', ' 4-Month endoxifen concentration: 106 participants', ' 9.30 (5.03)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/161 (0.00%)', ' headache * 20/161 (0.00%)', ' Mood alteration 2 [1]0/161 (0.00%)', ' Hemorrhage, GU 0/161 (0.00%)', ' thrombosis * 2 [2]0/161 (0.00%)', 'Adverse Events 2:', ' Total: 3/290 (1.03%)', ' headache * 21/290 (0.34%)', ' Mood alteration 2 [1]1/290 (0.34%)', ' Hemorrhage, GU 1/290 (0.34%)', ' thrombosis * 2 [2]1/290 (0.34%)']}

78949f1f-6738-4220-a233-e7831902e6f3

Comparison

Results

NCT00390455

NCT00558103

In both the secondary trial and the primary trial the test cohorts achieved better overall response than the control groups.

Contradiction

{'Clinical Trial ID': 'NCT00390455', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Lapatinib)', ' Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.', 'INTERVENTION 2: ', ' Arm II (Placebo)', ' Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.'], 'Eligibility': ['Inclusion Criteria:', ' Histologic, pathologic or cytologic diagnosis of cancer of the female breast in either primary or metastatic setting; histological documentation of metastatic/recurrent disease is not required if there is unequivocal clinical evidence for recurrence', ' Stage IV breast cancer (using American Joint Committee on Cancer [AJCC] criteria, 6th edition), or locally advanced (stage III) breast cancer not considered amenable to curative therapy', ' Patients with symptomatic brain metastases or other symptomatic central nervous system (CNS) metastases are not eligible for the study; no screening studies are required among asymptomatic patients; patients with previously treated brain metastases, who are free of symptoms referable to CNS disease and who are > 3 months from treatment for brain metastases are eligible', " Tumors (as determined on pathology from either primary or metastatic sites) must be potentially sensitive to endocrine therapy, defined as expressing estrogen receptor (ER) and/or progesterone receptor (PgR) as determined immunohistochemical methods according to the local institution's standard protocol, >= 1% cells will be considered to be positive", ' The protocol has been amended to permit tumors with any HER2 status, though a determination of HER2 status must have been made; patients will be considered to be eligible if HER2 expression is documented by one of the following methods:', ' Immunohistochemistry (IHC) 0 (i.e., negative), 1+, 2+, or 3+ levels of expression, or', ' Gene amplification (fluorescent in situ hybridization [FISH]) positive or negative', ' Patients must have at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2.0 cm with conventional techniques or as >= 1.0 cm with spiral computed tomography (CT) scan', ' Exception: Patients with lytic or blastic bone metastases as their only site of disease will be eligible for the study even though these patients are not considered to have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria; these patients will be evaluable for time to progression, but not response', ' Patients with all other lesions, including small lesions (longest diameter < 2.0 cm with conventional techniques or < 1.0 cm with spiral CT scan) and truly non-measurable lesions including those listed below are not eligible', ' Lesions that are considered non-measurable include the following:', ' Bone lesions (women with bone lesions will be eligible as described above)', ' Leptomeningeal disease', ' Ascites', ' Pleural/pericardial effusion', ' Inflammatory breast cancer', ' Lymphangitis cutis/pulmonitis', ' Abdominal masses that are not confirmed and followed by imaging techniques', ' Cystic lesions', ' Patients must have had one or two prior endocrine treatments for breast cancer in either the adjuvant or metastatic setting, exclusive of treatment-related amenorrhea or ovarian suppression; sequential use of two different third-generation aromatase inhibitors is considered "one" treatment; it is not required that tumors be resistant to such treatments; for example:', ' A patient with de novo metastatic breast cancer who had never received endocrine therapy is not eligible;', ' A patient who received adjuvant tamoxifen and subsequent therapy with an aromatase inhibitor (adjuvant or metastatic) is eligible;', ' A patient who received an aromatase inhibitor in either the adjuvant or metastatic setting, and who discontinued therapy after several months because of side effects, is eligible;', ' A patient who received an aromatase inhibitor in the adjuvant setting is eligible, regardless of whether they did or did not receive tamoxifen at some point;', ' A patient who received adjuvant tamoxifen, and subsequently a nonsteroidal aromatase inhibitor and a steroidal aromatase inhibitor for advanced breast cancer in the adjuvant or metastatic setting is eligible;', ' A patient who received adjuvant tamoxifen, and then a nonsteroidal aromatase inhibitor and subsequently megesterol acetate for advanced breast cancer is not eligible', ' Tumors potentially sensitive to endocrine therapy, defined as >= 3 months of prior endocrine therapy without disease progression in the adjuvant or metastatic setting', ' Patients must have had prior treatment in either the adjuvant or metastatic setting with a commercially available third-generation aromatase inhibitor (i.e. anastrozole, exemestane, or letrozole); it is not required that tumors be resistant to such therapies', ' Patients may have received up to one prior chemotherapy regimen for stage IV breast cancer; prior chemotherapy in the adjuvant and/or neoadjuvant setting is permitted; patients must have finished chemotherapy at least 1 week prior to starting protocol based treatment', ' Patients may have received prior trastuzumab therapy for stage IV breast cancer, in combination with up to one chemotherapy and/or endocrine therapy regimen, but that must have concluded at least 3 weeks prior to starting protocol-based therapy; prior trastuzumab therapy in the adjuvant and/or neoadjuvant setting is permitted, but must have concluded at least 3 weeks prior to starting protocol-based therapy', ' Prior therapy with commercially available inhibitor of EGFR (including but not limited to gefitinib, erlotinib, lapatinib or cetuximab) or experimental inhibitors of EGFR is prohibited', ' Patients may have initiated bisphosphonate therapy prior to study entry; such patients will have bone lesions considered evaluable for progression but not for response', ' Prior fulvestrant therapy is prohibited', ' Patients receiving a gonadotropin-releasing hormone (GnRH) agonist for ovarian suppression must remain on such therapy throughout the course of protocol treatment; patients must discontinue other endocrine treatments, including systemic hormone-replacement therapy and intravaginal estrogens prior to study entry; patients must have concluded radiation therapy prior to study entry; patients must be at least 1 week from prior chemotherapy or 3 weeks from prior trastuzumab therapy, with adequate recovery of bone marrow function and performance status', ' Patients must be postmenopausal women, defined as a woman fulfilling any of the following criteria:', ' Age >= 60 years; or', ' Age >= 45 years with an intact uterus and amenorrhea for 12 months or more; or', ' History of bilateral oophorectomy; or', ' Follicle stimulating hormone (FSH) levels within postmenopausal range according to the ranges established by the testing facility; or', ' Treatment with a GnRH agonist for ovarian suppression for at least 3 consecutive months prior to study registration, and remaining on such therapy throughout the course of protocol treatment', ' Women who are pregnant or nursing are not eligible for the study; clinicians should advise patients that there are no data for the safety of lapatinib or fulvestrant among pregnant patients, nor data on the impact of these agents on fertility or pregnancy', ' Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-2', ' Absence of pending visceral crisis, in the opinion of the treating physician', ' Absence of acquired or inherited bleeding disorder', ' Absence of need for therapeutic systemic anticoagulation (defined as maintaining international normalized ratio [INR] > 1.6); patients may take low-dose warfarin or aspirin (or equivalent) for maintenance of central venous catheter patency', ' Granulocytes >= 1,000/μl', ' Platelet count >= 100,000/μl', ' Creatinine =< 2 mg/dl', " Total bilirubin =< 1.5 x upper limits of normal (ULN) unless due to Gilbert's syndrome", ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN without liver metastases; =< 5 x ULN with liver metastases', ' INR =< 1.6', ' Left ventricular ejection fraction (LVEF) within institutional limits of normal'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per RECIST criteria).', ' Time frame: Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years', 'Results 1: ', ' Arm/Group Title: Arm I (Lapatinib)', ' Arm/Group Description: Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.', ' Overall Number of Participants Analyzed: 146', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.7 (3.7 to 5.7)', 'Results 2: ', ' Arm/Group Title: Arm II (Placebo)', ' Arm/Group Description: Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.', ' Overall Number of Participants Analyzed: 145', ' Median (95% Confidence Interval)', ' Unit of Measure: months 3.8 (3.8 to 5.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/141 (8.51%)', ' Cardiac pain 1/141 (0.71%)', ' Constipation 1/141 (0.71%)', ' Diarrhea 7/141 (4.96%)', ' Gastrointestinal disorder 0/141 (0.00%)', ' Nausea 5/141 (3.55%)', ' Vomiting 2/141 (1.42%)', ' Chest pain 1/141 (0.71%)', ' Disease progression 1/141 (0.71%)', ' Fatigue 8/141 (5.67%)', ' Gait abnormal 0/141 (0.00%)', ' Injection site reaction 1/141 (0.71%)', ' Pain 1/141 (0.71%)', 'Adverse Events 2:', ' Total: 14/137 (10.22%)', ' Cardiac pain 1/137 (0.73%)', ' Constipation 2/137 (1.46%)', ' Diarrhea 4/137 (2.92%)', ' Gastrointestinal disorder 1/137 (0.73%)', ' Nausea 3/137 (2.19%)', ' Vomiting 1/137 (0.73%)', ' Chest pain 1/137 (0.73%)', ' Disease progression 0/137 (0.00%)', ' Fatigue 5/137 (3.65%)', ' Gait abnormal 1/137 (0.73%)', ' Injection site reaction 0/137 (0.00%)', ' Pain 2/137 (1.46%)']}

{'Clinical Trial ID': 'NCT00558103', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo', ' Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).', 'INTERVENTION 2: ', ' Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg', ' Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.'], 'Eligibility': ['Inclusion criteria:', ' Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact patient eligibility is provided in the pazopanib IB and lapatinib prescribing information (or the lapatinib IB).', ' For Cohort 1 of this study, eligible patients met inclusion criteria outlined in the original version of the protocol and protocol amendment 1.', ' For Cohort 2 of this study, eligible patients must meet all of the following criteria:', ' Patients must have evaluable Inflammatory Breast Cancer (IBC) substantiated by all of the following prior to randomization:', ' History of invasive breast cancer documented by a biopsy and accompanying pathology report', ' Current photographs* (global view and close-up views of all skin lesions) submitted at screening demonstrating unequivocal evidence of IBC as determined by either the medical monitor alone or in consultation with one or more of the study Principal Investigators.', " All patients must have photography at screening. Canfield Scientific Inc. will provide centralized monitoring, tracking, and collection of patients' photographs throughout the study. Screening photographs must be uploaded to the Canfield Scientific Inc website and approved by Canfield Scientific Inc, as the central photography vendor. The photographs, along with the completed Inflammatory Breast Cancer Skin Assessment Tool (IBSAT), must be reviewed and approved by GSK before a patient can be randomized. Sites should allow a minimum of 3 business days for this process. Sites submitting quality photographs and IBSATs on a regular basis will receive an exemption from this requirement for future patients.", ' Patients with secondary IBC are eligible.', ' Measurable lesions (cutaneous or radiographic) may be in the field of prior standard or palliative radiation therapy; however, there must be at least a 4 week period between the last radiation treatment and the baseline scan documenting disease status for the lesion to be measurable. If the irradiated lesion is the only site of disease, documented progression of the irradiated lesion is required.', ' Disease progression or relapse following treatment for invasive breast cancer, which must have included a chemotherapy regimen. In regions where trastuzumab is available with no barriers to access*, patients must have received prior trastuzumab in addition to chemotherapy in order to be eligible. * (Barriers to access may include financial considerations.)', ' Unequivocal ErbB2 overexpressing breast cancer, defined as 3+ staining by immunohistochemistry (IHC), or 2+ staining by IHC in conjunction with ErbB2 gene amplification by FISH/CISH, or ErbB2 gene amplification by FISH/CISH alone (in subjects whose tumor blocks were not assessed by IHC). ErbB2 gene amplification is defined by: > six (6) ErbB2 gene copies/nucleus for test systems without an internal control probe or an ErbB2/CEP 17 ratio of more than 2.2.', ' Sites must submit a copy of the laboratory report demonstrating unequivocal ErbB2 overexpression, if testing performed at a local laboratory, with the screening worksheet. Archived tumor must be provided for all patients for ErbB2 FISH testing by the central laboratory. Patients will remain on study based on local ErbB2 expression results. If archived tumor is not available, a biopsy must be obtained at screening and sent to TMD Laboratories for ErbB2 FISH testing.', " - Patients must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up. Procedures conducted as part of the patient's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.", ' Note: Informed consent may be obtained prior to the protocol-specified screening window (i.e. Day -14 to Day -1).', ' Females age 18 years, except in Tunisia. In Tunisia, patients must be 20 years to be eligible for this study.', ' Adequate organ function as defined below:', ' System (Laboratory Values)', ' Hematologic:Absolute neutrophil count (ANC)( 1.5 X 10^9/L)Hemoglobin1( 9 g/dL)Platelets( 100 X 10^9/L)International normalized ratio (INR)( 1.2 X upper limit of normal (ULN))Partial thromboplastin time (PTT)( 1.2 X ULN)', ' Hepatic:Total bilirubin2 ( 1.5 X upper limit of normal (ULN))AST and ALT( 2.5 X ULN)', ' Renal:Serum Creatinine ( 1.5 mg/dL)Or, if serum creatinine >1.5 mg/dL,', ' Calculated creatinine clearance( 50 mL/min)', ' Urine Protein to Creatinine Ratio(<1)', ' Patients may not have had a transfusion within 7 days of screening assessment.', ' Exception: Patients with elevated bilirubin levels due to Gilberts syndrome are eligible.', ' Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive or where MUGA scans are the accepted standard. Patients with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure are not eligible.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.', ' A female is eligible to enter and participate in this study if she is of:', ' Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:', ' A hysterectomy', ' A bilateral oophorectomy (ovariectomy)', ' A bilateral tubal ligation', ' Is post-menopausal', ' Patients not using hormone replacement therapy (HRT) must have experienced total cessation of menses for 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40 mIU/mL and an estradiol value < 40pg/mL (<140 pmol/L).', ' Patients must discontinue HRT prior to study enrollment due to the potential for inhibition of CYP enzymes that metabolize estrogens and progestins (See Section 8). For most forms of HRT, at least 2-4 weeks must elapse between the cessation of HRT and determination of menopausal status; length of this interval depends on the type and dosage of HRT. If a female patient is determined not to be post-menopausal, they must use adequate contraception, as defined immediately below.', ' Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, has used adequate contraception since the pregnancy test and agrees to use adequate contraception as described below. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:', ' An intrauterine device with a documented failure rate of less than 1% per year.', " Vasectomized partner who is sterile prior to the female patient's entry and is the sole sexual partner for that female.", ' Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product.', ' Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).', ' Note: Oral contraceptives are not reliable due to potential drug drug interactions.', ' Female patients who are lactating should discontinue nursing prior to the first dose of investigational product and should refrain from nursing throughout the treatment period and for 14 days following the last dose of investigational product.', ' - French patients: In France, a patient will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.', 'Exclusion Criteria:', ' Patients meeting any of the following criteria must not be enrolled in the study:', ' Treatment in the 14 days prior to randomization with any cancer therapy (tumor embolization, chemotherapy, immunotherapy, biological therapy, or hormonal therapy) or treatment with mitomycin within 6 weeks prior to randomization. Such treatment may not be resumed or begun after study entry. Note: Patients receiving LH-RH analogue therapy prior to the study may continue to receive LH-RH analogues for the duration of study participation. Bisphosphonates are permitted if started prior to Day 1.', ' Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity (with the exception of alopecia).', ' Prior lapatinib therapy or other Her2/ErbB2 targeted therapy (except trastuzumab).', ' Prior therapy with an anti-VEGF antibody or other VEGF/VEGF-R targeted therapy.', ' Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.', ' Use of any prohibited medication within the timeframes listed in Section 8.1.3', ' History of another malignancy.', ' Note: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible. If subject previously had breast cancer, it must have been HER2+ with either 3+ overexpression by IHC or unequivocal HER2 gene amplification by FISH or CISH.', ' History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 2 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases.', ' Clinically significant gastrointestinal abnormalities that may increase the risk for GI bleeding including, but not limited to:', ' Active peptic ulcer disease', ' Known intraluminal metastatic lesion/s with suspected bleeding', ' Inflammatory bowel disease', ' Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation', ' History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.', ' Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but limited to:', ' Malabsorption syndrome', ' Major resection of the stomach or small bowel.', ' Presence of uncontrolled infection.', ' Prolongation of corrected QT interval (QTc) > 480 msecs.', ' History of any one or more of the following cardiovascular conditions within the past 6 months:', ' Cardiac angioplasty or stenting', ' Myocardial infarction', ' Unstable angina', ' Arterial thrombosis', ' Symptomatic peripheral vascular disease', ' Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) (see Section 15.9 Appendix 9 for description).', ' Poorly controlled hypertension [defined as systolic blood pressure (SBP) of 140mmHg or diastolic blood pressure (DBP) of 90mmHg].', " Note: Initiation or adjustment of antihypertensive medication(s) is permitted during the screening period, in order to control a patient's BP prior to randomization. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour. The mean SBP / DBP values from each blood pressure assessment must be < 140/90mmHg in order for a patient to be eligible for the study. See Section 6.2 and Section 6.4.2 for details on blood pressure control and reassessment prior to study enrollment.", ' History of cerebrovascular accident, including TIA, pulmonary embolism or deep venous thrombosis (DVT).', ' Prior major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (other than ulcers due to inflammatory breast cancer).', ' Evidence of active bleeding or bleeding diathesis.', ' Hemoptysis within 6 weeks prior to first dose of investigational product.', ' Known endobronchial lesions or involvement of large pulmonary vessels by tumor.', " Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety, provision of informed consent, or compliance to study procedures.", ' Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or lapatinib.', " Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)."], 'Results': ['Outcome Measurement: ', ' Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions', ' RECIST-based response assessment was done at Weeks (Wks) 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, CR is the disappearance of all target and non-target lesions; PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.', ' Time frame: Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks', 'Results 1: ', ' Arm/Group Title: Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo', ' Arm/Group Description: Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).', ' Overall Number of Participants Analyzed: 38', ' Measure Type: Number', ' Unit of Measure: participants 11', 'Results 2: ', ' Arm/Group Title: Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg', ' Arm/Group Description: Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.', ' Overall Number of Participants Analyzed: 38', ' Measure Type: Number', ' Unit of Measure: participants 17'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/38 (15.79%)', ' Neutropenia 1/38 (2.63%)', ' Sinus tachycardia 0/38 (0.00%)', ' Bradycardia 0/38 (0.00%)', ' Cardiopulmonary failure 0/38 (0.00%)', ' Vomiting 1/38 (2.63%)', ' Diarrhea 0/38 (0.00%)', ' Nausea 1/38 (2.63%)', ' Abdominal pain 0/38 (0.00%)', ' Pancreatitis 0/38 (0.00%)', ' Sudden death 1/38 (2.63%)', ' Fatigue 0/38 (0.00%)', ' Asthenia 0/38 (0.00%)', ' Hepatotoxicity 0/38 (0.00%)', 'Adverse Events 2:', ' Total: 14/38 (36.84%)', ' Neutropenia 1/38 (2.63%)', ' Sinus tachycardia 0/38 (0.00%)', ' Bradycardia 0/38 (0.00%)', ' Cardiopulmonary failure 0/38 (0.00%)', ' Vomiting 2/38 (5.26%)', ' Diarrhea 2/38 (5.26%)', ' Nausea 0/38 (0.00%)', ' Abdominal pain 0/38 (0.00%)', ' Pancreatitis 0/38 (0.00%)', ' Sudden death 1/38 (2.63%)', ' Fatigue 0/38 (0.00%)', ' Asthenia 0/38 (0.00%)', ' Hepatotoxicity 1/38 (2.63%)']}

135311d8-c579-4568-913e-937be00dde7e

Comparison

Intervention

NCT00258349

NCT01328249

Cohort 1 of the primary trial does not receive any Eribulin Mesylate With Prophylactic Filgrastim, whereas both cohorts in the secondary trial receive some.

Entailment

{'Clinical Trial ID': 'NCT00258349', 'Intervention': ['INTERVENTION 1: ', ' Vorinostat +Trastuzumab', ' Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks;', ' Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle'], 'Eligibility': ['Inclusion Criteria:', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No active or ongoing infection', ' No history of allergic reaction to compounds of similar chemical or biologic composition to vorinostat or other agents used in study', ' No psychiatric illness or social situation that would preclude study compliance', ' No other uncontrolled illness', ' More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin; 1 week for capecitabine) and recovered', ' More than 3 weeks since prior radiotherapy and recovered', ' Recovered from prior therapy', ' At least 2 weeks since prior valproic acid', ' More than 4 weeks since prior investigational agents', ' More than 4 weeks since prior lapatinib ditosylate', ' No concurrent combination antiretroviral therapy for HIV-positive patients', ' Measurable disease, defined as >= 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan', ' No other concurrent investigational agents', ' Concurrent bisphosphonates allowed provided therapy was initiated prior to study treatment', ' No other concurrent anticancer therapy', ' Recurrent or progressive disease while receiving prior trastuzumab (Herceptin) (with or without chemotherapy) OR relapsed within 3 months of last dose of prior adjuvant trastuzumab for metastatic disease', ' Histologically confirmed breast cancer', ' Must overexpress HER-2 gene', ' Metastatic or chest wall recurrent disease', ' Site of measurable disease must not have been irradiated (except chest wall recurrence treated with adjuvant radiation therapy)', ' No untreated brain metastases', ' Previously treated brain metastasis responsive to radiotherapy and/or surgery allowed provided the brain is not the sole site of measurable disease', ' ECOG 0-2', ' Absolute neutrophil count >= 1,500/mm^3', ' Platelet count >= 100,000/mm^3', ' Hemoglobin >= 9 g/dL', ' AST and ALT =< 2 times upper limit of normal', " Bilirubin =< 1.5 mg/dL (3 mg/dL in the presence of Gilbert's disease provided direct bilirubin is normal)", ' Creatinine =< 1.5 mg/dL', ' LVEF normal by nuclear scan or echocardiogram', ' No evidence of PR prolongation or AV block by EKG', ' No symptomatic congestive heart failure', ' No unstable angina pectoris', ' No cardiac arrhythmia'], 'Results': ['Outcome Measurement: ', ' Response Rate', ' Tumor response is assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Response included complete response (CR) and partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.', ' Time frame: Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy', 'Results 1: ', ' Arm/Group Title: Vorinostat +Trastuzumab', ' Arm/Group Description: Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks;', ' Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0 (0 to 26)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/9 (22.22%)', ' Thrombocytopenia 2/9 (22.22%)', ' Dyspnea 0/9 (0.00%)']}

{'Clinical Trial ID': 'NCT01328249', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1: Eribulin Mesylate With Filgrastim as Needed', " Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) intravenously (IV) on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade 2.", 'INTERVENTION 2: ', ' Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim', ' Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants 60 kg or 480 micrograms for participants >60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle.'], 'Eligibility': ['Inclusion Criteria', ' Male and female subjects aged greater than or equal to (>=) 18 years', ' Histologically confirmed Stage I to III invasive breast cancer. Subjects may have more than one synchronous primary breast tumor.', ' HER-2 normal as determined by fluorescence in situ hybridization (FISH) or 0 or 1+ by immunohistochemistry (IHC) staining.', ' Subject is a candidate for chemotherapy in the adjuvant setting. Adjuvant therapy must begin within 84 days of the final surgical procedure for breast cancer.', ' Adequate cardiac function, defined by baseline LVEF >=50 percent (%) by Multiple Gated Acquisition (MUGA) scan or echocardiogram.', ' ECOG performance status of 0 or 1.', ' Adequate renal function as evidenced by serum creatinine less than or equal to (<=) 1.5 mg/dL or calculated creatinine clearance >=40 mL/min per the Cockcroft and Gault formula.', ' Adequate bone marrow function as evidenced by ANC >=1.5 x 10^9/L, hemoglobin >=10.0 g/dL, and platelet count >=100 x 10^9/L.', ' Adequate liver function as evidenced by bilirubin <=1.5 times the upper limits of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <=3 x ULN.', ' Females of childbearing potential must have a negative urine or beta-human chorionic gonadotropin serum pregnancy test within 2 weeks prior to Cycle 1, Day 1. A urine pregnancy test should be repeated prior to chemotherapy if not conducted within 72 hours of start of treatment. Female subjects of childbearing potential must agree to be abstinent or to use a highly effective method of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a vasectomized partner) having started for at least one menstrual cycle prior to starting study drug and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Perimenopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential. Male subjects who are not abstinent or who have undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use, a highly effective method of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drug and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Subjects with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously).', ' Subjects willing and able to comply with the study protocol for the duration of the study and provide written informed consent prior to any study-specific screening procedures with the understanding that the subject may withdraw consent at any time without prejudice.', ' Exclusion Criteria', ' Stage IV breast cancer.', ' Prior chemotherapy, radiation therapy, immunotherapy, or biotherapy for current breast cancer.', ' Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs.', ' Subjects with a concurrently active second malignancy other than adequately treated nonmelanoma skin cancers or in situ cervical cancer.', ' Subjects with known positive human immunodeficiency virus (HIV) status.', ' Pregnancy or breast feeding at the time of study enrollment. Eligible subjects of reproductive potential (both sexes) must agree to use adequate contraceptive methods during study therapy.', ' Subjects with known allergy or hypersensitivity to doxorubicin, cyclophosphamide, or eribulin mesylate.', ' Inability to comply with the study and/or follow-up procedures.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Feasibility', ' The regimen was considered feasible if the participant was able to complete the eribulin portion without dose delay or reduction. Dose delay was defined as a delay due to eribulin-related adverse event (AE) for more than 2 days for subsequent doses (cycles after the initiation of full dose of eribulin, except holidays, scheduling difficulties and nonclinical logistical issues). If a participant had more than 1 dose omission, delay or reduction due to eribulin-related AE, these events were collectively counted as one entity in the same participant. Participants were followed for approximately 3 years after the last dose of the study treatment. Feasibility rates were calculated with or without growth factor support. In both cohorts, the percentage of participants who completed the eribulin portion of the regimen without a dose omission, delay or reduction due to eribulin-related AE was estimated via the observed completion rate and an exact 90% confidence interval (CI) was constructed.', ' Time frame: From date of first dose, up to 3 years after the last dose of study treatment, or up to approximately 4 years 2 months', 'Results 1: ', ' Arm/Group Title: Cohort 1: Eribulin Mesylate With Filgrastim as Needed', " Arm/Group Description: Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) intravenously (IV) on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade 2.", ' Overall Number of Participants Analyzed: 54', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 70.4 (58.5 to 80.4)', 'Results 2: ', ' Arm/Group Title: Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim', ' Arm/Group Description: Participants initially received doxorubicin (60 mg/m^2) plus cyclophosphamide (600 mg/m^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants 60 kg or 480 micrograms for participants >60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle.', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 60.0 (41.7 to 76.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/55 (10.91%)', ' Febrile neutropenia 2/55 (3.64%)', ' Nausea 2/55 (3.64%)', ' Oesophagitis 2/55 (3.64%)', ' Vomiting 2/55 (3.64%)', ' Mucosal inflammation 0/55 (0.00%)', ' Pyrexia 2/55 (3.64%)', ' Breast abscess 0/55 (0.00%)', ' Catheter site cellulitis 0/55 (0.00%)', ' Genital herpes 1/55 (1.82%)', ' Lung infection 0/55 (0.00%)', ' Upper respiratory tract infection 1/55 (1.82%)', 'Adverse Events 2:', ' Total: 4/26 (15.38%)', ' Febrile neutropenia 1/26 (3.85%)', ' Nausea 0/26 (0.00%)', ' Oesophagitis 0/26 (0.00%)', ' Vomiting 0/26 (0.00%)', ' Mucosal inflammation 1/26 (3.85%)', ' Pyrexia 1/26 (3.85%)', ' Breast abscess 1/26 (3.85%)', ' Catheter site cellulitis 1/26 (3.85%)', ' Genital herpes 0/26 (0.00%)', ' Lung infection 1/26 (3.85%)', ' Upper respiratory tract infection 0/26 (0.00%)']}

0984431d-4997-41dc-9ba4-07134568c3fa

Single

Eligibility

NCT00662129

Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 11 to 18 grams per deciliter are eligible for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00662129', 'Intervention': ['INTERVENTION 1: ', ' Paclitaxel + Gemcitabine + Bevacizumab', ' Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed infiltrating breast cancer', ' Clinical evidence of metastatic disease', ' Measurable disease, defined as at least one measurable lesion per RECIST criteria', ' No non-measurable disease only, defined as all other lesions, including small lesions (longest diameter < 2 cm) and truly non-measurable lesions, including any of the following:', ' Bone lesions', ' Leptomeningeal disease', ' Ascites', ' Pleural/pericardial effusion', ' Inflammatory breast disease', ' Lymphangitis cutis/pulmonis', ' Abdominal masses that are not confirmed and followed by imaging techniques', ' Cystic lesions', ' Patients with HER-2/neu positive tumors, must have received prior treatment with trastuzumab (Herceptin®) or have a contraindication for trastuzumab', ' No evidence of active brain metastasis, including leptomeningeal involvement, on MRI or CT scan', ' CNS metastasis controlled by prior surgery and/or radiotherapy allowed', ' Must be asymptomatic for 2 months with no evidence of progression prior to study entry', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' Life expectancy 12 weeks', ' ECOG performance status 0-1', ' ANC 1,500/mm³', ' Platelet count 100,000/mm³', ' Hemoglobin 9.0 g/dL', ' AST and ALT 2.5 times upper limit of normal (ULN)', ' Alkaline phosphatase 2.5 times ULN', ' Total bilirubin 1.5 times ULN', ' Creatinine 1.5 mg/dL', ' Urine protein:creatinine ratio < 1 or urinalysis < 1+ protein', ' Patients discovered to have 1+ proteinuria at baseline must demonstrate 24-hour urine protein < 1 g', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for 30 days after completion of study therapy', ' Able to complete questionnaires alone or with assistance', ' No peripheral neuropathy > grade 1', ' No history of allergy or hypersensitivity to albumin-bound paclitaxel, paclitaxel, gemcitabine hydrochloride, bevacizumab, albumin, drug product excipients, or chemically similar agents', ' No stage III or IV invasive, non-breast malignancy within the past 5 years', ' No other active malignancy, except nonmelanoma skin cancer or carcinoma in situ of the cervix', ' Patient must not be receiving other specific treatment for a prior malignancy', ' No uncontrolled hypertension (i.e., blood pressure [BP] > 160/90 mm Hg on 2 occasions at least 5 minutes apart)', ' Patients who have recently started or adjusted antihypertensive medications are eligible providing that BP is < 140/90 mm Hg on any new regimen for 3 different observations in 14 days', ' No bleeding diathesis or uncontrolled coagulopathy', ' No hemoptysis within the past 6 months', ' No prior arterial or venous thrombosis within the past 12 months', ' No history of cerebrovascular accident', ' No history of hypertensive crisis or hypertensive encephalopathy', ' No abdominal fistula or gastrointestinal perforation within the past 6 months', ' No serious non-healing wound, ulcer, or fracture', ' No clinically significant cardiac disease, defined as any of the following:', ' Congestive heart failure', ' Symptomatic coronary artery disease', ' Unstable angina', ' Cardiac arrhythmias not well controlled with medication', ' Myocardial infarction within the past 12 months', ' No comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No prior chemotherapy for metastatic disease', ' May have received one prior adjuvant chemotherapy regimen', ' Prior neoadjuvant chemotherapy allowed', ' More than 6 months since prior adjuvant or neoadjuvant taxane (i.e., docetaxel or paclitaxel) therapy', ' Prior hormonal therapy in either adjuvant or metastatic setting allowed', ' More than 4 weeks since prior radiotherapy (except if to a non-target lesion only, or single dose radiation for palliation)', ' Prior radiotherapy to a target lesion is allowed provided there has been clear progression of the lesion since radiotherapy was completed', ' More than 4 weeks since prior cytotoxic chemotherapeutic agent or investigational drug', ' More than 2 weeks since prior and no concurrent acetylsalicylic acid, anticoagulants, or thrombolytic agents (except for once-daily 81 mg acetylsalicylic acid)', ' More than 6 weeks since prior major surgery, chemotherapy, or immunologic therapy', ' More than 1 week since prior minor surgery (e.g., core biopsy)', ' Placement of a vascular access device within 7 days is allowed', ' More than 3 months since prior neurosurgery', ' No concurrent treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered', ' Trials related to symptom management (Cancer Control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this study may be allowed'], 'Results': ['Outcome Measurement: ', ' 6-month Progression-free Survival (PFS) Rate', ' The primary endpoint of this trial is the 6-month progression-free survival rate. A patient is considered to be a 6-month progression-free survivor if the patient is 6 months from registration without a documentation of disease progression (note, the patient need not be on study treatment at 6 months to be considered a success). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.', ' Time frame: at 6 months', 'Results 1: ', ' Arm/Group Title: Paclitaxel + Gemcitabine + Bevacizumab', ' Arm/Group Description: Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 48', ' Measure Type: Number', ' Unit of Measure: proportion of patients progression-free 0.792 (0.647 to 0.882)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/49 (40.82%)', ' Febrile neutropenia 1/49 (2.04%)', ' Hemoglobin decreased 3/49 (6.12%)', ' Constipation 1/49 (2.04%)', ' Diarrhea 3/49 (6.12%)', ' Mucositis oral 1/49 (2.04%)', ' Nausea 3/49 (6.12%)', ' Oral cavity fistula 1/49 (2.04%)', ' Vomiting 2/49 (4.08%)', ' Fatigue 3/49 (6.12%)', ' Fever 2/49 (4.08%)', ' Catheter related infection 1/49 (2.04%)', ' Infection 1/49 (2.04%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

d9dc4a6d-a913-46ac-b0aa-d50823ff2305

Comparison

Results

NCT02435680

NCT01743560

the secondary trial and the primary trial use non comparable evaluation metrics, and significantly different time frames.

