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Comparison

Intervention

NCT01928186

NCT00684983

All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.

Contradiction

{'Clinical Trial ID': 'NCT01928186', 'Intervention': ['INTERVENTION 1: ', ' Diagnostic (FLT PET)', ' Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.', ' Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.', ' Positron Emission Tomography: Undergo FLT PET', ' Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.'], 'Eligibility': ['Inclusion Criteria:', ' A new diagnosis of invasive breast cancer > 1.0 cm in size, ER+ clinical stage I-III', ' Patient must have surgical resection followed by systemic adjuvant therapy with an aromatase inhibitor (AIs) as part of planned treatment; any approved AI at standard clinical dosing may be used; in pre-menopausal patients, ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist will be started prior to initiation of the AI on a separate clinical trial in parallel with the imaging study', ' Have tissue block available from core biopsy for correlative biomarkers and genomic assay', ' Have menopausal status determined prior to study enrollment; for study purposes, postmenopausal is defined as', ' A prior documented bilateral oophorectomy, or', ' A history of at least 12 months without spontaneous menstrual bleeding, or', ' Age 60 or older with a prior hysterectomy without oophorectomy, or', ' Age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown) with a documented follicle-stimulating hormone (FSH) level demonstrating confirmatory elevation in the postmenopausal range for the lab', ' Negative pregnancy test within 7 days of baseline positron emission tomography (PET) scan for pre-menopausal patients', ' Tumor HER2/neu expression must be determined (as part of standard clinical care) prior to study enrollment; HER2 may be tested by any Food and Drug Administration (FDA) approved HER2 testing method; if determination is intermediate by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or another alternate HER2 test must be performed', ' Be a candidate for [18F]FLT PET imaging', ' 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', ' Be willing and able to comply with scheduled visits and other trial procedures', 'Exclusion Criteria:', ' Current use of aromatase inhibitor as prevention or treatment for breast cancer', ' Life expectancy of less than two months', ' HER2/neu positive by IHC and/or another FDA approved HER2 testing method', ' Inability to tolerate scanning (e.g. - claustrophobia, severe pain)', ' Weight exceeding capacity of imaging table'], 'Results': ['Outcome Measurement: ', ' Percent Change in Net Influx Constant (Ki) by FLT PET', ' Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.', " Association between Ki-67 and Ki by FLT (KFLT) decline will be analyzed using the mid-P adjustment to Fisher's exact test to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response.", ' Time frame: Baseline to up to 6 weeks', 'Results 1: ', ' Arm/Group Title: Diagnostic (FLT PET)', ' Arm/Group Description: Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.', ' Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.', ' Positron Emission Tomography: Undergo FLT PET', ' Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.', ' Overall Number of Participants Analyzed: 28', ' Median (Full Range)', ' Unit of Measure: % change -32.0 (-82.4 to 3953.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/28 (0.00%)']}

{'Clinical Trial ID': 'NCT00684983', 'Intervention': ['INTERVENTION 1: ', ' Arm A', ' Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO', 'INTERVENTION 2: ', ' Arm B', ' Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed, locally advanced: (a T4 primary tumor and stage IIIB or IIIC disease) or metastatic breast cancer that has progressed after treatment with regimens that included trastuzumab and either an anthracycline or a taxane or both', ' NOTE: Agents need not have been given concurrently, nor in the same regimen', ' NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment', ' Pre-treatment requirements:', ' Prior treatment with trastuzumab in the neo-adjuvant, adjuvant or metastatic setting is required', ' NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment', ' NOTE: Concomitant use of trastuzumab is not allowed in this study', ' Prior chemotherapy allowed in the neo-adjuvant, adjuvant, or metastatic setting; unlimited prior chemotherapy is allowed', ' Prior hormonal therapy allowed in the neo-adjuvant, adjuvant, or metastatic setting; unlimited prior hormonal therapy is allowed', ' HER2 positive, defined as:', ' Validated immunohistochemistry (IHC) assay score of 3+ (defined as uniform, intense staining of > 30% of invasive tumor cells)', ' -OR- Average HER2 gene copy number of > 6', ' -OR- Gene amplified (HER2:D17Z1 ratio > 2.20)', ' Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria', ' Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only', ' Hemoglobin > 9.0 g/dL (obtained =< 7 days prior to registration)', ' White blood cells (WBC) >= 3,000/mL (obtained =< 7 days prior to registration)', ' Absolute neutrophil count (ANC) >= 1500/mL (obtained =< 7 days prior to registration)', ' Platelet count >= 75,000/mL (obtained =< 7 days prior to registration)', ' Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 7 days prior to registration)', ' Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x ULN or SGOT (AST) and SGPT (ALT) =< 5 x ULN if elevations are due to liver metastases (obtained =< 7 days prior to registration)', ' Serum creatinine =< 1.5 x ULN (obtained =< 7 days prior to registration)', ' Creatinine clearance >= 30 mL/min (calculated according to Cockcroft and Gault) (obtained =< 7 days prior to registration)', ' NOTE: In patients with moderate renal impairment (calculated creatinine clearance 30-50 mL/min) at baseline, a dose reduction of the capecitabine starting dose is required', ' Fasting glucose < 120 mg/dL (obtained =< 7 days prior to registration)', ' NOTE: Patients with diabetes are allowed to participate, provided that their blood glucose is within the guidelines above upon enrollment', ' International normalization ratio (INR) =< 1.5 x ULN (obtained =< 7 days prior to registration)', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2', ' Adequate cardiac function defined as an ejection fraction >= 50% as determined by multi gated acquisition scan (MUGA) or echocardiogram', ' Life expectancy > 3 months', ' Has written informed consent been obtained?', ' Willingness to return to a North Central Cancer Treatment Group (NCCTG) or other participating cooperative group institution for treatment and follow-up', ' Patient willing to provide tissue and blood samples for research purposes', ' Availability of diagnostic material (i.e., diagnostic slides confirming locally advanced/metastatic disease and HER2 stained slides) and operative and pathology reports from diagnosis of locally advanced or metastatic breast cancer', ' NOTE: Biopsy of recurrent disease and submission of these materials is not required if materials available from initial diagnosis of locally advanced/metastatic disease', ' Ability to complete questionnaire(s) by themselves or with assistance', '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:', ' Pregnant women', ' Nursing women', ' 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 =< 5 years prior to registration', ' Actively being treated for other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix; if there is a history of prior malignancy, patient must not be receiving other specific treatment for their cancer', ' New York Heart Association class III or IV cardiovascular disease', " Current, active hepatic or biliary disease except Gilbert's syndrome or asymptomatic gallstones", ' Evidence of active brain metastasis including leptomeningeal involvement; central nervous system (CNS) metastasis controlled by prior surgery and/or radiotherapy is allowed', ' NOTE: 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 must have been discontinued', ' Major surgery, chemotherapy, or immunologic therapy =< 4 weeks prior to registration', ' Radiotherapy =< 4 weeks prior to registration, except if to a non-target lesion only; prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed; if patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting; acute adverse events from radiation must have resolved to =< Common Terminology Criteria for Adverse Events (CTCAE) version (v) 3.0 grade 1', ' Prior treatment with any therapy targeting IGF-I, IGF-II or its receptors (either monoclonal antibody or tyrosine kinase inhibitor), including but not limited to any of the following (which would have been received on a previous clinical trial):', ' IMC-A12 (cixutumumab)', ' CP-751,871 (figitumumab)', ' AMG-479', ' INSM-18', ' MK0646 (h7C10)', ' SCH717454 (19D12, robatumumab)', ' R1507', ' OSI-906', ' BMS-754807', ' PPP', ' NVP-AEW541', ' AVE-1642', ' MEDI-573', ' Prior therapy with any therapy targeting HER1 (EGFR) and/or HER2 (either monoclonal antibody or tyrosine kinase) other than trastuzumab, including but not limited to any of the following:', ' Lapatinib (Tykerb)', ' Gefitinib (Iressa)', ' Erlotinib (Tarceva)', ' Cetuximab (Erbitux)', ' Panitumumab (Vectibix)', ' Currently receiving treatment with any agents that are contraindicated by study therapies:', ' IMC-A12 - none identified to date', ' Lapatinib - CYP3A4 inhibitors and inducers, including grapefruit and grapefruit juice', ' Capecitabine - warfarin (Coumadin), cimetidine (Tagamet), allopurinol (Lopurin), sorivudine (Usevir) or brivudine (Brivex), ketoconazole (Nizoral), itraconazole (Sporanox), ritonavir (Norvir), amprenavir (Agenerase) or indinavir (Crixivan)', ' Uncontrolled intercurrent illness including, but not limited to:', ' Poorly controlled diabetes', ' Ongoing or active infection', ' Symptomatic congestive heart failure', ' Unstable angina pectoris', ' Cardiac arrhythmia', ' 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 the safety of the prescribed regimens', ' Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered', ' Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive with an acquired immune deficiency syndrome (AIDS)-defining illness; HIV positive patients with cluster of differentiation (CD) 4 count within institutional normal range and no history of an AIDS-defining illness are eligible; however, some antiviral/antiretroviral medications which have CYP3A4 interactions are prohibited on this study'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.', ' Time frame: From randomization to the earliest date of documentation of disease progression, up to 5 years', 'Results 1: ', ' Arm/Group Title: Arm A', ' Arm/Group Description: Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO', ' Overall Number of Participants Analyzed: 19', ' Median (95% Confidence Interval)', ' Unit of Measure: Median survival and CI in months 6.0 (4.3 to 8.6)', 'Results 2: ', ' Arm/Group Title: Arm B', ' Arm/Group Description: Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1 hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO', ' Overall Number of Participants Analyzed: 37', ' Median (95% Confidence Interval)', ' Unit of Measure: Median survival and CI in months 4.9 (2.9 to 8.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/19 (21.05%)', ' Hemoglobin decreased 0/19 (0.00%)', ' Hemolysis 0/19 (0.00%)', ' Diarrhea 2/19 (10.53%)', ' Ear, nose and throat examination abnormal 0/19 (0.00%)', ' Esophageal ulcer 0/19 (0.00%)', ' Gastritis 1/19 (5.26%)', ' Mucositis oral 0/19 (0.00%)', ' Nausea 1/19 (5.26%)', ' Vomiting 1/19 (5.26%)', ' Chest pain 0/19 (0.00%)', ' Chills 0/19 (0.00%)', ' Disease progression 1/19 (5.26%)', 'Adverse Events 2:', ' Total: 14/45 (31.11%)', ' Hemoglobin decreased 1/45 (2.22%)', ' Hemolysis 1/45 (2.22%)', ' Diarrhea 1/45 (2.22%)', ' Ear, nose and throat examination abnormal 1/45 (2.22%)', ' Esophageal ulcer 1/45 (2.22%)', ' Gastritis 1/45 (2.22%)', ' Mucositis oral 1/45 (2.22%)', ' Nausea 1/45 (2.22%)', ' Vomiting 1/45 (2.22%)', ' Chest pain 1/45 (2.22%)', ' Chills 1/45 (2.22%)', ' Disease progression 0/45 (0.00%)']}

5bc844fc-e852-4270-bfaf-36ea9eface3d

Single

Eligibility

NCT00662129

Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.

Contradiction

{'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': ''}

86b7cb3d-6186-4a04-9aa6-b174ab764eed

Comparison

Adverse Events

NCT00093145

NCT00703326

Heart-related adverse events were recorded in both the primary trial and the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00093145', 'Intervention': ['INTERVENTION 1: ', ' Albumin-bound Paclitaxel, Carboplatin + Herceptin', ' Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.'], 'Eligibility': ['Inclusion Criteria:', ' Confirmed adenocarcinoma of the breast', ' Tumor shows 3+ overexpression of the human epidermal growth factor receptor 2 (HER-2)/proto-oncogene by immunohistochemistry assay, or is fluorescence in situ hybridization (FISH)+', ' Stage IV disease', ' Measurable disease', ' At least 3 weeks since prior cytotoxic chemotherapy', ' At least 4 weeks since radiotherapy with full recovery', ' At least 4 weeks since major surgery with full recovery', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2', ' At least 18 years old', ' Absolute neutrophil count (ANC) at least 1.5 x 10^9 cells/L', ' Platelets at least 100 x 10^9 cells/L', ' Hemoglobin at least 9 g/dL', ' Aspartame aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5X upper limit normal', ' Alkaline Phosphatase less than 1.5X upper limit normal', ' Creatinine less than 1.5 gm/dL', ' Normal left ventricular ejection fraction', ' Negative pregnancy test', ' Agree to use method to avoid pregnancy', ' Informed Consent is obtained', 'Exclusion Criteria:', ' Up to one regimen of prior neo-adjuvant or adjuvant chemotherapy is allowed. One year since Taxane and Herceptin treatment.', ' Cumulative life-time dose of doxorubicin is greater than 360 mg/m^2', ' Concurrent immunotherapy or hormonal therapy', ' Parenchymal brain metastases, if present, must be documented to be clinically and radiographically stable for at least 6 months after treatment', ' Serious intercurrent medical or psychiatric illness, including serious active infection', ' History of congestive heart failure', ' History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer', ' Patients who have received an investigational drug within the previous 3 weeks', ' Patient is currently enrolled in another clinical study receiving investigational therapies', ' Pregnant or nursing women'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response', ' Percentage of participants who achieved an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing, or with the persistence of one or more non-target lesions and/or the maintenance of tumor marker level above the normal limits.', ' Time frame: Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months)', 'Results 1: ', ' Arm/Group Title: Albumin-bound Paclitaxel, Carboplatin + Herceptin', ' Arm/Group Description: Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 62.5 (45.7 to 79.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/32 (15.63%)', ' Febrile neutropenia 1/32 (3.13%)', ' Supraventricular tachycardia 1/32 (3.13%)', ' Hypersensitivity 2/32 (6.25%)', ' Catheter site infection 1/32 (3.13%)', ' Confusional state 1/32 (3.13%)']}

{'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%)']}

dbed5471-c2fc-45b5-b26f-430c9fa37a37

Single

Eligibility

NCT01097642

Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01097642', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone', ' Brand name is Ixempra ®; it is an epothilone B analog used in combination with other chemotherapeutics against cancer.', ' Ixabepilone: Ixabepilone will be given at 40mg/m^2 IV over 180 minutes on day 1 of each of four 21 day cycles.', 'INTERVENTION 2: ', ' Ixabepilone Plus Cetuximab', ' Cetuximab, brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor and monoclonal antibody used with Ixabepilone against cancer.', ' Cetuximab: Cetuximab will be given at 400mg/m^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m^2 IV over 60 minutes.', ' Ixabepilone: Ixabepilone will be given at 40mg/m^2 IV over 180 minutes on day 1 of each of four 21 day cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Patients with histologic confirmation of invasive breast carcinoma.', ' Patients must have intact primary tumor.', ' Patients greater than or equal to 18 years.', ' Patients should have T1N1-3M0 or T2-4 N0-3M0.', ' Patients with bilateral breast cancer are eligible.', ' Patients with second primary breast cancers are eligible.', ' Patients should have a Karnofsky performance scale of greater than or equal to 70%.', ' Patients must have clinically measurable disease to be treated in the neoadjuvant setting.', ' Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of greater than or equal to 1500/mm^3, and platelet count greater than or equal to 100000mm^3.', ' Patients must have adequate liver function with a bilirubin within normal laboratory values. Alkaline phosphatase and transaminases (ALT and AST) may be up to 1.5 x upper limit of normal (ULN) of the institution.', ' Patients should have adequate renal function with creatinine levels within normal range.', ' Patients should have a normal left ventricular ejection fraction (LVEF) of greater than or equal to 50%.', ' Negative serum or urine pregnancy test for a woman of childbearing potential (WOCBP).', ' WOCBP must use a reliable and appropriate contraceptive method during the study and six months after chemotherapy is completed. WOCBP are women who are not menopausal for 12 months or had no previous surgical sterilization.', ' Patients must agree to have study biopsies.', ' Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.', 'Exclusion Criteria:', ' Patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer.', ' Her2Neu, ER and PR positive patients should be excluded.', ' Patients with Inflammatory breast cancer (IBC) are excluded.', ' Patients with an organ allograft or other history of immune compromise.', ' Prior treatment with any investigational drug within the preceding 4 weeks.', ' Chronic treatment with systemic steroids or another immunosuppressive agent.', ' A Known history of HIV seropositivity.', ' Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin defined as 1 mg a day).', ' Other concurrent and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration).', ' Patients with a pre-existing peripheral neuropathy.'], 'Results': ['Outcome Measurement: ', ' Complete Response Rate', " The study's primary objective is to determine the pathologic complete response rate (pCR) (breast and axilla) of Ixabepilone versus Ixabepilone when combined with cetuximab in patients with invasive breast adenocarcinoma T1N1-N3M0 or T2-4 N0-3M0 disease who are triple negative and who are candidates for preoperative chemotherapy.", ' The criteria used: "Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by 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.", or similar definition that is accurate and appropriate.', ' Time frame: one year after treatment', 'Results 1: ', ' Arm/Group Title: Ixabepilone', ' Arm/Group Description: Brand name is Ixempra ; it is an epothilone B analog used in combination with other chemotherapeutics against cancer.', ' Ixabepilone: Ixabepilone will be given at 40mg/m^2 IV over 180 minutes on day 1 of each of four 21 day cycles.', ' Overall Number of Participants Analyzed: 15', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 13.3%', 'Results 2: ', ' Arm/Group Title: Ixabepilone Plus Cetuximab', ' Arm/Group Description: Cetuximab, brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor and monoclonal antibody used with Ixabepilone against cancer.', ' Cetuximab: Cetuximab will be given at 400mg/m^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m^2 IV over 60 minutes.', ' Ixabepilone: Ixabepilone will be given at 40mg/m^2 IV over 180 minutes on day 1 of each of four 21 day cycles.', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 8 32.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/15 (13.33%)', ' Neutropenia 0/15 (0.00%)', ' GI Events 0/15 (0.00%)', ' Peripheral neuropathy 2/15 (13.33%)', ' Rash 0/15 (0.00%)', 'Adverse Events 2:', ' Total: 6/25 (24.00%)', ' Neutropenia 2/25 (8.00%)', ' GI Events 1/25 (4.00%)', ' Peripheral neuropathy 2/25 (8.00%)', ' Rash 1/25 (4.00%)']}

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

20c35c89-8d23-4be3-b603-ac0ee0f3b4de

Comparison

Intervention

NCT00852930

NCT02308020

Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy.

Contradiction

{'Clinical Trial ID': 'NCT00852930', 'Intervention': ['INTERVENTION 1: ', ' Laser Therapy Alone', ' therapist administered laser treatment', ' laser: therapist administered laser', 'INTERVENTION 2: ', ' Mld Alone', ' therapist administered manual lymphatic drainage', ' manual lymphatic drainage: therapist administered massage therapy'], 'Eligibility': ['Inclusion Criteria:', ' Breast cancer survivors will be included if they:', ' are age 21 or older;', ' require professional treatment for Stage I or II lymphedema as defined by the International Society of Lymphology;', ' have an order for lymphedema treatment; and', ' are willing and able to drive to the study sites.', 'Exclusion Criteria:', ' Individuals will not be included if they:', ' are actively undergoing intravenous chemotherapy or radiation therapy;', ' have a history of bilateral lymphedema that prohibits extracellular fluid comparison to an unaffected limb;', ' are unable to stand upright for measurement of height and weight;', ' have active/metastatic cancer;', ' are pregnant,:', ' have artificial joints in areas where electrode placement is critical, or have a pacemaker/internal defibrillator; or', ' have congestive heart failure (CHF), chronic/acute renal or hepatic disease, pulmonary edema, thrombophlebitis, deep vein thrombosis (DVT), acute infection of any kind, and inflammation in the trunk or arms.'], 'Results': ['Outcome Measurement: ', ' LDex Change-', ' Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.', ' Time frame: Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks.', 'Results 1: ', ' Arm/Group Title: Laser Therapy Alone', ' Arm/Group Description: therapist administered laser treatment', ' laser: therapist administered laser', ' Overall Number of Participants Analyzed: 15', ' Median (Inter-Quartile Range)', ' Unit of Measure: LDex 28.0 (17 to 35)', 'Results 2: ', ' Arm/Group Title: Mld Alone', ' Arm/Group Description: therapist administered manual lymphatic drainage', ' manual lymphatic drainage: therapist administered massage therapy', ' Overall Number of Participants Analyzed: 16', ' Median (Inter-Quartile Range)', ' Unit of Measure: LDex 17.8 (3 to 38)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/15 (0.00%)', 'Adverse Events 2:', ' Total: 0/16 (0.00%)']}

{'Clinical Trial ID': 'NCT02308020', 'Intervention': ['INTERVENTION 1: ', ' Part A Abemaciclib: HR+, HER2+ Breast Cancer', ' Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.', 'INTERVENTION 2: ', ' Part B Abemaciclib: HR+, HER2- Breast Cancer', ' Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET).', ' Participants may continue to receive treatment until discontinuation criteria are met.'], 'Eligibility': ['Inclusion Criteria:', ' Have brain metastases secondary to hormone receptor positive breast cancer, NSCLC, or melanoma.', ' Have either human epidermal growth factor receptor 2 positive (HER2+) (Study Part A) or negative HER2- (Study Part B) breast cancer.', ' Participants in Study Part C must have HR+ breast cancer, NSCLC, or melanoma with brain lesions clinically indicated for surgical resection as well as consent to provide tissue for drug concentration determination after 5 to 14 days of study drug dosing.', ' Participants in Part D must have NSCLC of any subtype.', ' Participants in Part E must have melanoma of any subtype.', ' Participants in Part F must have HR+ breast cancer, NSCLC, or melanoma with leptomeningeal metastases.', ' For Parts A, B, D, and E: Must have at least 1 measurable brain lesion 10 millimeters (mm) in the longest diameter (LD).', ' For Part C (surgical): Have metastatic brain lesion(s) for which surgical resection is clinically indicated.', ' Have completed local therapy (surgical resection, whole-breast radiotherapy (WBRT), or SRS) 14 days prior to initiating abemaciclib and recovered from all acute effects.', ' If receiving concomitant corticosteroids, must be on a stable or decreasing dose for at least 7 days prior to the baseline Gd-MRI.', ' Have a Karnofsky performance status of 70.', ' Have a life expectancy 12 weeks.', ' For HR+ breast cancer participants in part A, B, C, and F: If currently receiving endocrine therapy, a participant may continue to receive the same endocrine therapy provided that extracranial disease is stable for at least 3 months and central nervous system (CNS) disease progression has occurred while on this endocrine therapy. If these conditions are not met, participants must discontinue endocrine therapy prior to initiation of abemaciclib.', ' For HER2+ breast cancer participants in parts A, C, and F: participants may receive concurrent treatment (ongoing or initiated simultaneously with abemaciclib) with IV trastuzumab.', ' For NSCLC participants in parts C, D, and F: if currently receiving gemcitabine or pemetrexed (single-agent or in combination with another therapy), a participant may continue to receive 1 of these 2 therapies provided that extracranial disease is stable for at least 6 weeks and CNS disease progression has occurred while on this therapy.', ' Have adequate organ function.', 'Exclusion Criteria:', ' Require immediate local therapy, including but not limited to WBRT, SRS, or surgical resection, for treatment of brain metastases.', ' Are taking concurrent enzyme-inducing antiepileptic drugs (EIAED).', ' Have evidence of significant (ie, symptomatic) intracranial hemorrhage.', ' For Parts A, B, C, D, E: Have evidence of leptomeningeal metastases. Note: discrete dural metastases are permitted.', ' Have experienced >2 seizures within 4 weeks prior to study entry.', ' For Parts A, B, D, E, and F: Have previously received treatment with any cyclin dependent kinase 6 (CDK6) inhibitor. For Part C participants may have received prior palbociclib or ribociclib, but not abemaciclib treatment.', ' Have known contraindication to Gd-MRI.', ' Have a preexisting chronic condition resulting in persistent diarrhea.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Intracranial Response Rate (OIRR)', ' OIRR is the percentage of participants with a (CR) or (PR) based on the Response Assessment in Neuro-Oncology Brain Metastasis (RANO-BM) response criteria. CR is measurable target lesions, the disappearance of all central nervous system (CNS) target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum longest duration (LD) of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Nontarget lesions requires disappearance CNS non-target lesions and no new CNS lesions. Stable disease (SD) is less than (<)30% decrease relative to baseline but <20% increase in sum LD relative to nadir. Progressive disease (PD) is greater than or equal to ( ) 20% increase in sum LD relative to nadir and a relative increase of 20%, 1 lesion must increase by absolute value of 5 millimeter (mm).', ' Time frame: Baseline to Objective Disease Progression (Up to 36 Months)', 'Results 1: ', ' Arm/Group Title: Part A Abemaciclib: HR+, HER2+ Breast Cancer', ' Arm/Group Description: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.', ' Overall Number of Participants Analyzed: 23', ' Measure Type: Number', ' Unit of Measure: percentage of participants 0', 'Results 2: ', ' Arm/Group Title: Part B Abemaciclib: HR+, HER2- Breast Cancer', ' Arm/Group Description: Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET).', ' Participants may continue to receive treatment until discontinuation criteria are met.', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: percentage of participants 5.8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/27 (22.22%)', ' Anaemia 0/27 (0.00%)', ' Thrombocytopenia 1/27 (3.70%)', ' Acute coronary syndrome 0/27 (0.00%)', ' Cardiac failure 0/27 (0.00%)', ' Myocardial infarction 0/27 (0.00%)', ' Glaucoma 0/27 (0.00%)', ' Diarrhoea 2/27 (7.41%)', ' Enterocolitis 1/27 (3.70%)', ' Haemorrhoidal haemorrhage 0/27 (0.00%)', ' Lower gastrointestinal haemorrhage 0/27 (0.00%)', ' Nausea 0/27 (0.00%)', 'Adverse Events 2:', ' Total: 16/58 (27.59%)', ' Anaemia 0/58 (0.00%)', ' Thrombocytopenia 0/58 (0.00%)', ' Acute coronary syndrome 0/58 (0.00%)', ' Cardiac failure 0/58 (0.00%)', ' Myocardial infarction 0/58 (0.00%)', ' Glaucoma 1/58 (1.72%)', ' Diarrhoea 2/58 (3.45%)', ' Enterocolitis 0/58 (0.00%)', ' Haemorrhoidal haemorrhage 0/58 (0.00%)', ' Lower gastrointestinal haemorrhage 0/58 (0.00%)', ' Nausea 0/58 (0.00%)']}

f17cb242-419d-4f5d-bfa4-41494ed5ac0e

Comparison

Eligibility

NCT00971945

NCT01027416

Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT00971945', 'Intervention': ['INTERVENTION 1: ', ' Treatment Arm', ' Paclitaxel 100 mg/m2 IV administered on Days 1, 8, 15, 22, 29, 36 and then suspended until Day 49 (1 course comprised of 49 days).'], 'Eligibility': ['Inclusion Criteria:', ' Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study'], 'Results': ['Outcome Measurement: ', ' Number of Participants Experiencing Adverse Events', ' This outcome describes the number of participants experiencing any type, any grade, any cause adverse events (assessed both subjectively and objectively)', ' Time frame: From first dose to end of follow-up period (up to approximately 33 months)', 'Results 1: ', ' Arm/Group Title: Treatment Arm', ' Arm/Group Description: Paclitaxel 100 mg/m2 IV administered on Days 1, 8, 15, 22, 29, 36 and then suspended until Day 49 (1 course comprised of 49 days).', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 6 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/6 (33.33%)', ' Nausea 1/6 (16.67%)', ' Vomiting 1/6 (16.67%)', ' Femur fracture 1/6 (16.67%)']}

{'Clinical Trial ID': 'NCT01027416', 'Intervention': ['INTERVENTION 1: ', ' No Intervention', ' No Intervention: Standard of care', 'INTERVENTION 2: ', ' Tamoxifen', ' Tamoxifen 20 mg orally 1x/day for 4 weeks', ' Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks'], 'Eligibility': ['Inclusion Criteria:', ' The patient must consent to be in the study and must have signed an approved consent form conforming to institutional guidelines', ' The patient must be 18 years or older.', ' Core biopsy should definitively demonstrate invasive carcinoma.', ' Invasive carcinoma should be ER-apha receptor positive', ' The tumor should be approximately at least 1 cm, to account for variability in imaging and imaging occult disease (physical exam, mammography, ultrasound). We recognize that from time to time because of this variation, there might not be enough tissue available for analysis after surgical excision but this will allow the greatest opportunity to capture as many eligible patients as possible.', ' Patients in whom surgical excision of the tumor is part of standard of care management', ' ECOG score of 0 or 1', ' Negative serum or urine beta-hCG pregnancy test at screening for patients of child-bearing potential (this is routinely done if the patient is premenopausal and having surgery)', ' Consent to participate in DBBR (RPCI only)', 'Exclusion Criteria:', ' Male patients are not eligible for this study', ' Female patients with inoperable tumors or women with stage 4 disease diagnosed on CT, PET, PET/CT or bone scan.', ' Patients with diagnosis by FNA cytology only', ' Pregnant or lactating women', ' Prior therapy for breast cancer, including irradiation, chemo- immuno- and/or hormonal therapy', ' Patients receiving any hormonal therapy, e.g. ovarian hormonal replacement therapy, infertility medications etc., are not eligible', ' Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient from being subjected to surgical excision', ' Psychiatric or addictive disorders that would preclude obtaining informed consent', ' Patients known or suspected to have hypercoagulable syndrome or with history of venous or arterial thrombosis, stroke, TIA, or pulmonary embolism', ' Women with non-invasive disease or microinvasion are not eligible.', ' Women undergoing neoadjuvant chemotherapy are not eligible', ' women currently on tamoxifen and raloxifene for prevention are not eligible', ' Patients shall not receive any herbal/alternative therapies such as flaxseed or soy products or black cohosh.', ' Patients with a known mutation in p53 (Li Fraumeni Syndrome)'], 'Results': ['Outcome Measurement: ', ' Mean Percent Positive Proximity Ligation Assays of All Tumor Protein p53-wild Type Breast Tumors in Participants by Treatment Arm', ' Status of estrogen receptor alpha (ERά) and tumor protein (p53) interaction in p53-wild type breast tumors in untreated patients verses patients treated with tamoxifen. Mean percent positive polylactide (PLA) of all p53-wild type breast tumors in participants by treatment arm', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: No Intervention', ' Arm/Group Description: No Intervention: Standard of care', ' Overall Number of Participants Analyzed: 23', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of positive PLA 27.0 (34.4)', 'Results 2: ', ' Arm/Group Title: Tamoxifen', ' Arm/Group Description: Tamoxifen 20 mg orally 1x/day for 4 weeks', ' Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks', ' Overall Number of Participants Analyzed: 12', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of positive PLA 4.4 (4.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/31 (3.23%)', ' Abdominal pain 1/31 (3.23%)', 'Adverse Events 2:', ' Total: 0/28 (0.00%)', ' Abdominal pain 0/28 (0.00%)']}

fc5c4554-7ce9-4c16-b374-a3cd9d15b021

Single

Eligibility

NCT00633750

Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00633750', 'Intervention': ['INTERVENTION 1: ', ' Tarceva', ' Following a pre-treatment core breast biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.'], 'Eligibility': ['Inclusion Criteria:', ' Clinical stage I or II (T1 or T2, N0 or N1) invasive mammary carcinoma', ' Diagnosis may be made by fine needle aspiration cytology or core biopsy', ' A repeat core biopsy is not required for patients who have a paraffin embedded diagnostic core biopsy specimen available for immunohistochemical staining', 'Exclusion Criteria:', ' Patients with locally advanced disease who are planning to undergo preoperative neoadjuvant therapy are not eligible*', ' Locally advanced disease includes any of the following:', ' Primary tumor 5 cm (T3)', ' Tumor of any size with direct extension to the chest wall or skin (T4a-c)', ' Inflammatory breast cancer (T4d)', ' Fixed axillary lymph node metastases (N2)', ' Metastasis to ipsilateral internal mammary node (N3) NOTE: *Patients with primary tumors 5 cm (T3) or tumors involving the chest wall or skin who are not candidates for preoperative chemotherapy or who decline preoperative chemotherapy are eligible', ' Measurable residual tumor at the primary site', ' Measurable disease is defined as any mass that can be reproducibly measured by physical examination', ' Planning to undergo surgical treatment with either segmental resection or total mastectomy', ' Patients with a prior history of contralateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer', ' No locally recurrent breast cancer', ' No evidence of distant metastatic disease (i.e., lung, liver, bone, or brain metastases)', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1', ' ANC 1,000/mm^3', ' Creatinine 1.5 times upper limit of normal (ULN)', ' Total bilirubin 1.5 times ULN', ' Serum glutamic oxaloacetic transminase (SGOT) and serum glutamic pyruvic transminase (SGPT) 1.5 times ULN', ' Must be at least 18 years old', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No serious medical illness that, in the judgement of the treating physician, places the patient at high risk of operative mortality', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No prior chemotherapy for this primary breast cancer', ' At least 7 days since prior tamoxifen or raloxifene as a preventive agent'], 'Results': ['Outcome Measurement: ', ' Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva', ' In situ anti-tumor effect of Tarceva as measured by a minimum 75% reduction in Ki67 compared to pre-treatment tumor cells in patients with operable breast cancer.', ' Time frame: 5-14 days', 'Results 1: ', ' Arm/Group Title: Tarceva', ' Arm/Group Description: Following a pre-treatment core breast biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Number', ' Unit of Measure: participants 8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/47 (2.13%)']}

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

96b77cdd-aa9f-4770-8447-8a04d9ca5da7

Comparison

Intervention

NCT00003404

NCT00711529

the primary trial and the secondary trial have Hypnotherapy based interventions, the secondary trial also used pain medication in its intervention.