Entailment

{'Clinical Trial ID': 'NCT02435680', 'Intervention': ['INTERVENTION 1: ', ' All MCS110+Carboplatin+Gemcitabine', ' experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 & 8', 'INTERVENTION 2: ', ' Carboplatin+Gemcitabine', ' comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 & 8 Carboplatin: Intravenous infusion AUC 2 Days 1 & 8'], 'Eligibility': ['Inclusion Criteria:', ' Adult women ( 18 years of age) with advanced TNBC.', ' Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-) Breast Cancer by local laboratory testing, based on last available tumor tissue.', ' ER/PgR negativity to follow local guidelines', ' If IHC HER2 2+, a negative FISH test is required', ' A pre-treatment tumor biopsy demonstrating high TAM content as assessed per the central laboratory', 'Patients must have:', ' At least one measurable lesion per RECIST 1.1. (Note: Measurable lesions include lytic or mixed (lytic + blastic) bone lesions, with an identifiable soft tissue component that meets the measurability criteria)', 'Exclusion Criteria:', ' Prior chemotherapy for advanced BC. Previous adjuvant/neoadjuvant chemotherapy is allowed (carboplatin, cisplatin or gemcitabine only if > 12 months has passed since last administration).', ' Therapy for underlying malignancy within 2 weeks prior to start of study treatment:', ' Chemotherapy, biologic therapy (antibodies and biologically targeted small molecules)', ' Radiotherapy', ' Major surgery', ' Patients receiving concomitant immunosuppressive agents or chronic corticosteroids ( 10 mg of prednisone or equivalent) at the time of first study dose.', ' Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.', ' Known history of human immunodeficiency virus or active infection with hepatitis virus or any uncontrolled active systemic infection.', ' Patients with the following laboratory values during screening and on Day 1 predose:', ' Absolute Neutrophil Count (ANC) < 1.5x109/L', ' Hemoglobin < 9 g/dL', ' Platelets < 100x109/L', ' Serum creatinine > 1.5 x ULN', ' Serum total bilirubin > 1.5 x ULN', ' AST/SGOT and ALT/SGPT > 3.0 x ULN'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS) as Per RECIST v1.1 (by Local Investigator Assessment)', ' PFS Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design.', ' Time frame: 4 years', 'Results 1: ', ' Arm/Group Title: All MCS110+Carboplatin+Gemcitabine', ' Arm/Group Description: experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 & 8', ' Overall Number of Participants Analyzed: 34', ' Median (90% Confidence Interval)', ' Unit of Measure: months 5.6 (4.5 to 8.7)', 'Results 2: ', ' Arm/Group Title: Carboplatin+Gemcitabine', ' Arm/Group Description: comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 & 8 Carboplatin: Intravenous infusion AUC 2 Days 1 & 8', ' Overall Number of Participants Analyzed: 16', ' Median (90% Confidence Interval)', ' Unit of Measure: months 5.5 (3.5 to 7.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/19 (52.63%)', ' Anaemia 0/19 (0.00%)', ' Atypical haemolytic uraemic syndrome 1/19 (5.26%)', ' Thrombocytopenia 0/19 (0.00%)', ' Myocardial ischaemia 0/19 (0.00%)', ' Nausea 0/19 (0.00%)', ' Obstructive pancreatitis 1/19 (5.26%)', ' Vomiting 0/19 (0.00%)', ' Fatigue 0/19 (0.00%)', ' Generalised oedema 1/19 (5.26%)', ' Pyrexia 1/19 (5.26%)', ' Device related infection 1/19 (5.26%)', 'Adverse Events 2:', ' Total: 7/15 (46.67%)', ' Anaemia 1/15 (6.67%)', ' Atypical haemolytic uraemic syndrome 0/15 (0.00%)', ' Thrombocytopenia 3/15 (20.00%)', ' Myocardial ischaemia 1/15 (6.67%)', ' Nausea 1/15 (6.67%)', ' Obstructive pancreatitis 0/15 (0.00%)', ' Vomiting 2/15 (13.33%)', ' Fatigue 1/15 (6.67%)', ' Generalised oedema 0/15 (0.00%)', ' Pyrexia 0/15 (0.00%)', ' Device related infection 0/15 (0.00%)']}

{'Clinical Trial ID': 'NCT01743560', 'Intervention': ['INTERVENTION 1: ', ' Everolimus and Exemestane', ' Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.'], 'Eligibility': ['Inclusion Criteria:', ' Histological or cytological confirmation of oestrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.', ' Availability of archival tumour tissue (the tissue block or slides will be sent to the central laboratory for analysis).', ' Postmenopausal women. The investigator must confirm postmenopausal status. Postmenopausal status is defined either by:', ' Age 55 years and one year or more of amenorrhea', ' Age < 55 years and one year or more of amenorrhea and postmenopausal levels of FSH and LH per local institutional standards', ' Prior hysterectomy and has postmenopausal levels of Follicle stimulating hormone (FSH) and Luteinizing Hormone (LH) per local institutional standards Surgical menopause with bilateral oophorectomy', ' Disease progression following prior therapy with NSAI, defined as:', ' Recurrence while on or after completion of an adjuvant treatment including letrozole or anastrozole, or', ' Progression while on or following the completion of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer', ' Note: Non-steroidal aromatase inhibitors (i.e. letrozole or anastrozole) do not have to be the last treatment prior to enrollment. Other prior anticancer therapy, e.g. tamoxifen, fulvestrant, exemestane are also allowed. Patients must have recovered to grade 1 or better from any adverse events (except alopecia) related to previous therapy prior to enrollment.', ' - Radiological evidence of recurrence or progression on last systemic therapy prior to enrollment.', 'Patients must have:', ' At least one lesion that can be accurately measured or', ' Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease', ' - Adequate bone marrow and coagulation function as shown by:', ' Absolute neutrophil count (ANC) 1.5 109/L', ' Platelets 100 ×109/L', ' Hemoglobin (Hb) 9.0 g/dL', ' International Normalized Ratio (INR) 2 .', ' - Adequate liver function as shown by:', ' Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5 ULN (or 5 if hepatic metastases are present)', ' Total serum bilirubin 1.5 × ULN ( 3 × ULN for patients known to have Gilbert Syndrome)', ' - Adequate renal function as shown by:', ' Serum creatinine 1.5 × ULN', ' Fasting serum cholesterol 300 mg/dl or 7.75 mmol/L and fasting triglycerides 2.5 × ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achieved', ' Eastern Cooperative Oncology Group (ECOG) performance status of PS </ 2', ' Written informed consent obtained before any screening procedure and according to local guidelines.', 'Exclusion Criteria:', ' HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).', ' Pre-menopausal, pregnant, lactating women.', ' Known hypersensitivity to mammilian target of Rapamycin (mTOR) inhibitors, e.g. sirolimus (rapamycin) or to their excipients.', ' Known hypersensitivity to exemestane, to the active substance or to any of the excipients.', ' Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.', ' Radiotherapy within four weeks prior to enrollment except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. Patients must have recovered from radiotherapy toxicities prior to enrollment.', ' Currently receiving hormone replacement therapy, unless discontinued prior to enrollment.', ' Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use, at the time of study entry except in cases outlined below:', ' Prolonged systemic corticosteroid treatment during study, except for topical applications (e.g. rash),inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) should not be given. However:', ' short duration (<2 weeks) of systemic corticosteroids is allowed (e.g. chronic obstructive pulmonary disease, anti-emetic)', ' low doses of corticosteroids for brain metastasis treatment is allowed', ' Patients with symptomatic visceral metastasis (e.g. significant dyspnoea related to pulmonary lymphangitic carcinomatosis and lung metastases or clinically meaningful symptomatic liver metastasis)', ' Symptomatic brain or other Central Nervous system (CNS) metastases.', ' Active, bleeding diathesis, or on oral anti-vitamin K medication (except low dose warfarin, low molecular weight heparin (LMWH) and acetylsalicylic acid or equivalent, as long as the INR is 2.0)', ' Any severe and / or uncontrolled medical conditions such as:', ' Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction 6 months prior to enrollment, serious uncontrolled cardiac arrhythmia', ' Uncontrolled diabetes as defined by fasting serum glucose > 1.5 × ULN', ' Acute and chronic, active infectious disorders (except for Hep B and Hep C positive patients) and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy', ' Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome)', ' Significant symptomatic deterioration of lung function. If clinically indicated, pulmonary function tests including measures of predicted lung volumes, DLco, O2 saturation at rest on room air should be considered to exclude restrictive pulmonary disease, pneumonitis or pulmonary infiltrates.', ' Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, telithromycin) within the last 5 days prior to enrollment', ' History of non-compliance to medical regimens', ' Patients unwilling to or unable to comply with the protocol', ' Another malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer'], 'Results': ['Outcome Measurement: ', ' Best Overall Response of Everolimus and Exemestane Treatment in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer', ' The best Overall Response (OR) for each patient is determined from the sequence of investigator overall lesion responses according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.). To be assigned a best OR of Complete Responese (CR) at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best OR of Partial Response (PR) at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required.The Overall Response Rate (ORR) was defined as the proportion of patients with a best OR of confirmed CR or PR by week 48.', ' Time frame: At 48 weeks', 'Results 1: ', ' Arm/Group Title: Everolimus and Exemestane', ' Arm/Group Description: Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: participants Patients with measurable disease at baseline: 39', ' Patients with non-measurable disease at baseline: 10', ' Best at WK 48 - Complete Response (CR): 0', ' Best at WK 48 - Partial Response (PR): 7', ' Best at WK 48 - Stable Disease (SD): 18', ' Best at WK 48 - Progressive Disease (PD): 15', 'Unknown: 1', 'Missing: 8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/49 (44.90%)', ' Anaemia 2/49 (4.08%)', ' Pericardial effusion 1/49 (2.04%)', ' Tachycardia 1/49 (2.04%)', ' Abdominal pain 1/49 (2.04%)', ' Abdominal pain upper 1/49 (2.04%)', ' Colitis 1/49 (2.04%)', ' Duodenal ulcer 1/49 (2.04%)', ' Gastric ulcer 1/49 (2.04%)', ' Haematemesis 1/49 (2.04%)', ' Oral pain 1/49 (2.04%)', ' Vomiting 2/49 (4.08%)', ' Mucosal inflammation 1/49 (2.04%)']}

9d9ab190-cdcf-4320-b69a-12f2dad9dba9

Comparison

Intervention

NCT01385137

NCT00593346

Placebo treatment is used in cohort 2 of the secondary trial, but there is only a test group in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01385137', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Omega-3-fatty Acid)', ' Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity', 'INTERVENTION 2: ', ' Arm II (Placebo)', ' Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed primary invasive adenocarcinoma of the breast', ' Stage I, II, or IIIA disease', ' No metastatic disease', ' Must have undergone modified radical mastectomy or breast-sparing surgery and recovered', ' Estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PR+)', ' Currently taking a third-generation aromatase inhibitor (AI) [e.g., anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®)] for 90 days prior to registration with plans to continue for 180 days after registration', ' Must have completed the S092 Brief Pain Inventory (BPI)-Short Form within the past 14 days, and must have a worst pain/stiffness of 5 on the BPI (item #2) that has started or increased with AI therapy', ' PATIENT CHARACTERISTICS:', ' Postmenopausal', ' Zubrod performance status 0-2', ' Willing to submit blood for serum-free estradiol, total estradiol, serum inflammatory markers (IL6, TNF-α, CRP), DHA and EPA, lipid profile (LDL, HDL, triglycerides), and DNA analysis (CYP19A1)', ' Able to complete study questionnaires in English', ' At least 5 years since other malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ of the breast or adequately treated stage I or II cancer from which the patient is currently in complete remission', ' Patients must not have a known allergy to soy, given that the placebo is suspended in soybean oil', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' At least 3 months since prior omega-3 fatty acid supplements and must agree to refrain from omega-3-fatty acid supplements from sources outside of this study', ' More than 28 days since prior investigational agents', ' No other medical therapy, alternative therapy, or physical therapy for joint pain/stiffness within the past 30 days', ' Patients must not be on anticoagulation medication (i.e., heparin/warfarin) because of increased risk of bleeding within 28 days prior to registration', ' Patients must not have a history of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to registration', ' Patients must not be on narcotics within 14 days of registration', ' Patients may have received corticosteroid treatment; however, the following criteria apply:', ' Patients must not have received oral or intramuscular corticosteroids within the 28 days prior to registration', ' Patients must not have received intra-articular steroids to the study, or any other, joint within 28 days prior to registration', ' Patients must not have received topical analgesics (e.g., capsaicin preparations) to the study joint or any other analgesics (e.g., opiates, tramadol; with the exception of nonsteroidal antiinflammatory drugs (NSAIDs) and acetaminophen) within 14 days prior to registration'], 'Results': ['Outcome Measurement: ', ' Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score', ' Linear regression model-adjusted week 12 mean score by treatment group.', ' Purpose: To assess the severity of pain Population: Patients with pain from chronic diseases or conditions such as cancer, osteoarthritis and low back pain, or with pain from acute conditions such as postoperative pain Responsiveness: Responds to both behavioral and pharmacological pain interventions Method: Self-report or interview Scoring: Higher scores indicate more pain Range: 0-10', ' Time frame: 12 weeks post-registration', 'Results 1: ', ' Arm/Group Title: Arm I (Omega-3-fatty Acid)', ' Arm/Group Description: Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity', ' Overall Number of Participants Analyzed: 102', ' Mean (95% Confidence Interval)', ' Unit of Measure: BPI score 5.3 (4.68 to 5.91)', 'Results 2: ', ' Arm/Group Title: Arm II (Placebo)', ' Arm/Group Description: Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity', ' Overall Number of Participants Analyzed: 107', ' Mean (95% Confidence Interval)', ' Unit of Measure: BPI score 5.47 (4.86 to 6.09)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/117 (0.00%)', 'Adverse Events 2:', ' Total: 0/124 (0.00%)']}

{'Clinical Trial ID': 'NCT00593346', 'Intervention': ['INTERVENTION 1: ', ' Accelerated Partial Breast Brachytherapy', ' Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.', ' Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.'], 'Eligibility': ['Inclusion Criteria:', ' AJCC stage 0, I, or II (TisN0, T1N0, T2N0 = 3 cm) histologically confirmed carcinoma of the breast, treated with tylectomy. Axillary sampling is required only for cases of invasive cancers. Tumor size is determined by the pathologist. Clinical size may be used if the pathologic size is indeterminate.', ' Signed study-specific informed consent for participation in the study.', ' Negative, or close but negative, inked histologic margins of tylectomy or reexcision specimen to be confirmed prior to placing the brachytherapy catheters. Margins generally are positive if there is invasive or noninvasive tumor at the inked resection margin, close but negative if the tumor is within 2 mm of the inked margin and negative if the tumor is at least 2 mm away from the inked edge.', ' Negative post-tylectomy or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before brachytherapy.', ' For patients with invasive cancer, no positive axillary lymph nodes with at least 6 axillary lymph nodes sampled or a negative sentinel node.', ' Invasive ductal, lobular, medullary, papillary, colloid (mucinous),or tubular histologies. Noninvasive ductal carcinoma in situ.', " Chemotherapy or hormonal therapy planned for = 2 weeks after removal of brachytherapy catheters is permitted. Hormonal therapy is allowed during brachytherapy at treating radiation oncologist's decision.", ' Negative pregnancy test for premenopausal patients with an intact uterus', 'Exclusion Criteria:', ' Patients with distant metastases.', ' Patients with in-situ lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.', ' Patients with proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.', ' Patients who are pregnant or lactating.', ' Patients with histologically confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.', ' Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy.', ' Patients with systemic lupus erythematosis, scleroderma, or dermatomyositis with a CPK level above normal or with an active skin rash.', ' Patients with coexisting medical conditions in whom life expectancy is < 2 years.', ' Patients with psychiatric or addictive disorders that would preclude obtaining informed consent or completing the full series of high dose rate brachytherapy treatments on an outpatient basis.', " Patients with Paget's disease of the nipple.", ' Patients with skin involvement, regardless of tumor size.', ' Patients with a breast unsatisfactory for brachytherapy. For example, if there is little breast tissue remaining between the skin and pectoralis muscle after surgery, placement of catheters is technically problematic.', ' Patients with tylectomies so extensive that the cosmetic result is fair or poor prior to brachytherapy.', ' Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation.', ' Any previously treated contralateral breast carcinoma or synchronous bilateral breast carcinoma.', ' Other malignancy, except non-melanoma skin cancer, 5 years prior to participation in this study; the disease free interval from any prior carcinoma must be continuous.', ' Time between final definitive breast procedure to radioactive source loading of the brachytherapy catheters is greater than 8 weeks.', ' Patients with diffuse (> 1 quadrant or >5 cm in diameter) suspicious microcalcifications.', ' Patients with suspicious microcalcifications remaining on the post-tylectomy mammogram'], 'Results': ['Outcome Measurement: ', ' Local Control Using Ipsilateral Breast Tumor Recurrence Rates', ' [Not Specified]', ' Time frame: 2 years after treatment completion', 'Results 1: ', ' Arm/Group Title: Accelerated Partial Breast Brachytherapy', ' Arm/Group Description: Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.', ' Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions.', ' Overall Number of Participants Analyzed: 151', ' Measure Type: Number', ' Unit of Measure: percentage of participants .7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/151 (0.00%)']}

89fdf182-7474-4e70-baf7-03c8920c4ff3

Single

Results

NCT00422903

Percentage of Participants With Clinical Objective Response (cOR) in the Breast, Evaluated by an Independent Radiological Evaluation Monitoring Committee was highest in cohort 2.

Contradiction

{'Clinical Trial ID': 'NCT00422903', 'Intervention': ['INTERVENTION 1: ', ' Letrozole + Placebo', ' Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.', 'INTERVENTION 2: ', ' Letrozole + Lapatinib', ' Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.'], 'Eligibility': ['Inclusion criteria:', ' Histologically confirmed infiltrating primary breast cancer of 2.0 cm or more in largest clinical diameter', ' ER and/or PgR positive cancer (> 10% of positive cancer cell assessed by IHC)', ' Postmenopausal status, defined by at least one of the following:', ' 60 years of age < 60 years of age and amenorrheic for 12 months prior to day 1 < 60 years of age and amenorrheic for < 12 months prior to day, or without a uterus: luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range Prior bilateral oophorectomy Prior radiation castration with amenorrhea for at least 6 months', ' HER2 negative tumors (IHC 0-2+, or FISH negative)', ' Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment', ' Age over 18 years', ' ECOG PS 0-1', ' Normal organ and marrow function as defined below:', ' leukocytes > 3000/mL absolute neutrophil count > 1,500/mL platelets > 100,000/mL total bilirubin within normal institutional limits AST (SGOT)/ALT(SGPT)< 2.5 X institutional upper limit of normal Creatinine within normal institutional limits', ' Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan.', ' Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review of their use by the Principal Investigator.', ' A list of medications and substances known or with the potential to interact with CYP450 isoenzymes is provided', ' Ability to understand and the willingness to sign a written informed consent document.', ' Ability to swallow and retain oral medication.', 'Exclusion criteria:', ' Stage IIIB, IIIC, and inflammatory breast cancer', ' Stage IV breast cancer', ' Contraindication to the treatment with letrozole', ' Prior treatment with chemotherapy, endocrine therapy or radiotherapy. Prior treatment with EGFR targeting therapies', ' Treatment with any other investigational agents, or with all herbal (alternative) medicines', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib', ' Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' HIV-positive patients receiving combination anti-retroviral therapy', " GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)", ' Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors (See section 3.7.4.2 Other concomitant treatments)'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Clinical Objective Response (cOR) in the Breast, Evaluated by an Independent Radiological Evaluation Monitoring Committee', ' cOR is defined as the documented evidence of complete response (CR) and partial response (PR) as assessed by ultrasound examination using Response Evaluation Criteria In Solid Tumors (RECIST). CR is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). PR for TLs is defined as a >=30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs, it is defined as the persistence of >=1 non-TL and no new TLs or non-TLs.', ' Time frame: From Baseline (Day 1) up to 6 months, evaluated every 12 weeks', 'Results 1: ', ' Arm/Group Title: Letrozole + Placebo', ' Arm/Group Description: Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.', ' Overall Number of Participants Analyzed: 48', ' Measure Type: Number', ' Unit of Measure: percentage of participants CR: 2', 'PR: 58', 'Results 2: ', ' Arm/Group Title: Letrozole + Lapatinib', ' Arm/Group Description: Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.', ' Overall Number of Participants Analyzed: 41', ' Measure Type: Number', ' Unit of Measure: percentage of participants CR: 12', 'PR: 54'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/49 (2.04%)', ' Myocardial infarction 1/49 (2.04%)', ' Cardiac failure 0/49 (0.00%)', ' Sphincter of Oddi dysfunction 0/49 (0.00%)', ' Overdose 0/49 (0.00%)', ' Spinal cord compression 0/49 (0.00%)', 'Adverse Events 2:', ' Total: 3/43 (6.98%)', ' Myocardial infarction 0/43 (0.00%)', ' Cardiac failure 1/43 (2.33%)', ' Sphincter of Oddi dysfunction 1/43 (2.33%)', ' Overdose 1/43 (2.33%)', ' Spinal cord compression 1/43 (2.33%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

9f2fd0cc-af87-433d-9d2f-6235591d6cb1

Comparison

Intervention

NCT02413008

NCT02725801

The interventions in the primary trial and the secondary trial are applied daily for a period of several months.

Contradiction

{'Clinical Trial ID': 'NCT02413008', 'Intervention': ['INTERVENTION 1: ', ' 0.005% Estriol Vaginal Gel', ' Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration', 'INTERVENTION 2: ', ' Placebo Vaginal Gel', ' Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration', 'Placebo'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent prior to beginning specific protocol procedures.', ' Patients must have histological confirmation of breast adenocarcinoma with stage I-IIIA, documented at a local pathology department.', ' The breast tumors must be estrogen-receptor positive and/or progesterone receptor positive ( 1% of stained tumor cells by Immunohistochemistry (IHC) as determined by the local laboratory) with any Human Epidermal Growth Factor Receptor 2(HER2) status.', ' Postmenopausal status defined as: 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 Milli-international units per milliliter (mIU/ml) or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.', ' Patient must be receiving the non-steroidal aromatase inhibitors anastrozole or letrozole as breast cancer treatment in the adjuvant setting for a minimum of 6 months.', ' Women suffering from moderate to severe vaginal dryness according to the FDA guidelines for drug development in postmenopausal women (Center for Drug Evaluation and Research, (CDER) Jan 2003). A moderate symptom will be considered if the symptom is present, bothersome and annoying, and a severe symptom will be considered if the symptom is present, bothersome and annoying, and interferes with the normal patient activity.', ' Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.', ' Adequate bone marrow as defined by the following laboratory values:', ' Absolute Neutrophil Count (ANC) 1.5 x 109/L.', ' Platelets (plt) 100 x 109/L.', ' Hemoglobin (Hgb) 10 g/dl.', ' Patient has adequate organ function as defined by the following laboratory values:', ' Serum creatinine 1.5 x Upper Limit of Normal (ULN).', ' Bilirubin 1.5 × ULN.', ' Alkaline phosphatase 2 × ULN.', ' Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 2 × ULN.', ' Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.', 'Exclusion Criteria:', ' Stage IIIB-IV breast cancer or bilateral breast cancer.', ' Treatment with any other current anti-tumoral therapy (chemotherapy, anti-Her2…etc) besides the NSAI. Pamidronate or Alendronate are permitted.', ' Prior history of other malignancy within 5 years of study entry, aside from non-melanoma skin cancer or carcinoma-in-situ of the uterine cervix adequately treated.', ' Postmenopausal uterine bleeding. Vaginal bleeding of unknown etiology.', ' Patients with endometrial thickness equal to or greater than 4 mm measured by transvaginal ultrasound.', ' Patients who have received any type of vulvovaginal treatment in the 15 days prior to the start of the study.', ' Use of any hormone, natural (phytoestrogens) or herbal products for the treatment of menopausal symptoms within the last 3 months.', ' Current or previous history of thromboembolic disease or coagulopathies.', ' Severe cardiovascular or respiratory diseases in the previous 6 months.', ' Renal Impairment.', ' Hepatitis B and/or hepatitis C carriers (unless with normal hepatic function).', ' Known human immunodeficiency virus infection.', ' Known hypersensitivity to NSAI.', ' Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.', ' Previous investigational treatment for any condition or participation in any clinical trial within 4 weeks of inclusion date.'], 'Results': ['Outcome Measurement: ', ' Variation in Serum Levels of Follicle Stimulating Hormone (FSH)', ' Change from Baseline (mean screening-baseline) to Week 12 in Serum Levels of Follicle Stimulating Hormone (FSH) compare to natural physiological variability (screening-baseline variation)', ' Time frame: from baseline to 12 weeks of treatment', 'Results 1: ', ' Arm/Group Title: 0.005% Estriol Vaginal Gel', ' Arm/Group Description: Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration', ' Overall Number of Participants Analyzed: 50', ' Median (Inter-Quartile Range)', ' Unit of Measure: mIU/ml -2.8 (-13.1 to 7.4)', 'Results 2: ', ' Arm/Group Title: Placebo Vaginal Gel', ' Arm/Group Description: Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration', ' Placebo', ' Overall Number of Participants Analyzed: 11', ' Median (Inter-Quartile Range)', ' Unit of Measure: mIU/ml 1.4 (-5.4 to 15.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/50 (2.00%)', ' Lymphoma [1]1/50 (2.00%)', 'Adverse Events 2:', ' Total: 0/11 (0.00%)', ' Lymphoma [1]0/11 (0.00%)']}

{'Clinical Trial ID': 'NCT02725801', 'Intervention': ['INTERVENTION 1: ', ' One-port', ' intervention is placement of one-port tissue expander at time of reconstruction', ' Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction', 'INTERVENTION 2: ', ' Two-port', ' intervention is placement of two-port tissue expander at time of reconstruction', ' AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction'], 'Eligibility': ['Inclusion Criteria:', ' patient agrees to immediate tissue expander breast reconstruction', ' a suitable patient for tissue expander reconstruction', 'Exclusion Criteria:', ' not a surgical candidate for immediate breast reconstruction', ' age less than 18', ' patient declines tissue expander reconstruction', ' patient anticipated to need radiation therapy postoperatively'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant', ' The number of patients that are able to undergo replacement of the tissue expander between the two arms will be compared', ' Time frame: 3 months', 'Results 1: ', ' Arm/Group Title: One-port', ' Arm/Group Description: intervention is placement of one-port tissue expander at time of reconstruction', ' Allergen one-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 8 100.0%', 'Results 2: ', ' Arm/Group Title: Two-port', ' Arm/Group Description: intervention is placement of two-port tissue expander at time of reconstruction', ' AlloX2 two-port tissue expander placement: patients will be randomized to receive a one port or two port tissue expander for breast reconstruction', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 12 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/8 (12.50%)', ' re-operation [1]1/8 (12.50%)', 'Adverse Events 2:', ' Total: 4/12 (33.33%)', ' re-operation [1]4/12 (33.33%)']}

90364098-7e9a-47be-ab2e-f66958cfb09d

Comparison

Intervention

NCT00331552

NCT01306942

The same dose of trastuzumab was used for the interventions in the primary trial and the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT00331552', 'Intervention': ['INTERVENTION 1: ', ' Phase I: Cyclophosphamide, Doxil, Trastuzumab', ' Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.', ' pegylated liposomal doxorubicin hydrochloride: Given IV', ' cyclophosphamide: Given orally', ' trastuzumab: Given IV'], 'Eligibility': ['Inclusion Criteria:', ' Patients must satisfy either a or b: a) Measurable disease by RECIST criteria; x-rays, scans or physical examinations used for tumor assessment must have been completed within 30 days prior to registration; any non-measurable disease must be assessed within 42 days prior to registration; b) Non-measurable disease only, but MUC-1 antigen level (either CA 27-29 or CEA) is > 2X ULN AND MUC-1 antigen has been documented to have increased by 1.5X prior to registration; x-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration', ' ECOG performance status of =< 2', ' ANC >= 1,500 cells/mm^3', ' Platelet count >= 100,000 cells/mm^3', ' Hemoglobin >= 9.0g/dL', ' Creatinine =< 2.5 mg/dL', ' In the absence of liver metastases, AST / ALT, alkaline phosphatase and total bilirubin must not exceed 2 x upper limit of normal (i.e., must be =< 2 x upper limit of normal)', ' In the presence of liver metastases, AST / ALT, alkaline phosphatase and total bilirubin must not exceed 3 x upper limit of normal (i.e., must be =< 3 x upper limit of normal)', ' Have a MUGA scan or 2-d echocardiogram indicating an ejection fraction of >= 50% within 42 days prior to first dose of study drug (the method used at baseline must be used for later monitoring)', ' Use an adequate contraceptive method (e.g., abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment if of reproductive potential', ' Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures', 'Exclusion Criteria:', ' Pregnant or lactating women', ' History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil', ' Patients who are HER2-neu positive with cardiac disease that would preclude the use of Doxil or Herceptin are not eligible, including active cardiac disease (i.e., angina pectoris that requires the use of antianginal medication, cardiac arrhythmia requiring medication, severe conduction abnormality, clinically significant valvular disease, cardiomegaly on chest x-ray, ventricular hypertrophy on EKG, uncontrolled hypertension [diastolic greater than 100 mm/Hg or systolic > 200 mm/hg], current use of digitalis or beta blockers for CHF, clinically significant pericardial effusion) and history of cardiac disease (i.e., myocardial infarction documented as a clinical diagnosis or by EKG or any other test, documented congestive heart failure, documented cardiomyopathy, documented arrhythmia or cardiac valvular disease that requires medication or is medically significant)', " Has anthracycline resistant disease defined as a) If anthracycline was given for non-metastatic disease: The cumulative dose of anthracycline exceeds 360 mg/m^ 2 for doxorubicin or 540 mg/m^2 for epirubicin AND the disease-free interval from discontinuation of anthracycline to diagnosis of metastatic disease is < 12 months; b) If anthracycline was given for metastatic disease: The cumulative dose of anthracycline exceeds 360 mg/m^2 for doxorubicin or 540 mg/m^2 for epirubicin AND the patient's disease progressed on anthracycline given as palliative therapy", ' Except for the following no other malignancy is allowed: synchronous ipsilateral breast cancer of the same subtype (ER/PR, HER-2/neu), adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other stage I or II cancer from which the patient has been disease free for at least 5 years', ' Any life-threatening illness other than the malignancy for which they are being treated', ' Mental illness', ' Have a life expectancy of less than 4 months', ' Unwillingness to participate or inability to comply with the protocol for the duration of the study'], 'Results': ['Outcome Measurement: ', ' Maximum Tolerated Dose and Optimal Tolerated Dose of Pegylated Liposomal Doxorubicin Hydrochloride (Doxil) When Given in Combination With Cyclophosphamide (Phase I)', ' The dose level in which 2 or more patients develop treatment-related toxicity of grade 3 or higher OR require a dose adjustment following the first course of treatment', ' Time frame: Up to 24 weeks', 'Results 1: ', ' Arm/Group Title: Phase I: Cyclophosphamide, Doxil, Trastuzumab', ' Arm/Group Description: Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.', ' pegylated liposomal doxorubicin hydrochloride: Given IV', ' cyclophosphamide: Given orally', ' trastuzumab: Given IV', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: mg/m^2 30'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/27 (0.00%)']}

{'Clinical Trial ID': 'NCT01306942', 'Intervention': ['INTERVENTION 1: ', ' Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2', ' Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.', 'INTERVENTION 2: ', ' Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2', ' Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.'], 'Eligibility': ['Inclusion Criteria:', ' Female with histologically confirmed breast cancer with documented metastasis.', ' Patients must have Human Epidermal Growth Factor Receptor 2 (HER2) overexpression by immunohistochemistry (3+, HercepTest®; DAKO) or a positive fluorescence in situ hybridization for HER2 amplification evaluated by central laboratory. It is recommended that a formalin-fixed paraffin embedded (FFPE) tumor tissue block from the metastatic site (or the primary tumor, if metastatic site not available) required for HER2 testing are provided.', ' Patients can have measurable or non measurable disease for the Phase I part. For the Phase II only patients with measurable disease defined per RECIST 1.1 will be included.', ' Signed Written Informed Consent.', ' Target Population:', ' Patients with Performance Status (ECOG) of 0 or 1.', ' Number of previous therapies allowed or previous therapies may have included:', ' Chemotherapy: no prior chemotherapy for MBC is permitted. Patients treated with adjuvant chemotherapy regimens based on taxanes are allowed to be included if they are fully recovered of any taxane associated toxicity and a minimum of 12 months have elapsed from the end of this therapy.', ' Hormonal Therapy: patients may have had prior hormonal therapy. All hormonal agents must be discontinued at least 3 weeks prior to study entry.', ' Radiation Therapy: patients may have had prior radiation therapy that has not exceeded 25% of the bone marrow reserve. A minimum of 21 days must have elapsed between the last dose of radiation and registration into the study. Patients must have recovered from any acute toxic effects from radiation prior to registration. Lesions that have been irradiated cannot be included as sites of measurable disease for the phase II unless clear tumor progression, according to RECIST criteria, has been documented in these lesions since the end of radiation therapy.', ' Previous Surgery: previous surgery is permitted provided that wound healing has occurred.', ' Anti-HER2 Therapies: no prior anti-HER2 therapy for MBC is permitted. Patients treated with adjuvant anti-HER2 therapies (including but not limited to trastuzumab and lapatinib) are allowed to be included if a minimum of 12 months have elapsed from the end of this therapy.', ' Adequate Organ Function (...).', ' Ability to take oral medication (dasatinib must be swallowed whole).', ' Concomitant Medications', ' i) Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy (discontinue St. Johns Wort at least 5 days before starting dasatinib) ii) Biphosphonates must not be initiated within 28 days prior to study therapy', ' Age and sex:', ' f) Patient, age 18 years old. g) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of study drug to minimize the risk of pregnancy. (...)', 'Exclusion Criteria:', ' Sex and reproductive status:', ' WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug', ' Women who are pregnant or breastfeeding.', ' Women with a positive pregnancy test', ' Target Disease Exceptions:', ' a) Central nervous system (CNS) metastases which are not well controlled. Eligible patients must be asymptomatic, cannot be receiving steroids or anticancer treatment, and must be enrolled at least 1 month after the end of the radiotherapy treatment', ' Medical History and Concurrent Diseases', ' No malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 5 years.', ' Concurrent medical condition which may increase the risk of toxicity, including: Pleural or pericardial effusion of any grade.', ' Cardiac Symptoms; any of the following should be considered for exclusion:', ' i) Uncontrolled angina, congestive heart failure or myocardial infarction (MI) within (6 months) ii). Patients with intercurrent cardiac dysfunction or left ventricular ejection fraction (LVEF) < 50%.', ' iii) Diagnosed congenital long QT syndrome. iv) Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).', ' v) Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (450 msec).', ' vi) Patients with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration.', " d) History of significant bleeding disorder unrelated to cancer, including: i) Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease). ii) Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).", ' iii) Ongoing or recent ( 3 months) significant gastrointestinal bleeding.', ' Allergies and Adverse Drug Reactions', ' a) Patients with known allergy to any of the study drugs or their components.', ' Prohibited Treatments and/or Therapies', ' a) Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib) i) quinidine, procainamide, disopyramide ii) amiodarone, sotalol, ibutilide, dofetilide iii) erythromycin, clarithromycin iv) chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide v) cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.', ' b) Concurrent anti-cancer therapy c) Potent CYP3A4 inhibitors', ' Other exclusion criteria:', ' Patients who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.', ' Patients with active or uncontrolled infections or with serious illnesses or medical conditions that would not permit the patient to be managed according to the protocol.', ' Patients unable or unwilling to give written informed consent prior to study participation.', ' Pre-existent motor or sensory neurotoxicity of severity grade 2 according to NCI common toxicity criteria (version 4.03).'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicity (DLT) Within the First Cycle of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I)', ' DLT was defined as the occurrence of any of the following adverse events or abnormal laboratory value (graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03), assessed as possibly, probably or definitively related to study drugs, occurring within the first cycle of study treatment: Need of any dose modification within the first cycle due to toxicity, grade 3 or 4 neutropenia complicated with fever 38.5° C or infection, grade 4 neutropenia (absolute neutrophil count (ANC)<0.5x1000000000/L) of at least 7 days duration, grade 3 thrombocytopenia complicated by hemorrhage, grade 4 thrombocytopenia, any grade 4 non-hematologic toxicity, grade 3 non-hematologic toxicities except nausea, vomiting, or diarrhea that can be controlled by appropriate medical intervention or prophylaxis, inability to resume dosing for cycle 2 at the current dose level within 14 days due to treatment related toxicity.', ' Time frame: Up to cycle 1', 'Results 1: ', ' Arm/Group Title: Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2', ' Arm/Group Description: Cohort 1: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 100mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%', 'Results 2: ', ' Arm/Group Title: Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2', ' Arm/Group Description: Cohort 2: Eligible patients were enrolled and treated with 4-week cycles of trastuzumab 2 mg/kg IV weekly (following a loading dose of 4 mg/kg in cycle 1) and paclitaxel 80 mg/m2 weekly x 3 weeks followed by a rest period of 7 days. Dasatinib 140mg was administered orally once daily (QD). Treatment was repeated on Day 1 of a 28-day cycle until radiographic or symptomatic progression or unacceptable toxicity occured. Only in the phase I, the first cycle lasted 38 days.', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 50.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/6 (16.67%)', ' Angina * [1]0/6 (0.00%)', ' Diarrhea * [2]1/6 (16.67%)', ' Sudden death * [3]0/6 (0.00%)', ' Soft tissue and skin infection * [2]0/6 (0.00%)', ' Catheter related infection * [1]0/6 (0.00%)', ' Overdose * [4]0/6 (0.00%)', ' Dyspnea * [2]0/6 (0.00%)', ' Pneumonitis * [2]0/6 (0.00%)', ' Febrile syndrome respiratory focus * [5]0/6 (0.00%)', 'Adverse Events 2:', ' Total: 2/4 (50.00%)', ' Angina * [1]0/4 (0.00%)', ' Diarrhea * [2]0/4 (0.00%)', ' Sudden death * [3]0/4 (0.00%)', ' Soft tissue and skin infection * [2]0/4 (0.00%)', ' Catheter related infection * [1]0/4 (0.00%)', ' Overdose * [4]0/4 (0.00%)', ' Dyspnea * [2]1/4 (25.00%)', ' Pneumonitis * [2]1/4 (25.00%)', ' Febrile syndrome respiratory focus * [5]0/4 (0.00%)']}

021c3f62-8067-49e3-9d4b-c7641feb2548

Single

Eligibility

NCT01702571

Patients with incurable and unresectable Breast Cancer are eligible for the primary trial, unless it is metastatic.

Contradiction

{'Clinical Trial ID': 'NCT01702571', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine (All Participants)', ' This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.', 'INTERVENTION 2: ', ' Trastuzumab Emtansine (Asian Participants)', ' This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.'], 'Eligibility': ['Inclusion Criteria:', ' HER2-positive disease determined locally', ' Histologically or cytologically confirmed invasive breast cancer', ' Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting must include both chemotherapy, alone or in combination with another agent, and an anti-HER2 agent, alone or in combination with another agent', ' Documented progression of incurable, unresectable, LABC, or mBC, defined by the investigator: progression must occur during or after most recent treatment for LABC/mBC or within 6 months of completing adjuvant therapy', ' Measurable and/or non-measurable disease', ' Left ventricular ejection fraction (LVEF) >/=50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2', ' Adequate organ function', ' Use of highly effective contraception as defined by the protocol', 'Exclusion Criteria:', ' History of treatment with trastuzumab emtansine', ' Prior enrollment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not', ' Peripheral neuropathy of Grade >/= 3 per National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v 4.0', ' History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer', ' History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria', ' History of exposure to cumulative doses of anthracyclines', ' History of radiation therapy within 14 days of first study treatment. The participant must have recovered from any resulting acute toxicity (to Grade </=1) prior to first study treatment.', ' Metastatic central nervous system (CNS) disease only', ' Brain metastases which are symptomatic', ' History of a decrease in LVEF to less than (<) 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment', ' History of symptomatic CHF (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment', ' History of myocardial infarction or unstable angina within 6 months of first study treatment', ' Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy', ' Current severe, uncontrolled systemic disease (clinically significant cardiovascular, pulmonary, or metabolic disease)', ' Pregnancy or lactation', ' Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus', ' History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Adverse Events of Primary Interest (AEPIs)', ' The AEPIs in this study were defined as the following: adverse events (AEs) Grade >/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade >/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.', ' Time frame: Baseline up to approximately 7 years', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine (All Participants)', ' Arm/Group Description: This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.', ' Overall Number of Participants Analyzed: 2002', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 23.1 (21.2 to 25.0)', 'Results 2: ', ' Arm/Group Title: Trastuzumab Emtansine (Asian Participants)', ' Arm/Group Description: This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.', ' Overall Number of Participants Analyzed: 181', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 51.4 (43.9 to 58.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 427/2002 (21.33%)', ' ANAEMIA 13/2002 (0.65%)', ' BONE MARROW FAILURE 1/2002 (0.05%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 1/2002 (0.05%)', ' FEBRILE NEUTROPENIA 1/2002 (0.05%)', ' THROMBOCYTOPENIA 11/2002 (0.55%)', ' ACUTE CORONARY SYNDROME 3/2002 (0.15%)', ' ANGINA PECTORIS 1/2002 (0.05%)', ' CARDIAC ARREST 1/2002 (0.05%)', ' CARDIAC FAILURE 1/2002 (0.05%)', ' CARDIAC TAMPONADE 1/2002 (0.05%)', 'Adverse Events 2:', ' Total: 36/181 (19.89%)', ' ANAEMIA 0/181 (0.00%)', ' BONE MARROW FAILURE 0/181 (0.00%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 0/181 (0.00%)', ' FEBRILE NEUTROPENIA 0/181 (0.00%)', ' THROMBOCYTOPENIA 10/181 (5.52%)', ' ACUTE CORONARY SYNDROME 1/181 (0.55%)', ' ANGINA PECTORIS 0/181 (0.00%)', ' CARDIAC ARREST 0/181 (0.00%)', ' CARDIAC FAILURE 0/181 (0.00%)', ' CARDIAC TAMPONADE 0/181 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

6893c9b4-d3a3-47a8-ada9-8aef67de2375

Single

Eligibility

NCT00859651

Helen had stage III ovarian cancer 2 years prior, from which she is still recovering, she is excluded from the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00859651', 'Intervention': ['INTERVENTION 1: ', ' Cholecalciferol 20,000 IU Group', ' Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.', 'INTERVENTION 2: ', ' Cholecalciferol 30,000 IU Group', ' Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.'], 'Eligibility': ['Inclusion Criteria:', ' Elevated risk of breast cancer defined as having at least one of the following: (1) Predicted 5-year modified Gail model risk of 1.67% or greater, (2) Lobular carcinoma in situ, (3) Known BRCA1 or BRCA2 deleterious mutation carrier, (4) Prior history of ductal carcinoma in situ, if no current tamoxifen use or prior radiation to the contralateral breast.', ' Age 21 years or older.', ' Postmenopausal defined as > 6 months since the last menstrual period, prior bilateral oophorectomy, or serum follicle-stimulating hormone (FSH)/luteinizing hormone (LH) values consistent with institutional normal values for the postmenopausal state.', ' Baseline mammographic density 25% as assessed qualitatively by the mammographer (25-50% = "scattered fibroglandular densities"; >50-75% = "heterogeneously dense breasts"; >75% = "extremely dense breasts").', ' Baseline serum 25-hydroxyvitamin D <32 ng/ml.', ' Normal breast exam and mammogram (Breast Imaging Reporting and Data System (BIRADS) score of 1 or 2) or abnormal breast imaging with a benign breast biopsy without evidence of cancer. Normal baseline breast magnetic resonance imaging (MRI) (BIRADS score of 1, 2, or 3).', ' Prior tamoxifen or raloxifene use is allowed provided treatment is discontinued at least 28 days prior to enrollment.', ' At least one breast available for imaging. No bilateral breast implants.', ' Willingness to not take vitamin D supplements during the one year intervention, but up to 1000mg of calcium supplementation is allowed.', ' Normal serum calcium.', ' Adequate renal and hepatic function: serum creatinine, bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase < 2.0 x the institutional upper limit of normal (IULN).', ' Performance status of 0 or 1.', 'Exclusion Criteria:', ' Other prior malignancy. The following is allowed: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer (including breast cancer) for which the participant has been disease-free for 5 years.', ' History of kidney stones.', ' Hypersensitivity reactions to vitamin D.', ' On estrogen replacement therapy.', ' Significant medical or psychiatric condition that would preclude study completion.'], 'Results': ['Outcome Measurement: ', ' Change in Serum 25(OH)D', ' 25(OH)D level at the end of one year intervention', ' Time frame: Baseline to 1 year', 'Results 1: ', ' Arm/Group Title: Cholecalciferol 20,000 IU Group', ' Arm/Group Description: Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 20,000 IU weekly, for one year.', ' Overall Number of Participants Analyzed: 18', ' Mean (Standard Deviation)', ' Unit of Measure: ng/ml 25 (5)', 'Results 2: ', ' Arm/Group Title: Cholecalciferol 30,000 IU Group', ' Arm/Group Description: Postmenopausal women who are at increased risk for breast cancer development receiving vitamin D3, oral cholecalciferol 30,000 IU weekly, for one year.', ' Overall Number of Participants Analyzed: 22', ' Mean (Standard Deviation)', ' Unit of Measure: ng/ml 33 (9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/18 (0.00%)', 'Adverse Events 2:', ' Total: 0/22 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

b88cde11-ae29-48e8-832b-4b9cb2596c30

Comparison

Results

NCT02472964

NCT00089661

the primary trial studies changes in tumour diameter, whereas the secondary trial investigates changes in heart failure rate.