Contradiction

{'Clinical Trial ID': 'NCT00003404', 'Intervention': ['INTERVENTION 1: ', ' Adjuvant Radiotherapy', ' Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.', ' Adjuvant Radiotherapy: Adjuvant radiation therapy'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following:', ' Borderline, defined as 5-9 mitoses/10 high power fields (HPF), pushing or infiltrating margins, 2+ atypia', ' Malignant, defined as 10 or more mitoses/10 HPF, predominantly infiltrating margins, usually 3+ atypia with occasional 2+ atypia', ' Must have been excised with breast-conserving resection and no positive margins', ' Local recurrence of a previously excised phyllodes tumor allowed if the recurrence is in the area of the prior excision', ' No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast', ' Hormone receptor status: Not specified', ' PATIENT CHARACTERISTICS:', ' Age: 18 and over', ' Sex: Female', ' Menopausal status: Not specified', 'Performance status: Not specified', ' Life expectancy: Not specified', ' Hematopoietic: Not specified', ' Hepatic: Not specified', ' Renal: Not specified', ' Other:', ' Not pregnant', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy: Not specified', ' Chemotherapy: Not specified', ' Endocrine therapy: Not specified', ' Radiotherapy: No prior radiotherapy to the ipsilateral breast', ' Surgery: See Disease Characteristics'], 'Results': ['Outcome Measurement: ', ' Local Recurrence Rate', ' Local recurrence rate of phyllodes tumors', ' Time frame: 36 months after initial excision', 'Results 1: ', ' Arm/Group Title: Adjuvant Radiotherapy', ' Arm/Group Description: Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.', ' Adjuvant Radiotherapy: Adjuvant radiation therapy', ' Overall Number of Participants Analyzed: 46', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/46 (0.00%)']}

{'Clinical Trial ID': 'NCT00711529', 'Intervention': ['INTERVENTION 1: ', ' Hypnotherapy', ' Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.', 'INTERVENTION 2: ', ' Gabapentin', ' Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).'], 'Eligibility': ['Inclusion criteria:', ' Women with histologic confirmation of a diagnosis of infiltrating carcinoma of the breast are eligible for participation.', ' Women with non-invasive or pre-invasive lesions of the breast, including but not limited to ductal carcinoma in situ (DCIS), atypical ductal hyperplasia (ADH) or lobular carcinoma in situ (LCIS) are eligible for participation.', ' Women with a known breast cancer susceptibility gene (eg, BRCA) mutation or strong family history of breast cancer are eligible.', ' Any woman age 60 years or more who cannot take estrogen therapy because of a real or perceived risk of developing breast cancer are eligible.', ' Women under the age of 60 with a Gail model score of 1.6% or more are eligible.', ' Subjective report of at least one daily hot flash.', ' Able to provide voluntary informed consent.', ' 18 years-old. There will be no upper limit for age inclusion.', ' Karnofsky performance status > 70%.', ' Women with a history of breast cancer must have undergone treatment with curative intent.', ' 4 weeks from completion of chemotherapy or radiation therapy, where appropriate.', ' adequate hematopoietic function (ANC 1500/mm3; Platelets 100,000/mm3; Hemoglobin 8 g/dL)', ' adequate renal and hepatic function [Bilirubin 1.5 times upper limit of normal (ULN), serum glutamic-oxaloacetic transaminase (SGOT) 2.5x ULN, Alkaline phosphatase 2.5x ULN, and Creatinine 2x ULN].', ' No clinical evidence of disease (complete remission).', ' Patients receiving neoadjuvant therapy will be eligible following completion of all adjuvant chemotherapy if indicated.', ' Patients receiving hormonal therapy in lieu of or following chemotherapy will be eligible to participate.', ' Patients must have access to a compact disk player.', 'Exclusion criteria:', ' History or active secondary cancer within the last 5 years (except for superficial basal cell skin cancers).', ' Any residual chemotherapy-induced CTCv3.0 Grade 2 or greater non-hematological toxicity.', ' Unable to give informed consent or unable to adhere to protocol.', ' Any serious medical or psychiatric illness likely to interfere with participation in this clinical study, concurrent uncontrolled illness, or ongoing or active infection will be excluded.', ' Any history of alcohol or drug abuse.', ' Allergy to gabapentin.', ' History of seizure disorder.'], 'Results': ['Outcome Measurement: ', ' Number of Daily Hot Flashes', ' Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is "number of daily hot flashes." The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries.', ' Time frame: Baseline', 'Results 1: ', ' Arm/Group Title: Hypnotherapy', ' Arm/Group Description: Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.', ' Overall Number of Participants Analyzed: 7', ' Median (Full Range)', ' Unit of Measure: daily hot flashes 5 (2 to 11)', 'Results 2: ', ' Arm/Group Title: Gabapentin', ' Arm/Group Description: Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).', ' Overall Number of Participants Analyzed: 8', ' Median (Full Range)', ' Unit of Measure: daily hot flashes 4.5 (2 to 9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/13 (0.00%)', 'Adverse Events 2:', ' Total: 0/14 (0.00%)']}

c73faed2-371b-4238-bf7d-293fae380203

Single

Eligibility

NCT00201773

Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial

Entailment

{'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': ''}

8765009d-ffc4-4395-ab7a-11ecdfd43a40

Comparison

Intervention

NCT02606708

NCT02504424

Only patients in the primary trial receive 40.5 Gy of brachytherapy, patients in the secondary trial receive no radiotherapy whatsoever.

Contradiction

{'Clinical Trial ID': 'NCT02606708', 'Intervention': ['INTERVENTION 1: ', ' Accelerated Intensity Modulated Radiation Therapy (AIMRT)', ' All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.', ' Accelerated intensity modulated radiation therapy (AIMRT)'], 'Eligibility': ['Inclusion Criteria:', ' Pre- or post-menopausal women with Stage I and II breast cancer', ' Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm', ' Status post segmental mastectomy. and after sentinel node biopsy and/or axillary node dissection', ' At least 2 weeks from last chemotherapy', ' Tumors < 5 mm do not require nodal assessment', 'Exclusion Criteria:', ' Previous radiation therapy to the ipsilateral breast.', ' More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation.', ' Active connective tissue disorders, such as lupus or scleroderma.', ' Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free > 5 years.', ' Pregnant or lactating women.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Local Recurrence in Breast', ' Defined by the discovery of invasive disease or DCIS in the same region of the breast after segmental mastectomy and radiation, by clinical or radiographic means.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Accelerated Intensity Modulated Radiation Therapy (AIMRT)', ' Arm/Group Description: All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.', ' Accelerated intensity modulated radiation therapy (AIMRT)', ' Overall Number of Participants Analyzed: 314', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 6 1.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/314 (0.00%)']}

{'Clinical Trial ID': 'NCT02504424', 'Intervention': ['INTERVENTION 1: ', ' AeroForm Tissue Expander', ' AeroForm Tissue Expansion inflation with carbon dioxide by remote control', ' AeroForm Tissue Expander: The AeroForm 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.'], 'Eligibility': ['Inclusion Criteria:', ' Subject is female between the ages of 18-70', ' Subject requires tissue expansion as part of breast reconstruction', ' Subject is able to provide written informed consent', ' Subject is able and willing to comply with all of the study requirements', ' Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen', 'Exclusion Criteria:', " Subject's tissue integrity is unsuitable for tissue expansion", ' Subject has residual gross malignancy at the intended expansion site', ' Subject has current or prior infection at the intended expansion site', ' Subject has a history of failed tissue expansion or breast reconstruction', ' Subject has any co-morbid condition determined by the Investigator to place the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes)', ' Subject is taking any concomitant medications determined by the Investigator to place the subject at an increased risk of complications (e.g., Prednisone, Coumadin).'], 'Results': ['Outcome Measurement: ', ' Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event', ' The primary endpoint is analyzed per breast. Breasts in which the expander is removed and/or replaced due to a device related adverse event or a device malfunction are counted as failures.', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: AeroForm Tissue Expander', ' Arm/Group Description: AeroForm Tissue Expansion inflation with carbon dioxide by remote control', ' AeroForm Tissue Expander: The AeroForm 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: 48', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Breasts Count of UnitsUnit of Measure: breasts: 80 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/50 (22.00%)', ' neutropenic fever, weakness 1/50 (2.00%)', ' urinary tract infection 1/50 (2.00%)', ' cellulitis 4/50 (8.00%)', ' wound dehiscence 1/50 (2.00%)', ' hematoma 1/50 (2.00%)', ' seroma 1/50 (2.00%)', ' inflammation (red breast syndrome) 2/50 (4.00%)']}

0ad7293d-df35-42e8-881d-f2afc3f7d3fd

Single

Eligibility

NCT00895414

Certain drinks are banned for patients undertaking the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00895414', 'Intervention': ['INTERVENTION 1: ', ' Doxorubicin Hydrochloride Alone', ' Participants who received doxorubicin hydrochloride alone in either Cycle 1 or Cycle 2.', 'INTERVENTION 2: ', ' Doxorubicin Hydrochloride With Enalapril', ' Participants who received doxorubicin hydrochloride with enalapril in either Cycle 1 or Cycle 2.'], 'Eligibility': ['Inclusion Criteria:', ' Tissue diagnosis of a breast carcinoma', ' The oncologist must have prescribed doxorubicin as part of the planned chemotherapy regimen', ' Have acceptable organ function within 14 days of enrollment defined as:', ' liver function: total bilirubin, AST and ALT within normal institutional limits', ' kidney function: estimated Creatinine Clearance > 60 ml/min calculated creatinine clearance (for females) - formula: (140 - age) x weight x .85 divided by (sCr x 72)', ' At least 18 years old', ' Patient must have given written informed consent indicating an understanding of the investigational nature of the study', ' Agrees not to consume grapefruit juice while on the study', 'Exclusion Criteria:', ' Known allergy to enalapril', ' Taking any known P450 cytochrome inducers or inhibitors', ' Taking any herbal supplements while on the study or the week prior to receiving doxorubicin', ' Taking an ace-inhibitor or angiotensin receptor blocker', ' Pregnant or lactating. Enalapril is Pregnancy Categories C (first trimester) and D (second and third trimesters)'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Doxorubicin Plasma Concentrations Demonstrating a Significant Increase or Decrease When Doxorubicin Was Given With Enalapril as Compared to When Doxorubicin Was Given Without Enalapril.', ' Doxorubicin plasma concentration (DPC) is the primary pharmacokinetic (PK) measure of the exposure. Each patient will have serial PKs performed twice - once with enalapril and once without enalapril. A mean increase or decrease of more than 115 ng/ml in DPC will be considered significant.', ' Time frame: Baseline, 0.5, 1.0, 2.0, 4.0, 24.0 and 48.0 hours after infusion of doxorubicin', 'Results 1: ', ' Arm/Group Title: Doxorubicin Hydrochloride Alone', ' Arm/Group Description: Participants who received doxorubicin hydrochloride alone in either Cycle 1 or Cycle 2.', ' Overall Number of Participants Analyzed: 17', ' Measure Type: Number', ' Unit of Measure: participants 0', 'Results 2: ', ' Arm/Group Title: Doxorubicin Hydrochloride With Enalapril', ' Arm/Group Description: Participants who received doxorubicin hydrochloride with enalapril in either Cycle 1 or Cycle 2.', ' Overall Number of Participants Analyzed: 17', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/8 (0.00%)', 'Adverse Events 2:', ' Total: 0/9 (0.00%)']}

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

2bc1e094-41a1-46d9-9b0c-b5a47f23323d

Single

Adverse Events

NCT00777049

Most of the cases of CHF in the primary trial, were in cohort 1.

Entailment

{'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%)']}

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

83b83400-1439-462d-bba3-42817b5b1fa1

Single

Eligibility

NCT00058058

Candidates for the primary trial must have a life expectancy over 6 months.

Contradiction

{'Clinical Trial ID': 'NCT00058058', 'Intervention': ['INTERVENTION 1: ', ' Reference Standard Positive (RS+)', ' Reference Standard Positive indicates a breast cancer diagnosed in the contralateral (study) breast. Participants who received a diagnosis of ductal carcinoma in situ or any invasive breast cancer as a result of a biopsy or surgery that was performed within 365 days of the initial MRI scan were considered positive for cancer. Participants were considered positive only on the basis of positive tissue diagnosis.', 'INTERVENTION 2: ', ' Reference Standard Negative (RS-)', ' Women with no diagnosis of cancer during the year after their enrollment were considered negative. All cases for whom no tissue diagnosis of cancer was reported during the 365 days following the initial MRI were considered negative, regardless of whether any additional imaging had been performed.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast', ' Confirmed by biopsy or fine needle aspiration (FNA) within the past 60 days', ' Negative or benign mammogram (BI-RADS assessment 1 or 2) and negative or benign clinical breast exam of the contralateral breast within the past 90 days', ' Prior biopsy of the contralateral breast (including FNA) is allowed provided it was performed at least 6 months prior to study entry', ' Prior magnetic resonance exam of the contralateral breast is allowed provided it was performed at least 1 year prior to study entry', ' No remote history of breast cancer', ' No new breast symptoms within the past 60 days for which further evaluation is recommended', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over', ' Sex', ' Female', ' Menopausal status', ' Not specified', ' Performance status', ' Not specified', ' Life expectancy', ' Not specified', ' Hematopoietic', ' Not specified', ' Hepatic', ' Not specified', ' Renal', ' Not specified', ' Cardiovascular', ' No pacemaker', ' No magnetic aneurysm clips', ' Other', ' Not pregnant', ' No implanted magnetic device', ' No severe claustrophobia', ' No other contraindications to MRI', ' No psychiatric, psychological, or other condition that would preclude informed consent', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Not specified', ' Chemotherapy', ' At least 6 months since prior anticancer chemotherapy', ' Endocrine therapy', ' No concurrent therapeutic hormonal therapy, tamoxifen, or aromatase inhibitors (preventive therapy allowed)', ' Radiotherapy', ' Not specified', ' Surgery', 'Not specified'], 'Results': ['Outcome Measurement: ', ' MRI Diagnostic Yield of Cancers in the Contralateral Breast', ' To assess the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam.', ' the "Test" status was defined based on combinations of the following 4 factors:', ' The initial BI-RADs: from the MRI of the contralateral breast', ' The final BI-RADs: determined after all subsequent work-up and follow-up within 365 from the initial MRI (an explicit recommendation for biopsy always resulted in a final BI-RADs of 4).', ' Subsequent work-up includes all procedures resultant from an Initial MRI finding (generally triggered by a BI-RADs 0 or 3) within 365 from the initial MRI', ' Whether or not biopsy procedure (Bx) were performed on the contralateral (Study) breast within 365 from the initial MRI', ' Time frame: within 90 days of a negative mammogram of the study breast', 'Results 1: ', ' Arm/Group Title: Reference Standard Positive (RS+)', ' Arm/Group Description: Reference Standard Positive indicates a breast cancer diagnosed in the contralateral (study) breast. Participants who received a diagnosis of ductal carcinoma in situ or any invasive breast cancer as a result of a biopsy or surgery that was performed within 365 days of the initial MRI scan were considered positive for cancer. Participants were considered positive only on the basis of positive tissue diagnosis.', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Test + (Final BI-RAD 0, 4, 5): 30 90.9%', 'Test Negative (T-): 3 9.1%', ' Test + (Initial MRI BI-RAD 4, 5/work-up): 30 90.9%', 'Test Negative (T-): 3 9.1%', ' Test + (Initial MRI BI-RAD 4, 5/work-up/comp bx): 30 90.9%', 'Test Negative (T-): 3 9.1%', ' Test + (Initial MRI BI-RAD 0, 4, 5): 30 90.9%', 'Test Negative (T-): 3 9.1%', ' Test + (Initial MRI BI-RAD 0, 3, 4, 5): 31 93.9%', 'Test Negative (T-): 2 6.1%', ' Test + (Initial MRI BI-RAD 0, 3, 4, 5/work-up)".: 31 93.9%', 'Test Negative (T-): 2 6.1%', 'Results 2: ', ' Arm/Group Title: Reference Standard Negative (RS-)', ' Arm/Group Description: Women with no diagnosis of cancer during the year after their enrollment were considered negative. All cases for whom no tissue diagnosis of cancer was reported during the 365 days following the initial MRI were considered negative, regardless of whether any additional imaging had been performed.', ' Overall Number of Participants Analyzed: 936', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Test + (Final BI-RAD 0, 4, 5): 114 12.2%', 'Test Negative (T-): 822 87.8%', ' Test + (Initial MRI BI-RAD 4, 5/work-up): 105 11.2%', 'Test Negative (T-): 831 88.8%', ' Test + (Initial MRI BI-RAD 4, 5/work-up/comp bx): 91 9.7%', 'Test Negative (T-): 845 90.3%', ' Test + (Initial MRI BI-RAD 0, 4, 5): 143 15.3%', 'Test Negative (T-): 793 84.7%', ' Test + (Initial MRI BI-RAD 0, 3, 4, 5): 247 26.4%', 'Test Negative (T-): 689 73.6%', ' Test + (Initial MRI BI-RAD 0, 3, 4, 5/work-up)".: 145 15.5%', 'Test Negative (T-): 791 84.5%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/1007 (0.00%)', 'Adverse Events 2:', ' ']}

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

c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f

Single

Eligibility

NCT02964234

Patients eligible for the primary trial must live in the USA.

Entailment

{'Clinical Trial ID': 'NCT02964234', 'Intervention': ['INTERVENTION 1: ', ' Empowerment', ' Behavior: Empowerment', ' Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks', 'INTERVENTION 2: ', ' Education', ' Behavior: Education', ' Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Age 52-75 years old;', ' Identification as Latina/Hispanic/Chicana female;', ' Residence in Pilsen, Little Village, East Side or South Chicago;', ' No history of health volunteerism;', ' No history of breast cancer; and', ' Lack of a mammogram within the last two years', 'Exclusion Criteria:', ' Not meeting all inclusion criteria;', ' Women will be excluded if they participated in formative focus groups'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Have Obtained Breast Cancer Screening', ' Receipt of mammogram based on medical records and self report within 6 months of baseline survey (Yes or No)', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Empowerment', ' Arm/Group Description: Behavior: Empowerment', ' Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks', ' Overall Number of Participants Analyzed: 54', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 49 90.7%', 'Results 2: ', ' Arm/Group Title: Education', ' Arm/Group Description: Behavior: Education', ' Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 29 51.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/76 (0.00%)', 'Adverse Events 2:', ' Total: 0/69 (0.00%)']}

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

17a821f8-5e68-4bf7-ac01-3f96ddfc5187

Comparison

Intervention

NCT02525718

NCT02606708

Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT.

Entailment

{'Clinical Trial ID': 'NCT02525718', 'Intervention': ['INTERVENTION 1: ', ' Placebo', ' Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.', ' Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)', 'INTERVENTION 2: ', ' 0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone', ' Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue.', ' Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.', ' 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.', '(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.'], 'Eligibility': ['Inclusion Criteria:', ' Patients who undergo mastectomy surgery with immediate reconstruction involving insertion of a tissue expander performed by the principal investigator beginning from the time of study approval until study enrollment is complete.', 'Exclusion Criteria:', ' Patients under the age of 18, or over the age of 79', ' Allergy to local anesthetics or corticosteroids', ' Patients with history of chronic pain or with chronic use of opioid analgesics', ' Patients with history of lung disease or prior anterior thoracotomy or median sternotomy'], 'Results': ['Outcome Measurement: ', ' Quality of Recovery Score', ' The primary outcome measure is a well-validated and widely used survey measuring the quality of recovery from anesthesia entitled the "Global 40 Item Quality of Recovery" survey. This is a 40 question survey administered to patients to allow them to rate their quality of recovery along a number of different dimensions, including emotional state, physical comfort, psychological support, physical independence, and pain. The score ranges from 40 to 200, with 40 representing a very poor overall quality of recovery and 200 representing the best possible recovery. The following reference explains the Global 40 Item Quality of Recovery survey in detail:', ' Myles, P.S., et al., Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth, 2000. 84(1): p. 11-5.', ' PMID: 10740540', ' Time frame: 24 hours post-operatively', 'Results 1: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.', ' Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)', ' Overall Number of Participants Analyzed: 22', ' Median (Inter-Quartile Range)', ' Unit of Measure: score on a scale 165 (143 to 179)', 'Results 2: ', ' Arm/Group Title: 0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone', ' Arm/Group Description: Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue.', ' Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.', ' 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.', '(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.', ' Overall Number of Participants Analyzed: 23', ' Median (Inter-Quartile Range)', ' Unit of Measure: score on a scale 169 (155 to 182)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/22 (0.00%)', 'Adverse Events 2:', ' Total: 0/23 (0.00%)']}

{'Clinical Trial ID': 'NCT02606708', 'Intervention': ['INTERVENTION 1: ', ' Accelerated Intensity Modulated Radiation Therapy (AIMRT)', ' All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.', ' Accelerated intensity modulated radiation therapy (AIMRT)'], 'Eligibility': ['Inclusion Criteria:', ' Pre- or post-menopausal women with Stage I and II breast cancer', ' Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm', ' Status post segmental mastectomy. and after sentinel node biopsy and/or axillary node dissection', ' At least 2 weeks from last chemotherapy', ' Tumors < 5 mm do not require nodal assessment', 'Exclusion Criteria:', ' Previous radiation therapy to the ipsilateral breast.', ' More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation.', ' Active connective tissue disorders, such as lupus or scleroderma.', ' Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free > 5 years.', ' Pregnant or lactating women.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Local Recurrence in Breast', ' Defined by the discovery of invasive disease or DCIS in the same region of the breast after segmental mastectomy and radiation, by clinical or radiographic means.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Accelerated Intensity Modulated Radiation Therapy (AIMRT)', ' Arm/Group Description: All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered.', ' Accelerated intensity modulated radiation therapy (AIMRT)', ' Overall Number of Participants Analyzed: 314', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 6 1.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/314 (0.00%)']}

d76d6c7f-ba39-483c-a89e-152af5ae2878

Comparison

Intervention

NCT01669343

NCT00146172

the primary trial administers letrozole for 28 days, whereas the secondary trial administers is intervention over 4 cycles of 21 days.

Contradiction

{'Clinical Trial ID': 'NCT01669343', 'Intervention': ['INTERVENTION 1: ', ' Post-menopausal Women Using Adjuvant Letrozole', ' Part A Routine Care Letrozole; Part B Double Dose Letrozole in overweight/obese participants', ' Letrozole: Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal female patients', ' histological confirmed diagnosis of estrogen receptor and/or progesterone receptor positive breast cancer (Stage I-III) who have completed local therapy', ' Currently prescribed and taking letrozole 2.5 mg daily for a minimum of 3 months', ' Willing to provide written informed consent to participate', ' for the experimental arm: all of the above and body mass index (BMI) > 25 kg/m2', 'Exclusion Criteria:', ' Known abnormal liver or renal function defined by:', ' Serum Creatinine > 1.25 times institutional upper limit of normal (ULN) or Calculated Creatinine Clearance < 40 mL/min', ' Serum Bilirubin, Aspartate transaminase (AST) or alanine transaminase (ALT) > 1.5 times ULN', ' Presence of persistent local or known metastatic cancer'], 'Results': ['Outcome Measurement: ', ' Part A Correlation of Day 29 Estradiol With BMI', ' Determine if estradiol levels vary with BMI levels after 28 days of monitored adherence to standard dose letrozole, by calculating the Pearson correlation between estradiol and log-transformed BMI', 'Time frame: Day 29', 'Results 1: ', ' Arm/Group Title: Post-menopausal Women Using Adjuvant Letrozole', ' Arm/Group Description: Part A Routine Care Letrozole; Part B Double Dose Letrozole in overweight/obese participants', ' Letrozole: Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period.', ' Overall Number of Participants Analyzed: 112', ' Measure Type: Number', ' Unit of Measure: correlation coefficient 0.06 (-0.13 to 0.24)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/121 (1.65%)', ' Renal Colic/Constipation [1]1/121 (0.83%)', ' Stroke [2]1/121 (0.83%)']}

{'Clinical Trial ID': 'NCT00146172', 'Intervention': ['INTERVENTION 1: ', ' Neratinib 40 mg', 'Neratinb 40 mg qd', 'INTERVENTION 2: ', ' Neratinib 80 mg', 'Neratinib 80 mg qd'], 'Eligibility': ['Inclusion Criteria:', ' Her2/neu or Her1/EGFR positive cancer', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2', ' Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)', 'Exclusion Criteria:', ' Prior treatment with anthracyclines with a cumulative dose of doxorubicin or equivalent of greater than 300 mg/m^2', ' Patients with significant cardiac risk factors', ' Active central nervous system metastasis'], 'Results': ['Outcome Measurement: ', ' Dose Limiting Toxicity (DLT)', ' DLT is defined as any neratinib-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) common terminology criteria (CTC) for AEs version 3.0. DLTs were assessed from the first single dose to 14 days of continuous daily administration.', ' Time frame: From first dose date to day 14', 'Results 1: ', ' Arm/Group Title: Neratinib 40 mg', ' Arm/Group Description: Neratinb 40 mg qd', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%', 'Results 2: ', ' Arm/Group Title: Neratinib 80 mg', ' Arm/Group Description: Neratinib 80 mg qd', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/3 (100.00%)', ' Anaemia 1/3 (33.33%)', ' Cardio-respiratory arrest 0/3 (0.00%)', ' Tachycardia 1/3 (33.33%)', ' Papilloedema 0/3 (0.00%)', ' Photophobia 0/3 (0.00%)', ' Vitreous haemorrhage 0/3 (0.00%)', ' Abdominal distension 0/3 (0.00%)', ' Abdominal pain 0/3 (0.00%)', ' Ascites 0/3 (0.00%)', ' Diarrhoea 0/3 (0.00%)', ' Nausea 0/3 (0.00%)', ' Small intestinal obstruction 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 1/4 (25.00%)', ' Anaemia 0/4 (0.00%)', ' Cardio-respiratory arrest 0/4 (0.00%)', ' Tachycardia 0/4 (0.00%)', ' Papilloedema 0/4 (0.00%)', ' Photophobia 0/4 (0.00%)', ' Vitreous haemorrhage 0/4 (0.00%)', ' Abdominal distension 0/4 (0.00%)', ' Abdominal pain 0/4 (0.00%)', ' Ascites 0/4 (0.00%)', ' Diarrhoea 0/4 (0.00%)', ' Nausea 0/4 (0.00%)', ' Small intestinal obstruction 0/4 (0.00%)']}

65f3e755-3e23-4e84-a218-87922759094d

Single

Eligibility

NCT00952692

Candidates for the primary trial must have adequate colon and liver function, and must not be currently receiving amiodarone or have received amiodarone in the last 28 day. Renal function is not relevant for inclusion.

Contradiction

{'Clinical Trial ID': 'NCT00952692', 'Intervention': ['INTERVENTION 1: ', ' dHER2 + AS15 ASCI + Lapatinib', ' Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine. The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.'], 'Eligibility': ['Inclusion Criteria:', ' The following criteria are to be checked at the time of study entry. The patients may only be included in the study if ALL of the following statements are FULLFILLED:', ' The patient (male or female) is at least 18 years old at the time of signature of the informed consent form.', ' Written informed consent has been obtained from the patient prior to the performance of any protocol-specific procedure.', ' The patient is diagnosed with confirmed invasive breast cancer with stage IV disease.', ' Note: If the metastatic disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology or histology.', ' The patient has documented disease progression or relapse following at least one prior standard therapy with trastuzumab (alone or in combination with chemotherapy).', ' Patients with prior lapatinib use are eligible. Furthermore,', ' The administration of the chemotherapeutic agent(s) should have been stopped for at least 28 days by the time of the first ASCI administration.', ' The administration of trastuzumab alone could be maintained after chemotherapy, but the last dose of trastuzumab should not have been given less than three weeks before the first ASCI administration.', ' The patient will not be given trastuzumab during the trial.', ' For metastatic patients whose disease is ER+ and/or PR+ the following criteria should be met:', ' Patients with visceral disease that requires chemotherapy (eg., patients with liver or lung metastases).', ' Rapidly progressing or life threatening disease, as determined by the investigator.', ' Patients who received hormonal therapy and are no longer benefiting from this therapy.', ' A tumor lesion from the patient biopsied before or during screening shows either:', ' Overexpression of the HER2 protein, as determined by immunohistochemistry (IHC, with result IHC 3+) or', ' Amplification of the HER2 gene as determined by FISH (at least 4 fold i.e. at least 8 copies).', ' Note: Overexpression/amplification measurements must be performed on a metastatic lesion in all cases where such a lesion is sufficiently easily accessible. If however such a biopsy is not possible, then these measurements can be performed on the primary tumor. Use of the primary tumor is to be documented and justified.', ' Ten FFPE tissue sections of the tumor on which the HER2 overexpression/amplification has been done -if available-may be requested. These may be used to retrospectively carry out part of the translational research (i.e. analysis of EGF receptor activity and of the presence of immune effector cells, refer to Section 7).', ' The patient has at least one measurable lesion according to RECIST criteria.', ' The patient has ECOG status of 0 or 1.', ' The patient has adequate bone marrow reserve as indicated by:', ' White blood cell count >/= 3,000/mm3.', ' Neutrophil count >/= 1,500/mm3.', ' Platelet count >/= 100,000/mm3.', ' Hemoglobin levels >/= 10.0 g/dl.', ' The patient has adequate renal function as shown by the creatinine levels (i.e. within the normal range).', ' The patient has adequate hepatic function as shown by serum bilirubin levels i.e:', ' Serum bilirubin levels within the normal limits.', ' Both AST and ALT levels <1.5 times the ULN. Note: However, for patients with liver metastasis, a serum bilirubin level <1.5 times the ULN and both AST and ALT levels <3 times the ULN will be accepted.', ' The patient has a baseline Left Ventricular Ejection Fraction (LVEF) measured by MUGA scan equal to or greater than the LLN for the radiology facility.', ' If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to treatment, have a negative pregnancy test and continue such precautions for two months after completion of the study treatment.', ' Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly (when applicable, as mentioned in the product label) for example abstinence, combined or progestogen oral contraceptives, injectable progestogen, implants of levonorgestrel, oestrogenic vaginal ring, percutaneous contraceptive patches or intrauterine device (IUD) or intrauterine system (IUS), vasectomy with documented azoospermia of the sole male partner or double barrier method (condom or occlusive cap plus spermicidal agent).', ' For azoospermia, "documented" refers to the outcome of the investigator\'s/ designee\'s medical examination of the subject or review of the subject\'s medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject\'s medical records.', ' Post-menopause: Menopause is the age associated with complete cessation of menstrual cycles, menses, and implies the loss of reproductive potential by ovarian failure. A practical definition accepts menopause after 1 year without menses with an appropriate clinical profile at the appropriate age e.g. > 45 years.', ' Able to swallow and retain oral medication.', ' In the view of the investigator, the patient can and will comply with the requirements of the protocol.', 'Exclusion Criteria:', ' The following criteria should be checked at the time of study entry. If any apply, the patient must not be included in the study:', ' The patient has received > 300 mg/m2 doxorubicin (cumulative dose) or > 600 mg/m2 epirubicin (cumulative dose).', ' The patient is receiving treatment with bisphosphonate UNLESS the biphosphonate treatment was initiated more than three weeks before the first ASCI administration. (See also section 5.3.2.).', ' The patient has received any investigational or non-registered product (drug or vaccine) other than the study treatment(s) within 30 days preceding the first dose of study treatment, or planned use during the study period.', ' The patient is currently receiving amiodarone or has received amiodarone in the 6 months prior to screening.', ' The patient requires concomitant treatment with systemic corticosteroids or any immunosuppressive agents. The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids or topical steroids is permitted.', ' The patient has a malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.', ' Patients with ulcerative colitis.', ' The patient has known coronary artery disease, arrhythmia requiring treatment, clinically significant valvular disease, cardiomegaly on chest X-ray, ventricular hypertrophy (found by ECG) or previous myocardial infarction.', ' The patient has any acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.', " The patient has current active hepatic or biliary's disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).", ' The patient presents with autoimmune disease (vitiligo and autoimmune thyroid disease is not an exclusion criterion).', ' The patient has a known family history of congenital or hereditary immunodeficiency.', ' The patient has any uncontrolled bleeding disorder or coagulation disorder or thrombocytopenia or pro-thrombotic disorder.', ' The patient has a history of anaphylaxis or severe allergic reaction to vaccines or unknown allergens.', ' The patient has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to Lapatinib. These include other anilinoquinazolines, such as gefitinib (Iressa), erlotinib (Tarceva), or other chemically related compounds or excipients.', ' The patient is known to be positive for the Human Immunodeficiency Virus (HIV).', ' The patient has (or has had) previous or concomitant malignancies at other sites except effectively treated:', ' Non-melanoma skin cancers or carcinoma in situ of the cervix', ' Malignancy that has been in remission for > 2 years and is considered highly likely to have been cured.', ' The patient has any psychiatric or addictive disorder that may compromise her ability to give informed consent, or to comply with the trial procedures.', " The patient has any other condition that in the opinion of the investigator might jeopardize the patient's safety or ability to comply with the requirements of the study.", ' The patient is pregnant or lactating.'], 'Results': ['Outcome Measurement: ', ' The Safety of dHER2+AS15 ASCI When Administered in Combination With Lapatinib Measured by Occurrence of Severe Toxicities (According to CTCAE, Version 3.0)', ' [Not Specified]', ' Time frame: 26 weeks', 'Results 1: ', ' Arm/Group Title: dHER2 + AS15 ASCI + Lapatinib', ' Arm/Group Description: Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine. The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/12 (16.67%)', ' pulmonary embolism 1/12 (8.33%)', ' chest pain 1/12 (8.33%)']}

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

d3590771-806b-4754-a455-38113bfedfca

Comparison

Intervention

NCT00994279

NCT00545077

both the primary trial and the secondary trial administer Bevacizumab to every single HER2+ patient.

Contradiction

{'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%)']}

941b960f-8d57-4830-9d4c-8e96765ba76c

Comparison

Intervention

NCT01425268

NCT01373671

CO2 is utilised as part of the intervention in a single one of the study groups in the primary trial, and not used in either of the study groups in the secondary trial.

Entailment

{'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%)']}

{'Clinical Trial ID': 'NCT01373671', 'Intervention': ['INTERVENTION 1: ', ' FFDM and DBT', ' FFDM exam and DBT scan on Siemens MAMMOMAT Inspiration', 'INTERVENTION 2: ', ' FFDM Only', 'FFDM exam only'], 'Eligibility': ['Inclusion Criteria:', ' All subjects enrolled into the collection study must:', ' Provide signed informed consent after receiving a verbal and written explanation of the purpose and nature of the study', ' be females, 40 years of age or older at the screening mammographic evaluation or age 30 or older presenting for a biopsy and have one of the following mammograms:', ' o Normal cases at screening (BI-RADS® 1, 2 and 3):', ' have a screening mammogram that includes the four standard screening views (RCC, RMLO, LCC and LMLO), as well as have both MLO and CC DBT scans of each breast,', ' o Actionable cases at screening (BI-RADS® 0, 4 or 5) with final BI-RADS® 1, 2, 3, 4 or 5:', ' have a screening mammogram with four SSVs and any clinically necessary diagnostic mammographic views, such as straight lateral projections, rolled, magnification view and spot compression views, and, both MLO and CC DBT scans of each breast plus 4 SSVs repeated at the diagnostic or biopsy visit if the screening images are unavailable or were acquired more than 45 days prior to DBT acquisition,', ' have supporting ground-truth documentation for the final BI-RADS® assessment as follows:', ' A one (1) year FFDM follow up without evidence of cancer for normal cases not undergoing biopsy', ' A six (6) or twelve (12) month FFDM follow up confirming benign status for biopsy proven benign cases', ' Pathology report for either benign or malignant biopsy finding', 'Exclusion Criteria:', ' Subjects with any of the following conditions or who have had the following procedures will be excluded from this study:', ' Pregnant women or women who believe they may be pregnant or are trying to become pregnant.', ' Mastectomy patients', ' Subjects who have had lumpectomy 5 years prior to the study entry', ' Inmates (in accordance with 45 CFR 46.306) or mentally disabled individuals', ' BI-RADS® Category 6 (e.g., for which the mammogram was performed for the purpose of planning cancer therapy)', ' BI-RADS® Category 4 or 5 without confirming pathology reports will be considered incomplete', ' Subjects with mammograms that lack the required views or with views judged to be technically inadequate will be considered incomplete and the cases will not be considered for the MRMC reader studies', ' Subjects being accrued from the screening population who know that they will not be in the United States or available for follow up mammograms in one year.'], 'Results': ['Outcome Measurement: ', ' Efficacy Based on the Area Under the Receiver Operating Characteristic (ROC) Curve in Breasts Analyzed With DBT as an Adjunct to FFDM vs. FFDM Alone', ' The primary objective of this study was to demonstrate the superiority of DBT and FFDM images together in comparison to FFDM images alone with respect to the ability of readers to detect and diagnose malignant lesions. A comparison of the breast-level ROC areas was used to evaluate the superiority of DBT as an adjunct to FFDM vs. FFDM alone.', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: FFDM and DBT', ' Arm/Group Description: FFDM exam and DBT scan on Siemens MAMMOMAT Inspiration', ' Overall Number of Participants Analyzed: 300', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Breasts Mean (Standard Error)Unit of Measure: unitless: 0.8527 (0.0268)', 'Results 2: ', ' Arm/Group Title: FFDM Only', ' Arm/Group Description: FFDM exam only', ' Overall Number of Participants Analyzed: 300', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Breasts Mean (Standard Error)Unit of Measure: unitless: 0.7516 (0.0281)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/764 (0.26%)', ' Ovarian cancer * [1]1/764 (0.13%)', ' Pneumonia * [2]1/764 (0.13%)', 'Adverse Events 2:', ' ']}

f79a9011-0a68-4255-a40f-5d73af412bf0

Comparison

Adverse Events

NCT00777101

NCT00559845

There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial.

Entailment

{'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%)']}

{'Clinical Trial ID': 'NCT00559845', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab', ' FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.', ' FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over 15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.', ' Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.', ' Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' female participants, >=18 years of age;', ' stage III, or inflammatory breast cancer;', ' estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human epidermal growth factor receptor 2 (HER-2) negative;', ' normal left ventricular ejection fraction (LVEF).', 'Exclusion Criteria:', ' previous chemotherapy/endocrine therapy;', ' evidence of distant metastatic disease;', ' other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer);', ' chronic daily treatment with >325 milligram per day (mg/day) aspirin, or >75mg/day clopidogrel.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Pathological Complete Response Following Principle Investigator Review', ' Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy.', ' Time frame: Up to 7.5 years', 'Results 1: ', ' Arm/Group Title: Bevacizumab', ' Arm/Group Description: FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.', ' FEC: 5-Fluorouracil 600 mg/m^2 i.v. bolus over 15 min; epirubicin 90 mg/m^2 i.v. infusion over 1 hour; cyclophosphamide 600 mg/m^2 i.v. infusion over 1 hour every 3 weeks for 4 cycles.', ' Paclitaxel: 80 mg/m^2 i.v. over 1 hour weekly for 12 weeks.', ' Bevacizumab: 10 mg/kg i.v. every 2 weeks for 6 cycles.', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Number', ' Unit of Measure: percentage of participants 23.2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/54 (14.81%)', ' Anaemia 1/54 (1.85%)', ' Febrile Neutropenia 1/54 (1.85%)', ' Retinopathy Hypertensive 1/54 (1.85%)', ' Febrile Infection 1/54 (1.85%)', ' Postoperative Wound Complication 1/54 (1.85%)', ' Cardiac Imaging Procedure Abnormal 1/54 (1.85%)', ' Malignant Melanoma In Situ 1/54 (1.85%)', ' Suicide Attempt 1/54 (1.85%)', ' Dyspnoea 1/54 (1.85%)']}

1b4f8828-cc7f-4831-a1c0-cc14e6ad23af

Comparison

Intervention

NCT00075270

NCT01781299

the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course.

Contradiction

{'Clinical Trial ID': 'NCT00075270', 'Intervention': ['INTERVENTION 1: ', ' Lapatinib With Paclitaxel', ' Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.', 'INTERVENTION 2: ', ' Placebo With Paclitaxel', ' Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.'], 'Eligibility': ['Inclusion criteria:', ' Signed Informed Consent', ' Able to swallow an oral medication', ' Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram', ' Adequate kidney and liver function', ' Adequate bone marrow function', ' Tumor tissue available for testing', ' Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone', ' No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested', 'Exclusion criteria:', ' Prior treatment regimens for advanced or metastatic breast cancer.', ' Pregnant or lactating', ' Conditions that would effect the absorption of an oral drug', ' Active infection', ' Brain metastases', ' Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor.', ' Known hypersensitivity to Taxol or excipients of Taxol', ' Peripheral neuropathy of Grade 2 or greater is not permitted', ' Severe Cardiovascular disease or cardiac disease requiring a device.', " Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent."], 'Results': ['Outcome Measurement: ', ' Time to Progression as Evaluated by the Investigator', ' Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The investigator assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors [RECIST] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the investigator, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.', ' Time frame: Randomization until the date of disease progression or death (average of 26 weeks)', 'Results 1: ', ' Arm/Group Title: Lapatinib With Paclitaxel', ' Arm/Group Description: Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.', ' Overall Number of Participants Analyzed: 291', ' Median (Inter-Quartile Range)', ' Unit of Measure: weeks 29.0 (13.9 to 46.9)', 'Results 2: ', ' Arm/Group Title: Placebo With Paclitaxel', ' Arm/Group Description: Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.', ' Overall Number of Participants Analyzed: 288', ' Median (Inter-Quartile Range)', ' Unit of Measure: weeks 22.9 (12.0 to 38.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 103/293 (35.15%)', ' Neutropenia 22/293 (7.51%)', ' Febrile neutropenia 10/293 (3.41%)', ' Disseminated intravascular coagulation 0/293 (0.00%)', ' Leukopenia 0/293 (0.00%)', ' Thrombocythemia 1/293 (0.34%)', ' Left ventricular dysfunction 2/293 (0.68%)', ' Atrial fibrillation 1/293 (0.34%)', ' Cardiac arrest 1/293 (0.34%)', ' Cardiac failure 1/293 (0.34%)', ' Myocardial infarction 0/293 (0.00%)', 'Adverse Events 2:', ' Total: 63/286 (22.03%)', ' Neutropenia 14/286 (4.90%)', ' Febrile neutropenia 3/286 (1.05%)', ' Disseminated intravascular coagulation 1/286 (0.35%)', ' Leukopenia 1/286 (0.35%)', ' Thrombocythemia 0/286 (0.00%)', ' Left ventricular dysfunction 1/286 (0.35%)', ' Atrial fibrillation 0/286 (0.00%)', ' Cardiac arrest 0/286 (0.00%)', ' Cardiac failure 0/286 (0.00%)', ' Myocardial infarction 1/286 (0.35%)']}

{'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%)']}

57f3a264-9119-4931-9f9c-9cb20e945973

Single

Results

NCT00305448

At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR).

Entailment

{'Clinical Trial ID': 'NCT00305448', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant 250 mg', 'Fulvestrant 250 mg', 'INTERVENTION 2: ', ' Fulvestrant 250 mg + Loading Dose', ' Fulvestrant 250 mg + Loading Dose'], 'Eligibility': ['Inclusion Criteria:', ' Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor', ' Requiring hormonal treatment', ' Postmenopausal women defined as a woman who has stopped having menstrual periods', 'Exclusion Criteria:', ' Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced breast cancer', ' Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer', ' An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response.', ' Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization', ' Time frame: baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)', 'Results 1: ', ' Arm/Group Title: Fulvestrant 250 mg', ' Arm/Group Description: Fulvestrant 250 mg', ' Overall Number of Participants Analyzed: 45', ' Measure Type: Number', ' Unit of Measure: percentage of participants 11.1', 'Results 2: ', ' Arm/Group Title: Fulvestrant 250 mg + Loading Dose', ' Arm/Group Description: Fulvestrant 250 mg + Loading Dose', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: percentage of participants 17.6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/45 (4.44%)', ' Cardiac Failure Congestive 0/45 (0.00%)', ' Diverticular Perforation 0/45 (0.00%)', ' Herpes Zoster 1/45 (2.22%)', ' Back Pain 0/45 (0.00%)', ' Fallopian Tube Cancer 0/45 (0.00%)', ' Fibroma 0/45 (0.00%)', ' Brain Stem Infarction 1/45 (2.22%)', ' Dizziness 0/45 (0.00%)', ' Optic Neuritis 0/45 (0.00%)', 'Adverse Events 2:', ' Total: 5/51 (9.80%)', ' Cardiac Failure Congestive 1/51 (1.96%)', ' Diverticular Perforation 1/51 (1.96%)', ' Herpes Zoster 0/51 (0.00%)', ' Back Pain 1/51 (1.96%)', ' Fallopian Tube Cancer 1/51 (1.96%)', ' Fibroma 1/51 (1.96%)', ' Brain Stem Infarction 0/51 (0.00%)', ' Dizziness 0/51 (0.00%)', ' Optic Neuritis 1/51 (1.96%)']}

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

589e2f5b-9286-465b-8162-bb1549cd5ece

Single

Adverse Events

NCT03066947

Less than 1/4 patients in the primary trial experienced adverse events.

Contradiction

{'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': ''}

8275f846-59b6-404d-a6d8-e01335279f1a

Single

Intervention

NCT01390064

The both Cohorts of the primary trial receive their treatment via Subcutaneous administration.

Entailment

{'Clinical Trial ID': 'NCT01390064', 'Intervention': ['INTERVENTION 1: ', ' Initial Cohort', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule', 'INTERVENTION 2: ', ' Escalation Cohort', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule'], 'Eligibility': ['Inclusion Criteria:', ' Female subjects of all races with histologically or cytologically confirmed stage IV breast cancer are eligible. The cancer may be newly diagnosed metastatic or relapsed after primary or adjunctive therapy and must not have required a treatment change for 2 months. Treatments with anti-estrogen therapy or chemotherapy are allowed. The chemotherapy regimen cannot contain steroids in the pre or post supportive care medications. If a subject is on an investigational drug, the drug must be cleared from the body over a period of 4 weeks.', ' Disease staging will be done according to the American Joint Commission on Cancer (AJCC), sixth edition.', ' Age 18 years and older of all races and ethnicity.', ' ECOG Performance Status 0 or 1.', ' Subjects must not have an active infection requiring treatment with antibiotics.', ' Subjects must not have other significant medical, surgical or psychiatric conditions, or require any medication or treatment, which may interfere with compliance of the treatment regimen.', ' Subjects must not have a diagnosis or evidence of organic brain syndrome, significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol.', ' Subjects must have no other current malignancies. Subjects with prior history at any time of any in situ cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration. Subjects with other malignancies are eligible if they have been continuously disease free for 5 years prior to the time of registration.', ' Subjects must not have autoimmune disorders or conditions of immunosuppression. This includes, but is not limited to being treated with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone), continuous use of topical steroid creams or ointments or any steroid-containing inhalers. Subjects who have been on systemic steroids will require a 6-week washout period. Subjects who discontinue the use of these classes of medication for at least 6 weeks prior to registration are eligible if, in the judgment of the treating physician, the subject is not likely to require these classes of drugs during the treatment period. Replacement doses of steroids for subjects with adrenal insufficiency are allowed.', ' Women of childbearing potential must not be pregnant (negative serum pregnancy test must be done 48 hours prior to receiving the first dose of study drug) or breastfeeding,due to the unknown effects of peptide/mimotope vaccines on a fetus or infant.', ' Women of childbearing potential must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment. Accepted methods include oral contraceptives, barrier method, Intrauterine Devices (IUDs), and abstinence.', ' Subjects must have obtained a white blood cell (WBC) count 3,000/mm3 and platelet count 100,000/mm3 within 2 weeks prior to registration.', ' Subjects must have a serum glutamic-oxaloacetic transaminase (SGOT)/aspartate aminotransferase test (AST) and bilirubin 2 x institutional upper limit (IUL) of normal and serum creatinine 1.8 mg/dl, all obtained within 2 weeks prior to registration.', ' Subjects must be immunocompetent as measured by responsiveness to two recall antigens by skin testing.', ' All subjects who wish to participate in the study must sign an informed consent approved by the UAMS Institutional Review Board (IRB).', ' Laboratory tests must be completed within 2 weeks before the first dose.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With a Dose-limiting Toxicity (Defined as an Adverse Event of Grade 3 or Higher)', ' The safety and tolerability of the P10s-PADRE/MONTANIDE ISA51 VG vaccine will be determined by toxicity assessments throughout the duration of the study. Subjects will be evaluated for toxicity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.', ' Time frame: 9 weeks per subject', 'Results 1: ', ' Arm/Group Title: Initial Cohort', ' Arm/Group Description: Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants 0', 'Results 2: ', ' Arm/Group Title: Escalation Cohort', ' Arm/Group Description: Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms', ' Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', 'Adverse Events 2:', ' Total: ']}

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

b3c1f5d1-6f7f-4bab-a4e8-5d1dab597cc7

Single

Eligibility

NCT01142661

the primary trial does not accept patients with grade 1 alopecia.

Entailment

{'Clinical Trial ID': 'NCT01142661', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate', 'Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.'], 'Eligibility': ['Inclusion Criteria', ' In order to receive eribulin under this protocol, the subjects oncologist must have documented experience treating subjects with eribulin in a prior clinical study. Subjects who meet all of the following criteria will be included in the treatment protocol:', ' Recurrent, locally advanced or metastatic breast cancer that has progressed on or after the last anti-cancer therapy.', ' Prior treatment with, ineligibility for, or commercial unavailability of each of the following therapies:', ' Anthracyclines, taxanes, and capecitabine.', ' Ixabepilone in countries where this agent is marketed.', ' Trastuzumab for Her-2 positive disease.', ' Hormonal therapy in hormone receptor-positive disease.', ' All other marketed therapies, eg, gemcitabine or vinorelbine, used for the treatment of advanced breast cancer.', ' Eastern Cooperative Oncology Group (ECOG) performance status </= 2.', ' Serum creatinine </= 2.0 mg/dL or creatinine clearance >/= 40 mL/min according to Cockcroft and Gault formula.', ' Absolute neutrophil count >/= 1.5 x 10^9/L, hemoglobin >/= 10 g/dL (can be corrected by growth factor or transfusion), and platelet count >/= 100 x 10^9/L.', ' Total bilirubin </= 1.5 x upper limit of normal (ULN). Alkaline phosphatase (AP), alanine aminotransferase, and aspartate aminotransferase </= 3 x ULN (</= 5 x ULN in case of liver metastases). In case AP is >3 x ULN (in absence of liver metastases) or >5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP.', ' Are willing and able to comply with all aspects of the treatment protocol.', ' Provide written informed consent.', ' Females, age >/= 18 years.', ' Female subjects of childbearing potential must agree to be abstinent or to use a highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intra-uterine device, or have a vasectomised partner) having started for at least one menstrual cycle prior to starting eribulin and throughout the entire treatment period and for 30 days (longer if appropriate) after the last dose of eribulin. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.', ' Exclusion Criteria Subjects who meet any of the following criteria will be excluded from participation in the treatment protocol:', ' Eligible for any other eribulin study that is open in the same region.', ' Existing anti-cancer therapy-related toxicities of Grade >/= 2, except that alopecia and Grade 2 neuropathy are acceptable.', ' History of congestive heart failure with New York Heart Association Classification >II, unstable angina, myocardial infarction within the past 6 months, serious cardiac arrhythmia.', " Electrocardiogram with QTc interval >/= 500 msec based upon Bazett's formula (QTcB).", ' The Investigator believes the subject to be medically unfit to receive eribulin or unsuitable for any other reason.', ' Females who are pregnant (positive B-hCG test) or breastfeeding.', ' Subject with hypersensitivity to eribulin or any of the excipients.', ' Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this treatment protocol. Any signs (eg, radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting the treatment protocol.', " Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject's ability to safely complete the treatment protocol.", ' Subjects who are known to be human immunodeficiency virus positive because the neutropenia caused by the eribulin treatment may make such subjects particularly susceptible to infection.', ' Subjects with meningeal carcinomatosis.', ' Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.', ' Subjects who have received any of the following treatments within the specified period before the start of treatment:', ' Any investigational drug, chemotherapy, radiation, or biological or targeted therapy within 2 weeks.', ' Hormonal therapy within 1 week.'], 'Results': ['Outcome Measurement: ', ' Safety', ' General safety will be assessed by monitoring and recording the number of patients with adverse events (serious and nonserious) for duration of treatment which continued until disease progression, unacceptable toxicity or death.', ' Time frame: For duration of treatment, an average of 5 months', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate', ' Arm/Group Description: Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/9 (77.78%)', ' Febrile Neutropenia1/9 (11.11%)', ' Neutropenia1/9 (11.11%)', ' Tachycardia1/9 (11.11%)', ' Hematemesis1/9 (11.11%)', ' Small Bowel Obstruction1/9 (11.11%)', ' Pneumonia1/9 (11.11%)', ' Hypokalemia1/9 (11.11%)', ' Alcohol Poisoning1/9 (11.11%)', ' Progressive Disease4/9 (44.44%)']}

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

18d9991c-ca96-4bab-93af-77654857a07f

Comparison

Intervention

NCT01925170

NCT00324259

Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography.

Contradiction

{'Clinical Trial ID': 'NCT01925170', 'Intervention': ['INTERVENTION 1: ', ' Mammography Only', ' For this reporting arm, the interpretation and analysis was done with mammography only.', 'INTERVENTION 2: ', ' Mammography With Adjunct MBI', ' For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.'], 'Eligibility': ['Inclusion Criteria:', ' Past prior SM interpreted as negative or benign [Breast Imaging Reporting and Data System (BI-RADS) Category 1 or 2]', ' Past prior SM interpreted as heterogeneously dense or extremely dense', 'Exclusion Criteria:', ' Subject is unable to understand and sign the consent form', ' Subject is pregnant or lactating', ' Subject is physically unable to sit upright and still for 40 minutes', ' Subject has self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass, etc.)', ' Subject has had needle biopsy within 3 months, or breast surgery within 1 year prior to the study', ' Subject is currently taking tamoxifen, Evista (raloxifene), Zoladex or an aromatase inhibitor for adjuvant therapy or chemoprevention.'], 'Results': ['Outcome Measurement: ', ' Cancer Detection Rate Per 1000 Women Screened, by Breast Density', ' The cancer detection rate per 1000 women screened is the estimate of the number of women with positive results from a screening test.', ' Time frame: Within 21 days of mammography', '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: 1585', ' Measure Type: Number', ' Unit of Measure: cancers per 1000 women screened All densities: 3.2 (1.3 to 7.4)', ' Scattered fibroglandular densities: 0 (0 to 26.2)', ' Heterogeneously dense: 3.3 (1.3 to 8.4)', ' Extremely dense: 4.5 (0.2 to 25.2)', 'Results 2: ', ' Arm/Group Title: Mammography With Adjunct MBI', ' Arm/Group Description: For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.', ' Overall Number of Participants Analyzed: 1585', ' Measure Type: Number', ' Unit of Measure: cancers per 1000 women screened All densities: 12.0 (7.7 to 18.6)', ' Scattered fibroglandular densities: 21.0 (7.2 to 59.9)', ' Heterogeneously dense: 10.6 (6.2 to 18.1)', ' Extremely dense: 13.6 (4.6 to 39.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/1585 (0.00%)', 'Adverse Events 2:', ' ']}

{'Clinical Trial ID': 'NCT00324259', 'Intervention': ['INTERVENTION 1: ', ' Arm 1 (6 mg Estradiol)', ' 6 mg of estradiol daily (2 mg tid).', 'INTERVENTION 2: ', ' Arm 2 (30 mg Estradiol)', ' 30 mg of estradiol. (10 mg tid)'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with advanced hormone receptor positive (ER and or PgR) breast cancer, has received prior treatment with an aromatase inhibitor in the advanced disease setting, and experienced at least 24 weeks of progression free survival. As long as the patient experienced an aromatase inhibitor response as defined this way, she is still eligible even if she has received further lines of endocrine therapy, which may include other aromatase inhibitors or tamoxifen, even if these subsequent lines of treatment were unsuccessful (see below for permitted chemotherapy and trastuzumab therapy).', ' OR', ' Postmenopausal women with systemic or unresectable local relapse after taking at least two years of adjuvant aromatase inhibitor therapy.', ' Clinical diagnosis of postmenopausal status is defined as either:', ' Age greater than 50 years and amenorrhea for 1 year', ' Bilateral Surgical ovariectomy', ' Serum FSH and estradiol level in the postmenopausal range before the initiation of AI therapy.', ' If the patient was receiving an LHRH agonist to maintain a postmenopausal state during AI therapy this should be continued since recovery of menses would lead to uncontrolled estrogen exposure and pregnancy during estrogen therapy is contraindicated.', ' Tumor cell expression of ER and/or PgR can be ascertained on either the primary or the metastatic site. However when both types of tissue are available, the metastatic site should be used to determine eligibility. ER and/or PgR positive are defined as at least 10% of malignant cells with positive nuclear staining.', ' The patients may have received adjuvant and/or neoadjuvant chemotherapy.', ' Prior radiotherapy is permitted as long as it was planned before the start of the study medication and is completed within 3 weeks of trial medication starting.', ' Prior tamoxifen therapy is also permitted as adjuvant or advanced disease therapy.', ' Patients with ER+ HER2+ disease are eligible even of they have received trastuzumab in the past (and even if it was administered in combination with endocrine treatment) as long as they meet all other eligibility criteria. Trastuzumab therapy must be held during estradiol treatment.', ' Use of prior experimental agents alone or in combination with endocrine therapy is also permissible, but a wash out of one month is required if the immediate prior therapy involved a study medication that had not been subject to regulatory approval.', ' Prior adjuvant chemotherapy is permitted as well as one line of chemotherapy for advanced disease.', ' Patient must have at least one measurable lesion defined by RECIST criteria. To be considered measurable, a baseline lesion must have a minimum diameter to compensate for measurement error: 1 cm for soft tissue lesions, 1 cm for lung lesions including pleural lesions measured by CT scan, 1 cm for liver lesions measured by CT scan.', ' Patients with bone only disease can also be enrolled if they meet the following criteria:', ' Four or more lesions more than one cm, measurable on CT scan bone windows.', ' At least one tumor marker that is elevated to at least two times the upper limit of normal.', ' All patients should have a baseline bone scan with X-ray evaluation of all hot spots, CT chest abdomen and pelvis (with bone windows), and tumor marker assessment. Also CT scan of the extremities should be done on suspicious areas seen on X-ray evaluation of all hot spots if these extremity lesions are to be followed for response.', ' The patient must have an ECOG performance status of 0-2', ' The patient should have a life expectancy of > 6 months.', ' The patient must have adequate hematologic function, defined as ANC >1000/mm3 and platelets > 75,000/mm3.', ' The patient must have adequate renal function, defined as serum creatinine less than or equal to 1.5 times the upper limit of normal.', ' The patient must have adequate liver function defined as serum bilirubin less than or equal to 1.5 times the upper limit of normal (three times the upper limit of normal for patients with hereditary benign hyperbilirubinaemia), transaminases (ALT, AST) less than or equal to 2.5 times the upper limit of normal in patients without liver metastasis or less than or equal to 5 times the upper limit of normal in patients with liver metastasis.', ' For patients with bone metastasis, treatment with i.v. bisphosphonates during the trial is mandatory because of the risk of hypercalcemia. Bisphosphonate therapy must be started before the patient begins protocol therapy.', ' Preexisting hypercalcemia should be treated and calcium normalized prior to study entry.', ' The patient must give written informed consent prior to initiation of any invasive study-related procedures that would otherwise not be performed, and must be able to comply with scheduled visits and evaluations.', ' Inclusion of Women and Minorities: Entry to this study is open to women of all racial and ethnic subgroups.', ' Patients with fasting blood glucose level 200 mg/dL. If greater, hyperglycemia must be treated before initiation of study investigations.', 'Exclusion Criteria:', ' Patients with CNS involvement with metastatic breast cancer or life threatening lymphangitic or large volume lung or liver disease that threatens organ function.', ' Patients with history of deep venous thrombosis, pulmonary embolism, stroke, acute myocardial infarction, congestive cardiac failure, untreated hypertension.', ' Ischemic changes on a baseline EKG or other evidence of ischemic heart disease.', ' Undiagnosed abnormal genital bleeding', ' Untreated cholelithiasis', ' Fasting serum triglycerides greater than 400. Patients should be treated and triglycerides controlled prior to study entry.', ' Treatment with fulvestrant within 12 months of study initiation (fulvestrant has been shown to antagonize estradiol induced apoptosis in preclinical models (5).', " The patient's only qualifying lesion (s) have been previously irradiated or are scheduled for irradiation following study entry.", ' Severe or uncontrolled concomitant disease from other causes.', ' EGOG Performance status 3 or 4.', ' The patient has previous malignancies other than breast cancer except a) adequately treated in situ carcinoma of the cervix, b) localized basal or squamous cell carcinoma of the skin c) any previous malignancy treated with curative intent with a recurrence risk of less than 30%.', ' The patient is unable to understand the informed consent or is unlikely to be compliant with the protocol.', ' More than one line of palliative chemotherapy for advanced disease.'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate (CR Plus PR Plus SD)', ' Complete response (CR) + partial response (PR) + stable disease (SD) using RECIST 1.0', ' CR = disappearance of all target lesions', ' PR = at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter', ' SD = neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for progressive disease', ' SD is defined as lack of disease progression by 24 weeks.', ' Time frame: 24 weeks after start of treatment', 'Results 1: ', ' Arm/Group Title: Arm 1 (6 mg Estradiol)', ' Arm/Group Description: 6 mg of estradiol daily (2 mg tid).', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Number', ' Unit of Measure: participants Complete response (CR): 0', ' Partial response (PR): 3', ' Stable disease (SD): 7', 'CR+PR+SD: 10', 'Results 2: ', ' Arm/Group Title: Arm 2 (30 mg Estradiol)', ' Arm/Group Description: 30 mg of estradiol. (10 mg tid)', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Number', ' Unit of Measure: participants Complete response (CR): 0', ' Partial response (PR): 1', ' Stable disease (SD): 8', 'CR+PR+SD: 9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/34 (23.53%)', ' Hemoglobin 0/34 (0.00%)', ' Eye pain 0/34 (0.00%)', ' Vison loss 0/34 (0.00%)', ' Abdominal pain 2/34 (5.88%)', ' Constipation 0/34 (0.00%)', ' Diarrhea 2/34 (5.88%)', ' GI hemorrhage 1/34 (2.94%)', ' Nausea 2/34 (5.88%)', ' Vomiting 2/34 (5.88%)', ' Fatigue 0/34 (0.00%)', ' Fever 2/34 (5.88%)', ' Pain 0/34 (0.00%)', ' Pneumonia 1/34 (2.94%)', ' Neutropenia 0/34 (0.00%)', 'Adverse Events 2:', ' Total: 8/32 (25.00%)', ' Hemoglobin 1/32 (3.13%)', ' Eye pain 1/32 (3.13%)', ' Vison loss 1/32 (3.13%)', ' Abdominal pain 1/32 (3.13%)', ' Constipation 2/32 (6.25%)', ' Diarrhea 1/32 (3.13%)', ' GI hemorrhage 0/32 (0.00%)', ' Nausea 3/32 (9.38%)', ' Vomiting 3/32 (9.38%)', ' Fatigue 1/32 (3.13%)', ' Fever 0/32 (0.00%)', ' Pain 1/32 (3.13%)', ' Pneumonia 0/32 (0.00%)', ' Neutropenia 1/32 (3.13%)']}

6fb9056d-277c-4dc2-9b45-d7661bb41831

Single

Adverse Events

NCT00129376

A single patient in the primary trial experienced a clinically significant inflammation of the back of the throat.