Contradiction

{'Clinical Trial ID': 'NCT02472964', 'Intervention': ['INTERVENTION 1: ', ' Herceptin© + Taxane', ' Part 1: Herceptin© (trastuzumab) intravenously+ paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.', ' Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Herceptin© (trastuzumab) alone once every 3 weeks until DP or subject withdrawal .', 'INTERVENTION 2: ', ' MYL-1401O Trastuzumab + Taxane', ' Part 1:Myl 1401OTrastuzumab Intravenously + paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.', ' Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Myl 1401O( Mylan Trastuzumab) alone once every 3 weeks until DP or subject withdrawal.'], 'Eligibility': ['Inclusion Criteria:', ' Locally recurrent or MBC that is not amenable to curative surgery and/or radiation.', ' Documentation of HER2 gene amplification by fluorescent in situ hybridization (FISH) (as defined by a ratio >2.0) or documentation of HER2-overexpression by immunohistochemistry (IHC) (defined as IHC3+, or IHC2+ with FISH confirmation) based on the sponsor-identified central laboratory prior to randomization. Archival tumor tissue samples can be used.', ' Pathologically confirmed breast cancer with at least one measurable metastatic target lesion (based on RECIST criteria, version 1.1). Bone, central nervous system (CNS), and skin lesions, as well as lesions that were irradiated, biopsied or had any form of local intervention or surgical manipulation are only to be assessed as non-target lesions.', ' Patients previously treated with trastuzumab or lapatinib in the adjuvant setting are allowed if metastatic disease was diagnosed at least one year after the last dose of treatment.', ' Prior treatment with hormonal agents or bisphosphonates/denosumab is allowed. Bisphosphonates/denosumab can be given simultaneously with study treatment but cannot start after randomization and is considered an indication of progressive disease (PD). Hormonal agents must be discontinued prior to beginning study therapy.', ' Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 - 2', ' Serum creatinine 1.5 x ULN (upper limit of normal),', " Total bilirubin 1.0 x ULN (>1.0 x ULN if documented Gilbert's disease),", ' Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) 2.5 x ULN,', ' AST and/or ALT <1.5 x ULN if alkaline phosphatase >2.5 x ULN,', ' Alkaline phosphatase >2.5 x ULN;if bone metastases present and no liver dysfunction present.', ' Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by multiple gated acquisition scan or echocardiogram.', 'Exclusion Criteria:', ' Prior systemic therapy in the metastatic disease setting. This includes: chemotherapy, signal transduction inhibitors (e.g., lapatinib), HER2 targeted therapy (e.g., trastuzumab), or other investigational anticancer therapy.', ' Prior treatment with neoadjuvant or adjuvant anthracyclines with a cumulative dose of doxorubicin of >400 mg/m2, epirubicin dose >800 mg/m2.', ' Patients with bone or skin as the only site of disease. Patients with skin lesions measurable by CT scans or MRI as only site of measurable disease are allowed.', ' Surgery or radiotherapy 2 weeks preceding Day 1. Target lesions have to be outside the irradiated fields and the patient has fully recovered from surgery or radiotherapy.', ' Presence of unstable angina or a history of congestive heart failure according to the New York Heart Association criteria, history of myocardial infarction <1 year from randomization, clinically significant valvular disease, serious cardiac arrhythmia requiring treatment, uncontrolled hypertension or known pulmonary hypertension.', ' Peripheral sensory or motor neuropathy Grade 2 or higher according to the National Cancer Institute-Common Terminology Criteria (NCI-CTC) Version 4.03 [19].', ' Any other cancer, including contralateral breast cancer, within 5 years prior to screening with the exception of adequately treated ductal carcinoma in situ, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.', ' Immunocompromized patients, including known seropositivity for human immunodeficiency virus, or current or chronic hepatitis B and/or hepatitis C infection (as detected by positive testing for hepatitis B surface antigen or antibody to hepatitis C virus with confirmatory testing).', ' Complete listing of Inc/Excl. within protocol'], 'Results': ['Outcome Measurement: ', ' Primary Endpoint : Compare Best Overall Response Rate (ORR) (According to Response Evaluation Criteria in Solid Tumor [RECIST] 1.1 Criteria) at Week 24 of MYL-1401O Plus Taxane Versus Herceptin® Plus Taxane in the ITT1 Population', ' Tumor measurements were perform by centralized blinded reviewers using RECIST 1.1 criteria. Per RECIST 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm.Partial Response (PR): >/= 30% decrease sum of the diameters of target lesions from baseline sum diameters.', ' Progressive Disease (PD): </= 20% increase in the sum of the diameters of target lesions, from the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions* denotes disease progression.', ' Stable Disease (SD): Neither sufficient decrease or increase. Evaluation of Non-Target Lesions Complete Response (CR): Disappearance of all non-target lesions. Non-complete Response/Non-Progressive Disease: Persistence of one or more non-target lesions. Progressive Disease (PD): Substantial, unequivocal progression of existing non-target lesions.', ' Time frame: from time of First treatment to week 24', 'Results 1: ', ' Arm/Group Title: Herceptin + Taxane', ' Arm/Group Description: Part 1: Herceptin (trastuzumab) intravenously+ paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.', ' Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Herceptin (trastuzumab) alone once every 3 weeks until DP or subject withdrawal .', ' Overall Number of Participants Analyzed: 228', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Response: 0 0.0%', ' Partial Response: 146 64.0%', ' Stable Disease: 49 21.5%', ' Progressive Disease: 20 8.8%', ' Not Evaluable: 13 5.7%', 'Results 2: ', ' Arm/Group Title: MYL-1401O Trastuzumab + Taxane', ' Arm/Group Description: Part 1:Myl 1401OTrastuzumab Intravenously + paclitaxel 80 mg/m2 weekly intravenously or docetaxel 75 mg/m2 intravenously once every three weeks (investigators choice) for 8 cycles then evaluate for primary endpoint.', ' Part 2: If SD or PR, CR at cycle 9 (week 24) proceed to Myl 1401O( Mylan Trastuzumab) alone once every 3 weeks until DP or subject withdrawal.', ' Overall Number of Participants Analyzed: 230', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Response: 3 1.3%', ' Partial Response: 157 68.3%', ' Stable Disease: 48 20.9%', ' Progressive Disease: 9 3.9%', ' Not Evaluable: 13 5.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 91/246 (36.99%)', ' Febrile Neutropenia 10/246 (4.07%)', ' Leukopenia 12/246 (4.88%)', ' Neutropenia 62/246 (25.20%)', ' Pancytopenia 0/246 (0.00%)', ' Thrombocytopenia 1/246 (0.41%)', ' Acute Myocardial Infarction 0/246 (0.00%)', ' Cardiac Failure 0/246 (0.00%)', ' Carditis 0/246 (0.00%)', ' Abdominal Pain 0/246 (0.00%)', ' Anal Fissure 0/246 (0.00%)', ' Diarrhoea 4/246 (1.63%)', 'Adverse Events 2:', ' Total: 97/247 (39.27%)', ' Febrile Neutropenia 11/247 (4.45%)', ' Leukopenia 5/247 (2.02%)', ' Neutropenia 68/247 (27.53%)', ' Pancytopenia 1/247 (0.40%)', ' Thrombocytopenia 0/247 (0.00%)', ' Acute Myocardial Infarction 1/247 (0.40%)', ' Cardiac Failure 2/247 (0.81%)', ' Carditis 1/247 (0.40%)', ' Abdominal Pain 1/247 (0.40%)', ' Anal Fissure 1/247 (0.40%)', ' Diarrhoea 3/247 (1.21%)']}

{'Clinical Trial ID': 'NCT00089661', 'Intervention': ['INTERVENTION 1: ', ' Denosumab 60 mg Q6M', '[Not Specified]', 'INTERVENTION 2: ', ' Placebo', '[Not Specified]'], 'Eligibility': ['Histologically or cytologically confirmed adenocarcinoma of the breast', ' Subjects with early stage disease who are estrogen receptor positive and who have completed their treatment pathway (surgery, chemo-therapy, radiation, and/or hormone therapy) and are currently on or will initiate aromatase inhibitor therapy, and are expected to stay on aromatase inhibitor therapy for the duration of the 24-month study', ' All treatment pathway must be completed 4 weeks prior to study entry, and all acute toxic effect of any above therapy must be resolved to Grade 1 by National Cancer Institution (NCI) Common Terminology Criteria for Adverse Events (CTCAE)', ' Female > 18 years of age', ' ECOG Performance status 0 and 1', ' Lumbar spine, total hip or femoral neck BMD equivalent to a t-score classification of -1.0 to -2.5', ' Subject is willing and able to provide signed consent before any study-specific procedure', ' Other criteria also apply.'], 'Results': ['Outcome Measurement: ', ' Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12', ' Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Denosumab 60 mg Q6M', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 123', ' Least Squares Mean (95% Confidence Interval)', ' Unit of Measure: Percent Change from Baseline 4.8 (4.3 to 5.4)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 122', ' Least Squares Mean (95% Confidence Interval)', ' Unit of Measure: Percent Change from Baseline -.7 (-1.3 to -.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/120 (9.17%)', ' Acute myocardial infarction 0/120 (0.00%)', ' Atrial fibrillation 1/120 (0.83%)', ' Atrioventricular block second degree 0/120 (0.00%)', ' Cardiac failure congestive 1/120 (0.83%)', ' Myocardial infarction 0/120 (0.00%)', ' Myocardial ischaemia 1/120 (0.83%)', ' Goitre 1/120 (0.83%)', ' Colitis ischaemic 0/120 (0.00%)', ' Diverticulum 0/120 (0.00%)', ' Faecaloma 1/120 (0.83%)', 'Adverse Events 2:', ' Total: 19/129 (14.73%)', ' Acute myocardial infarction 1/129 (0.78%)', ' Atrial fibrillation 0/129 (0.00%)', ' Atrioventricular block second degree 1/129 (0.78%)', ' Cardiac failure congestive 0/129 (0.00%)', ' Myocardial infarction 1/129 (0.78%)', ' Myocardial ischaemia 0/129 (0.00%)', ' Goitre 0/129 (0.00%)', ' Colitis ischaemic 1/129 (0.78%)', ' Diverticulum 1/129 (0.78%)', ' Faecaloma 0/129 (0.00%)']}

ebe7078c-fd8b-439a-b1f5-7bd482071ead

Single

Intervention

NCT02312622

Both cohorts of the primary trial receive identical interventions; Pegylated Irinotecan Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle), the difference between the cohorts is the type of cancers that patients are diagnosed with, cohort 1 is NSCLC, whereas cohort 2 is mBC.

Entailment

{'Clinical Trial ID': 'NCT02312622', 'Intervention': ['INTERVENTION 1: ', ' Cohort A - Pegylated Irinotecan to Treat NSCLC', ' Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.', ' Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)', 'INTERVENTION 2: ', ' Cohort C - Pegylated Irinotecan to Treat mBC', ' Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.', ' Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)'], 'Eligibility': ['Inclusion Criteria:', ' At least 18 years of age.', ' Life expectancy of 3 months or longer.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.', ' Advanced or refractory cancer, consisting of', ' Metastatic breast cancer (mBC) for which single-agent cytotoxic chemotherapy is indicated. OR', ' Histologically-proven metastatic lung cancer:', ' Non-small cell lung cancer (NSCLC) as Stage IV disease or recurrent metastatic disease [per lung cancer tumor, node and metastasis (TNM) classification system, 7th ed] (Cohort A) OR', ' Small cell lung cancer (SCLC) as extensive stage or recurrent metastatic disease (cohort B), including tumors with mixed small cell and non-small cell elements.', ' Prior chemotherapy (at least one of the following):', ' At least one line of prior systemic chemotherapy', ' At least one line of prior targeted treatment for metastatic disease Adjuvant systemic chemotherapy within prior 6 months Prior treatment for metastatic breast cancer (mBC) must have included taxane-based regimen', ' Prior chemotherapy, including other investigational therapy, has been completed prior to initiation of study treatment, according to the following:', ' 2 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered on a daily or weekly schedule', ' 3 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered every 2 weeks', ' 4 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered every 3 weeks Previously received at least one CNS directed treatment (such as surgery or radiation) OR not be eligible for CNS stereotactic radiosurgery Measurable CNS disease, either previously untreated (not counting systemic therapy), or progressed following previous radiation treatment. Lesions that have progressed after prior radiosurgery should not be selected as measurable disease if they are suspected of being radionecrosis.', ' The following measurement criteria are required, as visualized by contrast-enhanced MRI with slice thickness of 1.5 mm, unless absence of contrast or thicker slices is specifically authorized by Protocol Director. Measurements do not include tumor edema.', ' At least one CNS tumor measuring 10 mm in longest diameter, OR', ' At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two additional CNS tumors measuring 3 mm in longest diameter, for which the sum of the longest diameters is 10 mm. Additional tumors are not exclusionary.', ' Adequate organ function as evidenced by:', ' Absolute neutrophil count (ANC) 1.5 x 10e9/L without G-CSF (filgrastim, pegfilgrastim, or equivalent) support within 7 days', ' Hemoglobin (Hgb) 9.0 g/dL (90 g/L) without blood transfusion within 7 days', ' Platelet count 100 x 10e9/L without platelet transfusion within 7 days', " Bilirubin 1.5 X upper limit of normal (ULN), except for patients with documented history of Gilbert's disease who may have DIRECT bilirubin 1.5 X ULN", ' Alanine aminotransferase (ALT) 2.5 X ULN, except 5 X ULN for patients with liver metastases', ' Aspartate aminotransferase (AST) 2.5 X ULN, except 5 X ULN for patients with liver metastases', ' Serum creatinine 1.5 X ULN; or calculated creatinine clearance 50 mL/min (using Cockcroft-Gault formula), or measured creatinine clearance 50 mL/min.', 'Exclusion Criteria:', ' Previous treatment with a camptothecin derivative (eg, irinotecan, topotecan, and investigational agents including but not limited to exatecan, rubitecan, gimatecan, karenitecin, SN38 investigational agents, EZN 2208, SN 2310, and AR 67) is not allowed', ' Patients may not have a known history of leptomeningeal disease, as diagnosed by positive CSF cytology, unless prospective permission for enrollment is granted from the sponsor and the PI', ' Patients may not have had major surgery or radiotherapy (therapeutic and/or palliative) within 14 days prior to initiation of study treatment, including CNS-directed radiation therapy. Minor procedures, such as tumor biopsy, thoracentesis, or intravenous catheter placement are allowed with no waiting period', ' Patients may not have the following co morbid disease or concurrent illness:', ' Chronic or acute gastrointestinal (GI) disorders resulting in diarrhea of any severity grade; patients may not use chronic anti-diarrheal supportive care (more than 3 days/week) to control diarrhea in the 28 days prior to first dose of investigational drug. (exception: anti-diarrheal medications used to control symptoms from a medication that will be discontinued prior to study are allowed with a 7 day washout before study therapy, for example loperamide for erlotinib-associated diarrhea)', ' Known cirrhosis, defined as Child Pugh class A or higher liver disease', ' Other active malignancy, except for non melanoma skin cancer and carcinoma in situ (of the cervix or bladder)', ' Any other severe/uncontrolled inter current illness or significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation', ' Patients may not have a known allergy or hypersensitivity to any of the components of the investigational therapy, including polyethylene glycol (PEG) or topoisomerase inhibitors', ' Patients may not be receiving the following medications at the time of first dose of investigational drug:', ' Pharmacotherapy for known hepatitis B or C, tuberculosis, or human immunodeficiency virus (HIV)', ' Any of the following enzyme inducing anti epileptic medications (EIAEDs): phenytoin, carbamazepine, oxcarbazepine, phenobarbital', ' Other chemotherapy, hormonal therapy, immunotherapy, other investigational agents, or biologic agents for the treatment of cancer except for bisphosphonates or denosumab', ' Pregnant or nursing patients will be excluded from the study'], 'Results': ['Outcome Measurement: ', ' Central Nervous System (CNS) Disease Control Rate (Cohort A and C)', ' Central nervous system (CNS) disease control (DC) is defined as a complete response (CR); partial response (PR); or stable disease (SD). The outcome is reported as the number and percentage of participants who achieve DC, a number without dispersion.', ' Response criteria are as follows. Note that any lesion less than 10 mm in longest diameter (LD) is considered unchanged unless there is a 3 mm change in the sum of the LDs.', ' CR = Disappearance of all target lesions, sustained for 4 weeks with no new lesions; clinical condition stable or improved', ' PR = 30% decrease in target lesion LD and no new lesions, sustained for 4 weeks; clinical condition stable or improved', ' PD (progressive disease) = Any of 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration', ' SD = Neither PR or PD', ' Time frame: At 12 weeks', 'Results 1: ', ' Arm/Group Title: Cohort A - Pegylated Irinotecan to Treat NSCLC', ' Arm/Group Description: Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.', ' Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m as monotherapy once every 21 days (1 cycle)', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 16.7%', 'Results 2: ', ' Arm/Group Title: Cohort C - Pegylated Irinotecan to Treat mBC', ' Arm/Group Description: Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.', ' Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m as monotherapy once every 21 days (1 cycle)', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 16.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/12 (100.00%)', ' Febrile neutropenia 0/12 (0.00%)', ' Pericardial tamponade 1/12 (8.33%)', ' Pericardial Effusion 1/12 (8.33%)', ' Diarrhea 0/12 (0.00%)', ' Non-cardiac chest pain 1/12 (8.33%)', ' Sepsis 0/12 (0.00%)', ' Respiratory infection 1/12 (8.33%)', ' Septic Shock 0/12 (0.00%)', ' Spinal fracture 0/12 (0.00%)', ' Dehydration 2/12 (16.67%)', ' Disease progression 1/12 (8.33%)', 'Adverse Events 2:', ' Total: 3/3 (100.00%)', ' Febrile neutropenia 2/3 (66.67%)', ' Pericardial tamponade 0/3 (0.00%)', ' Pericardial Effusion 0/3 (0.00%)', ' Diarrhea 1/3 (33.33%)', ' Non-cardiac chest pain 0/3 (0.00%)', ' Sepsis 1/3 (33.33%)', ' Respiratory infection 0/3 (0.00%)', ' Septic Shock 1/3 (33.33%)', ' Spinal fracture 0/3 (0.00%)', ' Dehydration 1/3 (33.33%)', ' Disease progression 0/3 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

d0b9c11c-50f2-4803-a96c-fff3ca90cf36

Comparison

Intervention

NCT01256008

NCT00300781

the primary trial is investigating Cognitive behavioural therapy, a type of psychotherapy, in contrast the secondary trial studies Trastuzumab, a type of chemotherapy.

Contradiction

{'Clinical Trial ID': 'NCT01256008', 'Intervention': ['INTERVENTION 1: ', ' Stage 1 Clinical Management', ' The group will receive clinical management treatment only each session.', ' Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.', ' Following are major elements:', ' Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.', 'INTERVENTION 2: ', ' Stage 1 CBT', ' The experimental group will receive CBT each session.', " CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."], 'Eligibility': ['Inclusion Criteria:', ' Age: 20-65 years;', ' Pathologically diagnosed breast cancer patients, with the diagnosis from at least 2 comprehensive clinical attending physicians, in line with clinical diagnosis of breast cancer;', ' A week after breast cancer surgery;', ' With complaints and symptoms of depression or anxiety', ' HAMD-17 8 points or / and HAMA 8 points;', " Have some reading comprehension skills (could complete the self-rating scale independently or with others' help);", ' Informed consent', 'Exclusion Criteria:', ' Previous diagnosis of mental disorder or Bipolar Disorder; alcohol and drug abusing history;', ' Use antidepressants, antipsychotics or accept any form of psychological treatment, or participation in other clinical trials in the last month', ' Patients with cardiovascular disease, liver and kidney dysfunction and other serious diseases;', ' Hearing, visual or understanding impairment;', ' Severe depression, suicidal tendencies;', " Can not or will not comply with clinical treatment programs based on the physicians' judgment", ' Exit criteria:', ' Persons with poor compliance during the trial period;', ' Persons whose depression increased during the trial period, has serious suicidal tendencies and requires urgent intervention;', ' Persons who are believed have other circumstances and should be suspended by Physicians'], 'Results': ['Outcome Measurement: ', ' Hamilton Depression Rating Scale (HAMD-17)', ' The scale(HAMD-17) is used to assessed the depression symptoms of patients.', ' The scale range is 0-53.Higher value represents a worse outcome.', ' The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week', ' Time frame: baseline,2 w,4 w,8 w,12 w,16 w,24 w', 'Results 1: ', ' Arm/Group Title: Stage 1 Clinical Management', ' Arm/Group Description: The group will receive clinical management treatment only each session.', ' Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.', ' Following are major elements:', ' Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.', ' Overall Number of Participants Analyzed: 98', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale baseline: 11.52 (3.789)', ' 2W: 10.23 (3.207)', ' 4W: 9.80 (3.056)', ' 8W: 8.71 (3.601)', ' 12W: 8.01 (3.200)', ' 16W: 7.42 (3.019)', ' 24W: 7.01 (3.317)', 'Results 2: ', ' Arm/Group Title: Stage 1 CBT', ' Arm/Group Description: The experimental group will receive CBT each session.', " CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention.", ' Overall Number of Participants Analyzed: 98', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale baseline: 13.31 (5.090)', ' 2W: 11.72 (4.976)', ' 4W: 9.72 (4.835)', ' 8W: 7.80 (4.440)', ' 12W: 5.71 (3.979)', ' 16W: 5.13 (4.108)', ' 24W: 4.45 (3.875)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/98 (0.00%)', 'Adverse Events 2:', ' Total: 0/98 (0.00%)']}

{'Clinical Trial ID': 'NCT00300781', 'Intervention': ['INTERVENTION 1: ', ' Neratinib 240, Prior Trastuzumab', ' Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.', 'INTERVENTION 2: ', ' Neratinib 240, No Prior Trastuzumab', ' Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment.'], 'Eligibility': ['Inclusion Criteria:', ' Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV', ' Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)', ' Over-expression of HER2', ' Tumor tissue available and adequate for analysis at screening', ' At least one measurable lesion', 'Exclusion Criteria:', ' Prior treatment with Herceptin (Arm B only)', ' More than 4 prior cytotoxic chemotherapy regimens', ' Subjects with bone or skin as the only site of measurable disease', ' Inadequate cardiac function', ' Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1', ' Active central nervous system metastases', ' Pregnant or breastfeeding women', ' Inability to swallow the HKI-272 capsules'], 'Results': ['Outcome Measurement: ', ' 16-week Progression Free Survival', ' 16 week progression-free survival (PFS) rate of neratinib in women with human epidermal growth factor receptor 2 (HER2) positive breast cancer, either with prior trastuzumab or no prior trastuzumab therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks.', ' Time frame: From first dose to 16 weeks', 'Results 1: ', ' Arm/Group Title: Neratinib 240, Prior Trastuzumab', ' Arm/Group Description: Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.', ' Overall Number of Participants Analyzed: 66', ' Measure Type: Number', ' Unit of Measure: percentage of participants 58.2 (45.3 to 71.2)', 'Results 2: ', ' Arm/Group Title: Neratinib 240, No Prior Trastuzumab', ' Arm/Group Description: Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment.', ' Overall Number of Participants Analyzed: 70', ' Measure Type: Number', ' Unit of Measure: percentage of participants 77.8 (67.6 to 88.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/66 (28.79%)', ' Anaemia 0/66 (0.00%)', ' Atrioventricular block 0/66 (0.00%)', ' Bradycardia 0/66 (0.00%)', ' Diarrhoea 4/66 (6.06%)', ' Nausea 2/66 (3.03%)', ' Vomiting 3/66 (4.55%)', ' Asthenia 0/66 (0.00%)', ' Fatigue 1/66 (1.52%)', ' Malaise 0/66 (0.00%)', ' Pyrexia 0/66 (0.00%)', ' Disseminated tuberculosis 0/66 (0.00%)', ' Folliculitis 0/66 (0.00%)', ' Hepatitis E 0/66 (0.00%)', 'Adverse Events 2:', ' Total: 17/70 (24.29%)', ' Anaemia 1/70 (1.43%)', ' Atrioventricular block 1/70 (1.43%)', ' Bradycardia 1/70 (1.43%)', ' Diarrhoea 4/70 (5.71%)', ' Nausea 0/70 (0.00%)', ' Vomiting 6/70 (8.57%)', ' Asthenia 1/70 (1.43%)', ' Fatigue 0/70 (0.00%)', ' Malaise 1/70 (1.43%)', ' Pyrexia 1/70 (1.43%)', ' Disseminated tuberculosis 1/70 (1.43%)', ' Folliculitis 1/70 (1.43%)', ' Hepatitis E 1/70 (1.43%)']}

b620e1c5-69c4-4c30-9006-faa346200b60

Single

Results

NCT00325598

There is no difference in results or cohort size between cohort 1 and 2 of the primary trial, the increase in Gy has no notable effect.

Entailment

{'Clinical Trial ID': 'NCT00325598', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1 (36 Gy)', ' 36 Gy in 9 fractions BID x 4 1/2 treatment days', ' Partial Breast Irradiation (PBI)', 'INTERVENTION 2: ', ' Cohort 2 (40 Gy)', ' 40 Gy in 10 fractions BID over 5 treatment days', ' Partial Breast Irradiation (PBI)'], 'Eligibility': ['Inclusion Criteria', ' Histologic Documentation:', ' Patients will have histologically confirmed Unicentric Stage I (T1 N0 M0) invasive ductal breast cancer.', ' Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen.', ' Tubular, mucinous and medullary variant histologies of infiltrating ductal carcinoma are permitted.', ' Low-grade DCIS (I and II) of 2 cm or less with histologically negative margins of at least 2 mm margins (or a negative re-excision) are permitted.', ' Women age 70 years or older with T1 invasive ductal carcinoma which are estrogen-receptor positive (ER+) with clinically negative axillary nodes who do not undergo surgical lymph node evaluation are also eligible if patient will take hormonal therapy.', ' Patients with T1N0 (i+) tumors on sentinel lymph node mapping or dissection (i.e. is tumor deposit is 0.2mm or less, regardless of whether the deposit is detected by IHC or H&E staining) will also be eligible, provided that completion axillary dissection has been performed to confirm N0 status.', " In the case where invasive cancer is present, the invasive cancer's pathology will be used regardless if DCIS is also present.", ' Prior Treatment: Patient may have been treated with adjuvant chemotherapy. Patients may be on adjuvant hormonal therapy or begin hormonal therapy following XRT at the discretion of the medical oncologist.', ' Radiation therapy should begin within:', ' 4-12 weeks from definitive surgical procedure', ' 2-6 weeks after chemotherapy, if chemotherapy given first', ' Radiation cannot be delivered concurrently with chemotherapy.', ' Age >= 18 years of age', ' ECOG Performance Status 0-2.', ' Signed Informed Consent', ' Exclusion Criteria', ' The following guidelines are to assist physicians in selecting patients for whom protocol therapy is safe and appropriate. Physicians should recognize that the following may seriously increase the risk to the patient entering this protocol. Patients who meet the following criteria should not be entered in this study:', ' 1a Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5 cm of uninvolved tissue; alternatively, discontiguous tumors that are clinically or mammographically within separate breast quadrants or subareolar central region.', ' b Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region.', ' Tumor > 2.0 cm, nodal involvement on H&E staining, or metastatic involvement', ' Histological evidence of:', ' Lymphovascular invasion: as defined by a tumor embolus present in an endothelial-lined space; cases with tumor emboli present in a space not lined by endothelial cells but otherwise very suspicious for an angiolymphatic space were also considered ineligible.', ' EIC (Extensive Intraductal Component): defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumor area) and intraductal carcinoma present clearly beyond the edges of the invasive tumor, or as a predominantly intraductal tumor with one or more areas of focal invasion 7, 55.', ' Invasive Lobular Carcinoma', ' Infiltrating carcinoma with mixed ductal and lobular features: cases with ambiguous or mixed histologic features that showed positive E-cadherin staining throughout the tumor by immunohistochemistry were classified as ductal type and considered eligible 56, 57.', ' Infiltrating papillary carcinoma', ' Margins: In-situ or invasive carcinoma present less than 2 mm from the inked resection margin.', ' History of cosmetic or reconstructive breast surgery', ' Psychiatric illness which would prevent the patient from giving informed consent. Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or connective tissue diseases (lupus, systemic sclerosis or other collagen vascular diseases) which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.', ' Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 5% risk of relapse within three years.', ' Patients with diffuse (> 1 quadrant or > 5cm) suspicious microcalcifications', ' Women who are pregnant.'], 'Results': ['Outcome Measurement: ', ' Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan', ' -The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her.', ' Time frame: Within 1 year of protocol registration', 'Results 1: ', ' Arm/Group Title: Cohort 1 (36 Gy)', ' Arm/Group Description: 36 Gy in 9 fractions BID x 4 1/2 treatment days', ' Partial Breast Irradiation (PBI)', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: percentage of participants 100', 'Results 2: ', ' Arm/Group Title: Cohort 2 (40 Gy)', ' Arm/Group Description: 40 Gy in 10 fractions BID over 5 treatment days', ' Partial Breast Irradiation (PBI)', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: percentage of participants 100'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/50 (6.00%)', ' Fever 1/50 (2.00%)', ' Rigors/chills 1/50 (2.00%)', ' Chest pain 1/50 (2.00%)', ' Costochondritis 1/50 (2.00%)', ' Infection (mastitis) 1/50 (2.00%)', ' Breast pain 1/50 (2.00%)', ' Breast edema 1/50 (2.00%)', ' Pelvic pain 1/50 (2.00%)', ' Dyspnea 1/50 (2.00%)', ' Erythema 1/50 (2.00%)', 'Adverse Events 2:', ' Total: 0/50 (0.00%)', ' Fever 0/50 (0.00%)', ' Rigors/chills 0/50 (0.00%)', ' Chest pain 0/50 (0.00%)', ' Costochondritis 0/50 (0.00%)', ' Infection (mastitis) 0/50 (0.00%)', ' Breast pain 0/50 (0.00%)', ' Breast edema 0/50 (0.00%)', ' Pelvic pain 0/50 (0.00%)', ' Dyspnea 0/50 (0.00%)', ' Erythema 0/50 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

0900325b-6ecd-46f1-b3f1-a2ce1605d151

Comparison

Eligibility

NCT02419807

NCT00777101

Patients with HER2 + breast cancer are eligible for both the primary trial and the secondary trial. However, only patients with stage 1-2 breast cancer are eligible for the primary trial, and patients with stage 3-4 are eligilbe for the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT02419807', 'Intervention': ['INTERVENTION 1: ', ' Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer)', ' Participants receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, participants also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Participants then undergo Axillary Lymph Node Biopsy and surgery.'], 'Eligibility': ['Inclusion Criteria:', ' Participants with a confirmed diagnosis of clinical stage 1 or 2 breast cancer', ' Participants who are undergoing breast cancer surgery with lumpectomy or mastectomy', ' Participants with planned axillary sentinel node biopsy procedure', 'Exclusion Criteria:', ' Participants with cancer > 3 cm', ' Participants with clinically positive nodes', ' Participants with prior surgery for breast cancer in the index breast', ' Participants who have had bilateral breast surgeries', ' Thyroid dysfunction', ' Hypersensitivity to iodine', ' Hepatic insufficiency', ' Renal insufficiency'], 'Results': ['Outcome Measurement: ', ' Proportion of Sentinel Lymph Nodes (SLNs) Flagged by the Two Methods', ' Let A be the number of Tc-positive and ICG-positive sentinel nodes (SNs) detected, B be the number of Tc-positive and ICG-negative SNs detected, and C be the number of Tc-negative and ICG-positive SNs detected. The total number (N) of SNs detected is therefore N = (A + B + C); the proportion of SNs detected by the Tc method (PTc) is (A + B)/N; and the proportion of SNs detected by the ICG method (PICG) is (A + C)/N. Differences in the proportions of SLNs flagged will be compared using a two-sided 95% confidence interval.', ' Time frame: Baseline', 'Results 1: ', ' Arm/Group Title: Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer)', ' Arm/Group Description: Participants receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, participants also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Participants then undergo Axillary Lymph Node Biopsy and surgery.', ' Overall Number of Participants Analyzed: 92', ' Measure Type: Number', ' Unit of Measure: proportion of nodes Proportion of SNs (PTc) detected by Tc method: 0.86', ' Proportion of SNs (PICG) detected by ICG method: 0.95'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/102 (0.00%)']}

{'Clinical Trial ID': 'NCT00777101', 'Intervention': ['INTERVENTION 1: ', ' Neratinib', ' Neratinib', ' Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity', 'INTERVENTION 2: ', ' Lapatinib+Capecitabine', ' Lapatinib plus Capecitabine', ' Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.', ' Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer', ' Prior use of Herceptin (trastuzumab), and a taxane', ' Adequate cardiac and renal function', 'Exclusion Criteria:', ' More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]', ' Bone as the only site of disease', ' Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)', ' Significant gastrointestinal disorder with diarrhea as major symptom'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival', ' Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment.', ' Time frame: From randomization date to progression or death, assessed up to 69 months', 'Results 1: ', ' Arm/Group Title: Neratinib', ' Arm/Group Description: Neratinib', ' Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity', ' Overall Number of Participants Analyzed: 117', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.53 (3.12 to 5.65)', 'Results 2: ', ' Arm/Group Title: Lapatinib+Capecitabine', ' Arm/Group Description: Lapatinib plus Capecitabine', ' Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.', ' Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 116', ' Median (95% Confidence Interval)', ' Unit of Measure: months 6.83 (5.85 to 8.21)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 31/116 (26.72%)', ' Neutropenia 1/116 (0.86%)', ' Thrombocytopenia 1/116 (0.86%)', ' Acute myocardial infarction 1/116 (0.86%)', ' Myocardial infarction 0/116 (0.00%)', ' Pericardial effusion 0/116 (0.00%)', ' Abdominal pain 3/116 (2.59%)', ' Ascites 1/116 (0.86%)', ' Diarrhoea 3/116 (2.59%)', ' Gingival bleeding 1/116 (0.86%)', ' Intestinal haemorrhage 1/116 (0.86%)', ' Nausea 2/116 (1.72%)', 'Adverse Events 2:', ' Total: 24/115 (20.87%)', ' Neutropenia 1/115 (0.87%)', ' Thrombocytopenia 0/115 (0.00%)', ' Acute myocardial infarction 0/115 (0.00%)', ' Myocardial infarction 1/115 (0.87%)', ' Pericardial effusion 1/115 (0.87%)', ' Abdominal pain 0/115 (0.00%)', ' Ascites 0/115 (0.00%)', ' Diarrhoea 4/115 (3.48%)', ' Gingival bleeding 0/115 (0.00%)', ' Intestinal haemorrhage 0/115 (0.00%)', ' Nausea 3/115 (2.61%)']}

6f10e1f3-1197-464e-b574-d697fb49331d

Comparison

Intervention

NCT03592121

NCT01439711

the secondary trial and the primary trial both require their patients to receive their respective interventions on a daily basis.