Entailment

{'Clinical Trial ID': 'NCT00129376', 'Intervention': ['INTERVENTION 1: ', ' Doxorubicin + Cyclophosphamide Followed Docetaxel', ' Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles (days 1, 22, 43 and 64). Three weeks later, docetaxel (36 mg/m2) was administered as a 30-min intravenous infusion, weekly for six weeks (days 85, 92, 99, 106, 113 and 120) followed by a 2-week resting period (8-week cycle). After that, patients received a second docetaxel cycle (infusions on days 141, 148, 155, 162, 169 and 176).'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent.', ' Patients with breast cancer stages II and IIIA, with histological diagnoses as per true-cut or open biopsy.', ' Negative extension study, including bilateral mammography, thoracic x-ray, computed tomography (CT)-scan or abdominal echography and bone scintigraphy.', ' Analysis of hormone receptor status in primary tumour. It is highly recommended to obtain a tumour tissue sample before start of treatment, and after definitive surgery. These samples will be analysed centrally by Spanish Breast Cancer Research Group (GEICAM).', ' Age >= 18 and <= 70 years old.', ' Performance status as per Karnofsky index >= 80.', ' Minimum life expectancy of 6 months.', ' Electrocardiogram (EKG) 12 weeks before registration to the study. If abnormalities are suspected, cardiac function must be assessed by left ventricular ejection fraction (LVEF).', ' Haematology: neutrophils >= 2.0 x10^9/l; platelets >= 100 x10^9/l; hemoglobin >=10 g/dl.', ' Hepatic function: total bilirubin <= 1 x upper normal limit (UNL); Aspartate aminotransferase (AST) (SGOT) and and Alanine aminotransferase (ALT) (SGPT) <= 2.5 x UNL; alkaline phosphatase <= 5 x UNL.', ' Renal function: creatinine <= 1.5 x UNL; creatinine clearance >= 60 ml/min.', ' Patients able to comply with study requirements.', ' Negative pregnancy test.', ' Adequate contraceptive method during the study and up to 3 months after definitive surgery.', 'Exclusion Criteria:', ' Previous systemic therapy for breast cancer treatment.', ' Previous treatments with anthracyclines or taxanes for any malignancy.', ' Previous radiotherapy for breast cancer.', ' Bilateral invasive breast cancer.', ' Pregnant or lactating women.', ' Previous motor or sensorial neurotoxicity grade >=2.', ' Other serious pathologies: congestive heart failure or angina pectoris; history of myocardial infarction in the previous year; uncontrolled hypertension (HT) or high risk arrhythmias.', ' History of neurological or psychiatric impairment, precluding patients from providing free informed consent.', ' Active infection.', ' Active peptic ulcer; unstable diabetes mellitus.', ' History of previous or current malignancies other than breast cancer, except for basal skin carcinoma, cervical in situ carcinoma, other tumour diagnosed and treated more than 10 years before, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS).', ' Chronic treatment with corticoids unless the treatment started > 6 months before registration to the study, and low doses are administered.', ' Substitutive hormonal therapy. This treatment must be interrupted before inclusion in the study.', ' Concomitant treatment with other investigational products or administration in the 30 previous days.', 'Males.'], 'Results': ['Outcome Measurement: ', ' Pathological Complete Response (pCR) Rate', ' Pathological complete response was defined by the Miller & Payne criteria. pCR was defined as no invasive cells identifiable in breast sections at surgery. Response was measured by physical exam and breast imaging before surgery and was evaluated according to the World Health Organization (WHO) criteria. Pathological response after surgery, was based on the proportion of remaining tumor and postchemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes.', ' Time frame: Up to 29 weeks', 'Results 1: ', ' Arm/Group Title: Doxorubicin + Cyclophosphamide Followed Docetaxel', ' Arm/Group Description: Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles (days 1, 22, 43 and 64). Three weeks later, docetaxel (36 mg/m2) was administered as a 30-min intravenous infusion, weekly for six weeks (days 85, 92, 99, 106, 113 and 120) followed by a 2-week resting period (8-week cycle). After that, patients received a second docetaxel cycle (infusions on days 141, 148, 155, 162, 169 and 176).', ' Overall Number of Participants Analyzed: 61', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 11 18.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/63 (19.05%)', ' Febrile neutropenia * [1]4/63 (6.35%)', ' Congestive heart failure * [2]1/63 (1.59%)', ' Cardiac-ischemia/infarction * 1/63 (1.59%)', ' Vomiting * [1]1/63 (1.59%)', ' Acute Pharyngitis * 1/63 (1.59%)', ' Infection * 3/63 (4.76%)', ' Neutrophil count decreased * [1]1/63 (1.59%)', ' Pneumonitis/pulmonary infiltrates * [3]1/63 (1.59%)']}

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

52b23601-2276-4634-96c7-8b6e55596085

Single

Results

NCT00431067

More than 5% of the primary trial participants achieved partial response (PR).

Contradiction

{'Clinical Trial ID': 'NCT00431067', 'Intervention': ['INTERVENTION 1: ', ' Afatinib 50 mg', ' Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.'], 'Eligibility': ['Inclusion criteria:', 'Inclusion Criteria:', ' Male or female patients with confirmed diagnosis of Stage IIIB or IV HER2-positive metastatic breast cancer(HER2 2+ and FISH positive or HER2 3+).', ' Patients must have progressed following receipt of prior standard trastuzumab treatment or standard chemotherapy in conjunction with trastuzumab. Patients with visceral disease or rapid progression should not be included if they have not had previous chemotherapy in addition to trastuzumab. Patients who are intolerant to trastuzumab and who have received adequate chemotherapy and/or hormone therapy are eligible upon progression.', ' Age 18 years or older.', ' Life expectancy of at least four (4) months.', ' Written informed consent that is consistent with ICH-GCP guidelines.', ' Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2.', ' Patients should not have received treatment with chemotherapy or immune therapy within the last 4 weeks (2 weeks for trastuzumab). Patients should not have received treatment with hormone therapy within the last 2 weeks.', ' Patients must have recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC less than or equal to Grade 1.', ' Patients must have recovered from previous surgery.', ' Patients must have measurable disease as defined by RECIST criteria.', 'Exclusion criteria:', 'Exclusion Criteria:', ' Active infectious disease.', ' Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.', ' Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.', ' Patients with active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal MRI scan at screening and be at least three months post-radiation or surgery.', ' Cardiac left ventricular function with resting ejection fraction <50%.', ' Absolute neutrophil count (ANC) less than 1500 cells/mm3.', ' Platelet count less than 100 000 cells/mm3.', ' Bilirubin greater than 1.5 mg/dl (>26 micromol /L, SI unit equivalent).', ' Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than three times the upper limit of normal.', ' Serum creatinine greater than 1.5 mg/dl (>132 micromol/L, SI unit equivalent).', ' Women and men (and their partners) who are sexually active and unwilling to use a medically acceptable method of contraception.', ' Pregnancy or breast-feeding.', ' Treatment with other investigational drugs; chemotherapy, immunotherapy, radiotherapy or hormone therapy (including LHRH agonists, or other hormones taken for breast cancer), or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study. Treatment with bisphosphonates is allowed.', ' Prior treatment with an EGFR- or HER2 inhibiting drug (except trastuzumab).', ' Patients unable to comply with the protocol.', ' Active alcohol or drug abuse.', ' Patients with history of other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least 3 years.'], 'Results': ['Outcome Measurement: ', ' Objective Response (OR)', ' Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .', ' Time frame: From first dose of study medication to response measurement, up to 34 month', 'Results 1: ', ' Arm/Group Title: Afatinib 50 mg', ' Arm/Group Description: Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.', ' Overall Number of Participants Analyzed: 41', ' Measure Type: Number', ' Unit of Measure: Participants 4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/41 (19.51%)', ' Constipation 1/41 (2.44%)', ' Diarrhoea 1/41 (2.44%)', ' Nausea 2/41 (4.88%)', ' Vomiting 3/41 (7.32%)', ' Biliary colic 1/41 (2.44%)', ' Diarrhoea infectious 1/41 (2.44%)', ' International normalised ratio decreased 1/41 (2.44%)', ' Dehydration 2/41 (4.88%)', ' Hyponatraemia 1/41 (2.44%)', ' Malignant neoplasm progression 2/41 (4.88%)', ' Headache 1/41 (2.44%)']}

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

95e05332-4926-4381-90a4-87941269e7bf

Comparison

Intervention

NCT00054028

NCT02162719

Both the primary trial and the secondary trial at least partly administer their interventions orally.

Contradiction

{'Clinical Trial ID': 'NCT00054028', 'Intervention': ['INTERVENTION 1: ', ' Suramin and Paclitaxel', ' Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed stage IIIB or IV metastatic breast cancer (MBC)', 'Prior chemotherapy:', ' Phase I: patients must have received prior paclitaxel or other taxanes in either the adjuvant or metastatic setting; prior chemotherapy, radiation or surgery must be completed at least 21 days before study entry; prior treatment with anthracyclines is not required', ' Phase II: up to two prior chemotherapy regimens for stage IIIB or IV MBC; patients must have received prior paclitaxel or other taxanes in either the adjuvant or metastatic setting; prior chemotherapy, radiation or surgery must be completed at least 21 days before study entry; prior treatment with anthracyclines is not required', ' Measurable disease (phase II)', ' No known brain metastases', ' Hormone receptor status:', ' Not specified', ' Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2', ' White blood cell (WBC) at least 3,000/mm^3', ' Absolute neutrophil count at least 1,000/mm^3', ' Platelet count at least 100,000/mm^3', ' Hemoglobin at least 9.0 g/dL', ' Bilirubin no greater than 1.5 mg/dL', ' Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) no greater than 2.5 times upper limit of normal', ' Creatinine no greater than 1.5 mg/dL', ' Left ventricular ejection fraction (LVEF) at least lower limit of normal', ' No symptomatic congestive heart failure', ' No unstable angina pectoris', ' No cardiac arrhythmia', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No history of allergic reactions attributable to compounds of similar chemical or biological composition to Cremophor', ' No concurrent uncontrolled illness that would preclude study compliance', ' No ongoing or active infection', ' No uncontrolled diabetes mellitus', ' No psychiatric illness or social situations that would preclude study compliance', ' No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix', ' See Disease Characteristics', ' At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered', ' No more than 2 prior chemotherapy regimens for this malignancy (phase II)', ' No concurrent steroids or hormones except the following:', ' Steroids to prevent hypersensitivity reactions prior to paclitaxel administration', ' Hormones for nondisease-related conditions (e.g., insulin for diabetes)', ' At least 3 weeks since prior radiotherapy and recovered', ' At least 3 weeks since prior surgery and recovered', ' No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients', ' No other concurrent investigational agents', ' Concurrent bisphosphonates (i.e., pamidronate or zoledronate) are allowed for the treatment of hypercalcemia or palliation of skeletal metastases'], 'Results': ['Outcome Measurement: ', ' Percentage of Patients That Achieved Target Suramin Concentrations in Plasma', ' Target suramin concentration was considered achieved, if at least 5 of 6 patients achieved the target plasma concentration of 10-50 µM over the duration of 8-48 hours when paclitaxel levels are therapeutic.', ' Time frame: Up to 5 years', 'Results 1: ', ' Arm/Group Title: Suramin and Paclitaxel', ' Arm/Group Description: Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: percent of patients 88'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/31 (3.23%)', ' Adult respiratory distress syndrome (ARDS) 1/31 (3.23%)']}

{'Clinical Trial ID': 'NCT02162719', 'Intervention': ['INTERVENTION 1: ', ' Ipatasertib and Paclitaxel', ' Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.', 'INTERVENTION 2: ', ' Placebo and Paclitaxel', ' Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented triple-negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen, required prior to randomization', ' Measurable disease, according to the RECIST v1.1', ' Adequate hematologic and organ function within 14 days before the first study treatment', ' For female participants of childbearing potential, agreement (by both participant and partner) to use an effective form of contraception for the duration of the study and for 6 months after last dose of study treatment', 'Exclusion Criteria:', ' Any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast. Participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed greater than or equal to (>/=) 6 months prior to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with curative intent', ' Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1', ' Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor (ER) positive, or progesterone receptor (PR) positive breast cancer', ' Previous therapy with Akt, PI3K, and/or mTOR inhibitors', ' Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study', ' Known presence of the brain or spinal cord metastasis, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first.', ' Time frame: Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016)', 'Results 1: ', ' Arm/Group Title: Ipatasertib and Paclitaxel', ' Arm/Group Description: Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.', ' Overall Number of Participants Analyzed: 62', ' Median (90% Confidence Interval)', ' Unit of Measure: Months 6.18 (4.57 to 7.33)', 'Results 2: ', ' Arm/Group Title: Placebo and Paclitaxel', ' Arm/Group Description: Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.', ' Overall Number of Participants Analyzed: 62', ' Median (90% Confidence Interval)', ' Unit of Measure: Months 4.93 (3.58 to 5.36)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/61 (29.51%)', ' Pancytopenia 0/61 (0.00%)', ' Febrile Neutropenia 2/61 (3.28%)', ' Constipation 0/61 (0.00%)', ' Diarrhoea 3/61 (4.92%)', ' Nausea 1/61 (1.64%)', ' Pancreatitis 1/61 (1.64%)', ' Death 0/61 (0.00%)', ' Pyrexia 2/61 (3.28%)', ' Cholestasis 0/61 (0.00%)', ' Atypical Pneumonia 1/61 (1.64%)', ' Cystitis 0/61 (0.00%)', ' Gastroenteritis 0/61 (0.00%)', ' Influenza 0/61 (0.00%)', 'Adverse Events 2:', ' Total: 12/62 (19.35%)', ' Pancytopenia 1/62 (1.61%)', ' Febrile Neutropenia 0/62 (0.00%)', ' Constipation 1/62 (1.61%)', ' Diarrhoea 0/62 (0.00%)', ' Nausea 0/62 (0.00%)', ' Pancreatitis 0/62 (0.00%)', ' Death 1/62 (1.61%)', ' Pyrexia 1/62 (1.61%)', ' Cholestasis 1/62 (1.61%)', ' Atypical Pneumonia 0/62 (0.00%)', ' Cystitis 1/62 (1.61%)', ' Gastroenteritis 1/62 (1.61%)', ' Influenza 1/62 (1.61%)']}

20d51467-b059-4f39-b636-d32f2dc692da

Single

Adverse Events

NCT01427933

Neutropenia affected the majority of patients in cohort 1 of the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01427933', 'Intervention': ['INTERVENTION 1: ', ' Ramucirumab and Eribulin', ' Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle', ' Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle', 'INTERVENTION 2: ', ' Eribulin Monotherapy', ' Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle'], 'Eligibility': ['Inclusion Criteria:', ' Have histologically or cytologically confirmed invasive breast cancer which at the time of study entry is either locally recurrent disease not amenable to curative therapy or Stage IV disease (American Joint Committee on Cancer Staging Criteria for breast cancer)', ' Have measurable and/or nonmeasurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)', ' Have received at least 2 but not more than 4 prior cytotoxic chemotherapy regimens in the locally recurrent or metastatic setting', ' Have received prior treatment with both anthracyclines and taxanes, either in the metastatic, adjuvant or neoadjuvant setting', ' Have received Human Epidermal Growth Factor Receptor 2 (HER-2) directed treatment; or are not a candidate for HER-2-directed treatment if the patient has HER-2 positive disease', ' Have completed any prior radiotherapy and/or hormonal therapy at least 1 week prior to randomization and have recovered from all clinically significant treatment-related toxicities', ' Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1', ' Have left ventricular ejection fraction within normal limits', ' Have discontinued all previous chemotherapy treatments for cancer at least 3 weeks prior to randomization and recovered from clinically significant toxic effects', ' Have resolution to Grade less than or equal to 1 [by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0] of all clinically significant toxicities of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy, which must have resolved to Grade less than or equal to 2', ' Have adequate hematologic, hepatic, renal, and coagulation function', ' Test negative for pregnancy', ' Have a life expectancy of at least 3 months', 'Exclusion Criteria:', ' Have a concurrent active other malignancy other than adequately treated non-melanomatous skin cancer or other noninvasive or in situ neoplasms', ' Are currently enrolled in, or recently discontinued from, a clinical trial involving an investigational product, or concurrently enrolled in any other type of medical research judged not to be medically compatible with the study', ' Have received investigational therapy within 3 weeks prior to randomization', ' Have received prior ramucirumab or eribulin', ' Have a known sensitivity to agents of similar biologic composition as ramucirumab, halichondrin B and/or halichondrin B chemical derivative', ' Have received bevacizumab within 6 weeks prior to randomization', ' Have uncontrolled or poorly controlled hypertension', ' Have congenital prolonged QTc syndrome (or have a family history) or prolongation of QTc at baseline', ' Have a history of additional risk factors for torsades de pointes within the last year prior to randomization', ' Have an implantable pacemaker or automatic implantable cardioverter defibrillator', ' Have bradycardia', ' Have an acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention within 6 months prior to randomization', ' Have a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders', ' Have experienced a Grade 3 or greater bleeding event within 3 months prior to randomization', ' Have experienced any Grade 3 or greater arterial thromboembolic events within 6 months prior to randomization, or venous thromboembolic event within 3 months prior to randomization', ' Have undergone major surgery within 4 weeks prior to randomization or subcutaneous venous access device placement within 7 days prior to randomization', ' Have a planned major surgery to be performed during the course of the trial', ' Have uncontrolled metabolic conditions', ' Have an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy', ' Have known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)', ' Have pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment including the use of oxygen', ' Have received a prior allogeneic organ or tissue transplantation', ' Have had a serious nonhealing wound, ulcer, or bone fracture within 4 weeks prior to randomization', ' Have known leptomeningeal metastases', ' Have cirrhosis (Child-Pugh Level B or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS was defined as time from date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria or death from any cause, whichever is first. Progressive disease (PD) defined as 20% increase in sum of diameter (SOD) of target lesion with the sum demonstrating an increase of 5 mm; appearance of 1 new lesions or unequivocal progression of non-target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff date were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment.', ' Time frame: Start of treatment until documented disease progression or death from any cause up to 16.5 months', 'Results 1: ', ' Arm/Group Title: Ramucirumab and Eribulin', ' Arm/Group Description: Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle', ' Eribulin 1.4 mg/m administered by IV bolus on Day 1 and Day 8 of each 3-week cycle', ' Overall Number of Participants Analyzed: 71', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.4 (3.1 to 6.7)', 'Results 2: ', ' Arm/Group Title: Eribulin Monotherapy', ' Arm/Group Description: Eribulin 1.4 mg/m administered by IV bolus on Day 1 and Day 8 of each 3-week cycle', ' Overall Number of Participants Analyzed: 70', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.1 (3.2 to 5.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 26/69 (37.68%)', ' Anaemia 2/69 (2.90%)', ' Febrile neutropenia 3/69 (4.35%)', ' Neutropenia 4/69 (5.80%)', ' Cardiac arrest 1/69 (1.45%)', ' Cardiac failure congestive 1/69 (1.45%)', ' Cardiac tamponade 1/69 (1.45%)', ' Pericardial effusion 1/69 (1.45%)', ' Abdominal pain 1/69 (1.45%)', ' Ascites 2/69 (2.90%)', ' Colitis 1/69 (1.45%)', ' Gastritis 1/69 (1.45%)', ' Gastritis erosive 1/69 (1.45%)', 'Adverse Events 2:', ' Total: 12/65 (18.46%)', ' Anaemia 0/65 (0.00%)', ' Febrile neutropenia 1/65 (1.54%)', ' Neutropenia 1/65 (1.54%)', ' Cardiac arrest 0/65 (0.00%)', ' Cardiac failure congestive 0/65 (0.00%)', ' Cardiac tamponade 0/65 (0.00%)', ' Pericardial effusion 0/65 (0.00%)', ' Abdominal pain 2/65 (3.08%)', ' Ascites 2/65 (3.08%)', ' Colitis 0/65 (0.00%)', ' Gastritis 0/65 (0.00%)', ' Gastritis erosive 0/65 (0.00%)']}

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

15c83d26-f9ba-44cc-a920-6941781cdd8b

Comparison

Results

NCT01648322

NCT00436566

the primary trial has a shorter time frame than the secondary trial, both of these studies employ the same units of measure in their evaluation.

Contradiction

{'Clinical Trial ID': 'NCT01648322', 'Intervention': ['INTERVENTION 1: ', ' 80 µg/kg/Dose of F-627(TC)', ' This dose of F-627 given only to subjects that are to have TC chemotherapy.', ' F-627: subcutaneous injection given 1 per chemotherapy.', 'INTERVENTION 2: ', ' 240 µg/kg/Dose of F-627 (TC)', ' This dose of F-627 given to subjects receiving TC or TAC chemotherapy.', ' F-627: subcutaneous injection given 1 per chemotherapy.'], 'Eligibility': ['Inclusion Criteria:', ' Show evidence of a signed (personally or by a legally acceptable representative) and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.', ' Females 18 years of age.', ' Diagnosed with Stage I-IV breast cancer.', ' Subject is scheduled to undergo 4 cycles of TC or TAC chemotherapy (Taxotere®, doxorubicin and cyclophosphamide, 75, 50 and 600 mg/m2, respectively).', ' ECOG Performance status of 2.', ' White Blood Cell count (WBC) 4.0 × 109/L, hemoglobin 11.5 g/dL and a platelet count 150 × 109/L.', ' Demonstrate adequate renal, hepatic function (Liver function tests (ALT, AST, alkaline phosphatase and total bilirubin)) should be less than 2.5x upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.', ' All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide are also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.', 'Exclusion Criteria:', ' Subject is <18 or 75 years of age.', ' Disease progression has occurred while receiving a taxane regimen.', ' Subject has undergone radiation therapy within 4 weeks of enrollment.', ' Subject has undergone bone marrow or stem-cell transplantation.', ' Subject has a history of prior malignancy other than breast cancer.', ' Subjects that have used G-CSF within 6 weeks of the screening period are also excluded', ' Subject has had chemotherapy within 365 days of screening', ' Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, ECG test, or any other relevant test.', ' History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.', ' Unwillingness to participate in the study.', " Any underlying medical condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events.", ' Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment.', ' Any condition, which can cause splenomegaly.', ' Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.', ' ALT, AST, alkaline phosphatase > 2.5 upper limit of normal.', ' Patients with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C.', ' Women who are pregnant or breast-feeding.', ' Patients known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.', ' Patients with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated.', ' Subjects with Sickle Cell disease', " Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug."], 'Results': ['Outcome Measurement: ', ' Duration of Moderate Neurtopenia Post First Chemotherapy Administration', ' Number of days In which the patient has had an absolute neutrophil count (ANC) Level < 2.0 x 10^9/L after first cycle of chemotherapy', ' Time frame: The first of 4, 21 Day Chemotherapy Cycles', 'Results 1: ', ' Arm/Group Title: 80 g/kg/Dose of F-627(TC)', ' Arm/Group Description: This dose of F-627 given only to subjects that are to have TC chemotherapy.', ' F-627: subcutaneous injection given 1 per chemotherapy.', ' Overall Number of Participants Analyzed: 35', ' Mean (Standard Deviation)', ' Unit of Measure: days 0.6 (1.26)', 'Results 2: ', ' Arm/Group Title: 240 g/kg/Dose of F-627 (TC)', ' Arm/Group Description: This dose of F-627 given to subjects receiving TC or TAC chemotherapy.', ' F-627: subcutaneous injection given 1 per chemotherapy.', ' Overall Number of Participants Analyzed: 37', ' Mean (Standard Deviation)', ' Unit of Measure: days 0.6 (1.01)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/35 (0.00%)', ' Febrile neutropenia * 0/35 (0.00%)', ' Pancreatitis * 0/35 (0.00%)', ' Hepatitis Toxic * 0/35 (0.00%)', ' Cholecystitis acute * 0/35 (0.00%)', ' Pneumonia * 0/35 (0.00%)', ' Gastroenteritis * 0/35 (0.00%)', ' Hypersensitivity vasculitis * 0/35 (0.00%)', 'Adverse Events 2:', ' Total: 1/67 (1.49%)', ' Febrile neutropenia * 0/67 (0.00%)', ' Pancreatitis * 0/67 (0.00%)', ' Hepatitis Toxic * 0/67 (0.00%)', ' Cholecystitis acute * 0/67 (0.00%)', ' Pneumonia * 1/67 (1.49%)', ' Gastroenteritis * 0/67 (0.00%)', ' Hypersensitivity vasculitis * 0/67 (0.00%)']}

{'Clinical Trial ID': 'NCT00436566', 'Intervention': ['INTERVENTION 1: ', ' AC/PTL', ' Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed diagnosis of early-stage breast cancer', ' HER2 positive by immunohistochemistry (IHC) (3+) or fluorescent in situ hybridization (FISH)', ' Ductal carcinoma in situ (DCIS) components should not be counted in the determination of degree of IHC staining or FISH amplification', ' No locally advanced tumors (i.e., T4) at diagnosis, including the following:', ' Tumors fixed to chest wall', " Peau d'orange", ' Skin ulcerations or nodules', ' Clinical inflammatory changes (e.g., diffuse brawny cutaneous induration with an erysipeloid edge)', ' Has undergone mastectomy or lumpectomy with axillary node or sentinel node dissection within the past 84 days', ' Patients who have undergone a mastectomy must meet the following criteria:', ' No evidence of gross or microscopic tumor (i.e., invasive DCIS) at the surgical resection margins noted in final surgery or pathology reports', ' Patients with close margins are eligible', ' Radiation therapy is required for 4 or more positive lymph nodes and must be started after completion of chemotherapy', ' Patients who have undergone a lumpectomy with axillary node or sentinel node dissection must meet the following criteria:', ' No evidence of invasive cancer or DCIS at the surgical resection margins', ' No gross residual adenopathy', ' Planning to undergo radiation therapy to the breast with or without regional lymphatics after completion of chemotherapy', ' No active hepatic or biliary disease', " Patients with liver metastases, stable chronic liver disease, Gilbert's syndrome, or asymptomatic gallstones are eligible", ' Hormone receptor status:', ' Estrogen receptor and progesterone receptor status known', ' PATIENT CHARACTERISTICS:', ' Male or female', ' Menopausal status not specified', ' ECOG performance status 0-2', ' Absolute neutrophil count 1,500/mm³', ' Platelet count 100,000/mm³', ' Hemoglobin 10.0 g/dL', ' Bilirubin 1.5 times upper limit of normal (ULN)', ' AST and ALT 2.5 times ULN', ' Alkaline phosphatase 2.5 times ULN', ' Creatinine normal OR creatinine clearance 60 mL/min', ' LVEF 50% by MUGA scan or echocardiogram', ' Able to complete questionnaire(s) by themselves or with assistance', ' Able and willing to provide blood and tissue samples', ' No known sensitivity to benzyl alcohol', ' No sensory neuropathy grade 2', ' No active cardiac disease, including any of the following:', ' Myocardial infarction within the past 6 months', ' Prior or concurrent congestive heart failure', ' Prior or concurrent arrhythmia or cardiac valvular disease requiring medications or that is clinically significant', ' Uncontrolled hypertension, defined as diastolic blood pressure (BP) >100 mm Hg or systolic BP > 200 mm Hg on 2 separate occasions 14 days apart', ' Clinically significant pericardial effusion', ' Prior or concurrent uncontrolled or symptomatic angina', ' Other cardiac condition that, in the opinion of the treating physician, would put the patient at hazardous risk', ' No history of allergic reactions attributed to compounds of similar chemical or biologic composition as lapatinib ditosylate', ' No uncontrolled intercurrent illness including, but not limited to, the following:', ' Ongoing or active infection', ' Psychiatric illness or social situations that would preclude study compliance', ' Able to swallow and retain oral medication', ' No history of gastrointestinal (GI) disease resulting in an inability to take oral medication, including any of the following:', ' Malabsorption syndrome', ' Requirement for IV alimentation', ' Prior surgical procedures affecting absorption', " Uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)", ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for 6 months after completion of study treatment', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' No prior chemotherapy, radiation therapy, immunotherapy, or biotherapy for breast cancer', ' No primary breast radiation therapy as part of breast-conserving treatment', ' No prior anthracycline or taxane therapy for any malignancy', ' No prior epidermal growth factor receptor-targeting therapies (e.g., gefitinib, cetuximab, erlotinib hydrochloride, rituximab, trastuzumab [Herceptin®], lapatinib ditosylate, panitumumab, or nimotuzumab)', ' At least 14 days since prior and no concurrent CYP3A4 inducers, including the following:', ' Rifamycin-class antibiotics (e.g., rifampin, rifabutin, or rifapentine)', ' Anticonvulsants (e.g., phenytoin, carbamazepine, or barbiturates [e.g., phenobarbital])', ' Antiretrovirals (e.g., efavirenz or nevirapine)', ' Glucocorticoids (e.g., oral cortisone, hydrocortisone, prednisone, methylprednisolone, or dexamethasone)', ' Daily oral dexamethasone 1.5 mg (or equivalent) allowed', ' Modafinil', " Hypericum perforatum (St. John's wort)", ' At least 7 days since prior and no concurrent CYP3A4 inhibitors, including the following:', ' Antibiotics (e.g., clarithromycin, erythromycin, or troleandomycin)', ' Antifungals (e.g., itraconazole, ketoconazole, fluconazole [> 150 mg daily], or voriconazole)', ' Antiretrovirals and protease inhibitors (e.g., delaviridine, nelfinavir, amprenavir, ritonavir, indinavir, saquinavir, or lopinavir)', ' Calcium channel blockers (e.g., verapamil or diltiazem)', ' Antidepressants (e.g., nefazodone or fluvoxamine)', ' Gastrointestinal agents (e.g., cimetidine or aprepitant)', ' Grapefruit and grapefruit juice', ' At least 6 months since prior and no concurrent amiodarone', ' No herbal or alternative medicines or supplements 14 days before, during, and for 30 days after completion of study treatment', ' No concurrent hormonal agents (e.g., birth control pills, ovarian hormonal replacement therapy, or raloxifene)', ' Adjuvant hormonal agents (e.g., tamoxifen, aromatase inhibitors) allowed after completion of chemotherapy as part of treatment for breast cancer', ' No concurrent antiretroviral therapy for HIV-positive patients', ' No concurrent digitalis or beta-blockers for congestive heart failure', ' No concurrent arrhythmia or angina pectoris medication', ' No other concurrent investigational agents or anticancer therapies, including cytotoxic agents or immunotherapy'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment', ' [Not Specified]', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: AC/PTL', ' Arm/Group Description: Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.', ' Overall Number of Participants Analyzed: 109', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/108 (15.74%)', ' Febrile neutropenia 1/108 (0.93%)', ' Left ventricular failure 1/108 (0.93%)', ' Diarrhea 6/108 (5.56%)', ' Fatigue 1/108 (0.93%)', ' Pneumonia 1/108 (0.93%)', ' Skin infection 1/108 (0.93%)', ' Urinary tract infection 1/108 (0.93%)', ' Alanine aminotransferase increased 1/108 (0.93%)', ' Aspartate aminotransferase increased 1/108 (0.93%)', ' Leukopenia 2/108 (1.85%)']}

e100212f-5bef-4f84-a3c1-d18a6b3e8355

Single

Intervention

NCT02286843

the primary trial is testing a novel radiotracer called 89Zr-trastuzumab to evaluate its use for visualization of HER2+ lesions.

Entailment

{'Clinical Trial ID': 'NCT02286843', 'Intervention': ['INTERVENTION 1: ', ' HER2-targeted PET/CT', ' Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy.'], 'Eligibility': ['Inclusion Criteria:', ' Women age > 18', ' Biopsy proven HER2 negative primary breast cancer and biopsy proven metastatic disease.', ' 5 or more foci of demonstrable metastases on recent imaging modalities (CT, MR, FDG PET/CT)', ' ECOG performance score of 0-2', 'Exclusion Criteria:', ' Life expectancy < 3months', ' Pregnancy or lactation', ' Patients who cannot undergo PET/CT scanning because of weight limits', ' CNS only disease on recent imaging'], 'Results': ['Outcome Measurement: ', ' Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases', ' Both SUVmax and SUVpeak will be recorded for lesions, and SUVmax and SUVaverage will be recorded for background measurements. Only those foci qualitatively scored conspicuously positive by both readers (scores of 4 or 5) will be considered as "positive".', ' Time frame: 3 years', 'Results 1: ', ' Arm/Group Title: HER2-targeted PET/CT', ' Arm/Group Description: Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy.', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: % of participants 13'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/49 (12.24%)', ' Anemia 1/49 (2.04%)', ' Cardiac arrest 1/49 (2.04%)', ' Abdominal pain 1/49 (2.04%)', ' Duodenal ulcer 3/49 (6.12%)', ' Death NOS 1/49 (2.04%)', ' Pleural effusion 1/49 (2.04%)', ' Respiratory failure 1/49 (2.04%)']}

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

56d2a387-49dd-49b9-93bb-bcb092bf2714

Single

Intervention

NCT00300781

Participants of the primary trial are assigned an intervention depending on their prior treatments.

Entailment

{'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%)']}

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

2485a3e1-7520-47d2-b941-32ebf91e5b65

Comparison

Eligibility

NCT00899574

NCT01007942

the primary trial and the secondary trial use different inclusion criteria for their cohorts, so patients may be eligible for one cohort, but not the other.

Contradiction

{'Clinical Trial ID': 'NCT00899574', 'Intervention': ['INTERVENTION 1: ', ' Imiquimod', ' Each treatment cycle consists of 8 weeks.', ' Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.', ' Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease.'], 'Eligibility': ['Inclusion Criteria:', ' Patients with biopsy-confirmed breast cancer (prior histological documentation is acceptable).', ' Patients with measurable skin metastases (chest wall recurrence and/or non-chest wall skin metastases are eligible).', ' Skin metastases not suitable for or patient refusing definitive surgical resection and radiation.', ' (Cohort 1) Concurrent systemic cancer therapy (hormones, biologics or chemotherapy) is allowed if distant metastases have been non-progressing (stable or responding) on that regimen for > or = 12 weeks and skin metastases are non-responsive (stable or progressing) as assessed by the investigator.', ' (Cohort 2) Any concurrent systemic therapy is allowed', ' Age at least 18 years.', ' Eastern Cooperative Oncology Group (ECOG) performance status < or = 2.', ' Patients must have biopsy-accessible tumor (skin metastases) and agree to biopsies required by protocol.', ' Patients must have adequate organ and bone marrow function as defined below:', ' absolute neutrophil count > or = 1,500/microliter', ' hemoglobin > or = 9.5 grams/deciliter', ' platelets >or = 75,000/microliter', ' total bilirubin < or = 1.5 X institutional upper limit of normal', ' Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) < or = 2.5X institutional upper limit of normal', ' creatinine < or = 1.5 X institutional upper limit of normal', ' Informed consent.', 'Exclusion Criteria:', ' Brain metastases unless resected or irradiated and stable > or = 8 weeks.', ' Treatment with other investigational agents.', ' Patients who have received 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 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: ', ' Objective Response (Complete Clinical Response+ Partial Response)', ' This is defined as percentage of patients who achieved complete clinical response or partial response at end of cycle 1 of treatment. The tumor size will be measured as lesion surface area (region of interest, ROI). The response to the treatment is then evaluated as a function of post-treatment over pre-treatment ROI, expressed in percentage. Response criteria for this study are based on European Organisation for Research and Treatment of Cancer definitions for chest wall tumors: complete clinical response: absence of any detectable residual disease; partial response: <50% of ROI change.', ' Time frame: 9 weeks', 'Results 1: ', ' Arm/Group Title: Imiquimod', ' Arm/Group Description: Each treatment cycle consists of 8 weeks.', ' Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.', ' Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: percentage of patients 20 (3 to 56)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)']}

{'Clinical Trial ID': 'NCT01007942', 'Intervention': ['INTERVENTION 1: ', ' Everolimus + Vinorelbine + Trastuzumab', ' Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)', 'INTERVENTION 2: ', ' Placebo + Vinorelbine + Trastuzumab', ' Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.', ' HER2+ status defined as IHC 3+ staining or in situ hybridization positive', ' Patients with resistance to trastuzumab', ' Prior taxane therapy', ' Patients with an ECOG performance status of 0 - 2', ' Patients with measurable disease as per RECIST criteria', ' Documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. Sexually active pre-menopausal women must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study;', ' Patients must meet laboratory criteria defined in the study within 21 days prior to randomization', 'Exclusion Criteria:', ' Prior mTOR inhibitors or vinca alkaloid agents for the treatment of cancer', ' More than three prior chemotherapy lines for advanced disease.', ' Symptomatic CNS metastases or evidence of leptomeningeal disease. Previously treated asymptomatic CNS metastases are allowed provided that the last treatment for CNS metastases was completed >8 weeks prior to randomization', ' Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus', ' Peripheral neuropathy grade 2 at randomization', ' Active cardiac disease', ' History of cardiac dysfunction', ' Any 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', ' Known hypersensitivity to any study medication', ' Breastfeeding or pregnant'], 'Results': ['Outcome Measurement: ', ' Progressive-free Survival (PFS) Per Investigator Assessment', ' PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. 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: Every 6 weeks until disease progression or death which ever occurred first up to about 41 months', 'Results 1: ', ' Arm/Group Title: Everolimus + Vinorelbine + Trastuzumab', ' Arm/Group Description: Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)', ' Overall Number of Participants Analyzed: 284', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.00 (6.74 to 8.18)', 'Results 2: ', ' Arm/Group Title: Placebo + Vinorelbine + Trastuzumab', ' Arm/Group Description: Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)', ' Overall Number of Participants Analyzed: 285', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.78 (5.49 to 6.90)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 122/280 (43.57%)', ' Agranulocytosis 0/280 (0.00%)', ' Anaemia 10/280 (3.57%)', ' Febrile neutropenia 30/280 (10.71%)', ' Immune thrombocytopenic purpura 1/280 (0.36%)', ' Leukopenia 3/280 (1.07%)', ' Neutropenia 12/280 (4.29%)', ' Thrombocytopenia 4/280 (1.43%)', ' Acute myocardial infarction 1/280 (0.36%)', ' Cardiac failure 1/280 (0.36%)', ' Cataract 2/280 (0.71%)', 'Adverse Events 2:', ' Total: 58/282 (20.57%)', ' Agranulocytosis 1/282 (0.35%)', ' Anaemia 2/282 (0.71%)', ' Febrile neutropenia 4/282 (1.42%)', ' Immune thrombocytopenic purpura 0/282 (0.00%)', ' Leukopenia 0/282 (0.00%)', ' Neutropenia 3/282 (1.06%)', ' Thrombocytopenia 1/282 (0.35%)', ' Acute myocardial infarction 0/282 (0.00%)', ' Cardiac failure 0/282 (0.00%)', ' Cataract 1/282 (0.35%)', ' Cataract subcapsular 1/282 (0.35%)']}

b97d9465-db14-43af-9451-4b824e67abb8

Single

Eligibility

NCT02010021

A patient has recently been receiving Tamoxifen to treat breast cancer, they are excluded from the primary trial.

Entailment

{'Clinical Trial ID': 'NCT02010021', 'Intervention': ['INTERVENTION 1: ', ' No Drug Treatment', ' Post-menopausal women with stage I-III breast cancer with surgical resection of tumor and tumor tissue will be used to study cell growth signaling pathways ex-vivo.', 'INTERVENTION 2: ', ' Letrozole-presurgical', ' Patients received Letrozole for 10-21 days prior to surgical resection of tumor tissue. This tissue was used ex-vivo to study cell growth signaling pathway. The results will be compared to arm of the study with no intervention.'], 'Eligibility': ['Inclusion Criteria:', ' Histologic Documentation of invasive breast cancer by core needle or incisional biopsy. Excess baseline biopsy tumor tissue sufficient to make three 5-micron sections must be available for molecular analyses as part of this study.', ' The invasive cancer must be estrogen receptor alpha (ER)-positive, with ER staining present in greater than 50% staining of invasive cancer cells by IHC.', ' The invasive cancer must be human epidermal growth factor receptor 2 (HER2) negative (IHC 0-1+, or with a fluorescence in situ hybridization (FISH) ratio of <1.8 if IHC is 2+ or if IHC has not been done).', ' Clinical stage I-III invasive breast cancer with the intent to treat with surgical resection of the primary tumor. Tumor must be 2cm to provide adequate tissue.', ' Patients with multi-centric or bilateral disease are eligible if the target lesions meet the other eligibility criteria. Samples from all available tumors are requested for research purposes.', ' Women age 18, for whom adjuvant treatment with an aromatase inhibitor would be clinically indicated. Women must be either post-menopausal, or pre-menopausal having undergone oophorectomy.', ' Patients must meet the following clinical laboratory criteria:', ' Absolute neutrophil count (ANC) 1000/mm3 and platelet count 75,000/mm3. Total bilirubin 1.5 X the upper limit of normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 x ULN.', ' - Ability to give informed consent.', 'Exclusion Criteria:', ' Prior endocrine therapy for any histologically confirmed cancer is not allowed. Prior endocrine therapy that was administered 5 years ago for the prevention of breast cancer in patients with no history of breast cancer is allowed.', ' Systemic drug treatment to induce ovarian suppression if woman is pre-menopausal.', ' Any other neoadjuvant therapy for breast cancer (i.e., treatment with any other anti-cancer agent besides Letrozole (10-21)days before surgical resection of the primary tumor).'], 'Results': ['Outcome Measurement: ', ' Change in Insulin Receptor Substrate 1 (IRS-1) / Phosphoinositide 3-kinase (PI3K) / Serine-threonine Protein Kinase (AKT) Pathway Activation', ' The Primary Endpoint is to determine the effect of ex vivo mTORC1 inhibition with everolimus (RAD001) on IRS-1/PI3K/AKT pathway activation (as measured by phospho-AKT-T308 and phospho-AKT-S473) in ER+/human epidermal growth factor receptor 2 (HER2)- breast tumors treated with presurgical letrozole compared to ER+/HER2- breast tumors not treated with presurgical therapy.', ' Time frame: baseline and surgery, approximately 30 days', 'Results 1: ', ' Arm/Group Title: No Drug Treatment', ' Arm/Group Description: Post-menopausal women with stage I-III breast cancer with surgical resection of tumor and tumor tissue will be used to study cell growth signaling pathways ex-vivo.', ' Overall Number of Participants Analyzed: 10', ' Mean (Standard Deviation)', ' Unit of Measure: % change phospho-AKT-T308: 388 (623)', ' phospho-AKT-S473: 157 (35)', 'Results 2: ', ' Arm/Group Title: Letrozole-presurgical', ' Arm/Group Description: Patients received Letrozole for 10-21 days prior to surgical resection of tumor tissue. This tissue was used ex-vivo to study cell growth signaling pathway. The results will be compared to arm of the study with no intervention.', ' Overall Number of Participants Analyzed: 7', ' Mean (Standard Deviation)', ' Unit of Measure: % change phospho-AKT-T308: -10 (38)', ' phospho-AKT-S473: 135 (91)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)', 'Adverse Events 2:', ' Total: 0/7 (0.00%)']}

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

798c0983-5265-47ea-bfcd-735738793482

Comparison

Intervention

NCT02176083

NCT03061175

Neither the primary trial or NCT0306117 use chemotherapy or radiotherapy in their intervention.

Entailment

{'Clinical Trial ID': 'NCT02176083', 'Intervention': ['INTERVENTION 1: ', ' Intervention', ' Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness', ' Text message management prompts', 'INTERVENTION 2: ', ' Control', ' Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness'], 'Eligibility': ['Inclusion Criteria:', ' Breast cancer', ' Female', ' Completed primary breast cancer treatment', 'Age <=45'], 'Results': ['Outcome Measurement: ', ' Hot Flash Frequency', ' Median number of daily hot flashes over 4th week of study', 'Time frame: 1 week', 'Results 1: ', ' Arm/Group Title: Intervention', ' Arm/Group Description: Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness', ' Text message management prompts', ' Overall Number of Participants Analyzed: 11', ' Median (Inter-Quartile Range)', ' Unit of Measure: daily hot flashes 2.2 (1.2 to 3.6)', 'Results 2: ', ' Arm/Group Title: Control', ' Arm/Group Description: Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness', ' Overall Number of Participants Analyzed: 27', ' Median (Inter-Quartile Range)', ' Unit of Measure: daily hot flashes 1.4 (0.7 to 2.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/11 (0.00%)', 'Adverse Events 2:', ' Total: 0/27 (0.00%)']}

{'Clinical Trial ID': 'NCT03061175', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Web-Based CPM-DA)', ' Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.', ' Internet-Based Intervention: Receive web-based CPM-DA', ' Survey Administration: Ancillary studies', 'INTERVENTION 2: ', ' Arm II (Usual Care)', ' Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.', ' Survey Administration: Ancillary studies'], 'Eligibility': ['Inclusion Criteria:', ' PHASE I: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer (patients with bilateral breast cancer will be excluded from participation)', ' PHASE I: Speaks and reads English', ' PHASE I: Women with sporadic cancers (WSC) (does not have hereditary breast/ovarian cancer syndrome [BReast CAncer gene (BRCA) carrier, strong family history]); if there is any uncertainty, the surgeon will use the Tyrer-Cuzick (Tyrer et al., 2004) risk model to calculate risk; the Tyrer-Cuzick model calculates a personal lifetime risk of breast cancer based on multiple factors; it has become the standard model because it incorporates not only factors such as estrogen exposure and first degree relatives, but also second degree relatives and paternal lineage; a lifetime risk of 20% or greater is considered high risk and would necessitate increased screening methods to the traditional annual mammogram; for this study, anyone with a lifetime risk up to 19% on the Tyrer-Cuzick model will be considered average risk for breast cancer; anyone with a lifetime risk of 20% or greater will be excluded from participation', ' PHASE I: Able to provide meaningful informed consent', ' PHASE II: Completed initial surgical consult with breast cancer surgeon at Cancer Institute of New Jersey (CINJ)/Massachusetts General Hospital (MGH)/Memorial Sloan Kettering Cancer Center (MSKCC) and is considering CPM, regardless of the surgical treatment of their primary breast cancer (lumpectomy/mastectomy)', ' PHASE II: Has home internet access', ' PHASE II: Has a first, primary diagnosis of unilateral stage 0, 1, 2, or 3a breast cancer', ' PHASE II: Speaks and reads English', ' PHASE II: WSC (does not have hereditary breast/ovarian cancer syndrome [BRCA carrier, strong family history]); if there is any uncertainty, the surgeon will use the Tyrer-Cuzick (Tyrer et al., 2004) risk model to calculate risk; for this study, anyone with a lifetime risk up to 19% on the Tyrer-Cuzick model will be considered average risk for breast cancer; anyone with a lifetime risk of 20% or greater will be excluded from participation', ' PHASE II: Able to provide meaningful informed consent'], 'Results': ['Outcome Measurement: ', ' Contralateral Prophylactic Mastectomy (CPM) Knowledge Assessed by Surveys for CPM-DA Participants vs. UC Participants', " CPM knowledge is a 10-item multiple-choice measure developed by author Kirsten and Smith. Scores range from 0-100% correct with a higher score equaling more correct knowledge items. Items assessed understanding of the definition of CPM, surgical recovery time and risks/side effects, whether or not CPM improves survival, and whether CPM reduced the risk for disease progression. Will characterize the data using standard methods (estimated marginal means, standard errors, and Cohen's d effect sizes) separately by study arm. At follow-up scores will be reported as the difference between the knowledge score at two time points- the baseline knowledge score and follow-up knowledge score for both the CPM-DA arm and the UC arm.", ' Time frame: 2-4 week follow up', 'Results 1: ', ' Arm/Group Title: Arm I (Web-Based CPM-DA)', ' Arm/Group Description: Patients receive a website address, a secure username and password, and instructions for using the web-based CPM-DA.', ' Internet-Based Intervention: Receive web-based CPM-DA', ' Survey Administration: Ancillary studies', ' Overall Number of Participants Analyzed: 39', ' Mean (Standard Error)', ' Unit of Measure: score on a scale 62.47 (3.40)', 'Results 2: ', ' Arm/Group Title: Arm II (Usual Care)', ' Arm/Group Description: Patients undergo usual care available to patients considering CPM and receive information from a medical oncologist about CPM.', ' Survey Administration: Ancillary studies', ' Overall Number of Participants Analyzed: 44', ' Mean (Standard Error)', ' Unit of Measure: score on a scale 51.33 (3.24)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/46 (0.00%)', 'Adverse Events 2:', ' Total: ']}

127e9179-6781-4b9a-abe9-080d2ffad591

Comparison

Eligibility

NCT00089479

NCT02964234

Agatha had her 50th birthday last week, she has a histologically confirmed adenocarcinoma of the breast, with no evidence of metastatic disease. She is eligible for the primary trial but not the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00089479', 'Intervention': ['INTERVENTION 1: ', ' AC Then T', ' Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles', 'INTERVENTION 2: ', ' AC Then XT', ' Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles'], 'Eligibility': ['Inclusion Criteria:', ' female patients 18-70 years of age;', ' adenocarcinoma of the breast;', ' previous invasive breast cancer if diagnosed >5 years before entering study;', ' no evidence of metastatic disease.', 'Exclusion Criteria:', ' history of severe hypersensitivity reaction to Taxotere;', ' previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane;', ' treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.'], 'Results': ['Outcome Measurement: ', ' Disease Free Survival [Number of Events]', ' Number of patients with/without recurrence of breast cancer, or death due to any cause.', ' Time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.', 'Results 1: ', ' Arm/Group Title: AC Then T', ' Arm/Group Description: Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles', ' Overall Number of Participants Analyzed: 1304', ' Measure Type: Number', ' Unit of Measure: participants Patients with event: 164', ' Patients without events: 1140', 'Results 2: ', ' Arm/Group Title: AC Then XT', ' Arm/Group Description: Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles', ' Overall Number of Participants Analyzed: 1307', ' Measure Type: Number', ' Unit of Measure: participants Patients with event: 140', ' Patients without events: 1167'], 'Adverse Events': ['Adverse Events 1:', ' Total: 264/1305 (20.23%)', ' FEBRILE NEUTROPENIA 118/1305 (9.04%)', ' NEUTROPENIA 10/1305 (0.77%)', ' ANAEMIA 0/1305 (0.00%)', ' LEUKOCYTOSIS 2/1305 (0.15%)', ' LEUKOPENIA 1/1305 (0.08%)', ' PANCYTOPENIA 0/1305 (0.00%)', ' MYOCARDIAL INFARCTION 1/1305 (0.08%)', ' SUPRAVENTRICULAR TACHYCARDIA 2/1305 (0.15%)', ' ANGINA UNSTABLE 0/1305 (0.00%)', ' ATRIAL FLUTTER 0/1305 (0.00%)', 'Adverse Events 2:', ' Total: 200/1283 (15.59%)', ' FEBRILE NEUTROPENIA 80/1283 (6.24%)', ' NEUTROPENIA 11/1283 (0.86%)', ' ANAEMIA 5/1283 (0.39%)', ' LEUKOCYTOSIS 0/1283 (0.00%)', ' LEUKOPENIA 0/1283 (0.00%)', ' PANCYTOPENIA 1/1283 (0.08%)', ' MYOCARDIAL INFARCTION 1/1283 (0.08%)', ' SUPRAVENTRICULAR TACHYCARDIA 0/1283 (0.00%)', ' ANGINA UNSTABLE 1/1283 (0.08%)', ' ATRIAL FLUTTER 1/1283 (0.08%)']}

{'Clinical Trial ID': 'NCT02964234', 'Intervention': ['INTERVENTION 1: ', ' Empowerment', ' Behavior: Empowerment', ' Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks', 'INTERVENTION 2: ', ' Education', ' Behavior: Education', ' Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Age 52-75 years old;', ' Identification as Latina/Hispanic/Chicana female;', ' Residence in Pilsen, Little Village, East Side or South Chicago;', ' No history of health volunteerism;', ' No history of breast cancer; and', ' Lack of a mammogram within the last two years', 'Exclusion Criteria:', ' Not meeting all inclusion criteria;', ' Women will be excluded if they participated in formative focus groups'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Have Obtained Breast Cancer Screening', ' Receipt of mammogram based on medical records and self report within 6 months of baseline survey (Yes or No)', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Empowerment', ' Arm/Group Description: Behavior: Empowerment', ' Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks', ' Overall Number of Participants Analyzed: 54', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 49 90.7%', 'Results 2: ', ' Arm/Group Title: Education', ' Arm/Group Description: Behavior: Education', ' Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 29 51.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/76 (0.00%)', 'Adverse Events 2:', ' Total: 0/69 (0.00%)']}

a54e1dfa-3975-4dc6-8530-c0adc79b1b0d

Single

Results

NCT01401166

several patients in cohort 1 of the primary trial Preferred oral tablets as a Method of Drug Administration.

Contradiction

{'Clinical Trial ID': 'NCT01401166', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1: SC (SID) Then IV Herceptin', ' Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.', 'INTERVENTION 2: ', ' Cohort 1: IV Then SC (SID) Herceptin', ' Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed HER2-positive primary breast cancer', ' No evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neo-adjuvant or adjuvant)', ' Completed neo-adjuvant chemotherapy prior to entry, if received', ' At least 8 remaining cycles out of the total 18 planned 3-week cycles, if received IV Herceptin', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1', 'Exclusion Criteria:', ' History of other malignancy, except for ductal carcinoma in situ of the breast, curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or other curatively treated malignancies of which the participant has been disease-free for at least 5 years', ' Inadequate bone marrow function', ' Impaired liver function', ' Inadequate renal function', ' Serious cardiovascular disease', ' Human immunodeficiency virus or hepatitis B or C infection', ' Prior maximum cumulative dose of doxorubicin greater than (>) 360 milligrams per meter-squared (mg/m^2) or epirubicin >720 mg/m^2 or equivalent'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants by Preferred Method of Drug Administration', ' The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, "All things considered, which method of administration did you prefer?" at the end of the crossover period (Week 24). The percentage of participants who preferred each method of drug administration was reported.', ' Time frame: Week 24', 'Results 1: ', ' Arm/Group Title: Cohort 1: SC (SID) Then IV Herceptin', ' Arm/Group Description: Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.', ' Overall Number of Participants Analyzed: 117', ' Measure Type: Number', ' Unit of Measure: percentage of participants SC Herceptin: 95.7', ' IV Herceptin: 4.3', ' No Preference: 0.0', 'Results 2: ', ' Arm/Group Title: Cohort 1: IV Then SC (SID) Herceptin', ' Arm/Group Description: Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.', ' Overall Number of Participants Analyzed: 119', ' Measure Type: Number', ' Unit of Measure: percentage of participants SC Herceptin: 87.4', ' IV Herceptin: 9.2', ' No Preference: 3.4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/242 (1.65%)', ' Left ventricular dysfunction * 0/242 (0.00%)', ' Adverse drug reaction * 0/242 (0.00%)', ' Chest pain * 0/242 (0.00%)', ' Cholelithiasis * 0/242 (0.00%)', ' Breast abscess * 0/242 (0.00%)', ' Device related infection * 1/242 (0.41%)', ' Influenza * 0/242 (0.00%)', ' Postoperative wound infection * 0/242 (0.00%)', ' Pyelonephritis * 0/242 (0.00%)', 'Adverse Events 2:', ' Total: 2/241 (0.83%)', ' Left ventricular dysfunction * 0/241 (0.00%)', ' Adverse drug reaction * 0/241 (0.00%)', ' Chest pain * 0/241 (0.00%)', ' Cholelithiasis * 0/241 (0.00%)', ' Breast abscess * 0/241 (0.00%)', ' Device related infection * 0/241 (0.00%)', ' Influenza * 1/241 (0.41%)', ' Postoperative wound infection * 0/241 (0.00%)', ' Pyelonephritis * 0/241 (0.00%)']}

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

16dc5a77-5758-4d19-9801-6e9932d9fbc9

Comparison

Adverse Events

NCT00190671

NCT00455533

In the primary trial cohort 2 had more patients with Leukopenia than cohort 1, whereas in the secondary trial cohort 1 had more than cohort 2. Cohort 1 of the primary trial had the highest proportion of patients with leukopenia.

Contradiction

{'Clinical Trial ID': 'NCT00190671', 'Intervention': ['INTERVENTION 1: ', ' Pemetrexed 600mg/m2', ' Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles', 'INTERVENTION 2: ', ' Pemetrexed 1800mg/m2', ' Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles'], 'Eligibility': ['Inclusion Criteria: - You must be female and at least 18 years old. - You must have been diagnosed with breast cancer. - Your pre-study lab tests are within study requirements. - You must be willing to take folic acid and vitamin B12. Exclusion Criteria: - You are pregnant or breastfeeding. - You have another illness that your doctor thinks would make you unable to participate. - You are currently taking aspirin or aspirin-like medicine and are unable to stop for a few days during each cycle of therapy.'], 'Results': ['Outcome Measurement: ', ' Best Tumor Response', ' Tumor response was assessed using radiological imaging, which was repeated every 6 weeks prior to every other cycle. Confirmation of response was to occur no less than 4 weeks (28 days) after the first evidence of response.', ' Time frame: baseline to measured progressive disease', 'Results 1: ', ' Arm/Group Title: Pemetrexed 600mg/m2', ' Arm/Group Description: Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 0', ' Partial Response: 8', ' Stable Disease: 18', ' Progressive Disease: 13', ' Unknown: 3', 'Not Assessed: 0', 'Results 2: ', ' Arm/Group Title: Pemetrexed 1800mg/m2', ' Arm/Group Description: Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles', ' Overall Number of Participants Analyzed: 61', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 0', ' Partial Response: 20', ' Stable Disease: 26', ' Progressive Disease: 8', ' Unknown: 5', 'Not Assessed: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6', ' Agranulocytosis 0/42 (0.00%)', ' Anaemia 2/42 (4.76%)', ' Febrile neutropenia 1/42 (2.38%)', ' Leukopenia 0/42 (0.00%)', ' Neutropenia 1/42 (2.38%)', ' Thrombocytopenia 1/42 (2.38%)', ' Cardio-respiratory arrest 0/42 (0.00%)', ' Pericardial effusion 1/42 (2.38%)', ' Gastric ulcer haemorrhage 0/42 (0.00%)', ' Melaena 0/42 (0.00%)', ' Fatigue 1/42 (2.38%)', ' Multi-organ failure 0/42 (0.00%)', 'Adverse Events 2:', ' Total: 13', ' Agranulocytosis 1/61 (1.64%)', ' Anaemia 1/61 (1.64%)', ' Febrile neutropenia 0/61 (0.00%)', ' Leukopenia 2/61 (3.28%)', ' Neutropenia 2/61 (3.28%)', ' Thrombocytopenia 1/61 (1.64%)', ' Cardio-respiratory arrest 1/61 (1.64%)', ' Pericardial effusion 0/61 (0.00%)', ' Gastric ulcer haemorrhage 1/61 (1.64%)', ' Melaena 1/61 (1.64%)', ' Fatigue 1/61 (1.64%)', ' Multi-organ failure 1/61 (1.64%)']}

{'Clinical Trial ID': 'NCT00455533', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone', ' ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)', 'INTERVENTION 2: ', ' Paclitaxel', ' paclitaxel 80 mg/m^2 administered IV every week for 12 weeks'], 'Eligibility': ['Inclusion criteria', ' Histologically confirmed primary invasive adenocarcinoma of the breast , T2-3, N0-3, M0, with tumor size of 2 cm', ' All patients with early stage breast adenocarcinoma may enroll irrespective of receptor status', ' No prior treatment for breast cancer excluding therapy for DCIS', ' Karnofsky performance status of 80 - 100', ' left ventricular ejection fraction (LVEF) 50% by echocardiogram or multiple gated acquisition (MUGA)', ' Adequate hematologic, hepatic and renal function', ' Exclusion Criteria', ' women of child-bearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy during and up to 8 weeks after the last dose of the investigational drug', ' Women who are pregnant or breastfeeding', ' Inflammatory or metastatic breast cancer', ' Unfit for breast and/or axillary surgery', ' Evidence of baseline sensory or motor neuropathy', ' Significant history of cardiovascular disease, serious intercurrent illness or infections including known human immu immunodeficiency virus (HIV) infection', ' History of prior anthracycline therapy Allergies to any study medication or Cremophor® EL'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Achieving Pathologic Complete Response (pCR)', ' The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast.', ' Time frame: at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)', 'Results 1: ', ' Arm/Group Title: Ixabepilone', ' Arm/Group Description: ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)', ' Overall Number of Participants Analyzed: 148', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 24.3 (18.6 to 30.8)', 'Results 2: ', ' Arm/Group Title: Paclitaxel', ' Arm/Group Description: paclitaxel 80 mg/m^2 administered IV every week for 12 weeks', ' Overall Number of Participants Analyzed: 147', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 25.2 (19.4 to 31.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/145 (11.72%)', ' ANAEMIA 0/145 (0.00%)', ' LEUKOPENIA 2/145 (1.38%)', ' NEUTROPENIA 1/145 (0.69%)', ' LEUKOCYTOSIS 1/145 (0.69%)', ' THROMBOCYTOPENIA 1/145 (0.69%)', ' FEBRILE NEUTROPENIA 1/145 (0.69%)', ' THROMBOTIC THROMBOCYTOPENIC PURPURA 0/145 (0.00%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 0/145 (0.00%)', ' CARDIAC FAILURE 1/145 (0.69%)', ' ATRIAL FIBRILLATION 1/145 (0.69%)', 'Adverse Events 2:', ' Total: 11/144 (7.64%)', ' ANAEMIA 1/144 (0.69%)', ' LEUKOPENIA 0/144 (0.00%)', ' NEUTROPENIA 0/144 (0.00%)', ' LEUKOCYTOSIS 0/144 (0.00%)', ' THROMBOCYTOPENIA 0/144 (0.00%)', ' FEBRILE NEUTROPENIA 1/144 (0.69%)', ' THROMBOTIC THROMBOCYTOPENIC PURPURA 1/144 (0.69%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 1/144 (0.69%)', ' CARDIAC FAILURE 0/144 (0.00%)', ' ATRIAL FIBRILLATION 0/144 (0.00%)']}

2ed770a0-fe98-4029-9511-ad04a94a1a69

Single

Adverse Events

NCT00863655

There were 7 more cases of Anaemia and 1 more case of Disseminated intravascular coagulation in cohort 1 of the primary trial compared to cohort 2.