Contradiction

{'Clinical Trial ID': 'NCT03592121', 'Intervention': ['INTERVENTION 1: ', ' AB-101', ' Apply to both nipple/areola regions approximately 1 hour prior to sexual activity', ' AB-101: Apply approximately 1 hour prior to sexual activity', 'INTERVENTION 2: ', ' Placebo', ' Apply to both nipple/areola regions approximately 1 hour prior to sexual activity', ' Placebo: Apply approximately 1 hour prior to sexual activity'], 'Eligibility': ['Inclusion Criteria:', ' Female breast cancer survivor', ' Age: 18 to 70', ' First diagnosed with Stage I or II breast cancer', ' Have had breast surgery: nipple sparring mastectomy or lumpectomy', ' At least 3 years post surgery', ' Nipple neuropathy post breast surgery (change in Llikeart scale >= 3 between pre and post surgery)', ' Baseline nipple sensitivity <=5 (likeartLikert scale)', ' QoL-BC (>=7)', ' Delayed orgasm (CTCAE v4.0) Grade 2', ' One of the following: Delayed orgasm (CTCAE v4.0) Grade 2 and/or Vaginal dryness (CTCAE v4.0) Grade 2 or 3', ' Able to give informed consent', ' Currently in a monogamous heterosexual relationship for at least 12 months', ' Sexually active within the last 30 days', ' Willing to engage in sexual activity at least once a month during the duration of the study', ' Willing to use on a regular basis a web based form system to record sexual events i.e., have access to the Internet', ' Willing to use an adequate method of birth control', ' Able to comply with the study requirements for 8 consecutive weeks', ' Able to give informed consent', 'Exclusion Criteria:', ' Previous adverse event to alpha 1 agonists (oral, nasal, topical, or ocular) or drugs in this class', ' Currently pregnant', ' Nursing within the last 6 months prior to beginning the study', ' History of cardiovascular or cerebrovascular disease, e.g., heart attack, disease of the arteries of the heart, partial heart block, rapid ventricular heartbeat, slow heartbeat, chronic heart failure, severe hardening of the arteries, blood clot in an artery', ' Actively being treated for breast cancer', ' Changes in chronic medication for oncology, cardiology, or endocrinology in past 12 months', ' Uncontrolled or severe hypertension', ' Decreased oxygen in the tissues or blood', ' Active inflammation of the liver', ' Acute inflammation of the pancreas', ' Overactive thyroid gland', ' Acidosis', ' Diabetes', ' Spinal cord injury', ' Nipple dermatitis', ' Regional complex pain syndrome', ' Use of any hypertensive drugs', ' Use of MAO inhibitors', ' Subjects assigned to interventional drug arm and failed to report an increase >=2 from baseline in nipple sensitivity (likert scale) during phase I', ' In partners: sexual dysfunction or erectile dysfunction', ' Currently enrolled in any other medical study or has been enrolled in any medical study in the past 30 days', ' Nipple dermatitis', ' Regional complex pain syndrome', ' Unable to provide consent or make allotted clinical visits'], 'Results': ['Outcome Measurement: ', ' Change in Delayed Orgasm Grade', ' Change in Delayed Orgasm Grade (CTCAE v4.0 - Common Terminology of Adverse Events) CTCAE v4.0 is the NIH Common Terminology of Adverse Events v4.0', ' Delayed Orgasm is defined as: A disorder characterized by sexual dysfunction characterized by a delay in climax.', ' This is a binary grading system:', ' Grade 0:Delay in achieving orgasm not adversely affecting relationship Grade 1:Delay in achieving orgasm adversely affecting relationship', ' Time frame: [baseline, week 8]', 'Results 1: ', ' Arm/Group Title: AB-101', ' Arm/Group Description: Apply to both nipple/areola regions approximately 1 hour prior to sexual activity', ' AB-101: Apply approximately 1 hour prior to sexual activity', ' Overall Number of Participants Analyzed: 3', ' Mean (Standard Deviation)', ' Unit of Measure: Grade -0.33 (0.58)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Apply to both nipple/areola regions approximately 1 hour prior to sexual activity', ' Placebo: Apply approximately 1 hour prior to sexual activity', ' Overall Number of Participants Analyzed: 0', ' Mean (Standard Deviation)', ' Unit of Measure: Grade '], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 0/0']}

{'Clinical Trial ID': 'NCT01439711', 'Intervention': ['INTERVENTION 1: ', ' Letrozole + MRI', ' Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.'], 'Eligibility': ['Eligibility Criteria:', ' Histologic documentation: Pathologic confirmation of ductal carcinoma in situ (DCIS) of the female breast without invasive cancer, with diagnosis rendered on core biopsy only, completed within 60 days before registration. Patients diagnosed with DCIS on the basis of surgical biopsy are not eligible for this study.', ' Patients with microinvasion on diagnostic core biopsy, defined as tumor 1 mm in greatest dimension, will be allowed to participate.', ' All patients must have a clip placed, either at the time of the diagnostic biopsy or at the time of the baseline MRI prior to the start of treatment.', ' Tissue samples: Patient has diagnostic tissue available for correlative studies.', ' Clinical stage: Tis or T1mi N0, M0', " Hormone receptor status: DCIS must express estrogen and/or progesterone receptor, as determined by immunohistochemical methods on the diagnostic pathology sample, according to the local institution's standard protocol. Greater than or equal to 1% cells will be considered to be positive.", ' Menopausal status: Patients must be postmenopausal defined as:', ' Age 55 years and one year or more of amenorrhea', ' Age < 55 years and one year or more amenorrhea, with an estradiol assay < 20pg/ml', ' Surgical menopause with bilateral oophorectomy (at least 28 days must elapse from surgery to time of study registration)', ' The use of GnRH analogs to achieve post menopausal status is not allowed.', ' Prior treatment:', ' No prior surgical excision in the index breast for current DCIS diagnosis of DCIS', ' Any exogenous hormone therapy must be completed 4 weeks prior to registration', ' Any patients with a history of tamoxifen or raloxifene use within two years of current DCIS diagnosis are not eligible', ' No prior neoadjuvant/adjuvant therapy for current DCIS diagnosis', ' Contraindication to MRI: No contraindications to breast MRI', 'Measurable disease: Mammographic extent of calcifications must be accurately measurable in at least one dimension with each lesion 1 cm and 7 cm', ' DCIS must be visible on MRI based on central review.', ' Patients with palpable DCIS or adenopathy are not eligible to participate.', ' Patients with multifocal or bilateral disease are eligible.', ' History of osteoporosis: Women diagnosed with osteoporosis may participate in this trial provided they are receiving appropriate therapy or if they have declined therapy.', ' Age: Patients 18 years of age', 'Performance Status: ECOG performance status 0 or 1', ' Pregnancy/nursing status: Not pregnant or nursing', ' Required Initial Laboratory Values:', ' ANC 1,000/μL', ' Platelet count 100,000/μL', ' Serum creatinine 1.7 mg/dL', ' Bilirubin 2.0 mg/dL', ' AST/ALT 2.5 times upper limit of normal', ' Serum estradiol level assay < 20 pg/mL *Required for patients < 55 years of age and one year or more of amenorrhea'], 'Results': ['Outcome Measurement: ', ' Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 3 (V3)', ' Mean total MRI FTV change from baseline to month 3 (V3): For patients with more than one measureable lesion on the MRI, the sum over all measureable lesions on the MRI was calculated at each time point. V3 was calculated by subtracting the total MRI FTV measured (i.e. the sum over all lesions present with MRI FTV measurements) at 3 months from the total MRI FTV measured at baseline. For V3 the raw change in the volume will be calculated for each patient and a mean and 95% confidence interval will be constructed using two-sided t-tests.', ' Time frame: up to 3 months from start of treatment', 'Results 1: ', ' Arm/Group Title: Letrozole + MRI', ' Arm/Group Description: Protocol Therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a bilateral MRI for disease evaluation at months 3 and 6.', ' Overall Number of Participants Analyzed: 68', ' Mean (95% Confidence Interval)', ' Unit of Measure: cubic centimeters -1.93 (-2.87 to -0.98)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/90 (2.22%)', ' Heart failure 1/90 (1.11%)', ' Restrictive cardiomyopathy 1/90 (1.11%)', ' Fever 1/90 (1.11%)', ' Hypokalemia 1/90 (1.11%)', ' Arthralgia 1/90 (1.11%)', ' Myalgia 1/90 (1.11%)', ' Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify 1/90 (1.11%)', ' Hypertension 2/90 (2.22%)']}

cbf91beb-829b-488f-8e80-3b08b891a181

Single

Eligibility

NCT00254592

Patients needing active supportive care can participate in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00254592', 'Intervention': ['INTERVENTION 1: ', ' Chemotherapy With GM-CSF', ' Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel'], 'Eligibility': ['Inclusion Criteria:', ' Patients must be women with a histologically confirmed diagnosis of breast cancer that is more than 2 cm and/or lymph node positive. Histologic confirmation shall be by either core needle biopsy or incisional biopsy. Punch biopsy is allowed if invasive breast cancer is documented.', ' Patients must meet one of the criteria defined below (indicate one):', ' Selected Stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0) disease judged primarily unresectable by an experienced breast surgeon; or otherwise deemed - appropriate candidates for neoadjuvant treatment.', ' Stage IIIB (T4, Any N, M0) or (Any T, N3, M0) disease.', ' Physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration.', ' All patients must have a multiple gated acquisition (MUGA) scan or echocardiogram scan performed within 90 days prior to registration and left ventricular ejection fraction (LVEF) percentage must be greater than the institutional lower limit of normal.', ' Patients must have a serum creatinine and bilirubin the institutional upper limit of normal, and an serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) 2x the institutional upper limit of normal. These tests must have been performed within 90 days prior to registration.', ' Patients must have an absolute neutrophil count (ANC) of 1,500/μl and a platelet count of 100,000/μl. These tests must have been performed within 90 days prior to registration.', ' Patients must have a performance status of 0-2 by Zubrod criteria', ' In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday four weeks later would be considered Day 28. This allows for efficient patient scheduling without exceeding the guidelines. If Day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day.', ' All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.', 'Exclusion Criteria:', ' Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible.', ' Pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. A urine pregnancy test is required for women of childbearing potential.'], 'Results': ['Outcome Measurement: ', ' Overall Clinical Response to the Dose Dense Regimen', ' Measure clinical response rates in patients with breast cancer more than 2 cm and/or lymph node positive breast cancer treated with 2- 4 cycles of biweekly doxorubicin, cyclophosphamide with GMCSF (day 4-13) followed by weekly carboplatin/nab-paclitaxel given for 3 weeks, followed by 1 week of rest, for a total of 9-12 doses. (Her-2 positive patients, in addition, will receive Trastuzumab weekly (12-16 doses) and Her-2 negative patients will receive Bevacizumab (6-8 doses) q 2 weeks).', ' Time frame: 3 years', 'Results 1: ', ' Arm/Group Title: Chemotherapy With GM-CSF', ' Arm/Group Description: Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel', ' Overall Number of Participants Analyzed: 43', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 43 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/43 (9.30%)', ' Cardio Vascular Disease *1/43 (2.33%)', ' Neutropenic fever 3/43 (6.98%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

985df98b-b397-4dbc-8fad-43ada30927d7

Comparison

Intervention

NCT00356811

NCT00296036

The the secondary trial intervention is applied to the palms and soles twice daily, the primary trial participants are not administered any medication on the skin of the hands or feet, but rather onto the breast or chest wall.

Contradiction

{'Clinical Trial ID': 'NCT00356811', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib Plus Paclitaxel', ' Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.'], 'Eligibility': ['Inclusion Criteria:', ' A subject will be eligible for inclusion in this study only if all of the following criteria apply:', ' Signed informed consent.', ' Only females 18 years of age will be recruited:', ' Non-child-bearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation or hysterectomy, or women who are postmenopausal); or', ' Child-bearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea (severe), women who are perimenopausal and young women who have begun to menstruate. These subjects must provide a negative serum pregnancy test at Screening and agree to one of the following:', ' Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication; or', ' Consistent and correct use of one of the following acceptable methods of birth control:', " Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject.", ' Implants of levonorgestrel.', ' Injectable progestogen.', ' Any intrauterine device (IUD) with a documented failure rate of less than 1% per year.', ' Oral contraceptives (either combined or progestogen only).', ' Barrier methods, including diaphragm or condom with a spermicide.', ' Subjects must have histologically confirmed invasive breast cancer with stage IVdisease;', ' Where the disease is restricted to a solitary lesion, the neoplastic nature of the lesion should be confirmed by cytology or histology.', ' Subjects whose disease is ER+ and/or PR+ or unknown status will only be included in the study if they meet the following criteria:', ' They have symptomatic visceral disease that requires chemotherapy (e.g., patients with liver or lung metastases).', ' The disease is considered by the Investigator to be progressing rapidly or lifethreatening.', ' Subjects who have received endocrine therapy and who are no longer benefiting from this therapy.', ' Documented amplification of ErbB2 defined by FISH in primary or metastatic tumor tissue. Results of FISH testing at local laboratories are acceptable, however, tissue sample must still be sent to Central laboratory where results will be repeated but not used for eligibility criterion.', ' If a taxane had been administered in the neoadjuvant or adjuvant setting, progression must have occurred 12 months after completion of this treatment.', ' Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria [Stephens, 2004; Therasse, 2000].', ' Radiotherapy prior to initiation of study medication is allowed to a limited area (e.g., palliative treatment for painful bone metastases), if it is not the sole site of disease. Subject must have completed radiation treatment and recovered from all acute radiation treatment-related toxicities, in particular bone marrow suppression.', ' Bisphosphonate therapy for bone metastases is allowed however; treatment must be initiated prior to the first dose of study medication. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, is not permitted.', ' Subjects with stable central nervous system (CNS) metastases (stable for at least 3 months) as confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI)) or leptomeningeal involvement are eligible only if they are not taking oral steroids or enzyme-inducing anticonvulsants.', ' Subjects must have a cardiac ejection fraction within institutional range of normal as measured by echocardiogram (or multigated acquisition (MUGA) scan if an echocardiogram cannot be performed or is inconclusive). Subjects with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure are not eligible.', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1.', ' Considered by the Investigator to have a life expectancy of at least 3 months.', ' Able to swallow and retain oral medication.', ' Subjects must have new or archived tumor tissue available for analysis.', ' Subjects must complete all screening assessments as outlined in the protocol.', ' Subject must have adequate organ function as defined in Table 1.', ' Table 1 Baseline Laboratory Values for Adequate Organ Function SYSTEM LABORATORY VALUES', ' Haematologic', ' Absolute neutrophil count 1.5 × 10^9/L Haemoglobin 9 g/dL Platelets 100 × 10^9/L', ' Hepatic', ' Albumin 2.5 g/dL Serum bilirubin', ' 1.25 x ULN AST and ALT 3 × ULN without liver metastases', ' 5 × ULN with documented liver metastases', ' Renal', ' Serum Creatinine1 2.0 mg/dL', ' OR - Calculate Creatinine Clearance1 40 mL/min', ' Calculated by the Cockcroft and Gault Method. ALT = alanine aminotransferase; AST = aspartate aminotransferase', 'Exclusion Criteria:', ' A subject will not be eligible for inclusion in this study if any of the following criteria apply:', ' Pregnant or lactating females.', ' Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy for metastatic disease.', ' Prior therapy with ErbB1 and/or ErbB2 inhibitors.', ' Concurrent anti-cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy) while taking study medication.', ' Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment.', ' Peripheral neuropathy of grade 2 or greater.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded.', ' History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.', " Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety.", ' Active or uncontrolled infection.', ' Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.', ' Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.', ' Concurrent treatment with an investigational agent or participation in another clinical trial involving investigational agents.', ' Used an investigational drug within 30 days or five half-lives, whichever is longer, preceding the first dose of investigational treatment.', ' The subject has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib or excipients and those related to paclitaxel or excipients.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)', ' OR is defined as the number of participants achieving either a CR or PR, per Response Evaulation Criteria in Solid Tumors (RECIST). The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.', ' Time frame: From the first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)', 'Results 1: ', ' Arm/Group Title: Lapatinib Plus Paclitaxel', ' Arm/Group Description: Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 ( 2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.', ' Overall Number of Participants Analyzed: 57', ' Measure Type: Number', ' Unit of Measure: Participants CR: 0', 'PR: 29'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/57 (19.30%)', ' Neutropenia 4/57 (7.02%)', ' Cardiopulmonary failure 1/57 (1.75%)', ' Diarrhoea 2/57 (3.51%)', ' Abscess limb 1/57 (1.75%)', ' Abscess soft tissue 1/57 (1.75%)', ' Upper respiratory tract infection 1/57 (1.75%)', ' Dehydration 1/57 (1.75%)', ' Bronchospasm 1/57 (1.75%)']}

{'Clinical Trial ID': 'NCT00296036', 'Intervention': ['INTERVENTION 1: ', ' Urea/Lactic Acid Cream', ' Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.', 'INTERVENTION 2: ', ' Placebo Cream', ' Patients receive placebo cream applied to palms and soles twice daily.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast and/or other cancer', ' Undergoing first treatment with capecitabine as adjuvant (including neo-adjuvant) therapy OR for metastatic disease', ' Receiving a dose of capecitabine either 2,000 mg/day (1,000 mg twice daily) OR 2,500 mg/day for 14 days with 4 courses of therapy at 3 week (+/- 3 days) intervals', ' Hormone-receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Male or female', ' Menopausal status not specified', ' No history of allergy to urea-containing cream', ' No pre-existing neuropathy grade 2', ' No other dermatologic condition, that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment', ' PRIOR CONCURRENT THERAPY:', ' No other concurrent agents that function to prevent palmar-plantar erythrodysesthesia caused by capecitabine or topical agents in the hands or feet for other indications (e.g., dryness)', ' No concurrent vitamin B6 > 50 mg/day', ' No concurrent or planned use of over-the-counter products that contain urea or lactic acid, including any of the following:', ' Aqua Care®', ' Medicated Calamine^® lotion (0.3%)', ' Coppertone^® Waterproof Ultra Protection Sunblock', " Dr. Scholl's^® Smooth Touch deep moisturizing cream", ' Depicure^® So Smooth Cream', ' Dove^® Moisturizing Cream Wash', ' Cetaphil^ ®Moisturizing Cream', ' Vaseline Intensive Care ^ ® lotion'], 'Results': ['Outcome Measurement: ', ' To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia', ' A patient self-reported hand-foot syndrome (HFSD), also known as palmar-plantar erythrodysesthesia, was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms in either hands or feet were tabulated and percentages are reported.', ' Time frame: First 3 weeks of treatment', 'Results 1: ', ' Arm/Group Title: Urea/Lactic Acid Cream', ' Arm/Group Description: Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.', ' Overall Number of Participants Analyzed: 59', ' Measure Type: Number', ' Unit of Measure: percentage of participants 13.6', 'Results 2: ', ' Arm/Group Title: Placebo Cream', ' Arm/Group Description: Patients receive placebo cream applied to palms and soles twice daily.', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: percentage of participants 10.2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/67 (0.00%)', 'Adverse Events 2:', ' Total: ']}

0d4fdeef-89b2-463b-8252-66fa51d9ce8c

Single

Results

NCT02595372

27.6% of Patients Who Have Fatty Acid Synthase (FASN) Expression in the primary trial treated with Minocycline Hydrochloride did not have Pathological Complete Response.

Contradiction

{'Clinical Trial ID': 'NCT02595372', 'Intervention': ['INTERVENTION 1: ', ' High Dose Omeprazole Treatment', ' Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.'], 'Eligibility': ['Inclusion Criteria', ' Newly diagnosed triple negative breast cancer (TNBC) clinical stage Ic, II, or III', ' ER and PR < 10%', ' HER2 negative based on one of the following:', ' IHC 0 or 1+', ' IHC 2+ and FISH negative', ' IHC 2+ and FISH equivocal and no indication for HER2 targeted therapy based on the treating investigators discretion (i.e., HER2: CEP17 ratio < 2.0 or HER2 total copy number <6)', ' Planned neoadjuvant treatment with anthracycline and taxane containing chemotherapy', ' 18 years old at the time of informed consent', ' ECOG Performance Status 0-1', ' Ability to provide written informed consent and HIPAA authorization', ' Women of childbearing potential definition must have a negative pregnancy test within 14 days of registration. All women (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) are considered to have childbearing potential unless they meet one of the following criteria:', ' Prior hysterectomy or bilateral oophorectomy;', ' Has not had menses at any time in the preceding 24 consecutive months', ' Adequate organ function for anthracycline and taxane based therapy', ' LVEF > LLN based on cardiac ECHO or MUGA', ' Hgb > 8.5', ' ANC > 1,000', ' Platelets > 100,000', ' Creatinine < 1.5', ' T. bili < 1.3', ' AST < 2.5 x ULN', ' Exclusion Criteria', ' Use of prescription PPIs within 12 months prior to study entry [Dexlansoprazole (Dexilant), Pantoprazole (Protonix), Rabeprazole (Aciphex), Esomeprazole (Nexium), Lansoprazole (Prevacid), Omeprazole (Prilosec, Zegerid)]', ' Use of OTC PPIs within 6 months prior to study entry [Esomeprazole (Nexium), Lansoprazole (Prevacid), Omeprazole (Prilosec, Zegerid)]', ' Use of Orlistat or any other known FASN inhibitor within 6 months prior to study entry', ' Nursing mothers are excluded', ' Known hypersensitivity to any component of the formulation or substituted benzimidazoles', ' Prior osteoporotic fracture'], 'Results': ['Outcome Measurement: ', ' Percentage of Patients With Pathological Complete Response (pCR) in Patients Who Have Fatty Acid Synthase (FASN) Expression', ' pCR is defined as no invasive disease in the breast of axilla at the time of definitive surgery. A patient is considered to have FASN expression if the positivity was >= 15% at the baseline or after 4-7 days of Omeprazole monotherapy. FASN expression is evaluated using immunohistochemistry in core biopsy samples. The percent of patients with FASN expression that have pCR will be calculated with an exact 95% confidence interval.', ' Time frame: Up to 6 months', 'Results 1: ', ' Arm/Group Title: High Dose Omeprazole Treatment', ' Arm/Group Description: Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.', ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: percentage of participants 72.4 (52.8 to 87.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/42 (11.90%)', ' Febrile neutropenia * 3/42 (7.14%)', ' Constipation * 1/42 (2.38%)', ' Neutrophil count decreased * 1/42 (2.38%)', ' White blood cell decreased * 1/42 (2.38%)', ' Cough * 1/42 (2.38%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

2c270b8f-d1a4-4686-a75c-bb3ac4b0c6fe

Single

Results

NCT00450866

In the primary trial group A has a higher percentage of patients with >25% increase in tumor area at 3 months after treatment than group B.

Contradiction

{'Clinical Trial ID': 'NCT00450866', 'Intervention': ['INTERVENTION 1: ', ' Epothilone B: Group A', ' Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.', 'INTERVENTION 2: ', ' Epothilone B: Group B', ' Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed carcinoma of the breast', ' CNS metastases (i.e., brain parenchymal lesions and/or leptomeningeal disease), meeting 1 of the following criteria:', ' Recurrent or progressive CNS metastases after whole brain radiotherapy', ' If only evaluable site of CNS progression has been previously treated with stereotactic radiosurgery, radiation necrosis must be excluded by radiographic (e.g., positron emission tomography scan or magnetic resonance spectroscopy) or histologic assessment', ' Newly diagnosed, untreated, asymptomatic brain or leptomeningeal metastases', ' Patient must be neurologically stable, as demonstrated by a stable dose of steroids and anticonvulsants for 1 week prior to obtaining baseline gadolinium-enhanced MRI of the brain and/or 1 week prior to beginning study treatment', ' No CNS complications requiring urgent neurosurgical intervention (e.g., resection or shunt placement)', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Male or female', ' Menopausal status not specified', ' Karnofsky performance status 60-100%', ' Life expectancy 3 months', ' Absolute neutrophil count > 1,500/mm^3', ' Hemoglobin > 9.0 g/dL', ' Platelet count > 100,000/mm^3 (red blood cell transfusion and repeat evaluation allowed)', ' Bilirubin < 1.5 times upper limit of normal (ULN)', ' AST and ALT < 2.5 times ULN', ' Alkaline phosphatase < 2.5 times ULN', ' Creatinine < 1.5 times ULN', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for 3 months after completion of study therapy', ' No known hypersensitivity to epothilones', ' No peripheral neuropathy > grade 1', ' No unresolved diarrhea within the past 7 days', ' Grade 0 diarrhea required at study entry', ' No concurrent serious medical illness (e.g., HIV positivity or active hepatitis B or C)', ' No severe cardiac insufficiency (e.g., New York Heart Association class III-IV heart disease) with uncontrolled and/or unstable cardiac or coronary artery disease', ' No active or suspected acute or chronic uncontrolled infection, including abscess or fistulae', ' No other malignancy within the past 3 years except curatively treated nonmelanoma skin cancer, prostate cancer, or carcinoma in situ of the cervix', ' No history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits', ' No contraindications to MRI, including any of the following:', ' Pacemaker', ' Ferromagnetic implants', ' Claustrophobia', ' Extreme obesity', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' More than 2 weeks since prior noncytotoxic drugs (e.g., small molecule-targeted drugs) and recovered', ' More than 3 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered', ' More than 3 weeks since prior intracranial surgery and recovered', ' More than 4 weeks since prior radiotherapy and recovered', ' More than 4 weeks since prior major surgery', ' More than 28 days since prior investigational compounds or drugs', ' No prior epothilones', ' No concurrent known diarrheagenic agents', ' No other concurrent anticancer agents, including investigational agents, biological agents, or chemotherapy', ' No other concurrent experimental therapies', ' Concurrent hormone therapy and/or trastuzumab (Herceptin®) allowed', ' No concurrent Coumadin® or other agents containing warfarin', ' Low dose Coumadin® ( 1 mg) for prophylactic maintenance of indwelling lines or ports allowed', ' No concurrent radiotherapy for central metastases (e.g., vertebral or mediastinal metastases)', ' Concurrent radiotherapy for local peripheral metastases not being used as marker lesions allowed', ' No concurrent prophylactic hematopoietic growth factors during course 1', ' No concurrent herbal or nontraditional medications'], 'Results': ['Outcome Measurement: ', ' Central Nervous System (CNS) Progression-free Survival(PFS)', ' The number of patients that are documented to have progression free survival at 3 months after treatment. Progression free is define as <25% increase in tumor area.', ' PFS will be measured from the date of entry into the trial to the date of documented progression of brain metastases or death.', ' Time frame: 3 months after treatment', 'Results 1: ', ' Arm/Group Title: Epothilone B: Group A', ' Arm/Group Description: Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.', ' Overall Number of Participants Analyzed: 45', ' Measure Type: Number', ' Unit of Measure: participants 12', 'Results 2: ', ' Arm/Group Title: Epothilone B: Group B', ' Arm/Group Description: Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: participants 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/55 (32.73%)', ' Anemia * 1/55 (1.82%)', ' Neutropenia * 1/55 (1.82%)', ' Dehydration * 6/55 (10.91%)', ' Diarrhea * 8/55 (14.55%)', ' Hemorrhage, upper GI * 1/55 (1.82%)', ' Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) * 1/55 (1.82%)', ' Nausea * 1/55 (1.82%)', ' Pain - Abdomen NOS (not otherwise specified) * 1/55 (1.82%)', ' Ulcer, GI - Duodenum * 1/55 (1.82%)', 'Adverse Events 2:', ' ']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

494c1f01-5a2d-409e-b614-5871f408fbe6

Comparison

Adverse Events

NCT01008150

NCT00375427

In total the secondary trial recorded only 3 more cases of Pyrexia than the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01008150', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: Paclitaxel + Trastuzumab Then A C', ' 4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)', ' Paclitaxel', ' Trastuzumab', ' Doxorubicin', 'Cyclophosphamide', 'INTERVENTION 2: ', ' Arm 2: Paclitaxel + Neratinib Then A C', ' 4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)', ' Paclitaxel', ' Neratinib', ' Doxorubicin', 'Cyclophosphamide'], 'Eligibility': ['Inclusion Criteria:', ' Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer.', ' Submission of a block from the diagnostic biopsy sample and from the surgical sample, if gross residual disease greater than or equal to 1.0 cm was removed at the time of surgery, is required for all patients', ' Patients of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy and for at least 6 months after the last dose of study therapy.', ' The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.', ' Patients must have the ability to swallow oral medication.', ' The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or by limited incisional biopsy.', ' Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then progesterone receptor (PgR) analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.)', ' Breast cancer must be determined to be HER2-positive prior to randomization. Assays using FISH or CISH require gene amplification. Assays using IHC require a strongly positive (3+) staining score.', ' Clinical staging, based on the assessment by physical exam, must be American Joint Committee on Cancer (AJCC) stage IIB, IIIA, IIIB, or IIIC: cT2 and cN1; cT3 and cN0 or cN1; Any cT and cN2 or cN3; or cT4', ' The patient must have a mass in the breast or axilla measuring greater than or equal to 2.0 cm by physical exam, unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required.', ' At the time of randomization, blood counts performed within 4 weeks prior to randomization must meet the following criteria: absolute neutrophil count (ANC) must be greater than or equal to 1200/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 10 g/dL', " The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to randomization must be met: total bilirubin must be less than or equal to upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and aspartate aminotransferase (AST) and ALT must be less than or equal to 1.5 x ULN for the lab.", ' Patients with alkaline phosphatase greater than ULN but less than or equal to 2.5 x ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET, or PET-CT scan) performed within 4 weeks prior to randomization does not demonstrate metastatic disease and the requirements for adequate hepatic function are met.', ' Patients with either unexplained skeletal pain or alkaline phosphatase that is greater than ULN but less than or equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 4 weeks prior to randomization does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are determined to be benign by x-ray, MRI, or biopsy.', ' Serum creatinine performed within 4 weeks prior to randomization must be less than or equal to 1.5 x ULN for the lab.', " The left ventricular ejection fraction (LVEF) assessment by 2-D echocardiogram or multiple gated acquisition(MUGA) scan performed within 90 days prior to randomization must be greater than or equal to 50% regardless of the facility's LLN.", 'Exclusion Criteria:', ' fine-needle aspiration (FNA) alone to diagnose the primary breast cancer.', ' Excisional biopsy or lumpectomy performed prior to randomization.', ' Surgical axillary staging procedure prior to randomization. (Procedures that are permitted prior to study entry include: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy SN biopsy for patients with clinically negative axillary nodes.)', ' Definitive clinical or radiologic evidence of metastatic disease. (Note: Chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 90 days prior to randomization.)', ' History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral ductal carcinoma in situ (DCIS) treated with radiation therapy (RT). (Patients with a history of LCIS are eligible.)', ' Contralateral invasive breast cancer at any time. (Patients with contralateral DCIS or lobular carcinoma in situ (LCIS) are eligible.)', ' History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization.', ' Known metastatic disease from any malignancy (solid tumor or hematologic).', ' Previous therapy with anthracyclines, taxanes, cyclophosphamide, trastuzumab, or neratinib for any malignancy.', ' Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.', ' Continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.)', ' Any continued sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement therapy. Patients are eligible if these medications are discontinued prior to randomization.', ' Active hepatitis B or hepatitis C with abnormal liver function tests.', ' Intrinsic lung disease resulting in dyspnea.', ' Active infection or chronic infection requiring chronic suppressive antibiotics.', ' Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease or condition significantly affecting gastrointestinal function.', ' Persistent greater than or equal to grade 2 diarrhea regardless of etiology.', ' Sensory or motor neuropathy greater than or equal to grade 2, as defined by the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0.', ' Conditions that would prohibit intermittent administration of corticosteroids for paclitaxel premedication.', ' Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids).', ' Uncontrolled hypertension defined as a systolic BP greater than 150 mmHg or diastolic BP greater than 90 mmHg, with or without anti-hypertensive medications. (Patients with hypertension that is well-controlled on medication are eligible.)', ' Cardiac disease (history of and/or active disease) that would preclude the use of any of the drugs included in the treatment regimen. This includes but is not confined to: Active cardiac disease: symptomatic angina pectoris within the past 180 days that required the initiation of or increase in anti-anginal medication or other intervention; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis. History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; history of documented congestive heart failure (CHF); and documented cardiomyopathy.', ' Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.', ' Pregnancy or lactation at the time of randomization.', ' The investigator should assess the patient to determine if she has any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.', ' Use of any investigational agent within 4 weeks prior to randomization.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response in Breast and Axillary Lymph Nodes.', ' Number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes after neoadjuvant chemotherapy', ' Time frame: At time of surgery, approximately 7 months', 'Results 1: ', ' Arm/Group Title: Arm 1: Paclitaxel + Trastuzumab Then A C', ' Arm/Group Description: 4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)', ' Paclitaxel', ' Trastuzumab', ' Doxorubicin', ' Cyclophosphamide', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 16 38.1%', 'Results 2: ', ' Arm/Group Title: Arm 2: Paclitaxel + Neratinib Then A C', ' Arm/Group Description: 4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)', ' Paclitaxel', ' Neratinib', ' Doxorubicin', ' Cyclophosphamide', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 14 33.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/42 (16.67%)', ' Febrile neutropenia 1/42 (2.38%)', ' Left venrticular dysfunction 1/42 (2.38%)', ' Cardiac valve disease 1/42 (2.38%)', ' Diarrhoea 0/42 (0.00%)', ' Abdominal pain 1/42 (2.38%)', ' Colitis 0/42 (0.00%)', ' Nausea 0/42 (0.00%)', ' Vomiting 0/42 (0.00%)', ' Pyrexia 0/42 (0.00%)', ' Influenza like illness 1/42 (2.38%)', ' Oedema peripheral 1/42 (2.38%)', ' Fatigue 0/42 (0.00%)', 'Adverse Events 2:', ' Total: 7/42 (16.67%)', ' Febrile neutropenia 0/42 (0.00%)', ' Left venrticular dysfunction 1/42 (2.38%)', ' Cardiac valve disease 0/42 (0.00%)', ' Diarrhoea 0/42 (0.00%)', ' Abdominal pain 0/42 (0.00%)', ' Colitis 0/42 (0.00%)', ' Nausea 0/42 (0.00%)', ' Vomiting 0/42 (0.00%)', ' Pyrexia 2/42 (4.76%)', ' Influenza like illness 0/42 (0.00%)', ' Oedema peripheral 0/42 (0.00%)', ' Fatigue 0/42 (0.00%)']}

{'Clinical Trial ID': 'NCT00375427', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid Every 3 Months', ' Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.', 'INTERVENTION 2: ', ' Zoledronic Acid Every 4 Weeks', ' Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.'], 'Eligibility': ['Inclusion criteria:', ' Female patients 18 years of age.', ' Written informed consent given.', ' Histologically confirmed Stage IV breast cancer with at least one bone metastasis radiologically confirmed.', ' Previous treatment with zoledronic acid every 3-4 weeks, for 9-12 infusions over no more than 15 months.', ' Eastern Cooperative Oncology Group (ECOG) performance status 2 .', ' Life expectancy 1 year.', 'Exclusion criteria:', ' More than 3 months since last infusion of Zoledronic Acid (Zometa®).', ' Treatments with other bisphosphonate than Zoledronic Acid (Zometa®) at any time prior to study entry.', ' Serum creatinine > 3 mg/dL (265 μmol/L) or calculated (Cockcroft-Gault formula) creatinine clearance (CLCr) < 30 mL/min CrCl = ({[140-age (years)] x weight(kg)}/ [72 x serum creatinine (mg/dL)])x 0.85', ' Corrected (adjusted for serum albumin) serum calcium < 8 mg/dl (2 mmol/L) or > 12 mg/dL ( 3.0 mmol/L).', ' Current active dental problem including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a recurrent or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.', ' Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).', ' Pregnant patients (with a positive pregnancy test prior to study entry) or lactating patients. Women of childbearing potential not using effective methods of birth control (e.g. abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide).', ' History of non-compliance to medical regimens or potential unreliable behavior.', ' Known sensitivity to study drug(s) or class of study drug(s).', ' Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study', ' Use of any other investigational agent in the last 30 days.'], 'Results': ['Outcome Measurement: ', ' Annual Overall Skeletal Morbidity Rate (SMR)', ' The SMR was computed by summing all Skeletal Related Event(s) (SREs)which occurred during the observation period and dividing it by the ratio "days of observation period / 365.25", for each participant. SRE was defined as: pathologic bone fracture, spinal cord compression, surgery to bone both curative and prophylactic, radiation therapy to bone, or hypercalcemia of malignancy.', ' SMR (years) = 365.25 x SMR(days) where SMR (days) = total number of SREs / total SRE risk period (days). Risk period for SMR was computed as the days from randomization date to the date of last visit.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid Every 3 Months', ' Arm/Group Description: Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.', ' Overall Number of Participants Analyzed: 209', ' Mean (Standard Deviation)', ' Unit of Measure: Number of Skeletal Events per Year 0.26 (0.81)', 'Results 2: ', ' Arm/Group Title: Zoledronic Acid Every 4 Weeks', ' Arm/Group Description: Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.', ' Overall Number of Participants Analyzed: 216', ' Mean (Standard Deviation)', ' Unit of Measure: Number of Skeletal Events per Year 0.22 (0.57)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/209 (10.05%)', ' Anaemia 0/209 (0.00%)', ' Febrile neutropenia 0/209 (0.00%)', ' Thrombocytopenia 0/209 (0.00%)', ' Acute myocardial infarction 0/209 (0.00%)', ' Cardiac failure 0/209 (0.00%)', ' Diplopia 0/209 (0.00%)', ' Gastric haemorrhage 0/209 (0.00%)', ' Nausea 0/209 (0.00%)', ' Oral pain 0/209 (0.00%)', ' Vomiting 1/209 (0.48%)', ' Mucosal inflammation 0/209 (0.00%)', ' Pain 1/209 (0.48%)', 'Adverse Events 2:', ' Total: 29/216 (13.43%)', ' Anaemia 2/216 (0.93%)', ' Febrile neutropenia 2/216 (0.93%)', ' Thrombocytopenia 2/216 (0.93%)', ' Acute myocardial infarction 1/216 (0.46%)', ' Cardiac failure 1/216 (0.46%)', ' Diplopia 1/216 (0.46%)', ' Gastric haemorrhage 1/216 (0.46%)', ' Nausea 1/216 (0.46%)', ' Oral pain 2/216 (0.93%)', ' Vomiting 2/216 (0.93%)', ' Mucosal inflammation 1/216 (0.46%)', ' Pain 0/216 (0.00%)']}

17881072-2517-483f-9c03-1edad21a58cf

Single

Eligibility

NCT00093795

Patients with cancer cells that have metastasised into less than 3 lymph nodes, with at least one larger than 2mm, cannot enter the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00093795', 'Intervention': ['INTERVENTION 1: ', ' Group 1: TAC X 6', ' Doxorubicin, cyclophosphamide, and docetaxel.', ' Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles', ' Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles', ' Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles', ' Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles', ' Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles', 'INTERVENTION 2: ', ' Group 2: AC X 4 Then P X 4', ' Doxorubicin, cyclophosphamide, and paclitaxel', ' Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles', ' Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles', ' Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles', ' Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles', ' Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles'], 'Eligibility': ['Inclusion Criteria:', ' The patient must consent to participate in the study and must have signed an approved consent form conforming with federal and institutional guidelines.', ' The patient must have a life expectancy of at least 10 years and a Zubrod performance status of 0 or 1. (Comorbid conditions but not the diagnosis of breast cancer should be taken into consideration when determining life expectancy.)', ' The interval between the last surgery for breast cancer staging or treatment and randomization must be no more than 84 days.', ' The tumor must be invasive carcinoma of the breast on histologic examination.', ' All of the following staging criteria must be met:', ' By clinical and pathologic evaluation, primary tumor must be T1-3;', ' By clinical evaluation, ipsilateral nodes must be cN0, cN1, or cN2a;', ' By pathologic evaluation, ipsilateral nodes must be pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b (only if due to microscopic involvement of internal mammary node detected by sentinel lymph node dissection and with more than 3 positive axillary lymph nodes).', ' Patients must have an estrogen receptor (ER) analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then progesterone receptor (PgR) analysis must be performed. If ER analysis is positive, PgR analysis is desired, but not mandatory. ("Marginal" or "borderline" results [i.e., those not definitely negative] will be considered positive regardless of the methodology used.)', ' Patients must have had either a lumpectomy or a total mastectomy. Patients must have completed one of the following procedures for evaluation of pathologic nodal status.', ' Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes (This approach is strongly recommended.)', ' Sentinel lymphadenectomy alone if one of the following criteria is met:', ' Pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1b', ' Surgeon elects not to remove additional non-sentinel nodes (This approach is strongly discouraged, but will not preclude participation in B-38.)', ' Axillary lymphadenectomy without sentinel node isolation procedure.', ' Patients must have no clinical or radiologic evidence of metastatic disease.', ' Patients with either skeletal pain or alkaline phosphatase that is greater than ULN but less than or equal to 2.5 x ULN are eligible for inclusion in the study if bone scans fail to demonstrate metastatic disease. Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy.', ' Patients with aspartate transaminase (AST) or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging fails to demonstrate metastatic disease and the following requirements are met at the time of randomization.', ' Postoperative absolute granulocyte count (AGC) must be greater than or equal to 1200/mm3.', ' Postoperative platelet count must be greater than or equal to 100,000/mm3.', ' The following criteria for postoperative evidence of adequate hepatic function must be met:', " total bilirubin must be less than or equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin; and", ' alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and', ' the AST must be less than or equal to 1.5 x ULN for the lab; and', ' alkaline phosphatase and AST cannot both be greater than ULN.', ' Postoperative serum creatinine must be less than or equal to ULN.', ' At the time of randomization, the patient must have had the following: history and physical exam, EKG, and imaging of the chest within the past 3 months and bilateral mammogram within the past 6 months.', ' Within 3 months prior to entry, the patient must have a baseline left ventricular ejection fraction (LVEF), measured by Multiple Gated Acquisition (MUGA) scan or echocardiogram, greater than or equal to lower limit of normal (LLN) for the facility performing the procedure and no evidence of regional wall abnormalities.', ' Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.', ' Special conditions for eligibility of lumpectomy patients: radiation therapy and surgery. Patients treated by lumpectomy must meet all the eligibility criteria in addition to the following:', " Generally, lumpectomy should be reserved for tumors less than 5 cm. However, at the investigator's discretion, patients treated with lumpectomy for tumors greater than or equal to 5 cm are eligible if eligibility criteria for lumpectomy are met.", ' The margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. In patients for whom pathologic examination demonstrates tumor present at the line of resection, additional operative procedures may be performed to obtain clear margins. This is permissible even if axillary evaluation has been completed. Patients in whom tumor is still present at the resected margin after re-excision(s) must undergo total mastectomy to be eligible. (Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection.)', ' Irradiation of regional lymph nodes is optional, but plans for radiation therapy must be declared by the investigator prior to randomization for stratification purposes.', ' Special conditions for eligibility of mastectomy patients: radiation therapy o Postmastectomy chest wall and/or regional nodal irradiation is optional. Plans for radiation in mastectomy patients must be declared by the investigator prior to randomization for stratification purposes.', ' Ineligibility Criteria', ' Male patients are not eligible for this study. Women with one or more of the following conditions or prior therapies are also ineligible for this study:', ' Tumor that has been determined to be human epidermal growth factor receptor 2 (HER2)-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (positive for gene amplification).', ' Contralateral breast cancer (invasive or DCIS) or a mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy proof that the mass is not malignant.', ' Primary tumor staged as T4 for any reason.', ' Clinical nodal stages including cN2b and cN3 or pathologic nodal stages including pN0(i+), pN2b, pN3b with clinically apparent internal mammary nodes, or pN3c.', ' Suspicious nodes in the contralateral axilla or suspicious supraclavicular nodes. Patients with these conditions are considered ineligible unless there is biopsy evidence that these are not involved with tumor.', ' Prior history of breast cancer, including DCIS (patients with a history of LCIS are eligible).', ' Treatment, including radiation therapy, chemotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization. One exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before study entry. In such a case, hormonal therapy must stop at or before randomization and be re-started, if indicated, following chemotherapy. A second exception is radiation therapy for patients enrolled in NSABP B-39 and assigned to partial breast irradiation (Group 2). These patients may have received RT prior to B-38 study entry.', ' Prior therapy with anthracyclines or taxanes for any malignancy.', ' Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible if this therapy is discontinued prior to randomization.)', ' Therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen-receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. (Patients are eligible only if these medications are discontinued prior to randomization.', ' Cardiac disease that would preclude the use of anthracyclines. This includes:', ' history of myocardial infarction documented by elevated cardiac enzymes or regional wall abnormalities on assessment of left ventricular (LV) function;', ' angina pectoris that requires the use of anti-anginal medication;', ' any history of documented congestive heart failure;', ' serious cardiac arrhythmia requiring medication;', ' severe conduction abnormality;', ' valvular disease with documented cardiac function compromise; and', ' uncontrolled hypertension defined as blood pressure greater than 160/100 on antihypertensive therapy.', ' Conditions that would prohibit administration of corticosteroids.', " Sensory/motor neuropathy greater than or equal to grade 2, as defined by the NCI's Common Terminology Criteria for Adverse Events Version 3.0.", ' Non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude a patient from receiving any of the treatment options or would prevent prolonged follow-up.', ' History of hepatitis B or C.', ' Pregnancy or lactation at the time of proposed randomization. Women of reproductive potential must agree to use an effective non-hormonal method of contraception.', ' Concurrent treatment with other investigational agents for the treatment of breast cancer.', ' Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.', ' Special conditions for ineligibility of lumpectomy patients: radiation therapy and surgery', ' For patients treated by lumpectomy, whole breast irradiation is required.', ' The following patients will be ineligible:', ' Patients with diffuse tumors (as demonstrated on mammography) treated with lumpectomy. (These patients are eligible if they undergo mastectomy.)', ' Patients treated with lumpectomy in whom there is another clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins.', ' Patients in whom the margins of the resected specimen are involved with invasive tumor or DCIS.'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival: Any Recurrence, Contralateral Breast Cancer, Second Primary Cancer, Death From Any Cause Prior to Recurrence or Second Primary Cancer', ' The percentage of patients alive and cancer-free.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Group 1: TAC X 6', ' Arm/Group Description: Doxorubicin, cyclophosphamide, and docetaxel.', ' Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles', ' Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles', ' Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles', ' Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles', ' Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles', ' Overall Number of Participants Analyzed: 1610', ' Measure Type: Number', ' Unit of Measure: percentage of patients 80.1 (78.0 to 82.0)', 'Results 2: ', ' Arm/Group Title: Group 2: AC X 4 Then P X 4', ' Arm/Group Description: Doxorubicin, cyclophosphamide, and paclitaxel', ' Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles', ' Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles', ' Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles', ' Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles', ' Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles', ' Overall Number of Participants Analyzed: 1618', ' Measure Type: Number', ' Unit of Measure: percentage of patients 82.2 (80.2 to 84.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 277/1601 (17.30%)', ' Disseminated intravascular coagulation 1/1601 (0.06%)', ' Febrile neutropenia 40/1601 (2.50%)', ' Atrial fibrillation 2/1601 (0.12%)', ' Pericardial effusion 1/1601 (0.06%)', ' Pericarditis 1/1601 (0.06%)', ' Sinus tachycardia 2/1601 (0.12%)', ' Supraventricular tachycardia 2/1601 (0.12%)', ' Ventricular tachycardia 1/1601 (0.06%)', ' Glaucoma 1/1601 (0.06%)', 'Adverse Events 2:', ' Total: 158/1612 (9.80%)', ' Disseminated intravascular coagulation 0/1612 (0.00%)', ' Febrile neutropenia 45/1612 (2.79%)', ' Atrial fibrillation 3/1612 (0.19%)', ' Pericardial effusion 0/1612 (0.00%)', ' Pericarditis 0/1612 (0.00%)', ' Sinus tachycardia 0/1612 (0.00%)', ' Supraventricular tachycardia 1/1612 (0.06%)', ' Ventricular tachycardia 0/1612 (0.00%)', ' Glaucoma 0/1612 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

58ba5dfd-3d8d-42e4-8cff-3c179fcd43a7

Single

Adverse Events

NCT00912340

Less patients in cohort 2 of the primary trial had an unusual amount of fluid around the lungs than in cohort 1.