Contradiction

{'Clinical Trial ID': 'NCT00863655', 'Intervention': ['INTERVENTION 1: ', ' Everolimus + Exemestane', ' Everolimus 10 mg daily in combination with exemestane 25 mg daily', 'INTERVENTION 2: ', ' Placebo + Exemestane', ' Placebo of everolimus in combination with exemestane 25 mg daily'], 'Eligibility': ['Inclusion Criteria:', ' Adult women ( 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.', ' Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer', ' Postmenopausal women.', ' Disease refractory to non steroidal aromatase inhibitors (NSAI),', ' Radiological or clinical evidence of recurrence or progression on or after the last systemic therapy prior to randomization.', ' Patients must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease as defined above.', 'Exclusion Criteria:', ' HER2-overexpressing patients', ' Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.).', ' Patients who received more than one chemotherapy line for Advanced Breast Cancer.', ' Previous treatment with exemestane or mTOR inhibitors.', ' Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).', ' Radiotherapy within four weeks prior to randomization', ' Currently receiving hormone replacement therapy,', ' Other protocol-defined inclusion/exclusion criteria may apply'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.', ' Progression-free survival, the primary endpoint in this study, is defined as the time from the date of randomization to the date of first documented radiological progression or death due to any cause. Disease progression was based on the tumor assessment by the local radiologist or investigator using RECIST 1.0 criteria. If a patient did not progress or known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. For patients with lytic or mixed (lytic+sclerotic) bone lesions, the following is considered progression: appearance of 1 new lytic lesions in bone; the appearance of new lesions outside of bone and unequivocal progression of existing bone lesions.', ' Time frame: date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 19 months', 'Results 1: ', ' Arm/Group Title: Everolimus + Exemestane', ' Arm/Group Description: Everolimus 10 mg daily in combination with exemestane 25 mg daily', ' Overall Number of Participants Analyzed: 485', ' Median (95% Confidence Interval)', ' Unit of Measure: months 6.93 (6.44 to 8.05)', 'Results 2: ', ' Arm/Group Title: Placebo + Exemestane', ' Arm/Group Description: Placebo of everolimus in combination with exemestane 25 mg daily', ' Overall Number of Participants Analyzed: 239', ' Median (95% Confidence Interval)', ' Unit of Measure: months 2.83 (2.76 to 4.14)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 158/482 (32.78%)', ' Anaemia 7/482 (1.45%)', ' Disseminated intravascular coagulation 1/482 (0.21%)', ' Lymphadenopathy 0/482 (0.00%)', ' Neutropenia 0/482 (0.00%)', ' Thrombocytopenia 2/482 (0.41%)', ' Anaemia 28/482 (1.66%)', ' Disseminated intravascular coagulation 21/482 (0.21%)', ' Febrile neutropenia 21/482 (0.21%)', ' Lymphadenopathy 20/482 (0.00%)', ' Neutropenia 20/482 (0.00%)', 'Adverse Events 2:', ' Total: 37/238 (15.55%)', ' Anaemia 2/238 (0.84%)', ' Disseminated intravascular coagulation 0/238 (0.00%)', ' Lymphadenopathy 1/238 (0.42%)', ' Neutropenia 1/238 (0.42%)', ' Thrombocytopenia 0/238 (0.00%)', ' Anaemia 22/238 (0.84%)', ' Disseminated intravascular coagulation 20/238 (0.00%)', ' Febrile neutropenia 21/238 (0.42%)', ' Lymphadenopathy 21/238 (0.42%)', ' Neutropenia 21/238 (0.42%)']}

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

b4c97206-66fd-468b-8388-fac076222c10

Single

Eligibility

NCT00450723

There are several types of surgical and therapeutic treatments which are banned for patients wanting to take part in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00450723', 'Intervention': ['INTERVENTION 1: ', ' Sentinel Lymph Node Biopsy', '[Not Specified]'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast cancer', ' Stage I or II disease (T1-T2, N0, M0/MX disease)', ' No chest wall invasion by tumor (T3 disease)', ' Medially or centrally located lesion', ' No multicentric disease', ' Multifocal disease allowed', ' No clinically positive axillary nodes', ' No enlarged internal mammary nodes by CT scan', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Male or female', ' Menopausal status not specified', ' American Society of Anesthesiologists (ASA) physical status classification 1-2', ' Not pregnant or nursing', ' Negative pregnancy test', ' No other concurrent known, invasive malignancy', ' No known chronic pulmonary disease', ' No known allergy to methylene blue or isosulfan blue', ' PRIOR CONCURRENT THERAPY:', ' No prior thoracic or cardiac surgery', ' No prior ipsilateral chest tube placement', ' Contralateral chest tube placement allowed', ' No prior neoadjuvant chemotherapy', ' No prior radiotherapy to the mediastinum'], 'Results': ['Outcome Measurement: ', ' Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy', ' [Not Specified]', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Sentinel Lymph Node Biopsy', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Number', ' Unit of Measure: participants 31'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/34 (0.00%)']}

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

6e22d118-af77-41bd-bd47-9385779f33aa

Single

Results

NCT01945775

The shortest PFS in the Talazoparib group of the primary trial was over a month shorter than the Median PFS for that group.

Entailment

{'Clinical Trial ID': 'NCT01945775', 'Intervention': ['INTERVENTION 1: ', ' Talazoparib', " Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.", 'INTERVENTION 2: ', " Physician's Choice Treatment", " Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days."], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed carcinoma of the breast', ' Locally advanced breast cancer that is not amenable to curative radiation or surgical cure and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy', ' Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or BRCA2 mutation from Myriad Genetics or other laboratory approved by the Sponsor', ' No more than 3 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease (no limit on prior hormonal therapies or targeted anticancer therapies such as mechanistic target of rapamycin (mTOR) or CDK4/6 inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL4 or VEGF)', ' Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated', ' Have measurable or non-measurable, evaluable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1', ' Eastern Cooperative Oncology Group (ECOG) performance status 2', 'Exclusion Criteria:', ' First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy unless the Investigator determines that one of the 4 cytotoxic chemotherapy agents in the control arm would otherwise be offered to the subject', ' Prior treatment with a PARP inhibitor (not including iniparib)', " Not a candidate for treatment with at least 1 of the treatments of protocol-specific physician's choice (ie, capecitabine, eribulin, gemcitabine, vinorelbine)", ' Subjects who had objective disease progression while receiving platinum chemotherapy administered for locally advanced or metastatic disease; subjects who received low-dose platinum therapy administered in combination with radiation therapy are not excluded', ' Subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible; however, subjects may not have relapsed within 6 months of the last dose of prior platinum therapy', ' Cytotoxic chemotherapy within 14 days before randomization', ' Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization', ' HER2 positive breast cancer', ' Active inflammatory breast cancer', ' CNS metastases', ' Exception: Adequately treated brain metastases documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids (except prednisone 5 mg/day or equivalent) for management of CNS symptoms. A repeat CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases.', ' Subjects with leptomeningeal carcinomatosis are not permitted', ' Prior malignancy except for any of the following:', ' Prior BRCA-associated cancer as long as there is no current evidence of the cancer', ' Carcinoma in situ or non-melanoma skin cancer', ' A cancer diagnosed and definitively treated 5 years before randomization with no subsequent evidence of recurrence', ' Known to be human immunodeficiency virus positive', ' Known active hepatitis C virus, or known active hepatitis B virus', ' Known hypersensitivity to any of the components of talazoparib'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment', ' IRF assessed PFS was defined as time (in months) from randomization until the date of first documented radiologic progressive disease per response evaluation criteria in solid tumors (RECIST) version 1.1 or death from any cause, whichever occurs first. As per RECIST v1.1, progression defined as 1) for target lesions: at least a 20% increase in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), the absolute increase in the sum has to be at least 5 millimeter (mm); 2) for non-target lesions: unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions; 3) and/or appearance of one or more new lesions. The analysis was performed by Kaplan-Meier method.', ' Time frame: Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months)', 'Results 1: ', ' Arm/Group Title: Talazoparib', " Arm/Group Description: Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.", ' Overall Number of Participants Analyzed: 287', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.6 (7.2 to 9.3)', 'Results 2: ', " Arm/Group Title: Physician's Choice Treatment", " Arm/Group Description: Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m^2 (equivalent to eribulin 1.23 mg/ m^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.", ' Overall Number of Participants Analyzed: 144', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.6 (4.2 to 6.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 103/286 (36.01%)', ' Anaemia * 18/286 (6.29%)', ' Neutropenia * 3/286 (1.05%)', ' Thrombocytopenia * 2/286 (0.70%)', ' Febrile neutropenia * 1/286 (0.35%)', ' Leukopenia * 1/286 (0.35%)', ' Pancytopenia * 2/286 (0.70%)', ' Pericardial effusion * 3/286 (1.05%)', ' Atrial flutter * 1/286 (0.35%)', ' Cardiac tamponade * 1/286 (0.35%)', ' Diplopia * 2/286 (0.70%)', ' Vomiting * 5/286 (1.75%)', 'Adverse Events 2:', ' Total: 39/126 (30.95%)', ' Anaemia * 0/126 (0.00%)', ' Neutropenia * 4/126 (3.17%)', ' Thrombocytopenia * 0/126 (0.00%)', ' Febrile neutropenia * 1/126 (0.79%)', ' Leukopenia * 0/126 (0.00%)', ' Pancytopenia * 0/126 (0.00%)', ' Pericardial effusion * 0/126 (0.00%)', ' Atrial flutter * 0/126 (0.00%)', ' Cardiac tamponade * 0/126 (0.00%)', ' Diplopia * 0/126 (0.00%)', ' Vomiting * 2/126 (1.59%)']}

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

ccc5362a-33d0-4f1b-be46-d31729ba9194

Single

Intervention

NCT03765996

Participants in group 2 of the primary trial receive taping to anastomosis regions., but no Complex Decongestive Physiotherapy.

Contradiction

{'Clinical Trial ID': 'NCT03765996', 'Intervention': ['INTERVENTION 1: ', ' Decongestive Physiotherapy', ' This group received Complex Decongestive Physiotherapy.', ' Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.', 'INTERVENTION 2: ', ' Decongestive Physiotherapy Plus Taping', ' This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.', ' Decongestive Physiotherapy plus taping: This group received CDP as same protocol of active comparator. In addition, taping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region.'], 'Eligibility': ['Inclusion Criteria:', " Patients who had unilateral BCRL and women aged over 18 who were 'significant', 'marked', or 'severe' lymphoedema.", 'Exclusion Criteria:', ' Patients with paralysis on part of the affected arm,', ' Patients who had undergone CDP more than once within six months,', ' Patients who had an active infection,', ' Patients who had a skin disease.'], 'Results': ['Outcome Measurement: ', ' Change of the Limb Volume, (Last Value of the Follow-up - Baseline Value)', ' Limb size was quantified by using circumferential limb measurements. Measurements were taken with patients in a prone position and the arm abducted at 30°. The circumference was measured every 5cm, starting at the ulnar styloid and continuing 45cm proximally for both limbs. Limb volume was calculated for each segment by using the frustum formula. Frustum formula is a mathematical method for calculating limb volume based on the circumference measures, and this formula gives the result in milliliters. Limb measuring was carried out at the beginning of and after treatment (twenty sessions).', ' Time frame: At baseline and at 4 weeks', 'Results 1: ', ' Arm/Group Title: Decongestive Physiotherapy', ' Arm/Group Description: This group received Complex Decongestive Physiotherapy.', ' Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.', ' Overall Number of Participants Analyzed: 14', ' Median (Inter-Quartile Range)', ' Unit of Measure: milliliter 160.01 (81.50 to 650.56)', 'Results 2: ', ' Arm/Group Title: Decongestive Physiotherapy Plus Taping', ' Arm/Group Description: This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.', ' Decongestive Physiotherapy plus taping: This group received CDP as same protocol of active comparator. In addition, taping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region.', ' Overall Number of Participants Analyzed: 18', ' Median (Inter-Quartile Range)', ' Unit of Measure: milliliter 148.28 (52.29 to 552.85)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/18 (0.00%)', 'Adverse Events 2:', ' Total: 0/18 (0.00%)']}

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

fa530b28-9142-49f2-aa80-4d04fa532910

Single

Adverse Events

NCT00063570

None of the patients in cohort 1 of the primary trial had a platlet deficiency, and none of the patients in cohort 2 had Pyrexia.

Contradiction

{'Clinical Trial ID': 'NCT00063570', 'Intervention': ['INTERVENTION 1: ', ' Bi-Weekly Schedule', ' Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.', ' Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.', 'INTERVENTION 2: ', ' 21-Day Schedule', ' Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.', ' Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.'], 'Eligibility': ['Inclusion Criteria:', ' Must have received prior chemotherapy with Taxol (paclitaxel) or Taxotere (docetaxel).', ' Less than 3 different chemotherapy treatments for metastatic disease.', ' Prior treatment with hormonal and/or radiation therapy.', ' Must have disease that can be measured.', ' Must be able to take care of self needs for example personal hygiene', 'Exclusion Criteria:', ' Must not be pregnant or breast-feeding.', ' Cancer that has spread to the brain.', ' Treatment with Gemcitabine or Pemetrexed', ' Unable to take folic acid or Vitamin B12', ' Treatment for another cancer within the last 5 years'], 'Results': ['Outcome Measurement: ', ' Overall Tumor Response', ' Best overall (confirmed) response recorded from start of treatment until disease progression/recurrence, start of other anti-tumor therapy/intervention, or end of trial, whichever comes first. Response must be confirmed at least 6 weeks from previous scans. Best overall response assignment depends on both measurement and confirmation criteria.', ' Time frame: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated', 'Results 1: ', ' Arm/Group Title: Bi-Weekly Schedule', ' Arm/Group Description: Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.', ' Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression.', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 2', ' Partial Response: 8', ' Stable Disease: 26', ' Progressive Disease: 14', 'Unknown: 2', 'Results 2: ', ' Arm/Group Title: 21-Day Schedule', ' Arm/Group Description: Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.', ' Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression.', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 0', ' Partial Response: 5', ' Stable Disease: 10', ' Progressive Disease: 6', 'Unknown: 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17', ' Anaemia 2/52 (3.85%)', ' Febrile neutropenia 4/52 (7.69%)', ' Pancytopenia 1/52 (1.92%)', ' Thrombocytopenia 0/52 (0.00%)', ' Abdominal pain 1/52 (1.92%)', ' Constipation 1/52 (1.92%)', ' Pyrexia 2/52 (3.85%)', ' Hepatic failure 1/52 (1.92%)', ' Hyperbilirubinaemia 1/52 (1.92%)', ' Device related infection 1/52 (1.92%)', ' Pneumonia 2/52 (3.85%)', ' Sepsis 1/52 (1.92%)', 'Adverse Events 2:', ' Total: 7', ' Anaemia 0/21 (0.00%)', ' Febrile neutropenia 1/21 (4.76%)', ' Pancytopenia 0/21 (0.00%)', ' Thrombocytopenia 1/21 (4.76%)', ' Abdominal pain 0/21 (0.00%)', ' Constipation 0/21 (0.00%)', ' Pyrexia 1/21 (4.76%)', ' Hepatic failure 0/21 (0.00%)', ' Hyperbilirubinaemia 0/21 (0.00%)', ' Device related infection 0/21 (0.00%)', ' Pneumonia 0/21 (0.00%)', ' Sepsis 0/21 (0.00%)']}

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

7cbe445f-2df6-4a87-be6b-7ecc1e80b08b

Comparison

Adverse Events

NCT00503906

NCT01142661

The adverse events in the primary trial where all equally prevalent, whereas in the secondary trial, alcohol poisoning was reported as the most common event.

Contradiction

{'Clinical Trial ID': 'NCT00503906', 'Intervention': ['INTERVENTION 1: ', ' Abraxane, Avastin and Gemcitabine', ' Each treatment cycle is 28 days. Participants will be treated until disease progression:', ' Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;', ' Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;', ' Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.'], 'Eligibility': ['Inclusion Criteria', ' Patients must either be:', ' treatment-naïve with newly diagnosed her2neu non-overexpressing (non amplified) metastatic (Stage IV) breast cancer, or', ' HER2/neu-negative patients with metastasis diagnosed 6 or more months after completing primary systemic treatment (neoadjuvant, adjuvant chemotherapy).', ' No previous chemotherapy regimen for metastatic breast cancer.', ' 18 years of age or older.', ' Measurable disease as defined by RECIST criteria or evaluable disease.', ' Eastern Cooperative Oncology Group (ECOG) 0-1.', ' Life expectancy greater than 3 months.', ' For female (or male) patients, either pre- or post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study', ' Provide written informed consent before any study-related procedure not part of normal medical care is conducted', ' Willing and able to comply with the protocol requirement', ' Laboratory parameters as follows:', ' Neutrophils: 1.5 x109/L or greater', ' Platelets: 100 x109/L or greater', ' Hemoglobin: 9.0 g/dL', ' Serum Creatinine: 1.5mg/dL', ' Bilirubin: ULN, except when caused by metastatic disease', ' Alanine transaminase (ALT)/Aspartate transaminase (AST): 2.5 times the upper limit of the normal range (ULN) except when caused by metastatic disease', ' Urine protein creatinine (UPC) ratio < 1.0 at screening.', ' Exclusion Criteria', ' Previous treatment with gemcitabine.', ' History of Gastrointestinal Bleeding in the previous 3 months.', ' Chemotherapy within 4 weeks prior to enrollment.', ' Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.', ' Any major surgery within 4 weeks prior to enrollment.', ' Presence of central nervous system or brain metastases.', ' Urine protein: creatinine ratio 1.0 at screening.', ' Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).', ' A prior history of hypertensive crisis or hypertensive encephalopathy.', ' Peripheral neuropathy > grade I.', ' Clinical AIDS or known positive HIV serology', ' No concurrent clinically evident malignancy is allowed except inactive non-melanoma skin cancer and inactive cervical cancer diagnosed or other cancer for which the patient has been disease-free for five years.', ' Unstable angina.', ' New York Heart Association (NYHA) Grade II or greater congestive heart failure', ' History of myocardial infarction within 6 months.', ' History of stroke within 6 months.', ' Clinically significant peripheral vascular disease.', ' Evidence of bleeding diathesis or coagulopathy', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, anticipation of need for major surgical procedure during the course of the study.', ' Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to enrollment.', ' Pregnant (positive pregnancy test) or lactating.', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment', ' Serious, non-healing wound, ulcer, or bone fracture', ' Inability to comply with study and/or follow-up procedures', ' Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible.', ' Participants cannot have been in another experimental drug study other than a Bevacizumab cancer study within 4 weeks of the first infusion of these study medications.'], 'Results': ['Outcome Measurement: ', ' Median Progression-Free Survival', ' Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.', ' Time frame: Up to 24 months', 'Results 1: ', ' Arm/Group Title: Abraxane, Avastin and Gemcitabine', ' Arm/Group Description: Each treatment cycle is 28 days. Participants will be treated until disease progression:', ' Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;', ' Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;', ' Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.', ' Overall Number of Participants Analyzed: 29', ' Median (95% Confidence Interval)', ' Unit of Measure: months 10.4 (5.6 to 15.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/29 (27.59%)', ' Leukopenia [1]1/29 (3.45%)', ' Thrombocytopenia [1]1/29 (3.45%)', ' Abscess [1]1/29 (3.45%)', ' Breast Abscess 1/29 (3.45%)', ' Fever/Sepsis [1]1/29 (3.45%)', ' Neutropenic Fever [2]1/29 (3.45%)', ' Peripheral Neuropathy [1]1/29 (3.45%)', ' Seizure/Syncope [1]1/29 (3.45%)', ' Hematuria [1]1/29 (3.45%)', ' UTI [1]1/29 (3.45%)', ' Shortness of breath [1]1/29 (3.45%)']}

{'Clinical Trial ID': 'NCT01142661', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate', 'Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.'], 'Eligibility': ['Inclusion Criteria', ' In order to receive eribulin under this protocol, the subjects oncologist must have documented experience treating subjects with eribulin in a prior clinical study. Subjects who meet all of the following criteria will be included in the treatment protocol:', ' Recurrent, locally advanced or metastatic breast cancer that has progressed on or after the last anti-cancer therapy.', ' Prior treatment with, ineligibility for, or commercial unavailability of each of the following therapies:', ' Anthracyclines, taxanes, and capecitabine.', ' Ixabepilone in countries where this agent is marketed.', ' Trastuzumab for Her-2 positive disease.', ' Hormonal therapy in hormone receptor-positive disease.', ' All other marketed therapies, eg, gemcitabine or vinorelbine, used for the treatment of advanced breast cancer.', ' Eastern Cooperative Oncology Group (ECOG) performance status </= 2.', ' Serum creatinine </= 2.0 mg/dL or creatinine clearance >/= 40 mL/min according to Cockcroft and Gault formula.', ' Absolute neutrophil count >/= 1.5 x 10^9/L, hemoglobin >/= 10 g/dL (can be corrected by growth factor or transfusion), and platelet count >/= 100 x 10^9/L.', ' Total bilirubin </= 1.5 x upper limit of normal (ULN). Alkaline phosphatase (AP), alanine aminotransferase, and aspartate aminotransferase </= 3 x ULN (</= 5 x ULN in case of liver metastases). In case AP is >3 x ULN (in absence of liver metastases) or >5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP.', ' Are willing and able to comply with all aspects of the treatment protocol.', ' Provide written informed consent.', ' Females, age >/= 18 years.', ' Female subjects of childbearing potential must agree to be abstinent or to use a highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intra-uterine device, or have a vasectomised partner) having started for at least one menstrual cycle prior to starting eribulin and throughout the entire treatment period and for 30 days (longer if appropriate) after the last dose of eribulin. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.', ' Exclusion Criteria Subjects who meet any of the following criteria will be excluded from participation in the treatment protocol:', ' Eligible for any other eribulin study that is open in the same region.', ' Existing anti-cancer therapy-related toxicities of Grade >/= 2, except that alopecia and Grade 2 neuropathy are acceptable.', ' History of congestive heart failure with New York Heart Association Classification >II, unstable angina, myocardial infarction within the past 6 months, serious cardiac arrhythmia.', " Electrocardiogram with QTc interval >/= 500 msec based upon Bazett's formula (QTcB).", ' The Investigator believes the subject to be medically unfit to receive eribulin or unsuitable for any other reason.', ' Females who are pregnant (positive B-hCG test) or breastfeeding.', ' Subject with hypersensitivity to eribulin or any of the excipients.', ' Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this treatment protocol. Any signs (eg, radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting the treatment protocol.', " Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject's ability to safely complete the treatment protocol.", ' Subjects who are known to be human immunodeficiency virus positive because the neutropenia caused by the eribulin treatment may make such subjects particularly susceptible to infection.', ' Subjects with meningeal carcinomatosis.', ' Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.', ' Subjects who have received any of the following treatments within the specified period before the start of treatment:', ' Any investigational drug, chemotherapy, radiation, or biological or targeted therapy within 2 weeks.', ' Hormonal therapy within 1 week.'], 'Results': ['Outcome Measurement: ', ' Safety', ' General safety will be assessed by monitoring and recording the number of patients with adverse events (serious and nonserious) for duration of treatment which continued until disease progression, unacceptable toxicity or death.', ' Time frame: For duration of treatment, an average of 5 months', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate', ' Arm/Group Description: Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/9 (77.78%)', ' Febrile Neutropenia1/9 (11.11%)', ' Neutropenia1/9 (11.11%)', ' Tachycardia1/9 (11.11%)', ' Hematemesis1/9 (11.11%)', ' Small Bowel Obstruction1/9 (11.11%)', ' Pneumonia1/9 (11.11%)', ' Hypokalemia1/9 (11.11%)', ' Alcohol Poisoning1/9 (11.11%)', ' Progressive Disease4/9 (44.44%)']}

41cf791e-ed7a-48e5-af84-eefc9fa41ba7

Single

Adverse Events

NCT00894504

There were only 3 adverse events in the primary trial which occurred more than twice.

Contradiction

{'Clinical Trial ID': 'NCT00894504', 'Intervention': ['INTERVENTION 1: ', ' Panitumumab/Gemcitabine/Carboplatin', ' Panitumumab - 6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Carboplatin - AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Gemcitabine - 1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)'], 'Eligibility': ['Inclusion Criteria:', ' Female patients >=18 years of age.', ' Histologically or cytologically confirmed diagnosis of unresectable locally advanced or stage IV breast cancer.', ' No more than 1 prior treatment regimen for metastatic breast cancer.', ' Estrogen receptor and progesterone receptor negative (defined as <10% staining by IHC).', ' Paraffin-embedded tumor tissue (from the primary tumor or metastasis) for biomarker testing. (In the absence of paraffinembedded tissue, unstained paraffin-embedded tumor slides are acceptable).', ' Measurable disease, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) guidelines', ' HER2 negative tumors. HER2 negativity must be confirmed by one of the following:', ' FISH-negative (FISH ratio <2.2), or', ' IHC 0-1+, or', ' IHC 2-3+ AND FISH-negative (FISH ratio <2.2)', ' Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.', ' Absolute neutrophil count (ANC) >=1.5 × 109/L; platelet count >=100 × 109/L; hemoglobin >=9.0 g/dL.', ' Creatinine <=1.5 mg/dL, or creatinine clearance >=40 mL/min (as calculated by the Cockcroft-Gault method, as follows: Female creatinine clearance = (140 - age) × (weight in kg) × 0.85 (serum creatinine × 72)', ' Adequate hepatic function, defined as follows: total bilirubin <=1.5 x ULN; aspartate aminotransferase (AST) <=3 × ULN (or <= 5 x ULN if liver metastases); alanine aminotransferase (ALT) <=3 x ULN (or <=5 x ULN if liver metastases).', ' Magnesium level >= the institutional lower limit of normal (LLN).', ' 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:', ' Patients with brain metastases are not eligible.', ' History of another primary cancer, with the exception of the following:', ' Curatively treated in situ cervical cancer;', ' Curatively resected non-melanoma skin cancer;', ' Other primary solid tumor curatively treated with no known active disease present and no treatment administered for >=5 years prior to study enrollment.', ' History of interstitial lung disease (e.g., pneumonitis, pulmonary fibrosis), or any evidence of interstitial lung disease on the CT scan of the chest performed at the baseline visit.', ' Prior anti-EGFR antibody therapy (e.g., cetuximab), or treatment with small-molecule EGFR inhibitors (e.g., gefitinib, erlotinib, lapatinib).', ' Radiotherapy <=14 days prior to study enrollment. Any acute effects of radiotherapy must be resolved prior to the administration of study drugs.', ' Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies (e.g., bevacizumab) <=21 days prior to study enrollment.', ' Prior therapy with gemcitabine or carboplatin in the metastatic setting is not permitted. Patients who received gemcitabine or carboplatin as part of adjuvant therapy are eligible, as long as recurrence was first documented >12 months after the last exposure to the drug(s).', ' Major surgery within 28 days or minor surgery within 14 days of study enrollment.', ' Requirement of chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine).', ' Any investigational agent or therapy <=30 days prior to study enrollment.', ' Uncontrolled or intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.', ' History of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results.', ' Unwillingness or inability to comply with study requirements.', ' Women who are pregnant or breastfeeding.', ' Patients with known human immunodeficiency virus (HIV), hepatitis C virus, and/or acute or chronic hepatitis B virus infection.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' Measured from Day 1 of study drug administration to disease progression - defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as a 20% increase in the sum of the longest diameter of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions', ' Time frame: every 6 weeks until treatment discontinuation', 'Results 1: ', ' Arm/Group Title: Panitumumab/Gemcitabine/Carboplatin', ' Arm/Group Description: Panitumumab - 6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Carboplatin - AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Gemcitabine - 1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)', ' Overall Number of Participants Analyzed: 71', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 4.4 (3.2 to 5.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/71 (14.08%)', ' ATRIAL FIBRILLATION 1/71 (1.41%)', ' CARDIAC TAMPONADE 1/71 (1.41%)', ' PERICARDIAL EFFUSION 1/71 (1.41%)', ' SUPRAVENTRICULAR TACHYCARDIA 1/71 (1.41%)', ' DIARRHOEA 1/71 (1.41%)', ' NAUSEA 1/71 (1.41%)', ' VOMITING 1/71 (1.41%)', ' CHEST PAIN 1/71 (1.41%)', ' PNEUMONIA 1/71 (1.41%)', ' MALIGNANT PLEURAL EFFUSION 1/71 (1.41%)', ' HEPATIC ENCEPHALOPATHY 1/71 (1.41%)']}

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

d417aa7b-6d2c-46f8-812c-426ea60e0328

Single

Results

NCT00171704

Most patients in the Letrozole group of the primary trial had a decreased Bone Mineral Density of the Lumbar Spine after 24 months.

Entailment

{'Clinical Trial ID': 'NCT00171704', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' 2.5 mg once daily (q.d.)orally for 5 years', 'INTERVENTION 2: ', ' Tam-Let', ' 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.'], 'Eligibility': ['Inclusion Criteria', ' Female', ' Post-menopausal hormone status defined as:', ' Patients with menostasis (amenorrhea) > 12 months or history of oophorectomy.', ' Patients 55 years with history of hysterectomy or having continued/renewed menstruation on cyclic hormone treatment.', ' Patients of 50-54 years: Menopausal status was determined on the basis of follicle-stimulating hormone (FSH)/luteinizing hormone (LH) values.', ' Histologically confirmed resected breast cancer and eligible for adjuvant endocrine therapy. As a minimum, patients had to have receptor-positive tumors, which were defined either as estrogen receptor (ER) and/or progesterone receptor (PgR) 10 fmol/mg cytosol protein; or 10% of the tumor cells positive by immunocytochemical evaluation.', ' Adequate bone marrow function (white blood cell count [WBC] > 3.0 x 109 /L, platelets 100.0 x 109 /L, and hemoglobin > 10 g/dL).', ' Documented evidence of adequate renal function (creatinine < 180 µmol/L) and hepatic function (bilirubin < 30 µmol/L, alanine aminotransferase (ALT) < 1.5 x upper normal limit of the laboratory).', ' Life expectancy of at least 24 months at the time of enrollment.', ' Written voluntary informed consent prior to initiation of any study procedure.', ' Willingness to undergo all scheduled tests and examinations for evaluation of bone density and bone metabolism, and lipid profiles in addition to the standard assessments for monitoring their breast cancer status.', ' Exclusion Criteria', ' Patients with distant metastases as defined by the criteria of the Danish Breast Cancer Co-operative Group (DBCCOG).', " Pre-existing bone disease (e.g. osteomalacia, osteogenesis imperfecta, Paget's disease).", ' Patients receiving bisphosphonates for more than 3 months before randomization.', ' Chronic treatment with drugs known to interfere with bone metabolism, e.g.', ' Anti-convulsants within the past year.', ' Corticosteroids at doses greater than the equivalent of 5 mg/day prednisone for more than two weeks in the past 6 months (prior to randomization).', ' Any previous treatment with sodium fluoride at daily doses 5 mg/day for a period exceeding 1 month.', ' Anabolic steroids in the past 12 months.', ' Long term use of coumarin derivatives and heparin at the time of randomization.', " Metabolic diseases known to interfere with bone metabolism (e.g., Hyperparathyroidism, hypoparathyroidism, uncontrolled thyroid disease, Cushing's disease, vitamin D deficiency, malabsorption syndrome, etc.).", ' Treatment with lipid-lowering agents within the 3 months prior to randomization (this exclusion criterion did not apply to patients randomized in the United Kingdom).', ' Patients receiving other anti-cancer treatment.', ' Previous neoadjuvant / adjuvant chemotherapy and /or previous adjuvant endocrine therapy (e.g., anti-estrogens, AIs).', ' History of previous or concomitant malignancy within the past 5 years other than adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who had a previous other malignancy must have been disease free for five years. Patients with endometrial cancer and/or invasive breast cancer at any time in their medical history were excluded. Patients with invasive bilateral breast cancer were excluded. Patients with vaginal discharge/ vaginal bleeding with evidence of malignancy were excluded.', ' Any other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.'], 'Results': ['Outcome Measurement: ', ' Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)', ' Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.', ' Time frame: Baseline, 24 months', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: 2.5 mg once daily (q.d.)orally for 5 years', ' Overall Number of Participants Analyzed: 63', ' Median (Full Range)', ' Unit of Measure: Percent Change -4.63 (-14.21 to 4.32)', 'Results 2: ', ' Arm/Group Title: Tam-Let', ' Arm/Group Description: 20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.', ' Overall Number of Participants Analyzed: 68', ' Median (Full Range)', ' Unit of Measure: Percent Change 0.37 (-6.98 to 15.21)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 50/133 (37.59%)', ' Acute myocardial infarction 0/133 (0.00%)', ' Angina pectoris 1/133 (0.75%)', ' Angina unstable 0/133 (0.00%)', ' Arrhythmia 1/133 (0.75%)', ' Atrial fibrillation 2/133 (1.50%)', ' Atrial flutter 0/133 (0.00%)', ' Bundle branch block left 1/133 (0.75%)', ' Myocardial infarction 0/133 (0.00%)', ' Pericarditis 0/133 (0.00%)', ' Sinus bradycardia 0/133 (0.00%)', 'Adverse Events 2:', ' Total: 41/130 (31.54%)', ' Acute myocardial infarction 2/130 (1.54%)', ' Angina pectoris 1/130 (0.77%)', ' Angina unstable 1/130 (0.77%)', ' Arrhythmia 0/130 (0.00%)', ' Atrial fibrillation 2/130 (1.54%)', ' Atrial flutter 1/130 (0.77%)', ' Bundle branch block left 0/130 (0.00%)', ' Myocardial infarction 1/130 (0.77%)', ' Pericarditis 1/130 (0.77%)', ' Sinus bradycardia 1/130 (0.77%)']}

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

2744cc0a-86e9-4764-ae1c-f10f635dc283

Single

Intervention

NCT02392611

In the primary trial cohort 1 patients must have failed or be intolerant to standard therapy, or have no standard therapy available, and cohort 2 patients must respond well to standard therapy.

Contradiction

{'Clinical Trial ID': 'NCT02392611', 'Intervention': ['INTERVENTION 1: ', ' Monotherapy: Alobresib 0.6 mg', ' Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.', 'INTERVENTION 2: ', ' Monotherapy: Alobresib 1.4 mg', ' Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.'], 'Eligibility': ['Key Inclusion Criteria:', ' Group 1: Histologically or cytologically confirmed advanced malignant solid tumor or lymphoma (any subtype) that is refractory to or intolerant of standard therapy or for which no standard therapy is available', ' Group 2: Post-menopausal women with advanced stage estrogen receptor positive breast cancer who are candidates for exemestane or fulvestrant', ' Group 3: Individuals with lymphoma are limited to diffuse large B-cell lymphoma and peripheral T-cell lymphoma that are refractory to or intolerant of standard therapy or for which no standard therapy is available', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 1', ' Adequate organ function defined as follows:', ' Hematologic: Platelets 100 x 10^9/L; Hemoglobin 9.0 g/ dL; Absolute neutrophil count (ANC) 1.5 x 10^9/L (without platelet transfusion or any growth factors within previous 7 days of the hematologic laboratory values obtained at screening visit). Participants in the Group 3 lymphoma expansion may be enrolled with an ANC of 1.0 x 10^9 /L; Platelets 75 x 10^9 /L.', ' Hepatic: Aspartate transaminase (AST) / Alanine transaminase (ALT) 2.5 x upper limit of normal (ULN) (if liver metastases are present, 5 x ULN); Total or conjugated bilirubin 1.5 x ULN', ' Renal: Serum creatinine 1.5 x ULN or creatinine clearance (CrCl) 60 ml/min as calculated by the cockcroft-gault method', ' Coagulation: International Normalized Ratio (INR) 1.2', ' Key Exclusion Criteria:', ' Known brain metastasis or leptomeningeal disease', ' Myocardial infarction, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of study Day 1', ' Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of first dose of study drug', ' History of long QT syndrome or whose corrected QT interval (QTc) measured (Fridericia method) at screening is prolonged (> 450 ms for males and > 470 ms for females). Individuals who screen-fail due to this criterion are not eligible to be re-screened', ' Clinically significant bleeding within 28 days of study Day 1', ' Known human immunodeficiency virus (HIV) infection', ' Hepatitis B surface antigen positive', ' Hepatitis C virus (HCV) antibody positive', ' No active anticoagulation within 7 days of study Day 1; including acetylsalicylic acid, low molecular weight heparin, or warfarin.', ' Note: Other protocol defined Inclusion/Exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Number of Participants Experiencing Dose Limiting Toxicities (DLTs)', ' A DLT was a toxicity, considered possibly related to alobresib, and which occurred during DLT assessment window (Day 1 through Cycle 1 Day 28) in each cohort: Grade 4 neutropenia (absolute neutrophil count [ANC] < 500/mm^3); Grade 3 neutropenia (ANC< 1000/mm^3) with fever (a single temperature of > 38.3°C or a sustained temperature of 38°C for more than 1 hour [hr]); Grade 3 thrombocytopenia; Grade 2 bleeding; Grade 3 non hematologic toxicity, except Grade 3 nausea or emesis with maximum duration of 48 hrs on adequate medical therapy and Grade 3 diarrhea which persists for < 72 hrs in absence of maximal medical therapy; Grade 2 non hematologic treatment-emergent adverse event (TEAE) of potential clinical significance; treatment interruption 7 days due to unresolved toxicity; and any Grade 3 or 4 elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) associated with a Grade 2 elevation in bilirubin that is at least possibly related to alobresib.', ' Time frame: Baseline (Day 1) up to 28 days', 'Results 1: ', ' Arm/Group Title: Monotherapy: Alobresib 0.6 mg', ' Arm/Group Description: Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.', ' Overall Number of Participants Analyzed: 2', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0', 'Results 2: ', ' Arm/Group Title: Monotherapy: Alobresib 1.4 mg', ' Arm/Group Description: Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.', ' Overall Number of Participants Analyzed: 1', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/2 (50.00%)', ' Thrombocytopenia 0/2 (0.00%)', ' Atrioventricular block complete 0/2 (0.00%)', ' Adrenal haemorrhage 0/2 (0.00%)', ' Constipation 0/2 (0.00%)', ' Pain 0/2 (0.00%)', ' Pyrexia 0/2 (0.00%)', ' Cholangitis 1/2 (50.00%)', ' Pyelonephritis acute 0/2 (0.00%)', ' Sepsis 1/2 (50.00%)', ' Deep vein thrombosis 0/2 (0.00%)', 'Adverse Events 2:', ' Total: 1/1 (100.00%)', ' Thrombocytopenia 1/1 (100.00%)', ' Atrioventricular block complete 0/1 (0.00%)', ' Adrenal haemorrhage 0/1 (0.00%)', ' Constipation 0/1 (0.00%)', ' Pain 0/1 (0.00%)', ' Pyrexia 1/1 (100.00%)', ' Cholangitis 0/1 (0.00%)', ' Pyelonephritis acute 0/1 (0.00%)', ' Sepsis 0/1 (0.00%)', ' Deep vein thrombosis 0/1 (0.00%)']}

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

2e4717fd-b349-48a3-b751-88674dfaaa18

Comparison

Eligibility

NCT01237327

NCT00030823

the primary trial and the secondary trial do not have any overlapping inclusion criteria, apart from the mimimum age limit of 18.

Contradiction

{'Clinical Trial ID': 'NCT01237327', 'Intervention': ['INTERVENTION 1: ', ' Exemestane', ' Exemestane 25 milligram (mg) oral tablet taken once daily', 'INTERVENTION 2: ', ' Megestrol Acetate', ' Megestrol acetate 160 mg tablet taken once daily'], 'Eligibility': ['Inclusion Criteria:', ' Previous participation in study 971-ONC-0028-080.', 'Exclusion Criteria:', ' Subjects who had not previously participated in study 971-ONC-0028-080.'], 'Results': ['Outcome Measurement: ', ' Overall Survival', ' Overall survival in months measured from date of starting treatment in core study to date of death for any reason.', ' Time frame: Every 12 weeks up to 6 years', 'Results 1: ', ' Arm/Group Title: Exemestane', ' Arm/Group Description: Exemestane 25 milligram (mg) oral tablet taken once daily', ' Overall Number of Participants Analyzed: 43', ' Median (95% Confidence Interval)', ' Unit of Measure: months 29.2 (22.9 to 47.8)', 'Results 2: ', ' Arm/Group Title: Megestrol Acetate', ' Arm/Group Description: Megestrol acetate 160 mg tablet taken once daily', ' Overall Number of Participants Analyzed: 41', ' Median (95% Confidence Interval)', ' Unit of Measure: months 16.3 (11.6 to 27.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/41 (2.44%)', ' Chest pain NEC 0/41 (0.00%)', ' Back pain 0/41 (0.00%)', ' Cerebral haemorrhage 0/41 (0.00%)', ' Headache NOS 0/41 (0.00%)', ' Spinal cord compression 0/41 (0.00%)', ' Completed suicide 1/41 (2.44%)', 'Adverse Events 2:', ' Total: 2/40 (5.00%)', ' Chest pain NEC 1/40 (2.50%)', ' Back pain 1/40 (2.50%)', ' Cerebral haemorrhage 1/40 (2.50%)', ' Headache NOS 1/40 (2.50%)', ' Spinal cord compression 1/40 (2.50%)', ' Completed suicide 0/40 (0.00%)']}

{'Clinical Trial ID': 'NCT00030823', 'Intervention': ['INTERVENTION 1: ', ' Vaccine', ' Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Diagnosis of breast cancer at high risk for recurrence, defined by one of the following:', ' Stage IV that is free of all known disease after eradication by surgery, radiotherapy, or chemotherapy', ' May or may not have elevated CA 15-3 or CEA levels', ' Stage I, II, or III previously treated with adjuvant chemotherapy and clinically free of identifiable disease, but have rising CA 15-3 or CEA levels', ' Rising CA 15-3 and CEA defined as a prior normal level increased on 2 consecutive occasions at least 2 weeks apart', ' For patients with a significant history of smoking who have a chronically elevated CEA (less than 15), CEA must be increased at least 1.5 times the uppermost chronic value on 2 consecutive occasions at least 2 weeks apart', ' Stage III and completed adjuvant therapy no more than 24 months ago', ' Recurrence in the ipsilateral axilla after lumpectomy and/or axillary dissection or modified radical mastectomy', ' Recurrence in the ipsilateral breast after lumpectomy and/or axillary dissection', ' Stage II with at least 4 positive axillary nodes and completed adjuvant therapy no more than 24 months ago', ' Stage IV that is stable on hormonal therapy', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age:', ' 18 and over', ' Sex:', ' Male or female', ' Menopausal status:', ' Not specified', 'Performance status:', ' Karnofsky 80-100%', ' Life expectancy:', ' Not specified', ' Hematopoietic:', ' Lymphocyte count at least 500/mm^3', ' WBC at least 3,000/mm^3', ' Hepatic:', ' AST no greater than 1.5 times upper limit of normal (ULN)', ' Alkaline phosphatase no greater than 1.5 times ULN', ' Renal:', ' Creatinine no greater than 1.5 times ULN', ' Cardiovascular:', ' No clinically significant New York Heart Association class III or IV cardiac disease', ' Other:', ' Not pregnant', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No prior seafood allergy', ' No known prior immunodeficiency or autoimmune disease', ' No other active cancer except basal cell or squamous cell skin cancer', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy:', ' At least 6 weeks since prior immunotherapy', ' No prior vaccine with any of the antigens in this study', ' Chemotherapy:', ' See Disease Characteristics', ' At least 4 weeks since prior chemotherapy', ' No concurrent chemotherapy', ' Endocrine therapy:', ' See Disease Characteristics', ' Radiotherapy:', ' See Disease Characteristics', ' At least 4 weeks since prior radiotherapy', ' No concurrent radiotherapy', ' Surgery:', ' See Disease Characteristics', ' At least 4 weeks since prior surgery', ' Concurrent surgery for local recurrence allowed if patient remains disease free'], 'Results': ['Outcome Measurement: ', ' Safety', ' By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Vaccine', ' Arm/Group Description: Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Number', ' Unit of Measure: participants 13'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/13 (7.69%)', ' SGPT (ALT) 1/13 (7.69%)']}

b0c65cd7-8cad-404d-8704-ee074e480f57

Single

Adverse Events

NCT00509769

1 patient in the primary trial had toxic hepatitis.

Entailment

{'Clinical Trial ID': 'NCT00509769', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine 3.6 mg/kg', " Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle."], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent form.', ' Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC); tissue (slides or blocks) available for HER2 confirmation.', ' History of progression on HER2-directed therapy for the treatment of HER2-positive breast cancer.', ' At least 1, and no more than 3, chemotherapy regimens for MBC.', ' Granulocyte count 1500/μL, platelet count 100,000/μL, and hemoglobin 9 g/dL.', ' Serum bilirubin 1.5 mg/dL, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase 2.5x the upper limit of normal (ULN).', ' Serum creatinine 1.5 mg/dL or creatinine clearance 60 mL/min.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.', 'Exclusion Criteria:', ' Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biological therapy for the treatment of breast cancer within 2 weeks of the first study treatment.', ' Prior cumulative doxorubicin dose > 360 mg/m^2 or the equivalent.', ' History of significant cardiac disease, unstable angina, congestive heart failure (CHF), myocardial infarction, or ventricular arrythmia requiring medication.'], 'Results': ['Outcome Measurement: ', ' Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)', ' Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.', ' Time frame: Randomization until the analysis data cutoff-dates of 31 Jan 2009 (6 months after the last patient was enrolled in the study) and 25 Jun 2009 (approximately 12 months after the last patient was enrolled in the study, up to 23 months)', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine 3.6 mg/kg', " Arm/Group Description: Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.", ' Overall Number of Participants Analyzed: 109', ' Measure Type: Number', ' Unit of Measure: Percentage of patients Month 6 (n=109): 25.7 (17.9 to 34.5)', ' Month 12 (n=108): 26.9 (19.2 to 35.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 30/112 (26.79%)', ' Thrombocytopenia 1/112 (0.89%)', ' Dysphagia 1/112 (0.89%)', ' Haemorrhoidal haemorrhage 1/112 (0.89%)', ' Oesophageal stenosis 1/112 (0.89%)', ' Upper gastrointestinal haemorrhage 1/112 (0.89%)', ' Asthenia 1/112 (0.89%)', ' Disease progression 1/112 (0.89%)', ' Hepatotoxicity 1/112 (0.89%)', ' Cellulitis 3/112 (2.68%)', ' Pneumonia 2/112 (1.79%)', ' Osteomyelitis 1/112 (0.89%)']}

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

28e20650-e100-4e30-a319-5eceb69a979d

Comparison

Results

NCT02336737

NCT01432886

the secondary trial is testing for the DLT of its interventions, whereas the primary trial is evaluating the efficacy of lymph node detection through the use of SentiMag and SiennaXP.

Entailment

{'Clinical Trial ID': 'NCT02336737', 'Intervention': ['INTERVENTION 1: ', ' SiennaXP Injection', ' Single injection of SiennaXP in addition to comparator single dose of radioisotope (Technetium Tc99m Sulfur Colloid) and single dose of isosulfan blue dye.', ' Lymph node localization using the SentiMag handheld intraoperative localization system in addition to localization with standard of care handheld gamma probe.', ' SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe', ' Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)', 'Isosulfan blue dye: Injection of a single dose of isosulfan blue dye'], 'Eligibility': ['Inclusion Criteria:', ' Subjects with a diagnosis of primary breast cancer or subjects with pure ductal carcinoma in situ (DCIS).', ' Subjects scheduled for surgical intervention, with a sentinel lymph node biopsy procedure being a part of the surgical plan.', ' Subjects aged 18 years or more at the time of consent.', ' Subjects with an ECOG (Eastern Cooperative Oncology Group) performance status of Grade 0 - 2.', ' Subject has a clinical negative node status (i.e. T0-3, N0, M0).', 'Exclusion Criteria:', ' The subject is pregnant or lactating.', ' The subject has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes.', ' The subject has a known hypersensitivity to Isosulfan Blue Dye.', ' The subject has participated in another investigational drug study within 30 days of scheduled surgery.', " Subject has had either a) previous axilla surgery, b) reduction mammoplasty, or c) lymphatic function that is impaired in the surgeon's judgment.", ' Subject has had preoperative radiation therapy to the affected breast or axilla.', ' Subject has received a Feraheme® (ferumoxytol) Injection within the past 6 months.', ' Subject has intolerance or hypersensitivity to iron or dextran compounds or to SiennaXP.', ' Subject has an iron overload disease.', ' Subject has pacemaker or other implantable device in the chest wall.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Detected Lymph Nodes', ' The proportion of lymph nodes detected intraoperatively by SentiMag and SiennaXP in relation the proportion of lymph nodes detected by the combination of Technetium Sulfur Colloid and Isosulfan blue dye', ' Time frame: During surgical procedure <1 hour', 'Results 1: ', ' Arm/Group Title: SiennaXP Injection', ' Arm/Group Description: Single injection of SiennaXP in addition to comparator single dose of radioisotope (Technetium Tc99m Sulfur Colloid) and single dose of isosulfan blue dye.', ' Lymph node localization using the SentiMag handheld intraoperative localization system in addition to localization with standard of care handheld gamma probe.', ' SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe', ' Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)', 'Isosulfan blue dye: Injection of a single dose of isosulfan blue dye', ' Overall Number of Participants Analyzed: 146', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 145 99.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/147 (0.00%)']}

{'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%)']}

8cf0c320-9486-4531-9212-bb3284b734f1

Single

Eligibility

NCT00317603

Participants of the primary trial must be older than 18, have histologically confirmed stage 4 breast cancer, ECOG<2 and a life expectancy exceeding 6 months.

Entailment

{'Clinical Trial ID': 'NCT00317603', 'Intervention': ['INTERVENTION 1: ', ' Vaccine', ' Vaccinations will be administered on days 1,8,15 and every two weeks thereafter until the supply of vaccine has been exhausted or the patient is removed from study. As indicated in 5.2.5, vaccine cell dosage will be approximately 1x10 7 , 4x10 6 ,', ' 1x10 6 , or 1x10 5 depending on the final cell yield.', ' Autologous, Lethally Irradiated Breast Cancer Cells: Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed Stage IV breast cancer', ' Prior banked malignant effusion or significant malignant effusion for tumor harvest or surgically-accessible tumor nodule of at least 2cm in greatest diameter by physical exam, magnetic resonance imaging (MRI) or computed tomography (CT) scan', ' Must have received at least one prior regimen of chemotherapy for metastatic disease', ' Patients with HER2 positive tumors must have received at least one prior trastuzumab-based therapy in the metastatic setting, and may not receive trastuzumab therapy and vaccine treatment concurrently', ' Patients may receive concurrent bisphosphonate therapy and/or erythropoetin therapy at any point while on study', ' ECOG performance status 0 or 1', ' Estimated life expectancy of greater than or equal to 6 months', ' 18 years of age or older', ' Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy', ' Adequate recovery from drug-related toxicities from prior systemic therapies', ' Adequate recovery from recent surgery and radiation therapy', ' Greater than 6 months since bone marrow or peripheral blood stem cell transplant', 'Exclusion Criteria:', ' Urgent need for cytotoxic chemotherapy, radiotherapy, or surgery in the next 60 days', ' Uncontrolled active infection or illness', ' Psychiatric illness/social situation that would limit study compliance', ' Pregnant or nursing mothers', ' Evidence of HIV infection', ' Previous participation in an adenovirus-based trial', ' Concurrent invasive malignancy'], 'Results': ['Outcome Measurement: ', ' Minimum Number of Vaccine Doses Created Using Participant Tumor Sample', ' Tumor samples were obtained via malignant effusion or a surgically accessible tumor nodule of 2 cm in greatest diameter. Tumor cells were processed to single cell suspension and transduced with adenoviral vector encoding human Granulocyte-macrophage colony-stimulating factor (GM-CSF). Then, the cells washed extensively and irradiated with 10,000 cGy. Over the next 14 days, sterility cultures were tested for endotoxin and mycoplasma contamination. Individual vaccine cell dose and number varied depending on the final cell yield from vaccine production. The minimal dose was 1 x 10^5 cells and the maximal dose was 1 x 10^7 cells.', ' Time frame: Vaccine doses created and banked soon after registration, up to 8 days.', 'Results 1: ', ' Arm/Group Title: Vaccine', ' Arm/Group Description: Vaccinations will be administered on days 1,8,15 and every two weeks thereafter until the supply of vaccine has been exhausted or the patient is removed from study. As indicated in 5.2.5, vaccine cell dosage will be approximately 1x10 7 , 4x10 6 ,', ' 1x10 6 , or 1x10 5 depending on the final cell yield.', ' Autologous, Lethally Irradiated Breast Cancer Cells: Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: doses 6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/12 (25.00%)', ' Hemoglobin 1/12 (8.33%)', ' Alkaline phosphatase 1/12 (8.33%)', ' Dehydration 1/12 (8.33%)', ' Syncope 2/12 (16.67%)', ' Dyspnea 1/12 (8.33%)', ' Hypotension 1/12 (8.33%)']}

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

34a75478-e7cc-495e-86c3-d0accdaf1ddd

Comparison

Intervention

NCT00332709

NCT00659373

All the primary trial participants receive the same dose of Letrozole, and all patients in the secondary trial are administered the same dose of Tamoxifen.

Contradiction

{'Clinical Trial ID': 'NCT00332709', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' Letrozole 2.5 mg/day for 3 years', 'INTERVENTION 2: ', ' Letrozole + Zoledronic Acid', ' Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months'], 'Eligibility': ['Inclusion Criteria:', ' Compliant postmenopausal women with primary operable breast cancer after 4 to 6 years of therapy with tamoxifen (end of tamoxifen therapy within last 6 months)', ' Performance status 0-2 (Eastern Cooperative Oncology Group)', ' Patients without severe osteoporosis at study entry', ' No evidence of relapse at the time of randomization', ' Adequate function of bone marrow, kidney, and liver', 'Exclusion Criteria:', ' Estrogen- and progesterone-receptor status negative or unknown', ' Completion of adjuvant tamoxifen therapy more than 6 months prior to study start', ' Inflammatory breast cancer', ' Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures.', ' Recent (within 6 weeks) or planned dental or jaw surgery', " History of diseases with influence on bone metabolism such as Paget's disease and primary overactive parathyroid", ' Prior or concomitant therapies: chemotherapy within the last 12 months, intravenous or oral bisphosphonates, systemic corticosteroids, anabolic steroids or growth hormones, Tibolone, parathyroid hormone, systemic sodium fluoride or any drugs known to affect the skeleton (such as calcitonin, mithramycin, or gallium nitrate)', ' Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancers or in situ cancer of the cervix. Patients with previous other cancer(s) must have been disease-free for at least 5 years.', ' Patients currently receiving oral bisphosphonates must discontinue these at least 3 weeks prior to study start.', ' Additional protocol defined inclusion/exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Change in Bone Mineral Density (BMD) From Baseline to Month 36', ' Change in bone mineral density (BMD) measured by dual X-ray absorptiometry (DXA) in lumbar spine (L1-L4). Change calculated by (Month 36 BMD-Baseline BMD)/Baseline BMD*100.', ' Time frame: at 36 months as compared to baseline', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: Letrozole 2.5 mg/day for 3 years', ' Overall Number of Participants Analyzed: 21', ' Mean (Standard Deviation)', ' Unit of Measure: Percent -0.11 (0.14)', 'Results 2: ', ' Arm/Group Title: Letrozole + Zoledronic Acid', ' Arm/Group Description: Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months', ' Overall Number of Participants Analyzed: 20', ' Mean (Standard Deviation)', ' Unit of Measure: Percent 0.03 (0.08)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/40 (15.00%)', ' ACUTE MYOCARDIAL INFARCTION 0/40 (0.00%)', ' ANGINA PECTORIS 0/40 (0.00%)', ' ANGINA UNSTABLE 0/40 (0.00%)', ' CORONARY ARTERY STENOSIS 0/40 (0.00%)', ' SUPRAVENTRICULAR TACHYCARDIA 0/40 (0.00%)', ' VERTIGO POSITIONAL 1/40 (2.50%)', ' CONCOMITANT DISEASE PROGRESSION 1/40 (2.50%)', ' CHOLECYSTITIS 1/40 (2.50%)', ' DIVERTICULITIS 0/40 (0.00%)', ' CONTUSION 0/40 (0.00%)', 'Adverse Events 2:', ' Total: 7/41 (17.07%)', ' ACUTE MYOCARDIAL INFARCTION 1/41 (2.44%)', ' ANGINA PECTORIS 1/41 (2.44%)', ' ANGINA UNSTABLE 1/41 (2.44%)', ' CORONARY ARTERY STENOSIS 1/41 (2.44%)', ' SUPRAVENTRICULAR TACHYCARDIA 1/41 (2.44%)', ' VERTIGO POSITIONAL 0/41 (0.00%)', ' CONCOMITANT DISEASE PROGRESSION 0/41 (0.00%)', ' CHOLECYSTITIS 0/41 (0.00%)', ' DIVERTICULITIS 1/41 (2.44%)', ' CONTUSION 1/41 (2.44%)']}

{'Clinical Trial ID': 'NCT00659373', 'Intervention': ['INTERVENTION 1: ', ' Tamoxifen', ' Tamoxifen 20mg orally daily for 5 years', 'INTERVENTION 2: ', ' Ovarian Function Suppression', ' Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)', ' Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast cancer', ' Completely resected disease', ' Registered for clinical trial IBCSG-2402, but not yet started protocol hormonal therapy', ' Has not yet received any of the following adjuvant endocrine therapy, either before or after registration on IBCSG-2402:', ' Tamoxifen, exemestane, or gonadotropin-releasing hormone (GnRH) agonist', ' Ovarian irradiation', ' Bilateral oophorectomy', ' Hormone receptor status:', ' Estrogen and/or progesterone receptor positive', ' Each tumor must be hormone receptor positive', ' PATIENT CHARACTERISTICS:', ' Premenopausal', ' Can speak and read the local language(s) fluently', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics'], 'Results': ['Outcome Measurement: ', ' Change in Cognitive Function Over 1 Year in Premenopausal Breast Cancer Patients Who Receive Adjuvant Tamoxifen (T) Alone Against Those Receive Adjuvant Tamoxifen (T+OFS) or Exemestane (E+OFS) With Ovarian Function Suppression (OFS)', ' Objective cognitive function measured with CogState, a computerized test battery of 7 tasks: Detection, Identification, Monitoring, Memory, Learning, International Shopping List Task (ISLT) and ISLT-Delayed Recall. Performance speed is measured for Detection/Identification/Monitoring and performance accuracy is measured for Memory/Learning/ISLT/ISLT-Delayed Recall. Performance speed calculated as mean of the log10 transformed reaction time for correct responses (lower score=better); performance accuracy calculated as arcsine transformation of the proportion of correct responses (higher scores=better). Main outcome measure is a composite score (average of task scores after transformation and standardization by age-specific norms). A positive standardized score indicates that a patient performed better than average; a negative standardized score indicates below average results. Patients complete assessments at baseline and 1 year after randomization to parent IBCSG 24-02 (SOFT) study.', ' Time frame: 1 year after patient randomization to parent IBCSG 24-02 study', 'Results 1: ', ' Arm/Group Title: Tamoxifen', ' Arm/Group Description: Tamoxifen 20mg orally daily for 5 years', ' Overall Number of Participants Analyzed: 20', ' Mean (Standard Deviation)', ' Unit of Measure: standardized units -.04 (0.49)', 'Results 2: ', ' Arm/Group Title: Ovarian Function Suppression', ' Arm/Group Description: Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)', ' Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS.', ' Overall Number of Participants Analyzed: 54', ' Mean (Standard Deviation)', ' Unit of Measure: standardized units -0.21 (0.92)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/20 (0.00%)', 'Adverse Events 2:', ' Total: 0/54 (0.00%)']}

47780450-1202-4934-8e50-b29416b124f5

Single

Adverse Events

NCT00179309

There were 2 cases of severe back pain observed in the primary trial.

Contradiction

{'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': ''}

27421e64-e9f0-42a9-8070-bdfb0ce4ce7c

Comparison

Adverse Events

NCT01856543

NCT00365599

Across all cohorts of the secondary trial and the primary trial there was only a single recorded case of Myocarditis and Thrombosis.

Contradiction

{'Clinical Trial ID': 'NCT01856543', 'Intervention': ['INTERVENTION 1: ', ' Eucerin', ' Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT.', 'Eucerin', 'INTERVENTION 2: ', ' Mometasone Furoate 0.1%', ' Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments.', 'Mometasone F'], 'Eligibility': ['Inclusion Criteria:', ' Age 18 years', ' Stage 1-4 invasive breast cancer that is histologically confirmed at MSKCC', ' Status post mastectomy with axillary exploration (sentinel node biopsy and/or axillary lymph node dissection) to receive PMRT', ' ECOG Performance Status of 0 or 1', 'Exclusion Criteria:', ' Male', ' Patients with clinical evidence of gross disease', ' Patients who are pregnant or breastfeeding', ' Prior radiation therapy to the ipsilateral chest wall or thorax', ' Patients requiring a chest wall boost', ' Concurrent chemotherapy (biologic agents are allowed)', ' Psychiatric illness that would prevent the patient from giving informed consent', ' Inability or unwillingness to comply with skin care instructions and follow-up', ' Allergy to either Eucerin or MF', ' Residual grade >1 skin toxicity, cellulitis, or incompletely healed wound(s) at intended site of study drug application at the time of the start of RT', ' Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases)', ' Treatment with palliative or pre-operative radiation'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Moist Desquamation', ' Skin toxicity assessments will be done on a weekly basis while the patient is receiving RT, by the RN or physician utilizing CTCAE 4.0 and the weekly status check form, as per current standard practice.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Eucerin', ' Arm/Group Description: Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments. Patients will be provided diaries to record the date and time they applied the study cream. Pts should return the completed diaries on their weekly status checks and at the 2 weeks +/- 2 business days following the completion of RT.', ' Eucerin', ' Overall Number of Participants Analyzed: 73', ' Measure Type: Number', ' Unit of Measure: % of participants w/moist desquamation 66.7', 'Results 2: ', ' Arm/Group Title: Mometasone Furoate 0.1%', ' Arm/Group Description: Patient education regarding amount to be applied (amount depending on body habitus) and area of treatment field will be reinforced by the R.N. prior to the first radiation treatment. Part of patient education may involve application of the cream. Patients will be instructed to apply cream to the upper outer quadrant, upper inner quadrant, lower outer quadrant, and lower inner quadrant, as well as irradiated nodal fields. They will be instructed to apply cream in a thin, uniform layer twice a day, in the morning and evening, and not within the immediate 4 hours prior to radiation treatment. Patients will be informed that application immediately following radiation treatment is acceptable for those scheduled to receive morning treatments.', ' Mometasone F', ' Overall Number of Participants Analyzed: 70', ' Measure Type: Number', ' Unit of Measure: % of participants w/moist desquamation 43.8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/73 (4.11%)', ' Chest Pain - cardiac 1/73 (1.37%)', ' Myocarditis 1/73 (1.37%)', ' Pericarditis 1/73 (1.37%)', ' Ventricular tachycardia 1/73 (1.37%)', ' Skin infection 0/73 (0.00%)', ' Dermatitis radiation 0/73 (0.00%)', ' Dyspnea 1/73 (1.37%)', 'Adverse Events 2:', ' Total: 3/70 (4.29%)', ' Chest Pain - cardiac 0/70 (0.00%)', ' Myocarditis 0/70 (0.00%)', ' Pericarditis 0/70 (0.00%)', ' Ventricular tachycardia 0/70 (0.00%)', ' Skin infection 2/70 (2.86%)', ' Dermatitis radiation 1/70 (1.43%)', ' Dyspnea 0/70 (0.00%)']}

{'Clinical Trial ID': 'NCT00365599', 'Intervention': ['INTERVENTION 1: ', ' Vorinostat and Tamoxifen', ' Vorinostat and Tamoxifen as outlined in Intervention Descriptions'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have cytologically/histologically documented locally advanced or metastatic breast cancer with either:', ' Progression on treatment with any aromatase inhibitor for metastatic disease;', ' Recurrence while on adjuvant aromatase inhibitors or within 12 months of completion;', ' Recurrence after having completed adjuvant tamoxifen for at least 12 months;', ' Patient who are not candidates for or are intolerant of aromatase inhibitor treatment;', ' Patients are allowed (but not required) to have one prior chemotherapy regimen for metastatic disease.', ' Tumors must express estrogen or progesterone receptor.', ' Patients are eligible regardless of the menopausal status.', ' Age > 18 years old', ' Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.', ' Patients must be able to give informed consent and able to follow guidelines given in the study.', ' Patients must have acceptable organ function, as defined by the following laboratory parameters: white blood count (WBC) >3.0 x 10^9/L; absolute neutrophil count (ANC) >1.5 x 10^9/L; hemoglobin (Hgb) >10.0g/dL; platelets (PLT) >100 x 10^9/L, Bilirubin < 2.0 mg/dl, aspartate aminotransferase/alanine aminotransferase (AST/ALT) < 2.5 X upper limit of normal (ULN), Creatinine <1.8 mg/dl (Creatinine clearance >60 ml/min).', ' Women of childbearing age must have a negative pregnancy test. All patients of reproductive potential must use an effective method of contraception during the study and 6 months following termination of treatment. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to female patients who are older than 50 years and have not had a menstrual cycle in more than one year.', ' Patients must have measurable disease by RECIST criteria by staging studies performed within 30 days of enrollment. For patients with bone only disease: For this protocol isolated bone lesions can be classified as target lesions if they are measurable by MRI at screening and must be followed by MRI.', ' Both men and women of all races and ethnic groups are eligible for this trial.', 'Exclusion Criteria:', ' Patients must not have received tamoxifen for metastatic disease.', ' Patients must not have evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study entry.', ' Patients must be disease-free of prior invasive malignancies for > 5 years with the exception of: curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix.', ' Pregnant and breast-feeding women are excluded from the study because effects on the fetus are unknown and there may be a risk of increased fetal wastage.', ' Patients with uncontrolled central nervous system (CNS) metastasis or a history of seizures are excluded. Patients with stable CNS metastasis (either surgically resected, treated with gamma knife or stable for 3 months following whole brain radiation therapy [WBRT] are eligible). Patients with stable brain metastases will need an MRI within 4 weeks prior to start of therapy.', ' Patients may not be receiving any other investigational agents and must have stopped all other histone deacetylase inhibitors (including Valproic acid) or other hormonal therapies.', ' Patients must have discontinued their prior therapies for breast cancer and radiation therapy for a minimum of 3 weeks, patient is excluded if radiation therapy was given to a single measurable lesion and the disease is otherwise not measurable.', ' Patients are excluded if they have any known hypersensitivity reaction to tamoxifen.', ' Patient with a history of blood clots are not eligible.', ' Women who have abnormal vaginal bleeding and/or endometrial hyperplasia or cancer are not eligible.', ' Patients with evidence of visceral crisis are not eligible for this study.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Objective Response (OR)', ' The Objective Response Rate. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For the purposes of this study, patients were evaluated for response every 8 weeks. In addition to a baseline scan, confirmatory scans were also obtained 4 weeks following initial documentation of objective response.', ' Time frame: 24 weeks', 'Results 1: ', ' Arm/Group Title: Vorinostat and Tamoxifen', ' Arm/Group Description: Vorinostat and Tamoxifen as outlined in Intervention Descriptions', ' Overall Number of Participants Analyzed: 43', ' Measure Type: Number', ' Unit of Measure: participants 8'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/43 (9.30%)', ' Hemoglobin [1]1/43 (2.33%)', ' Hemorrhage/Bleeding [2]1/43 (2.33%)', ' Neutrophils/granulocytes (ANC/AGC) [3]1/43 (2.33%)', ' Platelets [4]1/43 (2.33%)', ' Anorexia [5]1/43 (2.33%)', ' Sodium, serum-low (hyponatremia) [1]1/43 (2.33%)', ' Thrombosis/thrombus/embolism [6]2/43 (4.65%)']}

c5e6497a-2e2f-4663-97fd-e73ba8904b0c

Single

Intervention

NCT01105650

Participants in cohort 1 of the primary trial weighing less than 45 kg receive 5 million units/m^2 less of IL-2, than participants over 45 kg, but all participants will be administered Methylprednisolone 3 times per week for 6 doses.