Contradiction

{'Clinical Trial ID': 'NCT00912340', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab', ' Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.', 'INTERVENTION 2: ', ' Everolimus', ' Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.'], 'Eligibility': ['Inclusion Criteria:', ' Patients will be included in the study based on the following criteria:', ' Hormone-refractory metastatic breast cancer defined as disease progression within 6 months from starting most recent hormonal therapy', ' At least one line of endocrine therapy in the metastatic setting', ' Candidate for hormonal therapy (ER and/or progestin receptor [PR]-positive at primary diagnosis and at metastatic diagnosis where tissue is available)', ' HER2/neu-negative breast cancer by standard criteria (immunohistochemistry [IHC] < 3+ or fluorescence in situ hybridization [FISH]-negative if IHC 3+) at primary diagnosis', ' Must have a biopsy in the metastatic setting with HER2 expression of 1+ or 2+ by IHC', ' If biopsy of metastatic lesion is performed prior to study entry, HER2 expression by IHC must be 1+ or 2+', ' Histologically confirmed, measurable or evaluable disease; if disease is measurable, Response Evaluation Criteria In Solid Tumors (RECIST) criteria should be used', ' Life expectancy > 6 months', ' Eastern Cooperative Oncology Group (ECOG) performance status 2', ' Adequate bone marrow function as indicated by the following:', ' Absolute neutrophil count (ANC) > 1500/µL', ' Platelets 100,000/µL', ' Hemoglobin > 10 g/dL', ' Adequate renal function, as indicated by creatinine 1.5x upper limit of normal (ULN)', ' Adequate liver function, as indicated by bilirubin 1.5x ULN', ' International normalized ratio (INR) 1.3 (or 3 on anticoagulants)', ' Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2x ULN unless related to primary disease', ' Signed informed consent', ' Adequate birth control', ' Fasting serum cholesterol 300 mg/dL OR 7.75 mmol/L AND fasting triglycerides 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.', 'Exclusion Criteria:', ' Patients will be excluded from the study based on the following criteria:', ' Prior treatment with trastuzumab or other HER2-directed therapies or with an mammalian target of rapamycin (mTOR) inhibitor within 12 months of study entry (when cancer was not definitely hormone refractory)', ' HER2 0 or 3+ by IHC on pre-treatment biopsy of metastatic lesion (if performed)', ' Active infection', ' Uncontrolled central nervous system metastases', ' Life-threatening, visceral metastases', ' Pregnant or lactating women', ' Prior chemotherapy within the last 4 weeks', ' Prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation)', ' Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix', ' History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias', ' Ejection fraction < 50% or below the lower limit of the institutional normal range, whichever is lower', ' Hypersensitivity to trial medications', ' Emotional limitations', ' Prior treatment with any investigational drug within the preceding 4 weeks', ' Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent', ' Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN', ' Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis', ' A known history of HIV seropositivity', ' Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)', ' Patients with an active, bleeding diathesis', ' Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus)', ' Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus)', ' Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest', ' Taking any of the following agents:', ' Chronic treatment with systemic steroids or another immunosuppressive agent', ' Live vaccines', ' Drugs or substances known to be inhibitors or inducers of the isoenzyme cytochrome P450, family 3, subfamily A (CYP3A)'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) Until First Progression', ' Median PFS will be calculated based on time to first progression or death.', ' Time frame: Every 3 to 4 weeks after study start, until progression or death, assessed up to 5 years', 'Results 1: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: Patients receive trastuzumab IV over 30 minutes once every 3 weeks and continue to receive their most recent hormone therapy. Patients achieving disease progression receive everolimus PO daily in combination with trastuzumab and hormone therapy.', ' Overall Number of Participants Analyzed: 24', ' Median (95% Confidence Interval)', ' Unit of Measure: months 2.0 (1.6 to 4.1)', 'Results 2: ', ' Arm/Group Title: Everolimus', ' Arm/Group Description: Patients receive everolimus PO daily and continue their most recent hormone therapy. Patients achieving disease progression receive trastuzumab IV over 30-90 minutes once every 3 weeks in combination with everolimus and hormone therapy.', ' Overall Number of Participants Analyzed: 30', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.7 (3.9 to 8.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/24 (4.17%)', ' Pericardial effusion *1/24 (4.17%)', ' Other cardiac disorder *0/24 (0.00%)', ' Ejection fraction decrease *0/24 (0.00%)', ' Hypertension *0/24 (0.00%)', ' Salivary gland infection *0/24 (0.00%)', ' Pleural effusion *0/24 (0.00%)', 'Adverse Events 2:', ' Total: 6/30 (20.00%)', ' Pericardial effusion *1/30 (3.33%)', ' Other cardiac disorder *1/30 (3.33%)', ' Ejection fraction decrease *1/30 (3.33%)', ' Hypertension *1/30 (3.33%)', ' Salivary gland infection *1/30 (3.33%)', ' Pleural effusion *2/30 (6.67%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

da6ce3a9-b653-47b2-9271-f831e4de3f19

Single

Adverse Events

NCT00828074

A higher number of cohort 2 participants from the primary trial experienced fever, compared to cohort 1.

Contradiction

{'Clinical Trial ID': 'NCT00828074', 'Intervention': ['INTERVENTION 1: ', ' Phase I: Dose Level 1 - Vinorelbine at 20mg/m^2', ' Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days', 'INTERVENTION 2: ', ' Phase I: Dose Level 2 - Vinorelbine at 25mg/m^2', ' Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed stage IV adenocarcinoma of the breast; (unless metastatic disease is documented by computed tomography [CT] scan, magnetic resonance imaging [MRI], or bone scan; also, skin disease that has not been biopsied maybe used if in the investigators clinical opinion this represents metastatic disease)', ' Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan', ' Prior adjuvant therapy, and up to 2 lines of prior chemotherapy (including trastuzumab containing regimens in Her-2 positive patients) for metastatic disease are allowed; prior radiation therapy is allowed, prior hormonal therapy is allowed; the total number of patients enrolled with prior trastuzumab containing regimens will not exceed 10; no more than 50% of enrolled patients will receive the study regimen in a third line setting', ' Life expectancy of greater than 6 months', 'Performance status: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2', ' Hemoglobin >= 9.0 g/dl', ' Absolute neutrophil count (ANC) >= 1,500/mm^3', ' Platelet count >= 100,000/mm^3', ' Total bilirubin =< 1.5 times ULN', ' Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 times the upper limit of normal (ULN) (=< 5 x ULN for patients with liver involvement)', ' Creatinine =< 1.5 times ULN', ' International normalized ratio (INR) < 1.5 or a prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate; for patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable', ' Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; women of childbearing potential must have a negative serum pregnancy test performed within 7 days to the start of treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior; patients who had bevacizumab within 4 weeks prior to entering the study are allowed', ' Patients may not be receiving any other investigational agents', ' Patients with known brain metastases are excluded from this clinical trial; patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2), symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy, or psychiatric illness/social situations that would limit compliance with study requirements', ' Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management', ' Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months', ' Pulmonary hemorrhage/bleeding event >= CTCAE Grade 2 within 4 weeks of first dose of study drug', ' Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 4 weeks of first dose of study drug', ' Serious non-healing wound, ulcer, or bone fracture', ' Evidence or history of bleeding diathesis or coagulopathy', ' Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug', " Use of St. John's Wort or rifampin (rifampicin)", ' Known or suspected allergy to sorafenib or any agent given in the course of this trial', ' Pregnant women', ' Human immunodeficiency virus (HIV)-positive patients', " Any condition that impairs patient's ability to swallow whole pills", ' Any malabsorption problem', ' Patients who received prior sunitinib are excluded'], 'Results': ['Outcome Measurement: ', ' Number of Participants With at Least One Dose Limiting Toxicity in Phase I', ' Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater non-hematologic toxicity (excluding alopecia, controllable nausea and vomiting, and serum triglycerides < 1,500 mg/dL which recover within 1 week), grade 4 or greater thrombocytopenia, grade 4 or greater febrile neutropenia requiring hospitalization, or treatment delay of > 2 weeks as a result of unresolved toxicity during the first cycle of therapy.', ' Time frame: 4 weeks from start of treatment, up to 2 years', 'Results 1: ', ' Arm/Group Title: Phase I: Dose Level 1 - Vinorelbine at 20mg/m^2', ' Arm/Group Description: Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants with DLTs 0', 'Results 2: ', ' Arm/Group Title: Phase I: Dose Level 2 - Vinorelbine at 25mg/m^2', ' Arm/Group Description: Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Number', ' Unit of Measure: participants with DLTs 3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/41 (36.59%)', ' Febrile neutropenia * 0/41 (0.00%)', ' Diarrhea * 1/41 (2.44%)', ' Stomach pain * 1/41 (2.44%)', ' Fever * 2/41 (4.88%)', ' Cytokine release syndrome * 1/41 (2.44%)', ' Infection * 1/41 (2.44%)', ' Skin infection * 2/41 (4.88%)', ' Urinary tract infection * 1/41 (2.44%)', ' Coagulopathy * 0/41 (0.00%)', ' INR increased * 0/41 (0.00%)', ' Lipase increased * 1/41 (2.44%)', 'Adverse Events 2:', ' Total: 2/5 (40.00%)', ' Febrile neutropenia * 1/5 (20.00%)', ' Diarrhea * 0/5 (0.00%)', ' Stomach pain * 0/5 (0.00%)', ' Fever * 0/5 (0.00%)', ' Cytokine release syndrome * 0/5 (0.00%)', ' Infection * 0/5 (0.00%)', ' Skin infection * 0/5 (0.00%)', ' Urinary tract infection * 0/5 (0.00%)', ' Coagulopathy * 1/5 (20.00%)', ' INR increased * 1/5 (20.00%)', ' Lipase increased * 0/5 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

66979ae5-a709-4adf-9067-287f0f92b9e2

Single

Eligibility

NCT02692755

Only Black women are eligible for the primary trial, as long as they do not have uncontrolled or symptomatic brain metastases.

Entailment

{'Clinical Trial ID': 'NCT02692755', 'Intervention': ['INTERVENTION 1: ', ' Palbociclib + Letrozole or Fulvestrant', ' Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months'], 'Eligibility': ['Inclusion Criteria:', ' Self-identified Black, African or African American women of 18 years of age with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)', ' ER-positive and/or PgR-positive tumor based on local laboratory results', ' HER2-negative breast cancer based on local laboratory results (test to be used as per local practice)', ' Patients must be appropriate candidates for letrozole or fulvestrant therapy', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2', ' Adequate bone marrow function:', ' Absolute Neutrophil Count (ANC) 1,000/mm3 (1.0 x 109/L);', ' Platelets 100,000/mm3 (100 x 109/L);', ' Hemoglobin 9 g/dL (90 g/L).', 'Exclusion Criteria:', ' Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4', " Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, as per Investigator's judgment, brain metastases are permitted.", ' Previous CDK4/6 inhibitor', '-'], 'Results': ['Outcome Measurement: ', ' Number of Patients Who Complete Planned Oncologic Therapy Without the Development of a Hematological Event', ' For study purpose febrile neutropenia will be defined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: "ANC less than 1000/mm3 with a single temperature of >38.3 degrees Celsius (101 degrees Fahrenheit) or a sustained temperature of 38 degrees Celsius (100.4 degrees Fahrenheit) for more than one hour."', ' Planned oncology therapy is defined as completion of one year of therapy for advanced breast cancer in the absence of disease progression or cessation of study drug due to progressive disease or non-hematological toxicity.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Palbociclib + Letrozole or Fulvestrant', ' Arm/Group Description: Palbociclib + Letrozole or Fulvestrant: Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 35 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/35 (22.86%)', ' Heart failure 1/35 (2.86%)', ' Colitis 1/35 (2.86%)', ' Diarrhea 1/35 (2.86%)', ' Fever 1/35 (2.86%)', ' Upper respiratory infection 1/35 (2.86%)', ' Urinary tract infection 1/35 (2.86%)', ' Neutrophil count decreased 1/35 (2.86%)', ' Anorexia 1/35 (2.86%)', ' Suicidal ideation 1/35 (2.86%)', ' Acute kidney injury 1/35 (2.86%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

0af6799b-655f-4b8b-a192-ce8dcbb2fcff

Single

Eligibility

NCT00072293

Patients with a palpable breast lesions and axillary lymph nodes are eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00072293', 'Intervention': ['INTERVENTION 1: ', ' Axillary Dissection', ' Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.', ' Axillary lymph node dissection: Axillary lymph node dissection', 'INTERVENTION 2: ', ' No Axillary Dissection', ' Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.', ' No axillary lymph node dissection: Therapeutic conventional surgery'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma', ' Largest tumor lesion 5 cm', ' Palpable or nonpalpable breast lesion', ' Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions', ' Prior (preoperative) or planned (intraoperative) sentinel node biopsy required', ' At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension', ' No clinical evidence of distant metastases', ' No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following:', ' Skeletal pain of unknown cause', ' Elevated alkaline phosphatase', ' Bone scan showing hot spots', ' No palpable axillary lymph node(s)', " No Paget's disease without invasive cancer", ' Hormone receptor status:', ' Estrogen receptor and progesterone receptor known', ' PATIENT CHARACTERISTICS:', ' Age', ' Any age', ' Sex', ' Female', ' Menopausal status', ' Any status', ' Performance status', ' Not specified', ' Life expectancy', ' Not specified', ' Hematopoietic', ' Not specified', ' Hepatic', ' See Disease Characteristics', ' Renal', ' Not specified', ' Other', ' Not pregnant or nursing', ' No other prior or concurrent malignancy except the following:', ' Adequately treated basal cell or squamous cell skin cancer', ' Adequately treated carcinoma in situ of the cervix', ' Adequately treated in situ melanoma', ' Contralateral or ipsilateral carcinoma in situ of the breast', ' No psychiatric, addictive, or other disorder that may compromise ability to give informed consent', ' Geographically accessible for follow-up', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Not specified', ' Chemotherapy', ' Not specified', ' Endocrine therapy', ' Not specified', ' Radiotherapy', ' Not specified', ' Surgery', ' See Disease Characteristics', ' Other', ' No prior systemic therapy for breast cancer', ' More than 1 year since prior chemopreventive agent'], 'Results': ['Outcome Measurement: ', ' 5-year Disease-Free Survival', ' Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death.', ' Time frame: 5-year estimate reported after a median follow-up of 60 months', 'Results 1: ', ' Arm/Group Title: Axillary Dissection', ' Arm/Group Description: Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.', ' Axillary lymph node dissection: Axillary lymph node dissection', ' Overall Number of Participants Analyzed: 464', ' Measure Type: Number', ' Unit of Measure: percentage of participants 84.4', 'Results 2: ', ' Arm/Group Title: No Axillary Dissection', ' Arm/Group Description: Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.', ' No axillary lymph node dissection: Therapeutic conventional surgery', ' Overall Number of Participants Analyzed: 467', ' Measure Type: Number', ' Unit of Measure: percentage of participants 87.8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/447 (0.22%)', ' Post-operative infection (L.axilla) 1/447 (0.22%)', 'Adverse Events 2:', ' Total: 0/453 (0.00%)', ' Post-operative infection (L.axilla) 0/453 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

3a3e2387-c4c7-48e6-b3ca-1257de7019c2

Comparison

Intervention

NCT00537771

NCT00354640

participants of cohort 1 in the primary trial and all participants of the secondary trial take 1 milligram of anastrozole PO QD.

Entailment

{'Clinical Trial ID': 'NCT00537771', 'Intervention': ['INTERVENTION 1: ', ' Arimidex Group', ' Anastrozole(ARIMIDEX): 1 mg once daily oral dose', 'INTERVENTION 2: ', ' TAM Group', ' Tamoxifen : 20 mg once daily oral dose'], 'Eligibility': ['Inclusion Criteria:', ' Histologically proven HR+ invasive breast cancer', ' Completed all primary surgery and chemotherapy (if given), and were candidates to receive hormonal adjuvant therapy', ' Postmenopausal woman', 'Exclusion Criteria:', ' clinical evidence of metastatic disease', ' previous adjuvant hormonal therapy for breast cancer', 'liver diseases'], 'Results': ['Outcome Measurement: ', ' Incidence of Fatty Liver Disease', ' The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.', ' Time frame: At 48 weeks, 96 weeks, 144 weeks', 'Results 1: ', ' Arm/Group Title: Arimidex Group', ' Arm/Group Description: Anastrozole(ARIMIDEX): 1 mg once daily oral dose', ' Overall Number of Participants Analyzed: 178', ' Measure Type: Number', ' Unit of Measure: participants 48 weeks: 9', ' 96 weeks: 15', '144 weeks: 26', 'Results 2: ', ' Arm/Group Title: TAM Group', ' Arm/Group Description: Tamoxifen : 20 mg once daily oral dose', ' Overall Number of Participants Analyzed: 175', ' Measure Type: Number', ' Unit of Measure: participants 48 weeks: 53', ' 96 weeks: 66', '144 weeks: 72'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/178 (2.25%)', ' Cardiac failure 1/178 (0.56%)', ' Supraventricular extrasystoles 0/178 (0.00%)', ' Hepatic cyst 1/178 (0.56%)', ' Cervicitis 0/178 (0.00%)', ' Fall 1/178 (0.56%)', ' Joint dislocation 1/178 (0.56%)', ' Spinal fracture 1/178 (0.56%)', ' Cyst 0/178 (0.00%)', ' Uterine atony 0/178 (0.00%)', 'Adverse Events 2:', ' Total: 4/175 (2.29%)', ' Cardiac failure 0/175 (0.00%)', ' Supraventricular extrasystoles 1/175 (0.57%)', ' Hepatic cyst 0/175 (0.00%)', ' Cervicitis 2/175 (1.14%)', ' Fall 0/175 (0.00%)', ' Joint dislocation 0/175 (0.00%)', ' Spinal fracture 0/175 (0.00%)', ' Cyst 1/175 (0.57%)', ' Uterine atony 1/175 (0.57%)']}

{'Clinical Trial ID': 'NCT00354640', 'Intervention': ['INTERVENTION 1: ', ' Anastrozole and Simvastatin', ' adjuvant therapy : laboratory analysis', ' pharmacological study : laboratory analysis', ' simvastatin : 40 milligram tablet PO QD for 14 days', ' anastrozole : 1 milligram tablet PO QD for 14 days'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Meets any of the following criteria:', ' History of invasive breast cancer', ' History of ductal carcinoma in situ', ' At high risk for breast cancer, defined as being on anastrozole for chemoprevention of breast cancer', ' Receiving anastrozole for 30 days as adjuvant breast cancer treatment or for prevention of breast cancer', ' No active breast cancer with known metastatic involvement', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Female', ' Postmenopausal', ' ECOG performance status 0-2', ' AST and ALT 3 times upper limit of normal', ' Creatinine clearance 30 mL/min', ' No active liver disease', ' No prior hypersensitivity to any HMG-CoA reductase inhibitor or any of its components', ' No daily alcohol use of > 3 standard drinks/day', ' A standard drink is defined as 10 g of alcohol, which is equivalent to 285 mL of beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No cholesterol-lowering drug, including a statin, within the past 3 months', ' No selective estrogen receptor modulator (SERM) within the past 3 months', ' No other hormone therapy within the past 3 months', ' No prior estrogen and/or progesterone hormone replacement therapy that lasted for 5 years', ' Vaginal estrogen preparations allowed', ' No other concurrent statin or cholesterol-lowering drug', ' No other concurrent SERM', ' No other concurrent hormone therapy', ' No other concurrent investigational drugs', ' No concurrent CYP3A4 inhibitors, including itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or cyclosporine', ' No concurrent chemotherapy or biological agents', ' No concurrent daily grapefruit juice > 8 oz/day', ' No other concurrent anticancer agents or therapies'], 'Results': ['Outcome Measurement: ', ' Change in Blood Concentrations', ' The change in blood concentrations of anastrozole at baseline and 14 days was measured.', ' Time frame: Baseline and 14 days', 'Results 1: ', ' Arm/Group Title: Anastrozole and Simvastatin', ' Arm/Group Description: adjuvant therapy : laboratory analysis', ' pharmacological study : laboratory analysis', ' simvastatin : 40 milligram tablet PO QD for 14 days', ' anastrozole : 1 milligram tablet PO QD for 14 days', ' Overall Number of Participants Analyzed: 9', ' Median (Full Range)', ' Unit of Measure: ng/ml Anastrozole concentration: 4.2 (-6.2 to 22.1)', ' Hydroxyanastrozole concentration: -0.03 (-0.14 to 0.08)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/11 (0.00%)']}

46ac8a9f-77ab-40cf-9421-64aad4ae6976

Comparison

Results

NCT00445458

NCT00950742

the primary trial and the secondary trial measure the DLT of their respective interventions, using the same time frame.

Entailment

{'Clinical Trial ID': 'NCT00445458', 'Intervention': ['INTERVENTION 1: ', ' Neratinib 160 mg + Paclitaxel 80 mg/m²', ' Neratinib 160 mg qd + Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.', 'INTERVENTION 2: ', ' Neratinib 240 mg + Paclitaxel 80 mg/m²', ' Neratinib 240 mg qd + Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Inclusion criteria for both parts of clinical trial:', ' Good performance status', ' Normal ejection fraction', ' Adequate cardiac, kidney, and liver function', ' Adequate blood counts', ' At least one measurable target lesion', ' Negative pregnancy test for female subjects', ' Inclusion Criteria for Part 1 Only:', ' - Pathologically confirmed solid tumor not curable with available standard therapy', ' Inclusion Criteria for Part 2 Only:', ' Pathologically confirmed breast cancer', ' HER2 positive tumor', ' Prior treatment with Herceptin', 'Exclusion Criteria:', ' Exclusion criteria for both parts of clinical trial:', ' Major surgery, radiotherapy, chemotherapy or investigational agents within two weeks of treatment day 1', ' Subjects with bone or skin as the only site of disease', ' Active central nervous system metastases', ' Significant cardiac disease or dysfunction', ' Significant gastrointestinal disorder', ' Inability or unwillingness to swallow HKI-272 capsules', ' Prior exposure to HKI-272 or other HER2 targeted agents, except trastuzumab (Part 2 only). Prior lapatinib is permitted in arm B of part 2.', ' Treatment with a taxane within 3 months of treatment day 1', ' Grade 2 or greater motor or sensory neuropathy', ' Pregnant or breast feeding women', ' Known hypersensitivity to paclitaxel or Cremophor EL', ' Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2', ' Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin', ' Exclusion Criteria for Part 2 Only:', ' - More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic disease'], 'Results': ['Outcome Measurement: ', ' Dose Limiting Toxicity Incidence of Neratinib in Combination With Paclitaxel', ' Dose Limiting Toxicity in subjects with solid tumors treated with neratinib, administered daily, in combination with paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.', ' Time frame: From first dose date through day 28', 'Results 1: ', ' Arm/Group Title: Neratinib 160 mg + Paclitaxel 80 mg/m ', ' Arm/Group Description: Neratinib 160 mg qd + Paclitaxel 80 mg/m IV on days 1, 8, and 15 of a 28 day cycle.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%', 'Results 2: ', ' Arm/Group Title: Neratinib 240 mg + Paclitaxel 80 mg/m ', ' Arm/Group Description: Neratinib 240 mg qd + Paclitaxel 80 mg/m IV on days 1, 8, and 15 of a 28 day cycle.', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/3 (33.33%)', ' Anaemia 0/3 (0.00%)', ' Febrile neutropenia 0/3 (0.00%)', ' Leukopenia 0/3 (0.00%)', ' Sinus tachycardia 1/3 (33.33%)', ' Cataract 0/3 (0.00%)', ' Abdominal discomfort 1/3 (33.33%)', ' Diarrhoea 1/3 (33.33%)', ' Nausea 0/3 (0.00%)', ' Vomiting 0/3 (0.00%)', ' Fatigue 0/3 (0.00%)', ' Gait disturbance 0/3 (0.00%)', ' Oedema peripheral 0/3 (0.00%)', ' Pyrexia 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 4/5 (80.00%)', ' Anaemia 2/5 (40.00%)', ' Febrile neutropenia 0/5 (0.00%)', ' Leukopenia 0/5 (0.00%)', ' Sinus tachycardia 0/5 (0.00%)', ' Cataract 0/5 (0.00%)', ' Abdominal discomfort 0/5 (0.00%)', ' Diarrhoea 1/5 (20.00%)', ' Nausea 1/5 (20.00%)', ' Vomiting 1/5 (20.00%)', ' Fatigue 0/5 (0.00%)', ' Gait disturbance 0/5 (0.00%)', ' Oedema peripheral 0/5 (0.00%)', ' Pyrexia 1/5 (20.00%)']}

{'Clinical Trial ID': 'NCT00950742', 'Intervention': ['INTERVENTION 1: ', ' Afatinib 20mg + Herceptin', ' Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit. This group includes patients from the dose-escalation cohort and from the expansion cohort.', 'INTERVENTION 2: ', ' Afatinib 30mg + Herceptin', ' Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.'], 'Eligibility': ['Inclusion criteria:', ' Female patients aged >18 years.', ' Advanced or metastatic breast cancer that over-expresses HER2 (immunohistochemistry 3+ or 2+ and gene amplification by FISH). Prior treatment with Herceptin® or Lapatinib® (in the adjuvant or metastatic settings) is permitted but not required.', 'Exclusion criteria:', ' Patients with untreated or symptomatic brain metastases. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past four weeks before the start of therapy or concomitantly with this study.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicities (DLT)', ' Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section.', ' Time frame: 28 days', 'Results 1: ', ' Arm/Group Title: Afatinib 20mg + Herceptin', ' Arm/Group Description: Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit. This group includes patients from the dose-escalation cohort and from the expansion cohort.', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Number', ' Unit of Measure: Participants 4', 'Results 2: ', ' Arm/Group Title: Afatinib 30mg + Herceptin', ' Arm/Group Description: Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.', ' Overall Number of Participants Analyzed: 2', ' Measure Type: Number', ' Unit of Measure: Participants 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/16 (18.75%)', ' Diarrhoea 1/16 (6.25%)', ' Renal failure acute 1/16 (6.25%)', ' Pulmonary embolism 1/16 (6.25%)', 'Adverse Events 2:', ' Total: 0/2 (0.00%)', ' Diarrhoea 0/2 (0.00%)', ' Renal failure acute 0/2 (0.00%)', ' Pulmonary embolism 0/2 (0.00%)']}

d2b7253b-0654-4bb1-a9a4-b203714d64f9

Comparison

Adverse Events

NCT00107276

NCT00232505

Less than 5% of patients undergoing the intervention in the primary trial had adverse events, in comparison almost 10% patients in cohort 1 of the secondary trial experienced an adverse event, and more than 30% of those in cohort 2 of the secondary trial had adverse events.

Entailment

{'Clinical Trial ID': 'NCT00107276', 'Intervention': ['INTERVENTION 1: ', ' Cyclophosphamide and Capecitabine', ' cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed stage IV breast cancer', ' Metastatic disease (M1) OR multiple sites of new disease that is clinically obvious metastatic disease (i.e., multiple sites of new osseous disease)', ' Meets 1 of the following criteria:', ' Measurable disease', ' Non-measurable disease', ' MUC-1 antigen level > 2 times upper limit of normal AND level has increased by 1.5 times', ' Must have documented MUC-1 antigen level', ' Either cancer antigen (CA) 15-3 or CA 27-29 allowed', ' Must have received at least 1 prior hormonal therapy for metastatic disease (estogen receptor-positive patients only)', ' No symptomatic brain or CNS metastases', ' Previously treated brain or CNS metastasis allowed provided radiotherapy was completed 8 weeks before study entry', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over', ' Sex', ' Female', ' Menopausal status', ' Not specified', ' Performance status', ' Zubrod 0-2', ' Life expectancy', ' Not specified', ' Hematopoietic', ' No known existing uncontrolled coagulopathy', ' Hepatic', ' Not specified', ' Renal', ' Creatinine clearance > 40 mL/min', ' Cardiovascular', ' No congestive heart failure', ' No symptomatic coronary artery disease', ' No cardiac arrhythmia not well controlled with medication', ' No myocardial infarction within the past 12 months', ' No other clinically significant cardiac disease', ' Gastrointestinal', ' Able to take oral medication', ' No uncontrolled nausea, vomiting, or diarrhea', ' No lack of physical integrity of the upper gastrointestinal tract', ' No malabsorption syndrome', ' Other', ' Not pregnant or nursing', ' Fertile patients must use effective contraception', ' No active infection requiring systemic therapy', ' No prior severe reaction to fluoropyrimidines', ' No known sensitivity to fluorouracil', ' No known dihydropyrimidine dehydrogenase deficiency', ' No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' No concurrent immunotherapy or biologic therapy for breast cancer', ' No concurrent gene therapy for breast cancer', ' No concurrent filgrastim (G-CSF)', ' Chemotherapy', ' At least 14 days since prior chemotherapy and recovered', ' No more than 2 prior chemotherapy regimens for metastatic disease', ' No prior capecitabine for metastatic disease', ' No prior oral cyclophosphamide for metastatic disease', ' Prior IV cyclophosphamide allowed', ' No other concurrent chemotherapy for breast cancer', ' Endocrine therapy', ' See Disease Characteristics', ' No concurrent hormonal therapy for breast cancer', ' Radiotherapy', ' See Disease Characteristics', ' At least 14 days since prior radiotherapy to non-CNS disease sites and recovered', ' No concurrent radiotherapy for breast cancer', ' Surgery', ' Not specified', ' Other', ' Concurrent bisphosphonates allowed', ' No concurrent full-dose warfarin', ' Concurrent prophylactic warfarin ( 1 mg/day) to maintain port patency allowed', ' No other concurrent antineoplastic therapy for breast cancer'], 'Results': ['Outcome Measurement: ', ' Response Rate (Complete and Partial, Confirmed and Unconfirmed)', ' Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.', ' Time frame: Patients assessed at least every six weeks while on protocol treatment', 'Results 1: ', ' Arm/Group Title: Cyclophosphamide and Capecitabine', ' Arm/Group Description: cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each', ' Overall Number of Participants Analyzed: 80', ' Measure Type: Number', ' Unit of Measure: participants 29'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/95 (4.21%)', ' Death not associated with CTCAE term - Death NOS 1/95 (1.05%)', ' Death - Disease progression NOS 2/95 (2.11%)', ' CNS cerebrovascular ischemia 1/95 (1.05%)']}

{'Clinical Trial ID': 'NCT00232505', 'Intervention': ['INTERVENTION 1: ', ' Cetuximab', ' Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.', ' cetuximab: Given IV', 'INTERVENTION 2: ', ' Cetuximab and Carboplatin After Cetuximab Alone', ' Patients from Arm 1 who progressed on cetuximab alone who went on to receive cetuximab + carboplatin'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast cancer', ' Metastatic (stage IV) disease', ' Measurable disease by RECIST criteria', ' Irradiated lesions are not considered measurable disease', ' Central nervous system (CNS) metastases allowed if disease is stable (no evidence of progression) 3 months after local therapy', ' No lesions identifiable only by positron emission tomography (PET) scan', ' HER2 nonoverexpressing disease by IHC (0 or 1) or non-gene amplified by Fluorescence In Situ Hybridization (FISH)', ' HER2 2+ by IHC allowed', ' Hormone receptor status:', ' Estrogen receptor-negative and progesterone receptor-negative tumor', ' Inclusion Criteria', ' At least 18 years of age', ' Metastatic breast cancer (Stage IV) with measurable disease by RECIST criteria', ' No more than three prior chemotherapy regimens either in the adjuvant or metastatic setting.', ' Histologically documented (either primary or metastatic site) breast cancer that is estrogen receptor- (ER-) negative, PR-negative, and HER-2 nonoverexpressing by immunohistochemistry (0,1) or non-gene amplified by FISH performed upon the primary tumor or metastatic lesion. HER-2 2+ by immunohistochemistry is usually negative by FISH, and this confirmatory test should be performed when possible, however may participate if fulfill other criteria.', ' Completion of prior chemotherapy at least 3 weeks prior to study entry.', ' Patients may have received therapy (ies) in the adjuvant or metastatic setting, however must have discontinued prior to entry. Patients may receive concurrent bisphosphonates, however if taking bisphosphonates, bone lesions may not be used for progression or response.', ' Radiation therapy must be completed at least 2 weeks prior to study entry, and radiated lesions may not serve as measurable disease.', ' Patients may have CNS metastases if stable (no evidence of progression) > 3 months after local therapy.', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and life expectancy of at least 6 months.', ' Adequate organ function defined as:absolute neutrophil count (ANC) > 1500/mm3, plts > 100,000/mm3, creatinine clearance >50 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 x upper limit of normal (ULN) (or 5 x ULN in case of liver metastases); total bilirubin 1.5 mg/dL.', ' Tissue block available for EGFR studies is recommended, although will not exclude patients from participating.', ' Pregnant or lactating women will be excluded. Women of child bearing potential must have documented negative pregnancy test within two weeks of study entry and agree to acceptable birth control during the duration of the study therapy.', ' Signed written informed consent.', ' Exclusion Criteria', ' Lesions identifiable only by PET.', ' More than three prior chemotherapy regimens (including adjuvant). Sequential regimens such as doxorubicin and cyclophosphamide followed by paclitaxel (AC-paclitaxel) are considered one regimen.', ' Prior therapy which specifically and directly targets the EGFR pathway with therapeutic intent.', ' Prior platinum agent for metastatic disease. If platinum agent was used adjuvantly, the patient must have had at least 12 months disease-free interval prior to relapse.', ' Prior severe infusion reaction to a monoclonal antibody.', ' Major medical conditions that might affect study participation (uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection).', ' Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy that is either symptomatic or asymptomatic but with decreased ejection fraction <45%', ' Other significant comorbid condition which the investigator feels might compromise effective and safe participation in the study.', ' Inability to comply with the requirements of the study.'], 'Results': ['Outcome Measurement: ', ' Overall Disease Response Rate', ' Overall response rate of single agent cetuximab and cetuximab + carboplatin will be measured by radiographic response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria every 8 weeks until subject experiences disease progression. Overall response will be measured as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD).Per RECIST v1.0 for target lesions and assessed by CT (spiral): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Cetuximab', ' Arm/Group Description: Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.', ' cetuximab: Given IV', ' Overall Number of Participants Analyzed: 31', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete response: 0 0.0%', ' Partial response: 2 6.5%', ' Stable disease: 3 9.7%', ' Stable disease > 6 months: 1 3.2%', ' Progressive disease: 26 83.9%', ' Not evaluable: 0 0.0%', 'Results 2: ', ' Arm/Group Title: Cetuximab and Carboplatin After Cetuximab Alone', ' Arm/Group Description: Patients from Arm 1 who progressed on cetuximab alone who went on to receive cetuximab + carboplatin', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete response: 0 0.0%', ' Partial response: 4 16.0%', ' Stable disease: 7 28.0%', ' Stable disease > 6 months: 3 12.0%', ' Progressive disease: 12 48.0%', ' Not evaluable: 2 8.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/31 (9.68%)', ' Edema: limb * 2/31 (6.45%)', ' Neutrophils/granulocytes (ANC/AGC) * 0/31 (0.00%)', ' Cardiac General - Other (Specify, __) * [1]0/31 (0.00%)', ' Cardiac General - Other (Specify, __) * [2]0/31 (0.00%)', ' Left ventricular diastolic dysfunction * 0/31 (0.00%)', ' Supraventricular and nodal arrhythmia - Atrial tachycardia/Paroxysmal Atrial Tachycardia * 0/31 (0.00%)', 'Adverse Events 2:', ' Total: 8/25 (32.00%)', ' Edema: limb * 1/25 (4.00%)', ' Neutrophils/granulocytes (ANC/AGC) * 0/25 (0.00%)', ' Cardiac General - Other (Specify, __) * [1]1/25 (4.00%)', ' Cardiac General - Other (Specify, __) * [2]0/25 (0.00%)', ' Left ventricular diastolic dysfunction * 1/25 (4.00%)', ' Supraventricular and nodal arrhythmia - Atrial tachycardia/Paroxysmal Atrial Tachycardia * 0/25 (0.00%)']}

9a896e4a-ae6b-468c-a7c0-32c1514c0b48

Comparison

Intervention

NCT00356811

NCT00296036

The the secondary trial intervention is applied to the palms and soles twice daily, the primary trial participants are not administered any medication topically.

Entailment

{'Clinical Trial ID': 'NCT00356811', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib Plus Paclitaxel', ' Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.'], 'Eligibility': ['Inclusion Criteria:', ' A subject will be eligible for inclusion in this study only if all of the following criteria apply:', ' Signed informed consent.', ' Only females 18 years of age will be recruited:', ' Non-child-bearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation or hysterectomy, or women who are postmenopausal); or', ' Child-bearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea (severe), women who are perimenopausal and young women who have begun to menstruate. These subjects must provide a negative serum pregnancy test at Screening and agree to one of the following:', ' Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication; or', ' Consistent and correct use of one of the following acceptable methods of birth control:', " Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject.", ' Implants of levonorgestrel.', ' Injectable progestogen.', ' Any intrauterine device (IUD) with a documented failure rate of less than 1% per year.', ' Oral contraceptives (either combined or progestogen only).', ' Barrier methods, including diaphragm or condom with a spermicide.', ' Subjects must have histologically confirmed invasive breast cancer with stage IVdisease;', ' Where the disease is restricted to a solitary lesion, the neoplastic nature of the lesion should be confirmed by cytology or histology.', ' Subjects whose disease is ER+ and/or PR+ or unknown status will only be included in the study if they meet the following criteria:', ' They have symptomatic visceral disease that requires chemotherapy (e.g., patients with liver or lung metastases).', ' The disease is considered by the Investigator to be progressing rapidly or lifethreatening.', ' Subjects who have received endocrine therapy and who are no longer benefiting from this therapy.', ' Documented amplification of ErbB2 defined by FISH in primary or metastatic tumor tissue. Results of FISH testing at local laboratories are acceptable, however, tissue sample must still be sent to Central laboratory where results will be repeated but not used for eligibility criterion.', ' If a taxane had been administered in the neoadjuvant or adjuvant setting, progression must have occurred 12 months after completion of this treatment.', ' Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria [Stephens, 2004; Therasse, 2000].', ' Radiotherapy prior to initiation of study medication is allowed to a limited area (e.g., palliative treatment for painful bone metastases), if it is not the sole site of disease. Subject must have completed radiation treatment and recovered from all acute radiation treatment-related toxicities, in particular bone marrow suppression.', ' Bisphosphonate therapy for bone metastases is allowed however; treatment must be initiated prior to the first dose of study medication. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, is not permitted.', ' Subjects with stable central nervous system (CNS) metastases (stable for at least 3 months) as confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI)) or leptomeningeal involvement are eligible only if they are not taking oral steroids or enzyme-inducing anticonvulsants.', ' Subjects must have a cardiac ejection fraction within institutional range of normal as measured by echocardiogram (or multigated acquisition (MUGA) scan if an echocardiogram cannot be performed or is inconclusive). Subjects with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure are not eligible.', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1.', ' Considered by the Investigator to have a life expectancy of at least 3 months.', ' Able to swallow and retain oral medication.', ' Subjects must have new or archived tumor tissue available for analysis.', ' Subjects must complete all screening assessments as outlined in the protocol.', ' Subject must have adequate organ function as defined in Table 1.', ' Table 1 Baseline Laboratory Values for Adequate Organ Function SYSTEM LABORATORY VALUES', ' Haematologic', ' Absolute neutrophil count 1.5 × 10^9/L Haemoglobin 9 g/dL Platelets 100 × 10^9/L', ' Hepatic', ' Albumin 2.5 g/dL Serum bilirubin', ' 1.25 x ULN AST and ALT 3 × ULN without liver metastases', ' 5 × ULN with documented liver metastases', ' Renal', ' Serum Creatinine1 2.0 mg/dL', ' OR - Calculate Creatinine Clearance1 40 mL/min', ' Calculated by the Cockcroft and Gault Method. ALT = alanine aminotransferase; AST = aspartate aminotransferase', 'Exclusion Criteria:', ' A subject will not be eligible for inclusion in this study if any of the following criteria apply:', ' Pregnant or lactating females.', ' Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy for metastatic disease.', ' Prior therapy with ErbB1 and/or ErbB2 inhibitors.', ' Concurrent anti-cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy) while taking study medication.', ' Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment.', ' Peripheral neuropathy of grade 2 or greater.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded.', ' History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.', " Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety.", ' Active or uncontrolled infection.', ' Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.', ' Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.', ' Concurrent treatment with an investigational agent or participation in another clinical trial involving investigational agents.', ' Used an investigational drug within 30 days or five half-lives, whichever is longer, preceding the first dose of investigational treatment.', ' The subject has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib or excipients and those related to paclitaxel or excipients.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)', ' OR is defined as the number of participants achieving either a CR or PR, per Response Evaulation Criteria in Solid Tumors (RECIST). The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.', ' Time frame: From the first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)', 'Results 1: ', ' Arm/Group Title: Lapatinib Plus Paclitaxel', ' Arm/Group Description: Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 ( 2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.', ' Overall Number of Participants Analyzed: 57', ' Measure Type: Number', ' Unit of Measure: Participants CR: 0', 'PR: 29'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/57 (19.30%)', ' Neutropenia 4/57 (7.02%)', ' Cardiopulmonary failure 1/57 (1.75%)', ' Diarrhoea 2/57 (3.51%)', ' Abscess limb 1/57 (1.75%)', ' Abscess soft tissue 1/57 (1.75%)', ' Upper respiratory tract infection 1/57 (1.75%)', ' Dehydration 1/57 (1.75%)', ' Bronchospasm 1/57 (1.75%)']}

{'Clinical Trial ID': 'NCT00296036', 'Intervention': ['INTERVENTION 1: ', ' Urea/Lactic Acid Cream', ' Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.', 'INTERVENTION 2: ', ' Placebo Cream', ' Patients receive placebo cream applied to palms and soles twice daily.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast and/or other cancer', ' Undergoing first treatment with capecitabine as adjuvant (including neo-adjuvant) therapy OR for metastatic disease', ' Receiving a dose of capecitabine either 2,000 mg/day (1,000 mg twice daily) OR 2,500 mg/day for 14 days with 4 courses of therapy at 3 week (+/- 3 days) intervals', ' Hormone-receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Male or female', ' Menopausal status not specified', ' No history of allergy to urea-containing cream', ' No pre-existing neuropathy grade 2', ' No other dermatologic condition, that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment', ' PRIOR CONCURRENT THERAPY:', ' No other concurrent agents that function to prevent palmar-plantar erythrodysesthesia caused by capecitabine or topical agents in the hands or feet for other indications (e.g., dryness)', ' No concurrent vitamin B6 > 50 mg/day', ' No concurrent or planned use of over-the-counter products that contain urea or lactic acid, including any of the following:', ' Aqua Care®', ' Medicated Calamine^® lotion (0.3%)', ' Coppertone^® Waterproof Ultra Protection Sunblock', " Dr. Scholl's^® Smooth Touch deep moisturizing cream", ' Depicure^® So Smooth Cream', ' Dove^® Moisturizing Cream Wash', ' Cetaphil^ ®Moisturizing Cream', ' Vaseline Intensive Care ^ ® lotion'], 'Results': ['Outcome Measurement: ', ' To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia', ' A patient self-reported hand-foot syndrome (HFSD), also known as palmar-plantar erythrodysesthesia, was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms in either hands or feet were tabulated and percentages are reported.', ' Time frame: First 3 weeks of treatment', 'Results 1: ', ' Arm/Group Title: Urea/Lactic Acid Cream', ' Arm/Group Description: Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.', ' Overall Number of Participants Analyzed: 59', ' Measure Type: Number', ' Unit of Measure: percentage of participants 13.6', 'Results 2: ', ' Arm/Group Title: Placebo Cream', ' Arm/Group Description: Patients receive placebo cream applied to palms and soles twice daily.', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: percentage of participants 10.2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/67 (0.00%)', 'Adverse Events 2:', ' Total: ']}

41eb4b9a-3b8f-4895-9aa3-cb43dbe27dd4

Comparison

Eligibility

NCT00290732

NCT02748213

Patients whose breast cancer has spread into both the skin and the chest wall are eligible for the secondary trial, but not the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00290732', 'Intervention': ['INTERVENTION 1: ', ' Intraductal Arm', ' Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed infiltrating carcinoma of the breast meeting any of the following criteria:', ' T1-3, any N disease', ' Proven ductal carcinoma in situ', ' Unresected disease', ' Planned mastectomy as definitive surgical procedure', ' Known or suspected metastatic disease allowed provided mastectomy is planned', ' Nonpalpable tumor allowed (e.g., initial T2-3 tumor that responded to preoperative therapy)', ' No inflammatory breast cancer or other T4 features', ' Successful baseline ductogram', ' Baseline nipple aspiration procedure must identify a duct productive of nipple aspirate fluid', ' No severe nipple retraction', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Female patients', ' Menopausal status not specified', ' ECOG performance status 0-2', ' Absolute neutrophil count 1,500/mm^3', ' Platelet count 100,000/mm^3', ' Hemoglobin 9.0 g/dL', ' Creatinine 2 times upper limit of normal (ULN)', ' Bilirubin 2 times ULN', ' AST and ALT 2.5 times ULN', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No significant history of severe allergy to iodinated contrast material or debilitating anxiety that may not allow for a ductogram', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' Prior preoperative chemotherapy, trastuzumab (Herceptin®), or hormonal therapy allowed provided it was completed 7-14 days prior to study treatment', ' No prior radiation therapy, excisional biopsy, breast reduction, areolar surgery, or breast implant (present or past history of implant that was removed)', ' No other prior procedure that may have altered the breast ductal system in the ipsilateral breast', ' No other concurrent chemotherapy, radiotherapy, endocrine therapy, or biologic agents for breast cancer', ' No other concurrent investigational drugs', ' Concurrent bisphosphonates allowed'], 'Results': ['Outcome Measurement: ', ' Maximum Tolerated Dose (MTD)', ' Maximum tolerated dose (MTD) of administering pegylated liposomal doxorubicin (PLD) into one duct of women with breast cancer awaiting mastectomy. MTD reflects highest dose of drug that did not cause Dose Limiting Toxicity (DLT) in more than 30% of patients.', ' Time frame: Until up to 30 days after PLD administration', 'Results 1: ', ' Arm/Group Title: Intraductal Arm', ' Arm/Group Description: Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Number', ' Unit of Measure: milligrams 10'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', ' Dermatology other (right areolar eschar) [1]0/3 (0.00%)']}

{'Clinical Trial ID': 'NCT02748213', 'Intervention': ['INTERVENTION 1: ', ' Herceptin + Taxotere + Xeloda', ' Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.', 'INTERVENTION 2: ', ' Herceptin + Taxotere', ' Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed, HER2-positive advanced and/or metastatic breast cancer not amenable to curative therapy', ' At least one measurable lesion according to RECIST', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Baseline left ventricular ejection fraction (LVEF) at least 50%', 'Exclusion Criteria:', ' Pregnant, lactating, or women of childbearing potential who are not surgically sterile or not willing to use adequate contraceptive methods', ' Previous treatment with Herceptin or other anti-HER therapies, or any previous chemotherapy for advanced or metastatic disease', ' Past medical history significant for any cardiac or central nervous system (CNS) disorders', ' Poor hematologic, renal, or hepatic function', ' Chronic corticosteroid therapy'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)', ' Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as greater than or equal to ( ) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed 4 weeks after the initial assessment of CR or PR. The percentage of participants with a best overall response for CR or PR was reported. The exact 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper method.', ' Time frame: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)', 'Results 1: ', ' Arm/Group Title: Herceptin + Taxotere + Xeloda', ' Arm/Group Description: Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.', ' Overall Number of Participants Analyzed: 112', ' Measure Type: Number', ' Unit of Measure: percentage of participants 70.5 (61.18 to 78.77)', 'Results 2: ', ' Arm/Group Title: Herceptin + Taxotere', ' Arm/Group Description: Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.', ' Overall Number of Participants Analyzed: 110', ' Measure Type: Number', ' Unit of Measure: percentage of participants 72.7 (63.41 to 80.78)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 52/112 (46.43%)', ' Febrile neutropenia * 16/112 (14.29%)', ' Neutropenia * 7/112 (6.25%)', ' Anaemia * 1/112 (0.89%)', ' Cardiac failure * 1/112 (0.89%)', ' Coronary artery disease * 1/112 (0.89%)', ' Left ventricular dysfunction * 1/112 (0.89%)', ' Pericardial effusion * 0/112 (0.00%)', ' Hyperthyroidism * 1/112 (0.89%)', ' Diarrhoea * 5/112 (4.46%)', ' Vomiting * 3/112 (2.68%)', 'Adverse Events 2:', ' Total: 51/110 (46.36%)', ' Febrile neutropenia * 26/110 (23.64%)', ' Neutropenia * 7/110 (6.36%)', ' Anaemia * 1/110 (0.91%)', ' Cardiac failure * 0/110 (0.00%)', ' Coronary artery disease * 0/110 (0.00%)', ' Left ventricular dysfunction * 0/110 (0.00%)', ' Pericardial effusion * 1/110 (0.91%)', ' Hyperthyroidism * 0/110 (0.00%)', ' Diarrhoea * 0/110 (0.00%)', ' Vomiting * 1/110 (0.91%)']}

0931065d-35e4-4f82-8ef6-ac6db900127a

Single

Eligibility

NCT00853996

Women classified as low-risk of developing breast cancer within the next 5 years by the Gail model , and no Family history consistent with hereditary breast cancer, are eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00853996', 'Intervention': ['INTERVENTION 1: ', ' Prevention (Acolbifene Hydrochloride)', ' Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.', ' acolbifene hydrochloride: Given orally'], 'Eligibility': ['Inclusion Criteria:', ' Gail risk >= 1.7% and/or relative risk >= 3 times that for 5-year age group', ' Premenopausal', ' More than 6 months since initiating or discontinuing oral contraceptives', ' At increased risk for breast cancer, as indicated by >= 1 of the following risk factors:', ' BRCA1/2 mutation characterized as deleterious or of uncertain significance', ' Prior atypical ductal hyperplasia, ductal carcinoma in situ, or lobular carcinoma in situ', ' Prior random periareolar fine needle aspiration (RPFNA) showing atypical hyperplasia', ' Family history consistent with hereditary breast cancer, as indicated by 1 of the following criteria:', ' >= 4 relatives with breast cancer', ' >= 2 relatives diagnosed with breast cancer at 50 years of age', ' Breast and ovarian cancer diagnosed in same relative', ' No suspicion for breast cancer on baseline mammogram performed between days 1-10 of menstrual cycle within 3 months prior to screening baseline RPFNA', ' Exhibits hyperplasia with or without atypia (Masood score >= 14) with >= 500 cells AND Ki-67 positivity >= 2% by RPFNA performed within 6 months prior to initiation of study drug', ' Estimated visual mammographic breast density category >= 5% on mammogram performed within 6 months prior to initiation of study drug', ' Has regular menstrual cycles (between 21 and 35 days) unless using extended regimen oral contraceptives or a contraceptive device (e.g., Mirena IUD) Values for metabolic profile and blood count within normal limits', ' Absolute granulocyte count > 1,000/mm^3', ' Platelets > 100,000/mm^3', ' Hemoglobin > 10 g/dL', ' Bilirubin < 2.0 mg/dL', ' AST < 2 times upper limit of normal (ULN)', ' Albumin > 3.0 g/dL', ' Creatinine < 1.5 mg/dL', ' Alkaline phosphatase < 2 times ULN', ' Concurrent hormonal contraceptives allowed provided patient remains on the same hormonal regimen from 3 months prior to baseline aspiration until the completion of study treatment', ' Fertile patients must use effective contraception during and for 3 months after completion of study treatment', ' Willing to ingest recommended dose of calcium and vitamin D for premenopausal bone health (1,200 mg calcium and 800 IU vitamin D daily)', ' Negative pregnancy test prior to receiving study agent', ' Exclusion Criteria', ' pregnant or nursing', ' nursing within the past 6 months', ' Known osteoporosis or severe osteopenia (T-score -2 or worse by DEXA)', ' History of symptomatic endometriosis with pelvic pain, poorly controlled migraines, or hot flashes', ' History of deep venous thrombosis', ' History of allergic reactions attributed to compounds of similar chemical or biological composition to the study agent', ' Other condition or concurrent illness that, in the opinion of the investigator, would make the patient a poor candidate for RPFNA', ' Less than 1 year since prior use of aromatase inhibitors (e.g., anastrozole, exemestane, or letrozole) or selective estrogen receptor modulators (e.g., tamoxifen citrate, raloxifene, or arzoxifene hydrochloride)', ' Other concurrent chemopreventive agents', ' Concurrent anticoagulants', ' Other concurrent investigational agents', ' Bilateral breast implants'], 'Results': ['Outcome Measurement: ', ' Change in the Percentage of Breast Epithelial Cells Expressing Ki-67, From Baseline to 6 Months', ' Change in proliferation as measured by Ki-67 immunocytochemical expression in breast epithelial cells obtained by random periareolar fine needle aspiration at baseline and at 6 months.', ' Time frame: Baseline to 6 months', 'Results 1: ', ' Arm/Group Title: Prevention (Acolbifene Hydrochloride)', ' Arm/Group Description: Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.', ' acolbifene hydrochloride: Given orally', ' Overall Number of Participants Analyzed: 25', ' Median (Inter-Quartile Range)', ' Unit of Measure: percentage of positive cells -3.0 (-20.2 to 2.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/25 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

70912726-ba1b-47ef-9005-9584c8caf559

Single

Results

NCT00493636

Cohort 1 of the primary trial had a longer PFS than cohort 2. However the patient with the longest PFS was in cohort 2.

Contradiction

{'Clinical Trial ID': 'NCT00493636', 'Intervention': ['INTERVENTION 1: ', ' A (Sorafenib + Gemcitabine or Capecitabine)', ' Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)', ' Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle', ' Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)', ' Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).', 'INTERVENTION 2: ', ' B (Placebo + Gemcitabine or Capecitabine)', ' Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)', ' Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle', ' Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)', ' Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed adenocarcinoma of the breast.', ' Measurable or evaluable locally advanced or metastatic disease.', ' Age 18 years.', ' Disease progression during or after treatment with a bevacizumab-containing regimen in the adjuvant or first-line metastatic setting.', ' Patients must have discontinued chemotherapy at least 3 weeks prior to randomization.', ' No more than one prior chemotherapy regimen for locally advanced or metastatic disease.', ' Prior hormonal therapy allowed provided it has been discontinued prior to randomization.', ' Prior radiation therapy is allowed but must be completed at least 3 weeks prior to randomization. Previously radiated area(s) must not be the only site of disease.', ' ECOG Performance Status of 0 or 1.', ' Adequate bone marrow, liver, and renal function', ' Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to randomization, and must agree to use adequate contraception prior to study entry, for the duration of study participation and 28 days after the last study drug dosing.', ' Patients must be able and willing to sign a written informed consent.', ' Patients must be able to swallow and retain oral medication.', 'Exclusion Criteria:', ' Patients with breast cancer over-expressing human epidermal growth factor receptor 2 (HER-2) (gene amplification by FISH or 3+ over-expression by immunohistochemistry). Patients with unknown HER-2 status are not eligible.', ' Patients with active brain metastases.', ' Major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization.', ' Prior use of gemcitabine/capecitabine or sorafenib.', ' Evidence or history of bleeding diathesis or coagulopathy.', ' Serious, non-healing wound, ulcer, or bone fracture.', " Substance abuse, or medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results.", ' Use of cytochrome P450 enzyme-inducing anti-epileptic drugs is not allowed.', ' Clinically significant cardiac disease', ' Uncontrolled hypertension', ' Thrombolic, embolic, venous, or arterial events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.', ' Pulmonary hemorrhage/bleeding event > NCI-CTCAE Grade 2 within 4 weeks of randomization.', ' Any other hemorrhage/bleeding event NCI-CTCAE Grade 3 within 4 weeks of randomization.', ' Active clinically serious infection > NCI-CTCAE Grade 2.', ' Known HIV infection or chronic hepatitis B or C (the safety and effectiveness of sorafenib in this patient population have not been studied).', ' Previous or concurrent cancer that is distinct in primary site or histology from breast cancer EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors [Ta and Tis] or any cancer curatively treated > 5 years prior to randomization.', ' Known or suspected allergy to sorafenib or gemcitabine/capecitabine.', " Prior or concurrent use of St. John's Wort or rifampin (rifampicin) within 3 weeks of randomization.", ' Concurrent anti-cancer therapy other than gemcitabine/capecitabine and sorafenib/placebo.', ' Prior treatment with any agent that targets VEGF or VEGFR (licensed or investigational), except bevacizumab.', ' Women who are pregnant or breast-feeding.', ' Use of any investigational drug within 30 days or 5 half-lives, whichever is longer, preceding randomization.', ' Inability to comply with protocol and/or not willing or not available for follow-up assessments.', " Any condition which in the investigator's opinion makes the patient unsuitable for the study participation."], 'Results': ['Outcome Measurement: ', ' Progression Free Survival', ' [Not Specified]', ' Time frame: From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.', 'Results 1: ', ' Arm/Group Title: A (Sorafenib + Gemcitabine or Capecitabine)', ' Arm/Group Description: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)', ' Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle', ' Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)', ' Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).', ' Overall Number of Participants Analyzed: 81', ' Median (95% Confidence Interval)', ' Unit of Measure: Days 103 (83 to 128)', 'Results 2: ', ' Arm/Group Title: B (Placebo + Gemcitabine or Capecitabine)', ' Arm/Group Description: Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)', ' Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle', ' Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)', ' Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).', ' Overall Number of Participants Analyzed: 79', ' Median (95% Confidence Interval)', ' Unit of Measure: Days 81 (48 to 95)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 32/79 (40.51%)', ' Febrile neutropenia * 2/79 (2.53%)', ' Neutropenia * 0/79 (0.00%)', ' Vomiting * 3/79 (3.80%)', ' Abdominal pain * 1/79 (1.27%)', ' Nausea * 2/79 (2.53%)', ' Diarrhea * 2/79 (2.53%)', ' Constipation * 0/79 (0.00%)', ' Stomatitis * 2/79 (2.53%)', ' Disease progression * 2/79 (2.53%)', ' Pyrexia * 1/79 (1.27%)', ' Fatigue * 3/79 (3.80%)', ' Mucosal inflammation * 2/79 (2.53%)', 'Adverse Events 2:', ' Total: 28/77 (36.36%)', ' Febrile neutropenia * 0/77 (0.00%)', ' Neutropenia * 2/77 (2.60%)', ' Vomiting * 2/77 (2.60%)', ' Abdominal pain * 3/77 (3.90%)', ' Nausea * 2/77 (2.60%)', ' Diarrhea * 1/77 (1.30%)', ' Constipation * 2/77 (2.60%)', ' Stomatitis * 0/77 (0.00%)', ' Disease progression * 2/77 (2.60%)', ' Pyrexia * 3/77 (3.90%)', ' Fatigue * 0/77 (0.00%)', ' Mucosal inflammation * 0/77 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

6743f85c-8318-49cc-acba-94aeb1f57130

Comparison

Intervention

NCT00784849

NCT02104895

Accelerated partial Breast breast irradiation is used in some form for both cohorts of the secondary trial, but not at all in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00784849', 'Intervention': ['INTERVENTION 1: ', ' Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue', ' One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes'], 'Eligibility': ['Inclusion Criteria:', ' Stage 0,I, II breast cancer', ' Clinical node status N0, N1', ' No know allergy to iodine, lymphazurin or methylene blue dyes', 'Exclusion Criteria:', ' Patient cannot be pregnant or nursing', ' Prisoners will not be eligible', ' Women under the age of 18 will not be eligible', ' Patients with a known allergy to iodine or methylene blue or lymphazurin blue dyes'], 'Results': ['Outcome Measurement: ', ' The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s)', ' [Not Specified]', ' Time frame: intraoperatively; up to 6 hours', 'Results 1: ', ' Arm/Group Title: Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue', ' Arm/Group Description: One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes', ' Overall Number of Participants Analyzed: 62', ' Measure Type: Number', ' Unit of Measure: participants Radioactive: 58', ' Blue: 55', ' Radioactive and Blue: 55', ' Efferent blue lymphatics leading up to the SLN: 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/62 (0.00%)']}

{'Clinical Trial ID': 'NCT02104895', 'Intervention': ['INTERVENTION 1: ', ' Whole Breast Irradiation (WBI)', ' Conventional whole breast irradiation (WBI)', ' Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)', 'INTERVENTION 2: ', ' Partial Breast Irradiation (APBI)', ' Accelerated partial breast irradiation (APBI)', ' Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)'], 'Eligibility': ['Inclusion Criteria:', ' Age at presentation >40 y', ' Tumor size <25 mm', ' Wide excision or quadrantectomy with clear margins (>5 mm)', ' Clips placed in tumor bed', ' Full informed consent from patient', 'Exclusion Criteria:', ' Cardiac dysfunction', ' Forced expiratory volume in 1 second (FEV1) <1 L/m', ' Extensive intraductal carcinoma', ' Multifocal cancer', ' Psychiatric problems', ' Recurrent breast cancer'], 'Results': ['Outcome Measurement: ', ' Ipsilateral Breast Tumor Recurrence', ' We defined local relapse (true recurrence) as the reappearance of the breast cancer in the index quadrant and ipsilateral breast tumours as any new breast cancer diagnosed in other quadrants of the same breast. The sum of local relapses and new ipsilateral breast tumours was defined as the ipsilateral breast tumour recurrence (IBTR). Locoregional tumour recurrence also included any recurrence in the ipsilateral axillary, supraclavicular, or internal mammary chain nodal regions.here we report the percentage of participants in each arm who experienced "Ipsilateral Breast Tumor Recurrence"', 'Time frame: 5-year', 'Results 1: ', ' Arm/Group Title: Whole Breast Irradiation (WBI)', ' Arm/Group Description: Conventional whole breast irradiation (WBI)', ' Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)', ' Overall Number of Participants Analyzed: 260', ' Measure Type: Number', ' Unit of Measure: percentage of participants 1.4', 'Results 2: ', ' Arm/Group Title: Partial Breast Irradiation (APBI)', ' Arm/Group Description: Accelerated partial breast irradiation (APBI)', ' Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)', ' Overall Number of Participants Analyzed: 260', ' Measure Type: Number', ' Unit of Measure: percentage of participants 1.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/260 (0.00%)', 'Adverse Events 2:', ' Total: 0/246 (0.00%)']}

ddffa26d-2581-477a-955c-ebf0c2ab0f97

Single

Adverse Events

NCT01201265

1 patient in the primary trial was affected by Sepsis.

Entailment

{'Clinical Trial ID': 'NCT01201265', 'Intervention': ['INTERVENTION 1: ', ' All Participants', ' Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Female participants, >/= 18 years of age', ' Metastatic breast cancer', ' Estrogen receptor-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative disease', ' Treatment-naïve for metastatic breast cancer', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2', ' Adequate hematological, renal and liver function', ' Patients should have received Anthracyclines and Taxanes in the adjuvant setting', ' Women of childbearing potential must agree to use adequate contraception (per institutional standard of care) during treatment and until 6 months after the last administration of investigational products', 'Exclusion Criteria:', ' Prior first line treatment for metastatic breast cancer', ' Central nervous system (CNS) metastasis', ' Uncontrolled hypertension (> 170/95 mmHg)', ' Evidence of bleeding diathesis, coagulopathy or hemorrhage at baseline', ' Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.', ' Prior therapy with gemcitabine or carboplatin in the metastatic setting. Participants having received gemcitabine or carboplatin as part of adjuvant therapy are eligible, if recurrence was first documented >6 months after the last exposure to the drug(s)', ' Requirement of chronic use of immunosuppressive agents', ' HIV, hepatitis B or hepatitis C infection'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' Progression free survival (PFS) was calculated in days from the date of registration until the earliest date of documented disease progression or death. The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method. The progression-free survival was assessed utilizing computer tomography (CT)/ magnetic resonance imaging (MRI)/bone scans and X-ray and Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.', ' Time frame: From the date of registration until the disease progression or death (up to 1541 days).', 'Results 1: ', ' Arm/Group Title: All Participants', ' Arm/Group Description: Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.', ' Overall Number of Participants Analyzed: 40', ' Median (95% Confidence Interval)', ' Unit of Measure: days 255 (157 to 465)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/40 (42.50%)', ' Anaemia 2/40 (5.00%)', ' Febrile Neutropenia 3/40 (7.50%)', ' Neutropenia 2/40 (5.00%)', ' Thrombocytopenia 5/40 (12.50%)', ' Pericardial Effusion 1/40 (2.50%)', ' Abdominal Pain Lower 1/40 (2.50%)', ' Disease Progression 6/40 (15.00%)', ' Fatigue 1/40 (2.50%)', ' Pyrexia 3/40 (7.50%)', ' Septic Shock 1/40 (2.50%)', ' Streptococcal Infection 1/40 (2.50%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

f1a45b47-498d-45c8-b6d9-6c8f035da30b

Single

Adverse Events

NCT00179309

There were no pain related adverse events observed in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00179309', 'Intervention': ['INTERVENTION 1: ', ' Arm I - PANVAC + Docetaxel', ' Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.', ' PANVAC-V : given subcutaneously', ' Sargramostim : given subcutaneously (NCI subjects only)', ' PANVAC-F : given subcutaneously', ' Docetaxel : given IV', 'INTERVENTION 2: ', ' Arm II - Docetaxel Alone', ' Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.', ' Docetaxel : given intravenous (IV)'], 'Eligibility': ['INCLUSION CRITERIA:', ' Metastatic Breast Cancer (either male or female) with evidence of metastatic disease (must have radiographic evidence of measurable disease) on computed tomography (CT) scan or X-ray, or evidence of evaluable disease on bone scan that is consistent with metastasis and a life expectancy of at least 4 months. Patients may have received unlimited prior hormonal therapy and chemotherapy.', ' Histologically confirmed adenocarcinoma of the breast cancer confirmed in the Pathology Clinical Center at National Cancer Institute (NCI), (or National Naval Medical Center (NNMC)) or MD Anderson Pathology Department prior to starting this study. Note: However, if no pathologic specimen is available, patients may enroll with a clinical course consistent with breast cancer and a pathological documentation of the disease.', ' 18 years of age or greater.', ' May have received docetaxel in the adjuvant setting at least 12 months prior to study entry.', ' Able to understand and give informed consent.', ' Able to avoid close household contact (close household contacts are those who share housing or have close physical contact) for at least two weeks after recombinant vaccinia vaccination with persons with active or a history of eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) until condition resolves; pregnant or nursing women; children 3 years of age and under; and immunodeficient or immunosuppressed persons (by disease or therapy), including human immunodeficiency virus (HIV) infection. We have vaccinated over 700 cancer patients and have reported no cases of either self inoculation or person to person transmission of the virus.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.', ' Serum creatinine less than 1.5 times upper limits of normal (ULN) OR creatinine clearance on a 24 hour urine collection of greater than or equal to 60 mL/min, standard liver function tests (LFT) limitations for patients receiving docetaxel therapy include bilirubin within ULN and serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) less than 1.5 times the ULN. If transaminases are greater than 1.5 times the ULN up to 2 times the ULN (as currently indicated), then alk phos should be less than 2.5 times the ULN. (Patients with renal abnormalities should be evaluated for creatinine clearance (CrCl) and interstitial abnormalities. A Cr Cl of greater than or equal to 60ml/min measured or calculated and proteinuria less than 1000mg per 24 hours are eligible unless explained by non-renal causes.)', ' Recovered completely from any grade 3 or 4 reversible hematologic and non hematologic toxicity associated with recent therapy. Typically this is 3-4 weeks for patients who most recently received cytotoxic therapy. Patients previously treated with mitomycin c or carboplatin will require a minimum of 6 weeks.', ' Hematological eligibility parameters (within 16 days of starting therapy):', ' Granulocyte count greater than or equal to1,500/mm^3', ' Platelet count greater than or equal to 100,000/mm^3', ' Hemoglobin (Hgb) greater than or equal to 8 Gm/dL', ' Must agree to use effective birth control or abstinence during and for a period of 4 months after the last vaccination therapy.', ' Patients whose tumors are estrogen receptor (ER) positive should have failed primary hormone therapy unless clinically indicated, i.e. in patients with visceral disease or symptomatic bone disease where up front chemotherapy is warranted. Patients who progressed or recurred following Trastuzumab (Herceptin) therapy if a patient is fluorescence in situ hybridization (FISH) positive or immunohistochemistry (IHC) 3+ positive for human epidermal growth factor receptor 2 (Her-2 neu). Those patients who have progressed on trastuzumab may continue to receive the drug by their referring physician. However, if trastuzumab has been discontinued at the time of enrolling on study, it cannot be resumed while a patient remains on study.', ' Patients randomized to docetaxel alone (arm B) may at time of progression go on to receive vaccine alone if their ECOG performance status remains 0-1, and they do not have any uncontrolled pain or organ dysfunction that would require another intervention such as radiation or chemotherapy.', ' Furthermore, patients initially randomized to arm B that would like to cross over and continue vaccine therapy must meet on-study eligibility and exclusion criteria with the exception of liver transaminase requirement. Patients with liver transaminase levels within Grade 1 by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (up to 3 x ULN) will be allowed to crossover to vaccine.', ' Patients should appear clinically stable (in the opinion of the principle investigator) to complete the full 3 month course of vaccination with an anticipated survival of 6 months or longer.', ' No other active malignancies within the past 12 months (with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder) or life threatening illnesses.', ' Patients with cardiovascular symptoms should be fully evaluated for signs and symptoms of cardiovascular disease and other standard evaluations including electrocardiogram (EKG), chest X-ray, cardiac enzymes, and echocardiogram as clinically indicated.', 'EXCLUSION CRITERIA:', ' Patients should have no evidence of being immunocompromised as listed below.', ' Human immunodeficiency virus positivity due to the potential for decreased tolerance and risk for severe side effects', ' Active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment. This requirement is due to the potential risks of exacerbating autoimmunity Patients with endocrine disease that is controlled by replacement therapy including thyroid disease and adrenal disease and vitiligo may be enrolled', ' Concurrent use of systemic steroids, except for local (topical, nasal, or inhaled) steroid use', ' History of allergy or untoward reaction to prior vaccination with vaccinia virus.', ' Pregnant or breast-feeding women', ' Altered immune function, including immunodeficiency or history of immunodeficiency; eczema; history of eczema, or other eczematoid skin disorders; or those with acute, chronic or exfoliative skin conditions (e.g. atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)', " Serious intercurrent medical illness which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis", ' Clinically active brain metastasis, or a history of seizures that have been active within one year', ' Medical conditions, which, in the opinion of the investigators would jeopardize the patient or the integrity of the data obtained', ' Prior docetaxel chemotherapy for metastatic disease', ' Serious hypersensitivity reaction to egg products', ' Clinically significant cardiomyopathy requiring treatment', ' Chronic hepatitis infection, including B and C, because of potential immune impairment', ' Although topical steroids are allowed, steroid eye-drops are contraindicated', ' Patients who have received prior PANVAC vaccine therapy', ' Patients with a prior history of allergy to eggs or egg products should not receive the vaccine', ' Patients with cardiac disease that have fatigue, palpitation, dyspnea or angina with ordinary physical activity (New York Heart Association class 2 or greater) are not eligible.', ' Prior splenectomy.', ' Cardiac complications, including recent myocardial infarction or cerebrovascular accident within one year, and/or unstable or uncontrolled angina.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' Time between the first day of treatment and disease progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions.', ' Time frame: 19.7 months', 'Results 1: ', ' Arm/Group Title: Arm I - PANVAC + Docetaxel', ' Arm/Group Description: Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.', ' PANVAC-V : given subcutaneously', ' Sargramostim : given subcutaneously (NCI subjects only)', ' PANVAC-F : given subcutaneously', ' Docetaxel : given IV', ' Overall Number of Participants Analyzed: 25', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 6.6 (3.7 to 9.4)', 'Results 2: ', ' Arm/Group Title: Arm II - Docetaxel Alone', ' Arm/Group Description: Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.', ' Docetaxel : given intravenous (IV)', ' Overall Number of Participants Analyzed: 23', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 3.8 (2.6 to 8.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/25 (12.00%)', ' Anemia 0/25 (0.00%)', ' Sinus tachycardia 0/25 (0.00%)', ' Pericardial effusion 1/25 (4.00%)', ' Gastrointestinal disorders - Other, specify -stomatitis) 0/25 (0.00%)', ' Vomiting 1/25 (4.00%)', ' Fever 0/25 (0.00%)', ' Injection site reaction 1/25 (4.00%)', ' Catheter related infection 0/25 (0.00%)', ' Activated partial thromboplastin time prolonged 0/25 (0.00%)', 'Adverse Events 2:', ' Total: 2/23 (8.70%)', ' Anemia 1/23 (4.35%)', ' Sinus tachycardia 1/23 (4.35%)', ' Pericardial effusion 0/23 (0.00%)', ' Gastrointestinal disorders - Other, specify -stomatitis) 1/23 (4.35%)', ' Vomiting 0/23 (0.00%)', ' Fever 1/23 (4.35%)', ' Injection site reaction 1/23 (4.35%)', ' Catheter related infection 1/23 (4.35%)', ' Activated partial thromboplastin time prolonged 1/23 (4.35%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

a5272c37-0e32-42db-a44a-d17df7bd70ff

Single

Eligibility

NCT00201773

Adele is an 85 year old woman with Stage IV histologically confirmed ER+ breast cancer with an ECOG of 0, she has a life expectancy below 6 months and a history of thrombotic events. She is eligible for the primary trial

Contradiction

{'Clinical Trial ID': 'NCT00201773', 'Intervention': ['INTERVENTION 1: ', ' Exemestane + Celecoxib', ' Exemestane + celecoxib (16 weeks) vs. Baseline', 'INTERVENTION 2: ', ' Exemestane', ' Exemestane (8 weeks) vs. Baseline'], 'Eligibility': ['Inclusion Criteria:', ' Must be female with histologically confirmed breast cancer', ' Stage II-IV disease', ' ER and/or PR positive', ' ECOG Performance Status 0-1', ' Tumor must be present following core needle biopsy as determined by physical exam or radiographic evaluation.', ' Postmenopausal', ' No prior treatment for current breast cancer. No other active malignancy is allowed.Adequately treated basal cell, squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years is permitted. Biphosphonates and palliative radiation for bone metastasis is permitted while on study.', ' Hormone replacement therapy must be discontinued. It is not permitted during the time on study.', 'Exclusion Criteria:', ' Known history of aspirin or NSAID induced asthma, urticaria or allergic reactions; or allergy to sulfonamides severe enough in nature to require emergency room treatment or hospitalization.', ' History of myocardial infarction or other thrombotic events.', ' Inflammatory breast cancer (edema or ulceration of the skin of the breast).', ' Significant renal dysfunction (serum creatinine > 1.5 x upper limit of normal).', ' Significant hepatic dysfunction (serum bilirubin > 1.5 x upper limit of normal or AST, ALT > 3 x upper limit of normal)', ' ANC <1.5, platelets <100,000 K/uL, and hemoglobin < 9 g/dL.', ' Use of other COX-2 inhibitors such as rofecoxib (Vioxx®, aspirin, trisalicylate (Trilisate®), is not permitted during the time on study. No washout period is required. Baby aspirin, 81 mg po daily, is permitted.', " Use of NSAID's such as ibuprofen (Advil® or Motrin®), naproxyn (Aleve® Naprosyn®, or Anaprox®), etodolac (Lodine®), oxaprozin (Daypro®), difusanil (Dolobid®), nabumetone (Relafin®), or tolmetin (Tolectin®) is not permitted during the time on study."], 'Results': ['Outcome Measurement: ', ' Number of Patients With Decreased Gene Expression of CYP19 in Breast Cancer by Adding COX-2 Inhibitor to Exemestane', ' Collected from postmenopausal women that receive neoadjuvant exemestane.', ' Time frame: up to 16 weeks', 'Results 1: ', ' Arm/Group Title: Exemestane + Celecoxib', ' Arm/Group Description: Exemestane + celecoxib (16 weeks) vs. Baseline', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Number', ' Unit of Measure: patients 0', 'Results 2: ', ' Arm/Group Title: Exemestane', ' Arm/Group Description: Exemestane (8 weeks) vs. Baseline', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: patients 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/22 (0.00%)', 'Adverse Events 2:', ' Total: ']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

4c67a7b4-36fa-4c20-a15a-122609550973

Single

Intervention

NCT00620373

the primary trial tests two different dental imaging modalities, namely Mammography and gamma imaging.

Contradiction

{'Clinical Trial ID': 'NCT00620373', 'Intervention': ['INTERVENTION 1: ', ' Mammography Only', ' For this reporting arm, the interpretation and analysis was done with mammography only.', 'INTERVENTION 2: ', ' Gamma Imaging', ' For this reporting arm, the interpretation and analysis was done with gamma imaging only.'], 'Eligibility': ['Inclusion Criteria:', ' Past prior screening mammography (SM) interpreted as negative or benign (This screening must have been performed at Mayo Clinic Rochester, Minnesota).', ' Past prior SM interpreted as heterogeneously dense or extremely dense (This screening must have been performed at Mayo Clinic Rochester, Minnesota).', ' Women younger than 50 years who had not undergone prior mammography, as most of these women have dense breasts.', ' Subjects had to have at least one of the following risk factors:', ' Known mutation in breast cancer susceptibility gene 1 (BRCA1) or breast cancer susceptibility gene 2 (BRCA2)', ' History of chest, mediastinal, or axillary irradiation', ' Personal history of breast cancer', ' History of prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ, or atypical papilloma', ' Gail or Claus model lifetime risk greater than or equal to 20%', ' Gail model 5 year risk greater or equal to 2.5%', ' Gail model 5 year risk greater or equal to 1.6%', ' One first-degree relative with history of breast cancer', ' Two second-degree relatives with history of breast cancer', 'Exclusion Criteria:', ' They are unable to understand and sign the consent form', ' They are pregnant or lactating', ' They are physically unable to sit upright and still for 40 minutes.', ' They have self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass etc.).', ' They have had needle biopsy within 3 months, or breast surgery within 1 year prior to the study.', ' They are currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention.'], 'Results': ['Outcome Measurement: ', ' Diagnostic Yield', ' Diagnostic yield is the likelihood that a test or procedure will provide the information needed to establish a diagnosis. In this case, it is the proportion of women with positive results of a screening test and positive results with the reference standard (verified cancer status).', ' Time frame: 12 months after mammography and gamma imaging', 'Results 1: ', ' Arm/Group Title: Mammography Only', ' Arm/Group Description: For this reporting arm, the interpretation and analysis was done with mammography only.', ' Overall Number of Participants Analyzed: 936', ' Measure Type: Number', ' Unit of Measure: cancers per 1000 women screened 3.2 (1.1 to 9.4)', 'Results 2: ', ' Arm/Group Title: Gamma Imaging', ' Arm/Group Description: For this reporting arm, the interpretation and analysis was done with gamma imaging only.', ' Overall Number of Participants Analyzed: 936', ' Measure Type: Number', ' Unit of Measure: cancers per 1000 women screened 9.6 (5.1 to 18.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/969 (0.00%)', 'Adverse Events 2:', ' ']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

120c6aa7-fcaa-4eaa-b520-6382968a6724

Single

Results

NCT00050011

the primary trial results show that Zoledronic Acid Upfront is a better treatment than Zoledronic Acid Delayed-start for preventing any change in Lumbar Spine (L1-L4) Bone Mineral Density (BMD).

Contradiction

{'Clinical Trial ID': 'NCT00050011', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid Upfront', ' Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.', ' Letrozole : Participants received 2.5 mg daily.', ' Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.', 'INTERVENTION 2: ', ' Zoledronic Acid Delayed-start', ' In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.', ' Letrozole : Participants received 2.5 mg daily.', ' Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent', ' Postmenopausal status defined by one of the following :', ' women equal to or greater than 55 years with cessation of menses', ' spontaneous cessation of menses within the past 1 year, but amenorrheic in women less than or equal to 55 years (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (follicle stimulating hormone levels >40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved', ' bilateral oophorectomy (prior to the diagnosis of breast cancer).', ' Adequately diagnosed and treated breast cancer defined as:', ' Patients with breast cancer whose tumor can be removed by an appropriate surgical procedure such as mastectomy or breast conserving surgery and who receive appropriate additional local treatments such as radiotherapy according to best practice.', ' Patients must be at the end of their local treatment without evidence of local residual disease.', ' Patients must have no clinical or radiological evidence of distant metastasis.', ' Hormone receptor positive defined as:', ' ER and/or PR greater than or equal to1 0 fmol/mg cytosol protein; or greater than or equal to 10% of the tumor cells positive by', ' immunohistochemical evaluation.', ' Patients with a baseline lumbar spine and total hip BMD T-score at or above -2.0 SD are eligible.', ' Patients who will receive adjuvant chemotherapy are eligible for participation. Adjuvant chemotherapy must be completed prior to randomization.', ' The date of randomization must not be more than the following:', ' 12 weeks from completion of surgery;', ' 12 weeks after completion of adjuvant chemotherapy;', " 12 weeks after completion of surgery and radiation therapy; however the patient may be randomized while receiving radiation therapy - this decision is at the Investigator's discretion.", " 12 weeks after completion of chemotherapy and radiation therapy; however, the patient may be randomized while receiving radiation therapy - this decision is at the Investigator's discretion.", ' Patients who have undergone neoadjuvant chemotherapy are eligible.', ' No prior treatment with Femara.', 'Exclusion criteria:', ' Patients with any clinical or radiological evidence of distant spread of their disease at any point before randomization.', ' Patients with clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip.', ' Patients with a history of fracture with low-intensity or no associated trauma.', ' Patients who have started adjuvant hormonal therapy or who have completed adjuvant hormonal therapy prior to randomization.', ' Patients who have received any endocrine therapy within the past 12 months (other than neoadjuvant tamoxifen or toremifene, insulin and/or oral anti-diabetic medications, and thyroid hormone replacement). Hormone replacement therapy must be discontinued prior to randomization.', ' Patients who have received prior treatment with intravenous bisphosphonates within the past 12 months.', ' Patients currently receiving oral bisphosphonates. Oral bisphosphonates must be discontinued within 3 weeks of baseline evaluations.', ' Patients who have received prior treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting, is acceptable).', ' Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months.', ' Patients with prior use of Tibolone within the last 6 months.', ' Any prior use of PTH for more than 1 week.', ' Prior use of systemic sodium fluoride for > 3 months during the past 2 years.', ' Patients currently treated with any drugs known to affect the skeleton (e.g., calcitonin, mithramycin, or gallium nitrate) within 2 weeks prior to randomization.', ' Patients with previous or concomitant malignancy (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for five years.', ' Patients with other non-malignant systemic diseases including uncontrolled infections, uncontrolled type 2 diabetes mellitus, uncontrolled thyroid dysfunction, cardiovascular, renal, hepatic, and lung diseases which would prevent prolonged follow-up. Patients with previous history of thrombosis or thromboembolism can be included only if medically suitable. Patients with a known history of HIV are excluded.', ' Uncontrolled seizure disorders associated with falls.', ' Patients with abnormal renal function as evidenced by a serum creatinine equal to or greater than 3 mg/dL (265.2 mmol/L).', " History of diseases with influence on bone metabolism, such as Paget's disease, Osteogenesis Imperfecta, and primary or secondary hyperthyroidism within 12 months prior to study entry.", ' Patients with baseline lumber spine or total hip BMD T-score below -2.0 SD.', ' Patients treated with systemic investigational drug(s) and/or device(s) within the past 30 days or topical investigational drugs within the past 7 days.', ' Additional Exclusion Criteria: (for Spine DXA)', ' History of surgery at the lumbosacral spine, with or without implantable devices.', ' Scoliosis with a Cobb angle >15 degree at the lumbar spine.', ' Immobility, hyperostosis or sclerotic changes at the lumbar spine, or evidence of sclerotic abdominal aorta sufficient to interfere with DXA scan.', ' Any disease of the spine that would preclude the proper acquisition of a lumbar spine DXA.', ' Additional protocol-defined inclusion/exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Percent Change From Baseline in Lumbar Spine (L1-L4) Bone Mineral Density (BMD)', ' Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader. Percent change = 100*((BMD at Month 12 - Baseline BMD)/Baseline BMD)). Missing data at month 12 were imputed by using the last observation carried forward (LOCF) method. Post-baseline non-missing data from month 6 were carried forward to month 12. Data prior to month 6 were not carried forward.', ' Time frame: Baseline, 12 months', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid Upfront', ' Arm/Group Description: Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.', ' Letrozole : Participants received 2.5 mg daily.', ' Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.', ' Overall Number of Participants Analyzed: 253', ' Mean (Standard Deviation)', ' Unit of Measure: Percentage of BMD 1.955 (3.3658)', 'Results 2: ', ' Arm/Group Title: Zoledronic Acid Delayed-start', ' Arm/Group Description: In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.', ' Letrozole : Participants received 2.5 mg daily.', ' Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.', ' Overall Number of Participants Analyzed: 256', ' Mean (Standard Deviation)', ' Unit of Measure: Percentage of BMD -2.325 (3.9542)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 83/300 (27.67%)', ' Anaemia 2/300 (0.67%)', ' Granulocytopenia 1/300 (0.33%)', ' Iron deficiency anaemia 1/300 (0.33%)', ' Thrombocytopenia 0/300 (0.00%)', ' Acute coronary syndrome 1/300 (0.33%)', ' Acute myocardial infarction 2/300 (0.67%)', ' Angina pectoris 2/300 (0.67%)', ' Aortic valve stenosis 1/300 (0.33%)', ' Atrial fibrillation 4/300 (1.33%)', ' Cardiac failure 0/300 (0.00%)', 'Adverse Events 2:', ' Total: 71/300 (23.67%)', ' Anaemia 0/300 (0.00%)', ' Granulocytopenia 0/300 (0.00%)', ' Iron deficiency anaemia 1/300 (0.33%)', ' Thrombocytopenia 1/300 (0.33%)', ' Acute coronary syndrome 0/300 (0.00%)', ' Acute myocardial infarction 1/300 (0.33%)', ' Angina pectoris 1/300 (0.33%)', ' Aortic valve stenosis 0/300 (0.00%)', ' Atrial fibrillation 4/300 (1.33%)', ' Cardiac failure 1/300 (0.33%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

e35ebcea-f1ca-4c26-aa3b-2dc5de1a8645

Comparison

Results

NCT00798135

NCT01209195

the primary trial and the secondary trial investigate different outcome measures for different interventions.

Entailment

{'Clinical Trial ID': 'NCT00798135', 'Intervention': ['INTERVENTION 1: ', ' Itraconazole', ' oral itraconazole 200mg a day until disease progression or unacceptable toxicities.'], 'Eligibility': ['Inclusion Criteria:', ' - Patients must have a pathologically confirmed diagnosis of invasive carcinoma of the breast. - Patients must carry a diagnosis of metastatic breast cancer. - Patients must be able to swallow oral medications. - Patients with HER 2+ tumors must have received trastuzumab in the past and may have had lapatinib. - Patients must have an ECOG performance status of 0-1. - Patients must be informed of the investigational nature of the study and must sign and give written informed consent. - Patients must have recovered to grade <1 from all acute toxicity of previous therapy for breast cancer with the exception of alopecia. - Adequate hematologic and hepatic function: 1)Absolute neutrophil count >= 1,500 mm3 2) Platelet count >= 100,000 mm3 3) Bilirubin <= 1.5mg/dL x ULN 4) AST and/or ALT <= 2 x ULN (< 5 x ULN in presence of known liver metastasis). - Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and must practice an effective method of birth control. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should also practice an effective method of birth control. - All WOCBP MUST have a negative serum or urine pregnancy test within 4 weeks prior to the start of study drug administration.', 'Exclusion Criteria:', ' Use of the following concomitant medications within 14 days of starting protocol therapy is prohibited: Cisapride, dofetilide, ergot derivatives, levomethadyl, lovastatin, midazolam, pimozide, quinidine, simvastatin, or triazolam.', ' Patients who are taking alprazolam (Xanax) are excluded from the trial.', ' Patients must not have an active infection requiring the use of intravenous antibiotics. The use of oral antibiotics is allowed.', ' Hypersensitivity to itraconazole, any component of the formulation, or to other azoles.', ' Patients with uncontrolled CNS metastasis are excluded. If patients have CNS metastasis they must have completed brain radiation at least 2 weeks prior to registration and must be off steroids for CNS metastasis.', ' Known preexisting congestive heart failure or left ventricular dysfunction. Patients with risk factors (ex. uncontrolled hypertension with BP >160/90) for cardiac dysfunction but no preexisting diagnosis of congestive heart failure or left ventricular dysfunction will have a screening EKG prior to enrollment. Subsequently, those patients with an abnormal EKG, as judged by the treating physician, will be excluded from the study.'], 'Results': ['Outcome Measurement: ', ' Pharmacokinetics (PK) of Oral Itraconazole', ' To determine the pharmacokinetics (PK) of oral itraconazole in patients with MBC by measuring mean trough plasma levels at steady state at weeks 2 and 4.', ' Time frame: pre-dose at Weeks 2 and 4', 'Results 1: ', ' Arm/Group Title: Itraconazole', ' Arm/Group Description: oral itraconazole 200mg a day until disease progression or unacceptable toxicities.', ' Overall Number of Participants Analyzed: 12', ' Mean (Standard Deviation)', ' Unit of Measure: ng/mL Week 2 Intraconazole Concentration: 230.7 (216.8)', ' Week 4 Intraconazole Concentration: 305.8 (334.8)', ' Week 2 6-OH Itraconazole Concentration: 454.8 (429.3)', ' Week 4 6-OH Itraconazole Concentration: 501.6 (502.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/13 (23.08%)', ' NAUSEA *1/13 (7.69%)', ' PAIN - ABDOMEN NOS *1/13 (7.69%)', ' VOMITING *1/13 (7.69%)', ' HEMORRHAGE, GI - UPPER GI NOS *1/13 (7.69%)', ' PAIN - BACK *1/13 (7.69%)', ' MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER *1/13 (7.69%)', ' PLEURAL EFFUSION (NON-MALIGNANT) *1/13 (7.69%)', ' THROMBOSIS/THROMBUS/EMBOLISM *1/13 (7.69%)']}

{'Clinical Trial ID': 'NCT01209195', 'Intervention': ['INTERVENTION 1: ', ' Part 1: Dose Escalation: Cohort 1', ' MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV', 'INTERVENTION 2: ', ' Part 1: Dose Escalation: Cohort 2', ' MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV', ' Paclitaxel - 80mg/m2 weekly IV'], 'Eligibility': ['Inclusion Criteria:', ' Cytological or histological confirmation of locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or endometrial cancer; OR, cytological or histological confirmation of locally advanced /metastatic Her2 non-overexpressing breast cancer', ' Eighteen years of age or above', ' Candidates for chemotherapy', ' Able to understand and sign an informed consent (or have a legal representative who is able to do so)', ' Measurable disease according to RECIST v1.1', ' ECOG Performance Score (PS) of 2', ' Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-121', 'Exclusion Criteria:', ' Prior radiation therapy to >25% of bone marrow-bearing areas', ' Evidence of any other active malignancy', ' Active infection or fever> 38.5°C during screening visits or on the first scheduled day of dosing', ' Symptomatic CNS disease', ' Known hypersensitivity to any of the components of MM-121 or who have had hypersensitivity reactions to fully human monoclonal antibodies', ' Received treatment, within 30 days prior to the first scheduled day of dosing, with any investigational agents that have not received regulatory approval for any indication or disease state', ' Pregnant or breast feeding'], 'Results': ['Outcome Measurement: ', ' Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT)', ' To establish the safety of escalating doses of MM-121 in combination with paclitaxel in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.', ' Time frame: From date of first dose to 30 days after termination, the longest 163 weeks', 'Results 1: ', ' Arm/Group Title: Part 1: Dose Escalation: Cohort 1', ' Arm/Group Description: MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: participants reporting DLTs 0', 'Results 2: ', ' Arm/Group Title: Part 1: Dose Escalation: Cohort 2', ' Arm/Group Description: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV', ' Paclitaxel - 80mg/m2 weekly IV', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants reporting DLTs 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/10 (40.00%)', ' SMALL INTESTINAL OBSTRUCTION * [1]3/10 (30.00%)', ' INTESTINAL OBSTRUCTION * [1]1/10 (10.00%)', ' INTESTINAL PERFORATION * [1]1/10 (10.00%)', ' ABDOMINAL PAIN * [1]0/10 (0.00%)', ' DIARRHOEA * [1]0/10 (0.00%)', ' GASTRITIS * [1]0/10 (0.00%)', ' PEPTIC ULCER * [1]0/10 (0.00%)', ' DEATH * [1]1/10 (10.00%)', ' DISEASE PROGRESSION * [1]0/10 (0.00%)', 'Adverse Events 2:', ' Total: 12/31 (38.71%)', ' SMALL INTESTINAL OBSTRUCTION * [1]0/31 (0.00%)', ' INTESTINAL OBSTRUCTION * [1]0/31 (0.00%)', ' INTESTINAL PERFORATION * [1]0/31 (0.00%)', ' ABDOMINAL PAIN * [1]1/31 (3.23%)', ' DIARRHOEA * [1]1/31 (3.23%)', ' GASTRITIS * [1]1/31 (3.23%)', ' PEPTIC ULCER * [1]1/31 (3.23%)', ' DEATH * [1]0/31 (0.00%)', ' DISEASE PROGRESSION * [1]3/31 (9.68%)', ' FATIGUE * [1]2/31 (6.45%)']}

ac997ae1-7e48-48e2-af9e-f7e289622250

Single

Results

NCT02915744

The difference in median Overall Survival (OS) of Patients between the two cohort of the primary trial was less than one month, the patient with the longest OS was in cohort 1.

Contradiction

{'Clinical Trial ID': 'NCT02915744', 'Intervention': ['INTERVENTION 1: ', ' NKTR-102', ' In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.', 'INTERVENTION 2: ', " Treatment of Physician's Choice (TPC)", ' In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.'], 'Eligibility': ['Inclusion Criteria:', ' Female or male, age 18 years.', ' Histologically-confirmed carcinoma of the breast (either the primary or metastatic lesions) for whom single-agent cytotoxic chemotherapy is indicated. Patients may have either measurable or non-measurable disease according to RECIST version 1.1.', ' Patients must have a history of brain metastases that are non-progressing.', ' For triple-negative breast cancer, a minimum of 1 prior cytotoxic chemotherapy regimen must have been administered for the indication of metastatic disease.Depending on receptor status, 1 or 2 prior cytotoxic regimens are required prior to enrollment in this trial; hormonal and/or human epidermal growth factor receptor 2 (HER2) -targeted agents may be required.', ' Have had prior therapy (administered in the neoadjuvant, adjuvant, and/or metastatic setting) with an anthracycline, a taxane, and capecitabine (prior anthracycline can be omitted if not medically appropriate or contraindicated for the patient).', ' Last dose of anticancer therapy must have been administered within 6 months of the date of randomization into this study.', ' All anticancer- and radiation therapy-related toxicities must be completely resolved or downgraded to Grade 1 or less (neuropathy may be Grade 2 or less).', ' Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.', ' Demonstrate adequate organ function obtained within 14 days prior to randomization and analyzed by the central laboratory.', ' Women of childbearing potential (WCBP) must agree to use highly effective methods of birth control throughout the duration of the study until 6 months following the last dose of study drug.', ' Males with female partners of child-bearing potential must agree to use a barrier contraception (e.g., condom with spermicidal foam/gel/film/cream/suppository) throughout the duration of the study until 6 months following the last dose of study drug; in addition to their female partner using either an intrauterine device or hormonal contraception and continuing until 6 months following the last dose of study drug. Male patients should not donate sperm until 6 months following the last dose of study drug.', 'Exclusion Criteria:', ' Last dose of anticancer therapy (including HER2-targeted therapy) within 14 days prior to randomization.', ' High-dose chemotherapy followed by stem cell transplantation (autologous or allogeneic).', ' Major surgery within 28 days prior to randomization.', ' Concomitant use of any anticancer therapy or use of any investigational agent(s).', ' Received prior treatment for cancer with a camptothecin-derived agent.', ' Lesions on imaging, by cerebrospinal fluid or with neurological findings that are consistent with leptomeningeal disease or meningeal carcinomatosis.', ' Chronic or acute GI disorders resulting in diarrhea of any severity grade.', ' Patients who are pregnant or lactating, plan to get pregnant, or have a positive serum pregnancy test prior to randomization.', ' Enzyme-inducing anti-epileptic drugs (EIAEDs) within 14 days of randomization.', ' Hepatitis B or C, tuberculosis, or HIV.', ' Cirrhosis.', ' Prior malignancy (other than breast cancer) unless diagnosed and definitively treated more than 5 years prior to randomization.', ' Daily use of oxygen supplementation.', ' Significant known cardiovascular impairment.', ' Prior treatment with NKTR-102.', ' Psychiatric illness, social situation, or geographical situation that preclude informed consent or limit compliance.', ' Known intolerance or hypersensitivity to any of the products used in this study or their excipients.', ' For patients selecting vinorelbine or gemcitabine as the TPC agent, patients may not receive yellow fever vaccine in the 28 days prior to randomization.'], 'Results': ['Outcome Measurement: ', ' Overall Survival (OS) of Patients', " To compare Overall Survival (OS) of patients who receive 145 mg/m2 NKTR-102 given once every 21 days (q21d) with OS of patients who receive Treatment of Physician's Choice (TPC). Overall survival is defined as the time from the date of randomization to the date of death from any cause. Patients will be followed until their date of death or until final database closure. Patients who are lost-to-follow-up or are alive at the time of analysis will be censored at the time they were last known to be alive or at the date of event cut-off for OS analysis.", ' Time frame: Within 3 years from study start', 'Results 1: ', ' Arm/Group Title: NKTR-102', ' Arm/Group Description: In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.', ' Overall Number of Participants Analyzed: 92', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.8 (6.1 to 10.2)', 'Results 2: ', " Arm/Group Title: Treatment of Physician's Choice (TPC)", ' Arm/Group Description: In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.', ' Overall Number of Participants Analyzed: 86', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.5 (5.8 to 10.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 33/90 (36.67%)', ' Febrile Neutropenia Grade 3 0/90 (0.00%)', ' Atrial Fibrillation Grade 3 1/90 (1.11%)', ' Cardiac Tamponade Grade 4 0/90 (0.00%)', ' Blindness Grade 3 0/90 (0.00%)', ' Colitis Grade 2 1/90 (1.11%)', ' Esophagitis Grade 3 1/90 (1.11%)', ' Vomiting Grade 2 3/90 (3.33%)', ' Diarrhea Grade 3 5/90 (5.56%)', ' Intestinal Obstruction Grade 3 1/90 (1.11%)', 'Adverse Events 2:', ' Total: 24/77 (31.17%)', ' Febrile Neutropenia Grade 3 1/77 (1.30%)', ' Atrial Fibrillation Grade 3 0/77 (0.00%)', ' Cardiac Tamponade Grade 4 1/77 (1.30%)', ' Blindness Grade 3 1/77 (1.30%)', ' Colitis Grade 2 0/77 (0.00%)', ' Esophagitis Grade 3 0/77 (0.00%)', ' Vomiting Grade 2 1/77 (1.30%)', ' Diarrhea Grade 3 0/77 (0.00%)', ' Intestinal Obstruction Grade 3 0/77 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

59328f44-6755-4dcb-b04c-4e0ce2ba3ac8

Single

Results

NCT00399802

The Lapatinib group of the primary trial had a smaller Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen than the Odanacatib 5 mg group

Contradiction

{'Clinical Trial ID': 'NCT00399802', 'Intervention': ['INTERVENTION 1: ', ' Single IV Infusion of ZA 4 mg', ' Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.', 'INTERVENTION 2: ', ' Once-daily Odanacatib 5 mg', ' Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.'], 'Eligibility': ['Inclusion Criteria:', ' Patient has histologically or cytologically-confirmed breast cancer', ' Patient has documented skeletal metastases', 'Exclusion Criteria:', ' Patient is undergoing current oral bisphosphonate therapy, or has a history of oral bisphosphonate use within 6 months of entry into study'], 'Results': ['Outcome Measurement: ', ' Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4', ' u-NTx is a biochemical index of bone resorption. Participants provided urine specimens on Day 1 (baseline) and at Week 4 for measurement of u-NTx.', ' Time frame: Baseline and Week 4', 'Results 1: ', ' Arm/Group Title: Single IV Infusion of ZA 4 mg', ' Arm/Group Description: Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.', ' Overall Number of Participants Analyzed: 14', ' Mean (95% Confidence Interval)', ' Unit of Measure: Percentage change -73 (-80 to -62)', 'Results 2: ', ' Arm/Group Title: Once-daily Odanacatib 5 mg', ' Arm/Group Description: Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.', ' Overall Number of Participants Analyzed: 27', ' Mean (95% Confidence Interval)', ' Unit of Measure: Percentage change -77 (-82 to -71)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/14 (14.29%)', ' Febrile neutropenia 0/14 (0.00%)', ' Ascites 0/14 (0.00%)', ' Breast cancer metastatic 1/14 (7.14%)', ' Metastases to bone 1/14 (7.14%)', 'Adverse Events 2:', ' Total: 4/29 (13.79%)', ' Febrile neutropenia 1/29 (3.45%)', ' Ascites 1/29 (3.45%)', ' Breast cancer metastatic 0/29 (0.00%)', ' Metastases to bone 2/29 (6.90%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

441c0760-ca4a-4f1d-864e-a77395fd1f18

Single

Results

NCT00723125

57% of patients in cohort 1 of the primary trial had Pathological Complete Response Rates at Surgery.

Entailment

{'Clinical Trial ID': 'NCT00723125', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1', ' Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks', ' Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)', 'INTERVENTION 2: ', ' Cohort 2', ' Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks', ' Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)'], 'Eligibility': ['Eligibility criteria', 'Inclusion criteria:', ' Histologically documented adenocarcinoma of the breast', ' ANC > 1000 cells', ' Female; age > 18', ' Zubrod PS 0-1', ' Platelets > 100,000', ' Stage IIA-IIIB disease', ' Total bilirubin < 1.5 ULN', ' No evidence of any metastatic disease', ' Serum Creatinine < 1.5 gm/dl', ' No prior systemic therapy for breast cancer or Creat Cl > 30 ml/min', ' Not pregnant or lactating', ' Serum ALT < 2.0 ULN', ' ER, PR and HER2 status required', ' LVEF (MUGA/echo WNL)', ' No baseline > 2 neuropathy', ' Urine protein: creat ratio < 1.0', ' HER2-negative - either IHC 0-1+ or FISH ratio < 2.0', ' Hemoglobin > 9 gm/dl', ' (FISH testing is required for all HER2 2-3+ tumors by IHC)', 'Exclusion criteria:', ' No Histologically documented adenocarcinoma of the breast', ' No-ANC > 1000 cells', ' Female; age < 18', ' Zubrod PS > 0-1', ' Platelets < 100,000', ' Stage IV disease', ' Total bilirubin > 1.5 ULN', ' metastatic disease', ' Serum Creatinine > 1.5 gm/dl', ' prior systemic therapy for breast cancer or Creat Cl > 30 ml/min', ' pregnant or lactating', ' Serum ALT > 2.0 ULN baseline > 2 neuropathy', ' Urine protein: creat ratio >1.0', ' HER2-positive', ' Hemoglobin < 9 gm/dl'], 'Results': ['Outcome Measurement: ', ' Pathological Complete Response Rates at Surgery', ' [Not Specified]', ' Time frame: at surgery approximately 5 months after initial treatment', 'Results 1: ', ' Arm/Group Title: Cohort 1', ' Arm/Group Description: Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks', ' Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: participants 16', 'Results 2: ', ' Arm/Group Title: Cohort 2', ' Arm/Group Description: Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks', ' Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)', ' Overall Number of Participants Analyzed: 27', ' Measure Type: Number', ' Unit of Measure: participants 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/28 (17.86%)', ' gr 3 Nausea, gr 3 vomiting 1/28 (3.57%)', ' gr 3 nausea, gr 2 infection with noraml ANC, gr 2 HGB, gr 1 glucose 1/28 (3.57%)', ' gr 2 non-cardiac chest pain, gr 2 anemia 1/28 (3.57%)', ' gr 3 infection (normal ANC) (cellulitis & pain in buttock - RT infection), gr 1 epistaxis 1/28 (3.57%)', 'Adverse Events 2:', ' Total: 8/27 (29.63%)', ' gr 3 Nausea, gr 3 vomiting 0/27 (0.00%)', ' gr 3 nausea, gr 2 infection with noraml ANC, gr 2 HGB, gr 1 glucose 0/27 (0.00%)', ' gr 2 non-cardiac chest pain, gr 2 anemia 0/27 (0.00%)', ' gr 3 infection (normal ANC) (cellulitis & pain in buttock - RT infection), gr 1 epistaxis 0/27 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

fbe60029-8944-4e12-b4b2-3413037a10cc

Comparison

Intervention

NCT00278109

NCT01881230

Gemcitabine is not used in the primary trial, and used only in cohort 2 of the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT00278109', 'Intervention': ['INTERVENTION 1: ', ' Experimental', ' cyclophosphamide: chemotherapy', ' doxorubicin hydrochloride: chemotherapy', ' adjuvant therapy: chemotherapy', ' radiation therapy: chemotherapy'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed adenocarcinoma of the breast by routine hematoxylin and eosin (H&E) staining', ' Primary tumor 4 cm and 0-3 positive axillary lymph nodes (pathologic T1-2, pathologic N0-N1, M0)', ' Patients with lymph nodes positive only by cytokeratin staining (i.e., H&E negative) are eligible', ' No squamous cell carcinoma or sarcoma of the breast', ' Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy within the past 14 weeks', ' Surgical margins at the time of SM must be negative (> 3 mm) for both invasive carcinoma and for non-invasive ductal carcinoma', ' No active local-regional disease', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' ECOG performance status 0-1', ' Sex: female', ' Menopausal status not specified', ' Not pregnant', ' Negative pregnancy test', ' Fertile patients must use effective non-hormonal contraception', ' No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix', ' No other serious or poorly controlled medical or psychiatric condition that could be exacerbated by, or complicate compliance with study treatment', ' PRIOR CONCURRENT THERAPY:', ' No prior radiation therapy to the breast', ' No prior trastuzumab (Herceptin ®)', ' No other concurrent chemotherapy', ' No concurrent hormonal therapy except the following:', ' Steroids given for adrenal failure', ' Hormones administered for non-disease-related conditions (e.g., insulin for diabetes, synthroid for hypothyroidism)', ' Intermittent dexamethasone as an antiemetic or premedication'], 'Results': ['Outcome Measurement: ', ' Number of Participants Experiencing Acute, Late Skin, and Subcutaneous Toxicity', ' Number of participants with Grade 4 toxicity as defined by the following criteria:', ' Acute Skin Toxicity: 0=No change, 1= Follicular, faint, or dull erythema/epilation/dry/desquamation/decreased swelling, 2= Tender or bright erythemal patchy moist desquamation/moderate edema, 3= Confluent moist desquamation other than skin folds, piting edema, 4= Ulceration, hemorrahage, necrosis, Late Skin Toxicity: 0= None, 1= Slight Atrophy, Pigmentation change, some hair loss, 2= Patch atrophy, moderate telangectasias, total hair loss, 3= Marked atrophy, gross telangectasias, 4= Ulceration; Subcutaneous Tissue Toxicity: 0= None, 1= Slight induration (fibrosis) and loss of subcutaneous fat, 2= Moderate fibrosis but asymptomatic; slight field contracture; <10% linear reduction, 3= Severe induration and loss subcutaneous tissue; field contracture >10% linear reduction; 4= Necrosis', ' Time frame: up to 5 years', 'Results 1: ', ' Arm/Group Title: Experimental', ' Arm/Group Description: cyclophosphamide: chemotherapy', ' doxorubicin hydrochloride: chemotherapy', ' adjuvant therapy: chemotherapy', ' radiation therapy: chemotherapy', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/25 (4.00%)', ' Neutropenia *1/25 (4.00%)']}

{'Clinical Trial ID': 'NCT01881230', 'Intervention': ['INTERVENTION 1: ', ' Arm A: Nab-Paclitaxel + Gemcitabine', ' Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration of each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment', 'INTERVENTION 2: ', ' Arm B: Nab-Paclitaxel + Carboplatin', ' Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.'], 'Eligibility': ['Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria are met:', ' Female subjects, age 18 years at the time informed consent is signed', ' Pathologically confirmed adenocarcinoma of the breast', ' Pathologically confirmed as triple negative, source documented, defined as both of the following', ' Estrogen Receptor (ER) and Progesterone Receptor (PgR) negative: < 1% of tumor cell nuclei are immunoreactive in the presence of evidence that the sample can express ER or PgR (positive intrinsic controls)', ' Human Epidermal Growth Factor Receptor 2 (HER2) negative as per American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines i. Immunohistochemistry (IHC) 0 or 1 Fluorescence In Situ Hybridization (FISH) negative (or equivalent negative test). Subjects with IHC 2 must have a negative by Fluorescence In Situ Hybridization (FISH),, (or equivalent negative test).', ' Subjects with prior breast cancer history of different phenotypes (ie, ER/PgR/HER2 positive) must have pathologic confirmation of triple negative disease in at least one of the current sites of metastasis', " Subjects must have received prior adjuvant or neoadjuvant anthracycline therapy; unless (a) anthracycline treatment was not indicated or was not the best treatment option for the subject in the opinion of the treating physician; and (b) anthracycline treatment remains not indicated or, in the opinion of the treating physician, is not the best treatment option for the subject's metastatic disease.", ' a. Newly diagnosed subjects presenting with TNMBC are eligible for the study if anthracycline treatment is not indicated or is not the best treatment option for the subject in the opinion of the treating physician.', ' Subjects with measurable metastatic disease, defined by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) guidelines', ' Life expectancy 16 weeks from randomization', ' No prior cytotoxic chemotherapy for metastatic breast cancer. Prior immunotherapy and/or monoclonal antibody therapy are acceptable. Prior treatments must have been discontinued at least 30 days prior to start of study treatment and all related toxicities must have resolved to Grade 1 or less.', ' Prior neoadjuvant or adjuvant chemotherapy, if given, must have been completed at least 6 months before randomization with all related toxicities resolved, and documented evidence of disease progression per RECIST 1.1 guidelines is required.', ' a. If prior neoadjuvant or adjuvant chemotherapy contained taxane, gemcitabine, or platinum agents, the treatment must have completed at least 12 months before randomization', ' Prior radiotherapy must have completed before randomization, with full recovery from acute radiation side effects. At least one measurable lesion must be completely outside the radiation portal or there must be unequivocal radiologic or clinical exam proof of progressive disease within the radiation portal, in accordance with RECIST 1.1 guidelines', ' At least 30 days from major surgery before randomization, with full recovery', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1', ' Subject has the following blood counts at screening:', ' Absolute Neutrophil Count (ANC) 1500/mm^2 ;', ' Platelets 100,000/mm^2 ;', ' Hemoglobin (Hgb) 9 g/dL', ' Subject has the following blood chemistry levels at screening:', ' Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT), Alanine Aminotransferase (ALT ) Serum Glutamic Pyruvate Transaminase (SGPT) 2.5 x upper limit of normal range (ULN); if hepatic metastases present 5.0 x ULN', " Total serum bilirubin ULN; or total bilirubin 3.0 × ULN with direct bilirubin within normal range in subjects with documented Gilbert's Syndrome", ' Creatinine clearance > 60 mL/min (by Cockcroft-Gault)', ' Females of child-bearing potential [defined as a sexually mature women who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months)] must:', ' Demonstrate a negative serum pregnancy test result at screening (performed by central lab) confirmed by local negative urine pregnancy dipstick within 72 hours prior to the first dose of IP); pregnancy test with sensitivity of at least 25 mIU/mL; and', ' Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, two physician approved effective contraception methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) without interruption for 28 days or longer as required by local guidelines, prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of the study or longer as required by local guidelines', ' Females must abstain from breastfeeding starting at randomization, during study participation and for 28 days or longer as required by local guidelines, after IP discontinuation', ' Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted', ' Able to adhere to the study visit schedule and other protocol requirements', 'Exclusion Criteria:', ' A subject will not be eligible for inclusion in this study if any of the following criteria apply:', ' Male subjects', ' Concurrent chemotherapy or any other anti tumor therapy for breast cancer. Prior immunotherapy & monoclonal antibody therapy are acceptable.', ' Subjects who received prior cytotoxic chemotherapy after incomplete resection of locoregional recurrent disease', ' History of, or known current evidence of brain metastasis, including leptomeningeal involvement.', ' Subjects with bone as the only site of metastatic disease', ' Subjects with regional lymph node as the only site of metastatic disease', ' Serious intercurrent medical or psychiatric illness, including serious active infection', ' History of class II-IV congestive heart failure or myocardial infarction within 6 months of randomization', ' History of other primary malignancy in the last 5 years prior to randomization. Subjects with prior breast cancer history are eligible, however, the most recently obtained biopsy must demonstrate triple negative disease (source documented). Subjects with prior history of in situ cancer or basal or localized squamous cell skin cancer are eligible.', ' Subjects with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple uncontrolled or unstable allergies which, in the opinion of the investigator, may lead to serious complications', ' Peripheral neuropathy Grade 2 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0', ' Subjects who have received an investigational product within the previous 4 weeks prior to randomization', ' Subject is currently enrolled, or will enroll in a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study', ' Pregnant or nursing women', ' Subjects with prior hypersensitivity to nab-paclitaxel, gemcitabine, carboplatin or any other platin, or nucleoside analogue agents', ' Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study', ' Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study', ' Any condition that confounds the ability to interpret data from the study', ' History of seropositive human immunodeficiency virus (HIV)', ' Subjects who are receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications'], 'Results': ['Outcome Measurement: ', ' Kaplan-Meier Estimates of Progression-Free Survival (PFS) Based on Investigator Assessment.', ' PFS was defined as the time from the date of randomization to the date of disease progression or death from any cause on or prior to the data cutoff date for the statistical analysis, whichever occurred earlier. Tumor responses were assessed every 6 weeks using, Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and defined as: Complete response (CR) is the disappearance of all target lesions; Partial response (PR) occurs when at least a 30% decrease in the sum of diameters of target lesions from baseline; Stable disease is neither sufficient shrinkage to qualify for a PR nor sufficient increase of lesions to qualify for Progressive disease (PD); Progressive Disease- is at least a 20% increase in the sum of diameters of target lesions from nadir.', ' Time frame: From date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C', 'Results 1: ', ' Arm/Group Title: Arm A: Nab-Paclitaxel + Gemcitabine', ' Arm/Group Description: Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration of each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment', ' Overall Number of Participants Analyzed: 61', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.5 (4.1 to 7.0)', 'Results 2: ', ' Arm/Group Title: Arm B: Nab-Paclitaxel + Carboplatin', ' Arm/Group Description: Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.', ' Overall Number of Participants Analyzed: 64', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.3 (5.7 to 10.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/60 (36.67%)', ' Anaemia 2/60 (3.33%)', ' Febrile neutropenia 1/60 (1.67%)', ' Neutropenia 1/60 (1.67%)', ' Pancytopenia 0/60 (0.00%)', ' Thrombocytopenia 0/60 (0.00%)', ' Acute myocardial infarction 0/60 (0.00%)', ' Atrial fibrillation 1/60 (1.67%)', ' Cardiac failure 1/60 (1.67%)', ' Myocardial infarction 0/60 (0.00%)', ' Palpitations 1/60 (1.67%)', ' Pericardial effusion 0/60 (0.00%)', 'Adverse Events 2:', ' Total: 20/64 (31.25%)', ' Anaemia 2/64 (3.13%)', ' Febrile neutropenia 3/64 (4.69%)', ' Neutropenia 2/64 (3.13%)', ' Pancytopenia 0/64 (0.00%)', ' Thrombocytopenia 0/64 (0.00%)', ' Acute myocardial infarction 0/64 (0.00%)', ' Atrial fibrillation 0/64 (0.00%)', ' Cardiac failure 0/64 (0.00%)', ' Myocardial infarction 1/64 (1.56%)', ' Palpitations 0/64 (0.00%)', ' Pericardial effusion 0/64 (0.00%)']}

fe1782aa-a871-4608-a7cb-8f83b7f76d8a

Comparison

Intervention

NCT02364388

NCT01425268

There is no overlap in treatments used in the primary trial and the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT02364388', 'Intervention': ['INTERVENTION 1: ', ' MAESTRO', 'Baseline'], 'Eligibility': ['Inclusion Criteria', ' Female', ' 18 years of age or older', ' Have an undiagnosed suspicious finding which may include more than one solid or complex cystic suspicious mass, classified by CDU as BI-RADS 4a or 4b within 3 weeks of their baseline Imagio Scan', 'Exclusion Criteria:', ' Have a condition or impediment that could interfere with the intended field of view (within one probe length or 4 cm of the mass), (i.e., breast implants within the previous 12 months, or tattoos)', ' Pregnant or lactating', ' Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU'], 'Results': ['Outcome Measurement: ', ' OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses', ' Outcome is the percentage of benign masses correctly downgraded by (OA/US) ultrasonography from a suspicious abnormality (4A or 4B) to benign or probably benign (BI-RADS 2 or 3). BI-RADS is the Breast Imaging Reporting and Data System established the American College of Radiology. BI-RADS scores range from 0 to 6, with increase in score indicating an increase in the probability of malignancy. A BI-RADS score of 4 or more indicates the need for biopsy. Specificity is reported with a 96% confidence interval using a normal approximation.', ' Time frame: CDU images and decision to biopsy to be done at Screening. OA/US imaging to be done within 10 days of Screening. Biopsy to be done within 30 days of Screening.', 'Results 1: ', ' Arm/Group Title: MAESTRO', ' Arm/Group Description: Baseline', ' Overall Number of Participants Analyzed: 143', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Masses Mean (96% Confidence Interval)Unit of Measure: percentage of masses: 41.1 (33.1 to 49.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/217 (0.00%)']}

{'Clinical Trial ID': 'NCT01425268', 'Intervention': ['INTERVENTION 1: ', ' AeroForm Tissue Expansion', ' AeroForm Tissue Expansion inflation with carbon dioxide by remote control', ' AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.', 'INTERVENTION 2: ', ' Saline Tissue Expansion', ' Saline Tissue Expansion inflated by needle injections of saline', ' Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.'], 'Eligibility': ['Inclusion Criteria:', ' Subject is a woman between the ages of 18-70.', ' Subject needs to have tissue expansion as part of her breast reconstruction.', ' Subject is able to provide written informed consent.', ' Subject is able and willing to comply with all of the study requirements.', ' Subject is able to understand and manage at home dosing regimen.', 'Exclusion Criteria:', ' Subjects skin is not suitable for tissue expansion.', ' Subject has remaining tumor cells following her mastectomy.', ' Subject has a current or prior infection at the intended expansion site.', ' Subjects skin has been damaged by previous radiation treatments and the use of non radiated tissue from another part of her body will not be used.', ' 4a. Subject had planned radiation therapy at the intended expansion site while the expander is implanted.', ' 5. Subject has a history of failed tissue expansion or breast implantation at the intended expansion site.', ' 6. Subject has any existing medical condition that the doctor thinks puts the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes).', ' 7. Subject is taking any medications that the doctor thinks puts the subject at an increased risk of complications (e.g., prednisone, Coumadin).', ' 8. Subject is currently participating in a concurrent investigational drug or device study.', ' 9. Subject is a current tobacco smoker. 10. Subject is overweight (BMI > 33). 11. Subject is unwilling to comply with the air travel or altitude restriction of not > 3300 feet (1000 meters) from baseline during the time the AeroForm tissue expander is implanted.', ' 12. Subject has a currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.', ' 13. Subject is pregnant or planning on becoming pregnant during the study period.', ' 14. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.'], 'Results': ['Outcome Measurement: ', ' Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event', ' The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: AeroForm Tissue Expansion', ' Arm/Group Description: AeroForm Tissue Expansion inflation with carbon dioxide by remote control', ' AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.', ' Overall Number of Participants Analyzed: 98', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Breasts Count of UnitsUnit of Measure: Breasts: 149 96.1%', 'Results 2: ', ' Arm/Group Title: Saline Tissue Expansion', ' Arm/Group Description: Saline Tissue Expansion inflated by needle injections of saline', ' Saline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.', ' Overall Number of Participants Analyzed: 52', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Breasts Count of UnitsUnit of Measure: Breasts: 82 98.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/99 (21.21%)', ' Neutropenic Fever [1]1/99 (1.01%)', ' Extrusion [2]1/99 (1.01%)', ' Deflation [3]1/99 (1.01%)', ' Under-Expansion [4]1/99 (1.01%)', ' Exposure [5]1/99 (1.01%)', ' Cellulitis [6]5/99 (5.05%)', ' Wound Infection [7]1/99 (1.01%)', ' Hematoma, Breast [8]1/99 (1.01%)', ' Seroma [9]1/99 (1.01%)', ' Hematoma, Chest VAP Site [10]1/99 (1.01%)', 'Adverse Events 2:', ' Total: 7/52 (13.46%)', ' Neutropenic Fever [1]0/52 (0.00%)', ' Extrusion [2]1/52 (1.92%)', ' Deflation [3]1/52 (1.92%)', ' Under-Expansion [4]0/52 (0.00%)', ' Exposure [5]0/52 (0.00%)', ' Cellulitis [6]2/52 (3.85%)', ' Wound Infection [7]2/52 (3.85%)', ' Hematoma, Breast [8]1/52 (1.92%)', ' Seroma [9]0/52 (0.00%)', ' Hematoma, Chest VAP Site [10]0/52 (0.00%)']}

a153ecbf-11ac-4c40-a3af-9dbb0e12c49b

Single

Eligibility

NCT00405938

Patients intracranial metastasis may be eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00405938', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab/Anastrozole', ' Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.', 'INTERVENTION 2: ', ' Bevacizumab/Fulvestrant', ' Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal breast cancer (adenocarcinoma) estrogen (ER)and/or progesterone (PR) receptor positive that is locally advanced or locally recurrent and not able to be surgically removed OR with measurable and/or disease that is able to be assessed including isolated bone metastasis', ' Female patients 18 years or older', ' Documentation of ER+ and/or PR+', ' No prior chemotherapy or hormone therapy for metastatic breast cancer or inoperable breast cancer that is locally recurrent or locally advanced', ' Measurable or evaluable disease', ' Radiation therapy to painful bone lesions or impending fractures is allowed as long as there is measurable or evaluable disease outside the radiated area.', ' Must have adequate bone marrow, renal and liver function', ' Patients receiving prior treatment with an anthracycline based chemotherapy must have a normal left ventricle ejection fraction', 'Exclusion Criteria:', ' No metastatic disease to the Central Nervous System', ' No history of myocardial infarction (MI), stroke or transient ischemic attacks in the last 6 months', ' No symptoms of peripheral vascular disease', ' No history of abdominal fistula, gastrointestinal perforation or intrabdominal abscess in the past 6 months', ' No known hypersensitivity to phosphate, trehalose or polysorbate', ' No serious non-healing wound, ulcer or bone fracture', ' No uncontrolled high blood pressure or history of hypertensive crisis', ' No New York Hear Association class II congestive heart failure', ' No extensive cancer involvement of the liver or lungs', ' No history of significant psychiatric disorders', ' No significant vascular disease', ' There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease', ' Progression Free Survival (PFS) is defined as the interval, in months, from the date of first treatment to the date of disease progression or death, whichever occurred first.', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: Bevacizumab/Anastrozole', ' Arm/Group Description: Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.', ' Overall Number of Participants Analyzed: 38', ' Median (95% Confidence Interval)', ' Unit of Measure: months 21 [1] (14 to NA)', 'Results 2: ', ' Arm/Group Title: Bevacizumab/Fulvestrant', ' Arm/Group Description: Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.', ' Overall Number of Participants Analyzed: 41', ' Median (95% Confidence Interval)', ' Unit of Measure: months 9 (5 to 13)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/38 (26.32%)', ' cTnI [1]0/38 (0.00%)', ' Superventricular Arrhythmia - Sinus Bradycardia 1/38 (2.63%)', ' Pain - Cardiac 0/38 (0.00%)', ' Cardiac Ischemia/Infarction 0/38 (0.00%)', ' Restrictive Cardiomyopathy 1/38 (2.63%)', ' Dehydration 0/38 (0.00%)', ' Diarrhea 1/38 (2.63%)', ' Vomiting 1/38 (2.63%)', ' Nausea 1/38 (2.63%)', ' Death 0/38 (0.00%)', ' Weakness 1/38 (2.63%)', 'Adverse Events 2:', ' Total: 12/41 (29.27%)', ' cTnI [1]1/41 (2.44%)', ' Superventricular Arrhythmia - Sinus Bradycardia 0/41 (0.00%)', ' Pain - Cardiac 1/41 (2.44%)', ' Cardiac Ischemia/Infarction 1/41 (2.44%)', ' Restrictive Cardiomyopathy 0/41 (0.00%)', ' Dehydration 1/41 (2.44%)', ' Diarrhea 0/41 (0.00%)', ' Vomiting 0/41 (0.00%)', ' Nausea 0/41 (0.00%)', ' Death 1/41 (2.44%)', ' Weakness 0/41 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

bcd48c1e-bfeb-4f1e-993f-cbbe4fadbf6e

Single

Results

NCT00263588

The majority of the primary trial subjects either had Progressive disease or undetermined CNS objective response rate.

Entailment

{'Clinical Trial ID': 'NCT00263588', 'Intervention': ['INTERVENTION 1: ', ' Cohort A', ' 750mg lapatinib administered orally twice daily. Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings', 'INTERVENTION 2: ', ' Cohort B', ' 750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.'], 'Eligibility': ['Inclusion criteria:', ' Signed Informed Consent', ' ErbB2(HER2)overexpressing breast cancer.', ' Brain lesion(s) which are progressing.', ' Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR)and/or Stereotactic Radiosurgery (SRS).', ' Prior treatment with trastuzumab (Herceptin), either alone or in combination with chemotherapy.', ' Cardiac ejection fraction(LVEF)within the institutional range of normal as measured by Echocardiogram.', ' Able to swallow an oral medication.', ' Adequate kidney and liver function.', ' Adequate bone marrow function.', 'Exclusion criteria:', ' Pregnant or lactating females.', ' Conditions that would effect the absorption of an oral drug.', ' History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents.', ' Pre-existing severe cerebral vascular disease, such as stroke involving a major vessel.', " Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent."], 'Results': ['Outcome Measurement: ', ' The Number of Participants With Central Nervous System (CNS) Best Overall Response', ' Summary of CNS Objective Response (Lapatinib Monotherapy - MITT Population)', ' Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer.', ' The primary indicator of drug efficacy was CNS objective response rate. A CNS objective response was defined as either a Complete response (CR) or Partial response (PR), as assessed by volumetric analysis of brain Magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of Neurological signs and symptoms (NSS)', ' A CNS objective response rate was defined as a 50% volumetric reduction in sum of CNS target lesions, with no new or progressive CNS or non-CNS lesions, no increases in tumor-related steroid requirements and no worsening of neurological signs or symptoms', ' Time frame: time from baseline to data cutoff (25 Sept 2007); approximately 2 years', 'Results 1: ', ' Arm/Group Title: Cohort A', ' Arm/Group Description: 750mg lapatinib administered orally twice daily. Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings', ' Overall Number of Participants Analyzed: 94', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete response (CR): 0 0.0%', ' Partial response (PR): 6 6.4%', ' Stable disease (SD): 40 42.6%', ' Progressive disease (PD): 40 42.6%', 'Unknown: 8 8.5%', 'Results 2: ', ' Arm/Group Title: Cohort B', ' Arm/Group Description: 750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings.', ' Overall Number of Participants Analyzed: 143', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete response (CR): 0 0.0%', ' Partial response (PR): 9 6.3%', ' Stable disease (SD): 46 32.2%', ' Progressive disease (PD): 70 49.0%', ' Unknown: 18 12.6%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 36/95 (37.89%)', ' Atrial fibrillation 0/95 (0.00%)', ' Cardio-respiratory arrest 1/95 (1.05%)', ' Left ventricular dysfunction 0/95 (0.00%)', ' Pericardial effusion 0/95 (0.00%)', ' Vertigo 0/95 (0.00%)', ' Constipation 1/95 (1.05%)', ' Diarrhoea 6/95 (6.32%)', ' Duodenal ulcer 0/95 (0.00%)', ' Duodenal ulcer haemorrhage 0/95 (0.00%)', ' Gastrointestinal haemorrhage 0/95 (0.00%)', 'Adverse Events 2:', ' Total: 52/147 (35.37%)', ' Atrial fibrillation 1/147 (0.68%)', ' Cardio-respiratory arrest 0/147 (0.00%)', ' Left ventricular dysfunction 1/147 (0.68%)', ' Pericardial effusion 1/147 (0.68%)', ' Vertigo 1/147 (0.68%)', ' Constipation 0/147 (0.00%)', ' Diarrhoea 4/147 (2.72%)', ' Duodenal ulcer 1/147 (0.68%)', ' Duodenal ulcer haemorrhage 1/147 (0.68%)', ' Gastrointestinal haemorrhage 2/147 (1.36%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

4dc22366-3ff3-41c8-aa4c-7342d7b7085d

Comparison

Adverse Events

NCT00645333

NCT00006110

the primary trial records several central nervous system related adverse events in its patients, whereas the secondary trial does not.

Contradiction

{'Clinical Trial ID': 'NCT00645333', 'Intervention': ['INTERVENTION 1: ', ' MK-0752 and Docetaxel', ' MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.'], 'Eligibility': ['Inclusion Criteria:', ' Men or women with metastatic (Stage IV) breast cancer, or with locally advanced breast cancer (Stages IIIA > 10 cm, or Stages IIIB and IIIC) that did not respond to first-line anthracycline-based chemotherapy, for whom docetaxel is a recommended therapy', ' Presence of measurable or evaluable disease', ' Adequate organ function', ' Ability to swallow intact study drug capsules', ' Zubrod Performance Status of 0-1 with at least a 3 month life expectancy', ' Appropriate time must have elapsed since prior anti-neoplastic therapy with resolution of acute toxicity', 'Exclusion Criteria:', ' Concurrent treatment with hormonal therapy intended to treat cancer', ' Radiotherapy within 7 days prior to first dose', ' Symptomatic central nervous system, and/or epidural metastases or symptomatic carcinomatous meningitis or with radiation treatment completed within the past 8 weeks', ' Serious comorbid illness which will limit the ability of the patient to safely receive anticancer treatment', ' Patients who are pregnant or nursing', ' Confounding factors present to provide misinterpretation of data (i.e., concurrent malignancy)'], 'Results': ['Outcome Measurement: ', ' Dose Limiting Toxicity (DLT)', ' The number of DLTs experienced by participants within the first 21 days.', ' DLTs were defined as toxicities possibly, probably, or definitely related to the study drug observed during the first 2 cycles (first 42 days) as follows:', ' Non-hematologic toxicity Grade 3 by the NCI CTCAE version 3.0.', ' ANC<1000 for more than 7 days despite use of pegfilgrastim.', ' Platelet count <25,000 for more than 7 days, or associated with bleeding, or less than 10,000 at any time.', ' Time frame: first 21 days', 'Results 1: ', ' Arm/Group Title: MK-0752 and Docetaxel', ' Arm/Group Description: MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Number', ' Unit of Measure: Dose Limiting Toxicities 5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/30 (53.33%)', ' Chest pain *1/30 (3.33%)', ' Abdominal pain *1/30 (3.33%)', ' Diarrhea *2/30 (6.67%)', ' Edema limbs *1/30 (3.33%)', ' Hypersensitivity *2/30 (6.67%)', ' Autoimmune disorder *1/30 (3.33%)', ' Immune system disorder *1/30 (3.33%)', ' Device related infection *2/30 (6.67%)', ' Upper respiratory infection *1/30 (3.33%)', ' Fracture *1/30 (3.33%)']}

{'Clinical Trial ID': 'NCT00006110', 'Intervention': ['INTERVENTION 1: ', ' Herceptin Regimen After AC', ' Patients in the adjuvant and neoadjuvant groups after receiving [AC-TP] Chemotherapy (doxorubicin & cyclophosphamide).', 'INTERVENTION 2: ', ' Herceptin Regimen After TP', ' Patients in the adjuvant and neoadjuvant groups after receiving chemotherapy and Taxol + Herceptin.'], 'Eligibility': ['Inclusion Criteria', ' Histologically confirmed stage IIB, IIIA, IIIB, IIIC, or previously untreated stage IV primary carcinoma of the breast', ' Fine needle aspiration, core needle biopsy, or incisional biopsy allowed', ' No excisional biopsy', ' Any of the following:', ' Tumor size 2, Nodes 1 (T2N1) or tumor size 3 nodes 0 (T3N0)', ' Any T with N2 (including axillary lymph nodes matted to one another) or N3', ' Any T4, including inflammatory breast cancer', ' Adjuvant patients with at least 4 positive lymph nodes and HER-2 overexpressing tumor', ' Supraclavicular or infraclavicular positive lymph nodes without distant metastases', ' Distant metastases with measurable disease in breast or lymph nodes', ' Synchronous bilateral primary breast cancer allowed if the more serious cancer meets entry criteria', ' Measurable or evaluable disease', ' PATIENT CHARACTERISTICS:', ' Age: Not specified', ' Sex: Female', ' Menopausal status: Not specified', 'Performance status: Not specified', ' Life expectancy: Not specified', ' Hematopoietic:', ' White cell count > 3000 / mm3 Platelet count > 100,000 / mm3', ' Hemoglobin > 9 mg / dl Bilirubin < 1.5 x normal Creatinine < 1.5 x normal left ventricular ejection fraction (LVEF) normal by resting nuclear ventriculogram Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception', ' Exclusions', ' Prior malignancies except:', ' Effectively treated squamous cell or basal cell skin cancer Carcinoma in situ of the cervix that has been curatively treated by surgery alone Nonbreast malignancy from which patient has been disease-free for 5 years and is at low risk of recurrence'], 'Results': ['Outcome Measurement: ', ' Cardiac Toxicity of Weekly Taxol Given With Weekly Herceptin When Delivered Immediately Following Four Cycles of Standard Dose AC.', ' Doxorubicin + cyclophosphamide in combination with paclitaxel and trastuzumab (AC-TP) Associated Systolic Dysfunction. Systolic function was measured by the ventricular ejection fraction (LVEF). LVEF is a measurement in determining how well your heart is pumping out blood and in diagnosing and tracking heart failure.', ' Time frame: 78 weeks (1.5 years)', 'Results 1: ', ' Arm/Group Title: Herceptin Regimen After AC', ' Arm/Group Description: Patients in the adjuvant and neoadjuvant groups after receiving [AC-TP] Chemotherapy (doxorubicin & cyclophosphamide).', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Asymptomatic LVEF < 50%: 1 1.9%', ' Congestive Heart Failure: 0 0.0%', 'Results 2: ', ' Arm/Group Title: Herceptin Regimen After TP', ' Arm/Group Description: Patients in the adjuvant and neoadjuvant groups after receiving chemotherapy and Taxol + Herceptin.', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Asymptomatic LVEF < 50%: 8 16.0%', ' Congestive Heart Failure: 1 2.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/52 (13.46%)', ' Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 0/52 (0.00%)', ' Atrial Fibrillation * 1/52 (1.92%)', ' Sepsis * 1/52 (1.92%)', ' Muscle weakness upper limb * 1/52 (1.92%)', ' Dizziness * 1/52 (1.92%)', ' Seizure * 1/52 (1.92%)', ' Nervous system disorders - Other, specify * [1]1/52 (1.92%)', 'Adverse Events 2:', ' Total: 1/30 (3.33%)', ' Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1/30 (3.33%)', ' Atrial Fibrillation * 0/30 (0.00%)', ' Sepsis * 0/30 (0.00%)', ' Muscle weakness upper limb * 0/30 (0.00%)', ' Dizziness * 0/30 (0.00%)', ' Seizure * 0/30 (0.00%)', ' Nervous system disorders - Other, specify * [1]0/30 (0.00%)']}

196c2132-c735-4b79-bf03-3a830fcaf0fc

Single

Adverse Events

NCT02924883

In the primary trial, all cases of Enteritis, Vertigo and Cardiac failure occurred in cohort 2.

Entailment

{'Clinical Trial ID': 'NCT02924883', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine + Placebo', ' Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)', 'INTERVENTION 2: ', ' Trastuzumab Emtansine + Atezolizumab', ' Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)'], 'Eligibility': ['Inclusion Criteria:', ' Archival tumor samples must be obtained from primary and/or metastatic sites', ' Able to submit tumor tissue that is evaluable for programmed death- ligand 1 (PD-L1) expression', ' HER-2 positive BC as defined by an immunohistochemistry score of 3 or gene amplified by in-situ hybridization as defined by a ratio of greater than or equal to (>=) 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies', ' Histologically or cytologically confirmed invasive BC: incurable, unresectable, locally advanced BC previously treated with multimodality therapy or metastatic BC', ' Prior treatment for BC in the: adjuvant; unresectable locally advanced; or metastatic settings; which must include both, a taxane and trastuzumab (alone or in combination with another agent)', ' Progression must have occurred during or after most recent treatment for locally advanced/metastatic BC or within 6 months after completing adjuvant therapy', ' Participants must have measurable disease that is evaluable as per RECIST v1.1', ' Eastern Cooperative Oncology Group Performance Status of 0 or 1', ' Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women and for women less than 12 months after the onset of menopause', ' Use of highly effective method of contraception as defined by the protocol', 'Exclusion Criteria:', ' Prior treatment with trastuzumab emtansine, cluster of differentiation 137 agonists, anti-programmed death-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents', ' Receipt of any anti-cancer drug/biologic or investigational treatment within 21 days prior to Cycle 1 Day 1 except hormone therapy, which can be given up to 7 days prior to Cycle 1 Day 1; recovery of treatment related toxicity consistent with other eligibility criteria', ' Radiation therapy within 2 weeks prior to Cycle 1, Day 1', ' History of exposure to the cumulative doses of anthracyclines', ' History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or participants who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrence', ' Cardiopulmonary dysfunction, symptomatic pleural effusion, pericardial effusion, or ascites', ' Participants with severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia', ' Current severe, uncontrolled systemic disease', ' Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment', ' Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, autoimmune hepatic disorders, sclerosis cholangitis or active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus', ' Need for current chronic corticosteroid therapy (>=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)', ' Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for greater than (>) 2 weeks prior to randomization', ' Participants with known central nervous system disease', ' Leptomeningeal disease', ' History of autoimmune disease', ' Prior allogeneic stem cell or solid organ transplantation', ' Active tuberculosis', ' Receipt of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live, attenuated vaccine will be required during the study', ' Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug (whichever is shorter) prior to randomization', ' Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial', ' Participants who are breastfeeding, or intending to become pregnant during the study'], 'Results': ['Outcome Measurement: ', " Progression-Free Survival (PFS) as Determined by Investigator's Tumor Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)", ' PFS was defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions.', ' Time frame: Baseline up to approximately 15 months', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine + Placebo', ' Arm/Group Description: Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)', ' Overall Number of Participants Analyzed: 69', ' Median (95% Confidence Interval)', ' Unit of Measure: months 6.8 (4.0 to 11.1)', 'Results 2: ', ' Arm/Group Title: Trastuzumab Emtansine + Atezolizumab', ' Arm/Group Description: Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)', ' Overall Number of Participants Analyzed: 133', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.2 (5.8 to 10.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 52/133 (39.10%)', ' Thrombocytopenia 2/133 (1.50%)', ' Anaemia 1/133 (0.75%)', ' Disseminated intravascular coagulation 0/133 (0.00%)', ' Atrial thrombosis 1/133 (0.75%)', ' Cardiac failure 0/133 (0.00%)', ' Vertigo 0/133 (0.00%)', ' Vomiting 3/133 (2.26%)', ' Nausea 1/133 (0.75%)', ' Colitis 1/133 (0.75%)', ' Constipation 1/133 (0.75%)', ' Enteritis 0/133 (0.00%)', ' Abdominal pain 0/133 (0.00%)', 'Adverse Events 2:', ' Total: 16/67 (23.88%)', ' Thrombocytopenia 0/67 (0.00%)', ' Anaemia 0/67 (0.00%)', ' Disseminated intravascular coagulation 1/67 (1.49%)', ' Atrial thrombosis 0/67 (0.00%)', ' Cardiac failure 1/67 (1.49%)', ' Vertigo 1/67 (1.49%)', ' Vomiting 0/67 (0.00%)', ' Nausea 1/67 (1.49%)', ' Colitis 0/67 (0.00%)', ' Constipation 0/67 (0.00%)', ' Enteritis 1/67 (1.49%)', ' Abdominal pain 2/67 (2.99%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

72619b0a-57c2-465c-8428-72019b59f8ae

Single

Eligibility

NCT02732119

Mark complained he had a racing heart twice in the last month and he is therefore excluded from the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT02732119', 'Intervention': ['INTERVENTION 1: ', ' Cohort A', ' Ribociclib (250 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally for 28 days. If no DLTs occurred, progressed to Cohort B', 'INTERVENTION 2: ', ' Cohort B', ' Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally'], 'Eligibility': ['Inclusion Criteria:', ' Adult men and women', ' Patient has a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer', ' Patient must have either measurable disease by RECIST 1.1 or bone lesions in absence of measurable disease.', ' ECOG Performance Status 0 - 1', ' Disease refractory to either, AI, tamoxifen or fulvestrant', ' Previously treated on any CDK 4/6 inhibitor.', ' Patient has adequate bone marrow and organ function.', 'Exclusion Criteria:', " Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.", ' Patient has received more than one line of chemotherapy for advanced disease.', ' Previous treatment with mTOR inhibitors, or exemestane for advanced disease.', ' Progressed on more than one CDK 4/6 inhibitor', ' Patient with CNS involvement unless they are at least 4 weeks from prior therapy completion.', ' Clinically significant, uncontrolled heart disease and/or recent cardiac events.'], 'Results': ['Outcome Measurement: ', ' Participants With Dose Limiting Toxicities by Preferred Term in Cycle 1 (28 Days) - in Phase I', ' A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as having a reasonably possible relationship to the study medication(s) and is unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment (cycle 1) and meets any of the criteria defined in the protocol. National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 will be used for all grading.', ' Time frame: Baseline up to 28 days', 'Results 1: ', ' Arm/Group Title: Cohort A', ' Arm/Group Description: Ribociclib (250 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally for 28 days. If no DLTs occurred, progressed to Cohort B', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Febrile neutropenia Grade 3: 1 12.5%', ' Neutropenia Grade 4: 0 0.0%', ' Thrombocytopenia Grade 4: 0 0.0%', ' Cardiac tamponade Grade 4: 1 12.5%', ' Diarrhea Grade 3: 1 12.5%', ' Hyperglycemia Grade 4: 0 0.0%', 'Results 2: ', ' Arm/Group Title: Cohort B', ' Arm/Group Description: Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Febrile neutropenia Grade 3: 1 10.0%', ' Neutropenia Grade 4: 1 10.0%', ' Thrombocytopenia Grade 4: 1 10.0%', ' Cardiac tamponade Grade 4: 0 0.0%', ' Diarrhea Grade 3: 0 0.0%', ' Hyperglycemia Grade 4: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/8 (37.50%)', ' Anaemia 0/8 (0.00%)', ' Febrile neutropenia 1/8 (12.50%)', ' Neutropenia 2/8 (25.00%)', ' Acute coronary syndrome 0/8 (0.00%)', ' Atrial fibrillation 0/8 (0.00%)', ' Cardiac failure 0/8 (0.00%)', ' Cardiac tamponade 1/8 (12.50%)', ' Abdominal pain 1/8 (12.50%)', ' Diarrhoea 1/8 (12.50%)', ' Intestinal obstruction 0/8 (0.00%)', ' Nausea 0/8 (0.00%)', 'Adverse Events 2:', ' Total: 3/10 (30.00%)', ' Anaemia 0/10 (0.00%)', ' Febrile neutropenia 0/10 (0.00%)', ' Neutropenia 0/10 (0.00%)', ' Acute coronary syndrome 0/10 (0.00%)', ' Atrial fibrillation 0/10 (0.00%)', ' Cardiac failure 0/10 (0.00%)', ' Cardiac tamponade 0/10 (0.00%)', ' Abdominal pain 0/10 (0.00%)', ' Diarrhoea 0/10 (0.00%)', ' Intestinal obstruction 1/10 (10.00%)', ' Nausea 0/10 (0.00%)']}

{'Clinical Trial ID': '', 'Intervention': '', 'Eligibility': '', 'Results': '', 'Adverse Events': ''}

b8663fa7-585a-4cd9-afd2-89e8e1a58b82

Comparison

Intervention

NCT02536794

NCT00712985

the primary trial and the secondary trial both administer treatments to their patients through IV.

Entailment

{'Clinical Trial ID': 'NCT02536794', 'Intervention': ['INTERVENTION 1: ', ' Treatment (MEDI4736, Tremelimumab)', ' Patients receive anti-B7H1 monoclonal antibody MEDI4736 IV over 1 hour and tremelimumab IV over 1 hour on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Four weeks after the last combination dose, patients continue to receive anti-B7H1 monoclonal antibody MEDI4736 every 2 weeks for up to 18 additional doses in the absence of disease progression or unacceptable toxicity. Patients achieving PD or clinical benefit (CR, PR, or SD) may be retreated with anti-B7H1 monoclonal antibody MEDI4736 for an additional 52 weeks.', ' Anti-B7H1 Monoclonal Antibody MEDI4736: Given IV', ' Laboratory Biomarker Analysis: Correlative studies', ' Pharmacological Study: Correlative studies', ' Tremelimumab: Given IV'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have a histologically documented (either primary or metastatic site) diagnosis of breast cancer that is HER2 non-overexpressing by immunohistochemistry, namely 0 or 1; if they have an equivocal immunohistochemistry, 2, the tumor must be non-gene amplified by fluorescence in situ hybridization (FISH) performed upon the primary tumor or metastatic lesion (ratio < 2 and HER2 copy number < 4); estrogen receptor (ER) positivity is defined as 1% or greater', ' Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria', ' Patients who are ER negative must have progressed through at least one prior chemotherapy regimen in the metastatic setting or within 12 months of their last adjuvant systemic treatment; patients who are ER positive must have progressed through standard hormone therapy options and have received at least one line of chemotherapy in the metastatic setting', ' Completion of prior chemotherapy systemic anticancer therapy at least 2 weeks prior to study entry', ' Radiation therapy must be completed at least 2 weeks prior to study entry; radiated lesions may not serve as measurable disease unless they have been radiated over 12 months prior to enrollment', ' Patients may have parenchymal brain metastases if stable (no evidence of progression) for at least 1 month after local therapy (radiation or surgery); leptomeningeal disease is excluded; must have completed any prescribed steroid taper', ' Patients may have had a prior diagnosis of cancer if it has been > 5 years since their last treatment', ' Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2', ' Absolute neutrophil count >= 1,000/mcL', ' Platelets >= 50,000/mcl', ' Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN) (or =< 3 times ULN in case of liver metastasis)', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SPGT]) =< 2.5 X institutional ULN (or =< 5 times ULN in case of liver metastasis)', ' Creatinine =< 2 ng/ml', ' Females of child-bearing potential (FOCBP) and males must agree to use 2 methods of adequate contraception prior to study entry, for the duration of study participation, and for number (#) days following completion of therapy; should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately', ' NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:', ' Has not undergone a hysterectomy or bilateral oophorectomy', ' Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)', ' FOCBP must have a negative pregnancy test within 7 days prior to registration on study', ' Willingness to provide a fresh biopsy prior to study enrollment and after 2 cycles of treatment', ' Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study', 'Exclusion Criteria:', ' Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are not eligible.', ' Current or prior use of immunosuppressive therapy within 2 weeks of starting investigational therapy', ' Patients who are taking any herbal (alternative) medicines are NOT eligible for participation; patients must be off any such medications by the time of registration for at least 2 weeks; NOTE: Vitamin supplements are acceptable', ' Patients may not have received any other investigational agents within 4 weeks prior to registration', ' Prior treatment with immune therapy (including but not limited to cluster of differentiation [CD]137, OX40, programmed death [PD]-1, PD-L1 or cytotoxic T-lymphocyte antigen 4 [CTLA4] inhibitors)', ' Prior severe infusion reaction to a monoclonal antibody', ' Patients with a history of or active autoimmune disease within the past 3 years with the following exceptions:', ' Vitiligo or alopecia', ' Hypothyroidism on stable doses of thyroid replacement therapy', ' Psoriasis not requiring systemic therapy within the past 3 years', ' History of primary immunodeficiency disease or tuberculosis', ' Major medical conditions that might affect study participation (uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection) are not eligible; other significant comorbid condition which the investigator feels might compromise effective and safe participation in the study', ' Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:', ' Uncontrolled pulmonary, renal, or hepatic dysfunction', ' Ongoing or active infection requiring systemic treatment', ' Known active or chronic viral hepatitis or human immunodeficiency virus (HIV)', ' Psychiatric illness/social situations that would limit compliance with study requirements', " Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints", ' Female patients who are pregnant or nursing are not eligible'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR) in Patients With Metastatic HER2 Negative Breast Cancer Treated With Durvalumab in Combination With Tremelimumab', ' Overall response rate is defined as the number of patients with partial response (PR), plus those with complete response (CR) using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 with the following definitions:', ' Complete Response - Disappearance of all lesions Partial Response - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.', ' Time frame: Up to a maximum of 49 cycles where 1 cycle = 4 weeks for the first 4 cycles and than 1 cycle =2 weeks for 45 cycles', 'Results 1: ', ' Arm/Group Title: Treatment (MEDI4736, Tremelimumab)', ' Arm/Group Description: Patients receive anti-B7H1 monoclonal antibody MEDI4736 IV over 1 hour and tremelimumab IV over 1 hour on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Four weeks after the last combination dose, patients continue to receive anti-B7H1 monoclonal antibody MEDI4736 every 2 weeks for up to 18 additional doses in the absence of disease progression or unacceptable toxicity. Patients achieving PD or clinical benefit (CR, PR, or SD) may be retreated with anti-B7H1 monoclonal antibody MEDI4736 for an additional 52 weeks.', ' Anti-B7H1 Monoclonal Antibody MEDI4736: Given IV', ' Laboratory Biomarker Analysis: Correlative studies', ' Pharmacological Study: Correlative studies', ' Tremelimumab: Given IV', ' Overall Number of Participants Analyzed: 27', ' Measure Type: Number', ' Unit of Measure: participants 4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/30 (60.00%)', ' Myocarditis and Ventricular Tachycardia 1/30 (3.33%)', ' Vomiting 1/30 (3.33%)', ' Vomiting [1]1/30 (3.33%)', ' Enteritis [2]1/30 (3.33%)', ' Fever and chills [3]2/30 (6.67%)', ' Fever [4]1/30 (3.33%)', ' Hepatitis 2/30 (6.67%)', ' Hepatitis [5]1/30 (3.33%)', ' Spontaneous bacterial peritonitis 1/30 (3.33%)', ' Urosepsis [6]1/30 (3.33%)', ' Disease progression 2/30 (6.67%)']}

{'Clinical Trial ID': 'NCT00712985', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid 5 mg IV', ' Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with Stage I, II or IIIa breast cancer being treated with a non-steroidal Aromatase Inhibitor (AI) .Negative bone scan (no bone metastases).', ' Calculated creatinine clearance > 40 ml/min', ' Documented T score of less than or equal to -1.5 on Dual Energy X-ray Absorptiionmetry (DXA) scan at the lumbar spine or femoral neck within 3 months prior to screening.', ' Urine NTx > 50 nano moles(nM)based on second morning void.', ' Signed informed consent.', ' Ambulatory patients at least 18 years of age.', ' Eastern Cooperative Oncology Group (ECOG)0-2.', ' Ability to comply with trial requirements.', 'Exclusion Criteria:', ' Bone Metastases.', ' Any woman of child bearing potential.', ' Patients with fractures occurring within three months prior to randomization. - Greater than a 2+ protein on urine dipstick without evidence of contamination or bacteriuria (may be repeated one time, at least a day apart).', ' Calculated creatinine clearance less than 30 mL/min at screening.', ' Serum calcium > 2.75 mmol/L (11.0 mg/dL) or < 2.00 mmol/L (8.0 mg/dL).', ' Liver Function tests (LFT)> 2.0 x upper limit of normal (ULN).', ' Serum alkaline phosphatase > 1.5 x ULN. History of hypersensitivity to bisphosphonates.', ' Evidence of vitamin D deficiency (serum 25-(OH) D of less than 15 ng/ml).', ' History of uveitis or iritis, except when secondary to trauma, and must have resolved > 2 years prior to entry.', ' A history of invasive malignancy of any organ system, treated or untreated, within the past 12 months prior to screening; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, Ductal Carcinoma in-situ (DCIS) that has been surgically removed, and Carcinoma in-situ (CIS) of the uterine cervix that has been surgically removed.', ' Previous major solid organ transplant recipient or on a transplant waiting list.', ' Treatment with any investigational drug within 30 days prior to randomization.', " History of hyperparathyroidism, hypoparathyroidism, Osteogenesis imperfecta, Paget's disease or any metabolic bone disease other than osteoporosis.", ' Any medical condition which would interfere with the action of the study drug or limit life expectancy to less than 6 months.', ' Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial.', ' Prior treatment with IV bisphosphonates within the last 2 years.', ' Previous use of oral bisphosphonates within the past 2 years (unless used for less than 8 weeks*). *NOTE: If used less than 8 weeks, the washout period is 6 months.', ' Treatment with raloxifene, calcitonin, tibolone or hormone replacement therapy. The washout period for these medications is 6 months prior to randomization.', ' Any treatment with strontium ranelate, samarium, sodium fluoride or parathyroid hormone.', ' Use of systemic high dose corticosteroids at an average dose of > 7.5 mg per day of oral prednisone or equivalent for a period of three months or more prior to screening.', ' Known hypersensitivity to zoledronic acid or other bisphosphonates.', ' Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.', ' Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants).'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Urine and Serum NTx and Serum CTx Within Normal Range at 12 Months', ' 17 women with early breast cancer receiving adjuvant Aromatase Inhibitor (AI) therapy were treated with a single 5 mg IV dose of zoledronic acid. Urine and serum NTx and serum CTx were measured at baseline and month 12.', ' Time frame: One year', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid 5 mg IV', ' Arm/Group Description: Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Number', ' Unit of Measure: participants 13'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/17 (0.00%)']}

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