Contradiction

{'Clinical Trial ID': 'NCT01105650', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: CsA', ' Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).', ' Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.', 'Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14', ' Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.', ' Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).', 'INTERVENTION 2: ', ' Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2', ' Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).', ' Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.', 'Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14', ' Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.', ' Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).', 'Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9.'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of recurrent ovarian cancer, fallopian tube, or primary peritoneal cancer that has failed or progressed after at least 2 prior salvage chemotherapy regimens (directed at recurrent/metastatic disease).', ' OR', ' Diagnosis of metastatic breast cancer (female or male) that has progressed on or failed at least one salvage chemotherapy regimen for metastatic disease and that meets the following disease specific related criteria:', ' If estrogen receptor or progesterone receptor positive must have progressed on prior hormonal therapy and/or', ' if HER2-neu positive must have progressed on trastuzumab, lapatinib, or similar agent', ' Women with a history of both cancers are eligible for this study provided that they currently meet eligibility for one of the diseases. Women who have had another malignancy and have been disease free for at least 3 year, or with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.', ' Measurable disease per disease specific Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 - patients with bone as their only site of disease will not be eligible.', ' If history of brain metastases must be stable for at least 3 months after treatment - A brain computed tomography (CT) scan will only be required in subjects with known brain metastases at the time of enrollment or in subjects with clinical signs or symptoms suggestive of brain metastases.', ' Available related HLA-haploidentical natural killer (NK) cell donor (by at least class I serologic typing at the A&B locus)', ' Age 18 years or older', ' Karnofsky performance status > or = 50%', ' Adequate organ function as determined by the following criteria within 14 days of study enrollment', ' Bone marrow: platelets > or = 80,000 x 10^9/L and hemoglobin > or = 9 g/dL, unsupported by transfusions; absolute neutrophil count (ANC) > or = 1000 x 10^9/L, unsupported by growth colony stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)', ' Renal function: creatinine (Cr) < or = 2.0 mg/dL', ' Liver function: Aspartate aminotransferase (AST), Alanine transaminase (ALT), total bilirubin, alkaline phosphatase < 5 times upper limit of institutional normal (ULN)', ' Cardiac: Left ventricular ejection fraction >40% (within 28 days of treatment start)', 'Pulmonary function: >50% corrected Carbon Monoxide Diffusing Capacity (DLCO) and Forced Expiratory Volume in One Second (FEV1), if presence of pleural effusion due to metastatic disease >40% corrected DLCO and FEV1 is acceptable (within 28 days of treatment start)', ' Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to Day 0', ' At least 14 days must lapse between last prior anti-cancer treatment and 1st day of preparative regimen', ' Voluntary written informed consent', 'Exclusion Criteria:', ' Pregnant or nursing - The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. Participants of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy and agree to use adequate birth control during study treatment', ' Active infection - subjects must be afebrile, off antibiotics, and with no uninvestigated radiologic lesions (infiltrates or lesions with negative cultures or biopsies) are allowed'], 'Results': ['Outcome Measurement: ', ' Response Rate', ' Response includes Complete Response (CR), Partial Response (PR), and Stable Disease (SD) as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease.', ' Time frame: Month 3', 'Results 1: ', ' Arm/Group Title: Arm 1: CsA', ' Arm/Group Description: Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).', ' Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.', 'Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14', ' Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.', ' Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants 1', 'Results 2: ', ' Arm/Group Title: Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2', ' Arm/Group Description: Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).', ' Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.', 'Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14', ' Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.', ' Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).', 'Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/3 (100.00%)', ' Atrial flutter0/3 (0.00%)', ' Hearing impairmed0/3 (0.00%)', ' Vestibular disorder0/3 (0.00%)', ' Blurred vision0/3 (0.00%)', ' Abdominal pain1/3 (33.33%)', ' Death NOS3/3 (100.00%)', ' Fever0/3 (0.00%)', ' Acute kidney injury0/3 (0.00%)', ' Dyspnea1/3 (33.33%)', ' Respiratory failure0/3 (0.00%)', 'Adverse Events 2:', ' Total: 3/3 (100.00%)', ' Atrial flutter0/3 (0.00%)', ' Hearing impairmed1/3 (33.33%)', ' Vestibular disorder1/3 (33.33%)', ' Blurred vision1/3 (33.33%)', ' Abdominal pain0/3 (0.00%)', ' Death NOS2/3 (66.67%)', ' Fever0/3 (0.00%)', ' Acute kidney injury1/3 (33.33%)', ' Dyspnea0/3 (0.00%)', ' Respiratory failure0/3 (0.00%)']}

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

c4dd814d-f525-465f-abe1-a7975771d57e

Single

Adverse Events

NCT00924352

One patient in the primary trial had abnormally low red blood cells, white blood cells, and platelets.

Entailment

{'Clinical Trial ID': 'NCT00924352', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone + Dasatinib', ' Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.', ' Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.', ' Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.', ' Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.', ' Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.'], 'Eligibility': ['Inclusion Criteria:', ' A patient must meet each of the following criteria to be considered eligible for inclusion in this study:', ' Patient has the ability to understand and the willingness to sign a written informed consent including form according to institutional guidelines.', ' Patient has histologically-proven breast cancer.', ' Patient has locally recurrent or metastatic disease, measurable or non- measurable by RECIST criteria.', ' Patient has HER2-negative disease or disease that is refractory to HER2- directed therapy.', ' Patient is female or male 18 years of age.', ' Patient has(ECOG)performance status of 2.', ' Patient must have received at least 1 but no more than 2 prior chemotherapy regimens for locally recurrent or metastatic disease. Patients may have received neoadjuvant and/or adjuvant chemotherapy. These prior regimens can not have included ixabepilone or dasatinib. A line of chemotherapy will be defined as one or more agents used continuously or discontinuously (i.e., allowing a break or chemo holiday) without the addition of a new agent. Hormonal therapy will not be considered a line of therapy.', ' Prior chemotherapy must have been completed at least 3 weeks prior to study treatment start (6 weeks for nitrosoureas and mitomycin), and the patient must have recovered from all associated toxicities (except for alopecia and neuropathy grade 1 according to CTCAE, v3.0 classification).', ' Radiation therapy, immunotherapy, biologic therapy, and hormonal/endocrine therapy must have been completed at least 2 weeks prior to study treatment start. Any major surgery must have been completed at least 4 weeks prior to study treatment start.', ' Patient has adequate organ, metabolic and bone marrow function as follows:', ' Total bilirubin 1.0 × institutional ULN', ' AST, ALT 2.5 × institutional ULN', ' Serum sodium, potassium, calcium, magnesium, and phosphate institutional LLN. (Hypokalemia or hypomagnesemia must be corrected prior to dasatinib administration.)', ' Serum creatinine < 1.5 × institutional ULN', ' Hematologic function: - ANC 1500/mm3. -Platelet count 100,000/mm3. - Hemoglobin 10.0 g/dL', ' PT and PTT < 1.5 x institutional ULN', ' Ability to take oral medication (dasatinib must be swallowed whole).', ' Concomitant medications:', " Patient agrees to discontinue St John's Wort at least 5 days prior to starting dasatinib therapy and while receiving dasatinib therapy.", ' Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.', ' The use of CYP3A4 inducers, inhibitors, and substrates; medications that prolong QT interval; antacids; H2 blockers and proton pump inhibitors; and medications that inhibit platelet function and anticoagulation should be avoided during dasatinib therapy. These are restricted therapies that are permitted with caution when medically indicated.', ' Women of childbearing potential must have a negative serum or urine pregnancy test prior to the start of study treatment.', ' Patients of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study treatment is stopped.', 'Exclusion Criteria:', ' A patient who meets any of the following criteria will be considered not eligible for inclusion in this study:', ' Patient has had prior treatment with ixabepilone, dasatinib, or both.', ' Patient has had more than 2 prior lines of chemotherapy for locally recurrent or metastatic breast cancer. A line of chemotherapy will be defined as one or more agents used continuously or discontinuously (i.e., allowing a break or chemo holiday) without the addition of a new agent. Hormonal therapy will not be considered a line of therapy.', ' Patient has received a cumulative dose of > 360 mg/m2 of doxorubicin or > 600 mg/m2 of epirubicin.', ' Prior radiation must not have included 30% of major bone marrow containing areas (pelvis, lumbar spine).', ' Patients with CTC grade 2 or greater neuropathy (motor or sensory) at study entry.', ' Patient has evidence CNS or brain metastases, unless CNS or brain metastases have been treated and stable for > 3 months.', ' Patient has psychiatric illness or social situation that would limit or prohibit compliance with study requirements.', ' Patient has an inability to take oral medication or inability to absorb oral medication.', ' Patient has had any invasive cancer other than the one being treated in this study within 3 years with the exception of surgically cured nonmelanoma skin cancer; in situ carcinoma of the cervix; in situ carcinoma of the breast.', ' Patient is receiving concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, or hormonal therapy for cancer).', ' Patient has other serious medical conditions as judged by the Principal Investigator.', ' Patient has a concurrent medical condition which may increase the risk of toxicity.', ' Patient has a pleural or pericardial effusion of any grade.', ' Patient has cardiac symptoms including any of the following:', ' Uncontrolled angina, congestive heart failure or myocardial infarction within 6 months of study entry.', ' Diagnosed congenital long QT syndrome.', ' Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).', ' Prolonged QTc on pre-entry ECG (> 450 msec).', ' Hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration.', ' Patient has a history of significant bleeding disorder unrelated to cancer, including:', " Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease).", ' Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).', ' Ongoing or recent ( 3 months) significant GI bleeding.', ' Patient is taking any of the following concomitant medications at study entry:', ' 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.):', ' quinidine, procainamide, disopyramide.', ' amiodarone, sotalol, ibutilide, dofetilide.', ' erythromycin, clarithromycin.', ' chlorpromazine,haloperidol,mesoridazine, thioridazine,pimozide .', ' cisapride,bepridil, droperidol, methadone, arsenic, chloroquine, domperidone,halofantrine, levomethadyl, pentamidine,sparfloxacin, lidoflazine.', ' Patient has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ixabepilone or dasatinib. Ixabepilone is contraindicated in patients who have a known, prior, severe (CTC grade 3 or 4) history of hypersensitivity reaction to a drug formulated in Cremophor® EL (polyoxyethylated castor oil).', ' Patient has received any investigational agent or therapy within 30 days prior to study treatment start.', ' Patient is unwilling or unable to comply with study requirements.', ' Women 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 cessation of study treatment, or', ' have a positive pregnancy test at baseline, or', ' are pregnant or breastfeeding.', ' Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.'], 'Results': ['Outcome Measurement: ', ' Determination of the Maximum Tolerated Dose (MTD) of Dasatinib When Given in Combination With Ixabepilone (Phase I)', ' The MTD of dasatinib (taken daily, continuously) when given in combination with ixabepilone (administered on Days 1, 8, and 15 of a 28-day cycle) was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. The MTD was defined as the dose at which 1 of 6 patients experienced DLT, and above which 2 of 6 patients experienced DLT.', ' Time frame: MTD was assessed during the first cycle of combination therapy (days 1-28).', 'Results 1: ', ' Arm/Group Title: Ixabepilone + Dasatinib', ' Arm/Group Description: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.', ' Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.', ' Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.', ' Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.', ' Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.', ' Overall Number of Participants Analyzed: 12', ' Measure Type: Number', ' Unit of Measure: mg daily 100'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/56 (19.64%)', ' Febrile Neutropenia * 3/56 (5.36%)', ' Neutropenia * 1/56 (1.79%)', ' Pancytopenia * 1/56 (1.79%)', ' Atrial Fibrillation * 1/56 (1.79%)', ' Coronary Artery Disease * 1/56 (1.79%)', ' Constipation * 1/56 (1.79%)', ' Chest Pain * 1/56 (1.79%)', ' Non-Cardiac Chest Pain * 1/56 (1.79%)', ' Edema due to Cardiac Disease * 1/56 (1.79%)', ' Cellulitis * 1/56 (1.79%)']}

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

cfd93077-87c5-458b-8712-e1896929309d

Comparison

Adverse Events

NCT00503906

NCT01142661

The adverse events in the primary trial where all equally prevalent, whereas in the secondary trial, progression of disease was reported as the most common event.

Entailment

{'Clinical Trial ID': 'NCT00503906', 'Intervention': ['INTERVENTION 1: ', ' Abraxane, Avastin and Gemcitabine', ' Each treatment cycle is 28 days. Participants will be treated until disease progression:', ' Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;', ' Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;', ' Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.'], 'Eligibility': ['Inclusion Criteria', ' Patients must either be:', ' treatment-naïve with newly diagnosed her2neu non-overexpressing (non amplified) metastatic (Stage IV) breast cancer, or', ' HER2/neu-negative patients with metastasis diagnosed 6 or more months after completing primary systemic treatment (neoadjuvant, adjuvant chemotherapy).', ' No previous chemotherapy regimen for metastatic breast cancer.', ' 18 years of age or older.', ' Measurable disease as defined by RECIST criteria or evaluable disease.', ' Eastern Cooperative Oncology Group (ECOG) 0-1.', ' Life expectancy greater than 3 months.', ' For female (or male) patients, either pre- or post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study', ' Provide written informed consent before any study-related procedure not part of normal medical care is conducted', ' Willing and able to comply with the protocol requirement', ' Laboratory parameters as follows:', ' Neutrophils: 1.5 x109/L or greater', ' Platelets: 100 x109/L or greater', ' Hemoglobin: 9.0 g/dL', ' Serum Creatinine: 1.5mg/dL', ' Bilirubin: ULN, except when caused by metastatic disease', ' Alanine transaminase (ALT)/Aspartate transaminase (AST): 2.5 times the upper limit of the normal range (ULN) except when caused by metastatic disease', ' Urine protein creatinine (UPC) ratio < 1.0 at screening.', ' Exclusion Criteria', ' Previous treatment with gemcitabine.', ' History of Gastrointestinal Bleeding in the previous 3 months.', ' Chemotherapy within 4 weeks prior to enrollment.', ' Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.', ' Any major surgery within 4 weeks prior to enrollment.', ' Presence of central nervous system or brain metastases.', ' Urine protein: creatinine ratio 1.0 at screening.', ' Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).', ' A prior history of hypertensive crisis or hypertensive encephalopathy.', ' Peripheral neuropathy > grade I.', ' Clinical AIDS or known positive HIV serology', ' No concurrent clinically evident malignancy is allowed except inactive non-melanoma skin cancer and inactive cervical cancer diagnosed or other cancer for which the patient has been disease-free for five years.', ' Unstable angina.', ' New York Heart Association (NYHA) Grade II or greater congestive heart failure', ' History of myocardial infarction within 6 months.', ' History of stroke within 6 months.', ' Clinically significant peripheral vascular disease.', ' Evidence of bleeding diathesis or coagulopathy', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, anticipation of need for major surgical procedure during the course of the study.', ' Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to enrollment.', ' Pregnant (positive pregnancy test) or lactating.', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment', ' Serious, non-healing wound, ulcer, or bone fracture', ' Inability to comply with study and/or follow-up procedures', ' Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible.', ' Participants cannot have been in another experimental drug study other than a Bevacizumab cancer study within 4 weeks of the first infusion of these study medications.'], 'Results': ['Outcome Measurement: ', ' Median Progression-Free Survival', ' Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.', ' Time frame: Up to 24 months', 'Results 1: ', ' Arm/Group Title: Abraxane, Avastin and Gemcitabine', ' Arm/Group Description: Each treatment cycle is 28 days. Participants will be treated until disease progression:', ' Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;', ' Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;', ' Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.', ' Overall Number of Participants Analyzed: 29', ' Median (95% Confidence Interval)', ' Unit of Measure: months 10.4 (5.6 to 15.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/29 (27.59%)', ' Leukopenia [1]1/29 (3.45%)', ' Thrombocytopenia [1]1/29 (3.45%)', ' Abscess [1]1/29 (3.45%)', ' Breast Abscess 1/29 (3.45%)', ' Fever/Sepsis [1]1/29 (3.45%)', ' Neutropenic Fever [2]1/29 (3.45%)', ' Peripheral Neuropathy [1]1/29 (3.45%)', ' Seizure/Syncope [1]1/29 (3.45%)', ' Hematuria [1]1/29 (3.45%)', ' UTI [1]1/29 (3.45%)', ' Shortness of breath [1]1/29 (3.45%)']}

{'Clinical Trial ID': 'NCT01142661', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate', 'Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.'], 'Eligibility': ['Inclusion Criteria', ' In order to receive eribulin under this protocol, the subjects oncologist must have documented experience treating subjects with eribulin in a prior clinical study. Subjects who meet all of the following criteria will be included in the treatment protocol:', ' Recurrent, locally advanced or metastatic breast cancer that has progressed on or after the last anti-cancer therapy.', ' Prior treatment with, ineligibility for, or commercial unavailability of each of the following therapies:', ' Anthracyclines, taxanes, and capecitabine.', ' Ixabepilone in countries where this agent is marketed.', ' Trastuzumab for Her-2 positive disease.', ' Hormonal therapy in hormone receptor-positive disease.', ' All other marketed therapies, eg, gemcitabine or vinorelbine, used for the treatment of advanced breast cancer.', ' Eastern Cooperative Oncology Group (ECOG) performance status </= 2.', ' Serum creatinine </= 2.0 mg/dL or creatinine clearance >/= 40 mL/min according to Cockcroft and Gault formula.', ' Absolute neutrophil count >/= 1.5 x 10^9/L, hemoglobin >/= 10 g/dL (can be corrected by growth factor or transfusion), and platelet count >/= 100 x 10^9/L.', ' Total bilirubin </= 1.5 x upper limit of normal (ULN). Alkaline phosphatase (AP), alanine aminotransferase, and aspartate aminotransferase </= 3 x ULN (</= 5 x ULN in case of liver metastases). In case AP is >3 x ULN (in absence of liver metastases) or >5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP.', ' Are willing and able to comply with all aspects of the treatment protocol.', ' Provide written informed consent.', ' Females, age >/= 18 years.', ' Female subjects of childbearing potential must agree to be abstinent or to use a highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intra-uterine device, or have a vasectomised partner) having started for at least one menstrual cycle prior to starting eribulin and throughout the entire treatment period and for 30 days (longer if appropriate) after the last dose of eribulin. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.', ' Exclusion Criteria Subjects who meet any of the following criteria will be excluded from participation in the treatment protocol:', ' Eligible for any other eribulin study that is open in the same region.', ' Existing anti-cancer therapy-related toxicities of Grade >/= 2, except that alopecia and Grade 2 neuropathy are acceptable.', ' History of congestive heart failure with New York Heart Association Classification >II, unstable angina, myocardial infarction within the past 6 months, serious cardiac arrhythmia.', " Electrocardiogram with QTc interval >/= 500 msec based upon Bazett's formula (QTcB).", ' The Investigator believes the subject to be medically unfit to receive eribulin or unsuitable for any other reason.', ' Females who are pregnant (positive B-hCG test) or breastfeeding.', ' Subject with hypersensitivity to eribulin or any of the excipients.', ' Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this treatment protocol. Any signs (eg, radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting the treatment protocol.', " Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject's ability to safely complete the treatment protocol.", ' Subjects who are known to be human immunodeficiency virus positive because the neutropenia caused by the eribulin treatment may make such subjects particularly susceptible to infection.', ' Subjects with meningeal carcinomatosis.', ' Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.', ' Subjects who have received any of the following treatments within the specified period before the start of treatment:', ' Any investigational drug, chemotherapy, radiation, or biological or targeted therapy within 2 weeks.', ' Hormonal therapy within 1 week.'], 'Results': ['Outcome Measurement: ', ' Safety', ' General safety will be assessed by monitoring and recording the number of patients with adverse events (serious and nonserious) for duration of treatment which continued until disease progression, unacceptable toxicity or death.', ' Time frame: For duration of treatment, an average of 5 months', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate', ' Arm/Group Description: Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/9 (77.78%)', ' Febrile Neutropenia1/9 (11.11%)', ' Neutropenia1/9 (11.11%)', ' Tachycardia1/9 (11.11%)', ' Hematemesis1/9 (11.11%)', ' Small Bowel Obstruction1/9 (11.11%)', ' Pneumonia1/9 (11.11%)', ' Hypokalemia1/9 (11.11%)', ' Alcohol Poisoning1/9 (11.11%)', ' Progressive Disease4/9 (44.44%)']}

a3faaf85-62c6-430f-acf2-9c5992ee5221

Comparison

Adverse Events

NCT01931163

NCT00274469

Less than 5% of cohort 1 of the primary trial had High blood sugar, 0% of the secondary trial patients were recorded as having High blood sugar.

Entailment

{'Clinical Trial ID': 'NCT01931163', 'Intervention': ['INTERVENTION 1: ', ' Everolimus Plus Cisplatin', ' Everolimus 10mg by mouth daily for 12 weeks; Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles'], 'Eligibility': ['Inclusion Criteria:', ' Female patients 18 years of age.', ' Clinical/pathological documentation of residual disease after neo-adjuvant therapy.', ' Patients with synchronous bilateral cancers are eligible only if:', ' Index cancer is triple-negative, defined as ER-, PR-, and HER2-.', ' HER2 negative tumors. HER2 negativity must be confirmed by one of the following:', ' FISH-negative (FISH ratio <2.2), or', ' IHC 0-1+, or', ' IHC 2-3+ AND FISH-negative (FISH ratio <2.2).', ' Estrogen receptor negative and progesterone receptor negative (<10% staining by IHC for estrogen receptor and progesterone receptor).', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.', ' Adequate hematologic function, defined by:', ' Absolute neutrophil count 2 >1000/mm3', ' Platelet count 100,000/mm3', ' Hemoglobin >9 g/dL', ' Adequate liver function, defined by:', ' AST and ALT 2.5 x the upper limit of normal (ULN)', " Total bilirubin 1.5 x ULN (unless the patient has grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin).", ' Adequate renal function, defined by:', ' Serum creatinine 1.5 x ULN', ' Complete staging work-up 24 weeks prior to initiation of study treatment with computed tomography (CT) scans of the chest and abdomen/pelvis (abdomen/pelvis preferred; abdomen accepted), a CT scan of the head or MRI of the brain (if symptomatic), and either a positron emission tomography (PET) scan or a bone scan.', ' Adequate cardiac function, defined by a left ventricular ejection fraction (LVEF) value of >50% (or normal per institutional guidelines) by MUGA scan or echocardiogram (ECHO).', ' Patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.', ' Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.', ' Patient must be accessible for treatment and follow-up.', ' Women of childbearing potential must agree to use an acceptable method of birth control to avoid pregnancy for the duration of study treatment, and for 3 months thereafter.', ' Able to swallow and retain oral medication.', ' Patient must be willing to undergo breast biopsies as required by the study protocol.', ' All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.', 'Exclusion Criteria:', ' Women who are pregnant or breastfeeding.', ' History of previously treated ductal carcinoma in situ (DCIS) is acceptable.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.', ' Known intolerance or hypersensitivity to Everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus);', ' Previous cancer (with the exception of non-melanoma skin cancer or cervical carcinoma in situ) in the past 5 years.', ' Patients who have any severe and/or uncontrolled medical conditions such as:', ' unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction 6 months prior to start of Everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease', ' Symptomatic congestive heart failure of New York heart Association Class III or IV', ' active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA),', ' known severely impaired lung function (spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air),', ' active, bleeding diathesis;', ' Patients may not receive any other investigational or anti-cancer treatments while participating in this study.', ' Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.', ' Inability to comply with study and/or follow-up procedures.', ' Patients who have received live attenuated vaccines within 1 week of start of Everolimus and during the study. Patient should also avoid close contact with others who have received live attenuated vaccines.', ' Examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines;', ' Known history of HIV seropositivity;', ' Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment. Highly effective contraception methods include combination of any two of the following (a+b or a+c or b+c):', ' Use of oral, injected or implanted hormonal methods of contraception or;', ' 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;', ' Total abstinence or;', ' Male/female sterilization. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential.', ' Chronic treatment with corticosteroids or other immunosuppressive agents. Topical or inhaled corticosteroids are allowed;'], 'Results': ['Outcome Measurement: ', ' Tumor Response', ' Evaluate tumor response using RECIST criteria after 12 weeks of treatment at definitive surgery.', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by 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.", or similar definition that is accurate and appropriate.', ' Time frame: tumor response at 12 weeks after treatment', 'Results 1: ', ' Arm/Group Title: Everolimus Plus Cisplatin', ' Arm/Group Description: Everolimus 10mg by mouth daily for 12 weeks; Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles', ' Overall Number of Participants Analyzed: 22', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 22 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/22 (27.27%)', ' Thrombocytopenia 1/22 (4.55%)', ' leucocytopenia 1/22 (4.55%)', ' neutropenia 1/22 (4.55%)', ' papilledema 1/22 (4.55%)', ' Nausea 1/22 (4.55%)', ' hyperglycemia 1/22 (4.55%)']}

{'Clinical Trial ID': 'NCT00274469', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant 500 mg', 'Fulvestrant 500 mg', 'INTERVENTION 2: ', ' Anastrozole 1 mg', 'Anastrozole 1 mg'], 'Eligibility': ['Inclusion Criteria:', ' Confirmed hormone receptor positive advanced breast cancer, postmenopausal women', 'Exclusion Criteria:', ' Previous treatment for advanced breast cancer (previous treatment for early breast cancer is allowed).'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate', ' A Clinical Benefit (CB) responder is defined as a patient having a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks evaluated according to modified RECIST. The Clinical Benefit Rate is the percentage of patients with CB.', ' Time frame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.', 'Results 1: ', ' Arm/Group Title: Fulvestrant 500 mg', ' Arm/Group Description: Fulvestrant 500 mg', ' Overall Number of Participants Analyzed: 102', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 72.5', 'Results 2: ', ' Arm/Group Title: Anastrozole 1 mg', ' Arm/Group Description: Anastrozole 1 mg', ' Overall Number of Participants Analyzed: 103', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 67.0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 24/101 (23.76%)', ' LYMPHADENOPATHY 0/101 (0.00%)', ' FEBRILE NEUTROPENIA 20/101 (0.00%)', ' ATRIAL FIBRILLATION 1/101 (0.99%)', ' ARRHYTHMIA 20/101 (0.00%)', ' CARDIAC FAILURE 22/101 (1.98%)', ' CARDIAC FAILURE CONGESTIVE 20/101 (0.00%)', ' CORONARY OSTIAL STENOSIS 20/101 (0.00%)', ' LACRIMAL DISORDER 0/101 (0.00%)', ' BLINDNESS 21/101 (0.99%)', ' GASTRIC ULCER 1/101 (0.99%)', ' NAUSEA 1/101 (0.99%)', 'Adverse Events 2:', ' Total: 22/103 (21.36%)', ' LYMPHADENOPATHY 1/103 (0.97%)', ' FEBRILE NEUTROPENIA 21/103 (0.97%)', ' ATRIAL FIBRILLATION 1/103 (0.97%)', ' ARRHYTHMIA 21/103 (0.97%)', ' CARDIAC FAILURE 20/103 (0.00%)', ' CARDIAC FAILURE CONGESTIVE 21/103 (0.97%)', ' CORONARY OSTIAL STENOSIS 21/103 (0.97%)', ' LACRIMAL DISORDER 1/103 (0.97%)', ' BLINDNESS 20/103 (0.00%)', ' GASTRIC ULCER 0/103 (0.00%)', ' NAUSEA 0/103 (0.00%)']}

65e3afbb-70f6-4e1a-89e6-d819f8b95ab6

Comparison

Intervention

NCT00574145

NCT03167359

Radiotherapy and healing touch therapy is used in all cohorts of the primary trial and the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT00574145', 'Intervention': ['INTERVENTION 1: ', ' Radiotherapy/Supportive Care (A)', ' Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy', 'INTERVENTION 2: ', ' Control ARM (B)', ' Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy'], 'Eligibility': ['Inclusion Criteria:', ' Histologically proven breast cancer', ' Receiving post lumpectomy or post mastectomy radiation therapy (RT)', ' Eastern Cooperative Oncology Group performance status of 0, 1 or 2', ' Prescribed a minimum of 5 weeks of RT', ' Between the ages of 21 and 75', ' Able to speak English.', ' Provides written informed consent', 'Exclusion Criteria:', ' Documented active psychiatric illness', ' Documented cognitive impairment that would preclude the ability to provide informed consent.', ' Stage IV breast cancer', ' Receiving concurrent chemotherapy and RT'], 'Results': ['Outcome Measurement: ', ' Fatigue Using the Brief Fatigue Inventory (BFI)', " 9-items with an 11-point rating scale measures intensity of fatigue (3 items, 0 = no fatigue to 10 = fatigue as bad as you can imagine) and interference of fatigue on daily life (6 items, 0 = does not interfere to 10 = completely interferes. Each participant's score is summed with a possible minimum score of 0 and a possible maximum score of 90. A mean score was then determined.", ' Time frame: 6 weeks', 'Results 1: ', ' Arm/Group Title: Radiotherapy/Supportive Care (A)', ' Arm/Group Description: Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy', ' Overall Number of Participants Analyzed: 20', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 2.786 (0.1963)', 'Results 2: ', ' Arm/Group Title: Control ARM (B)', ' Arm/Group Description: Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy', ' Overall Number of Participants Analyzed: 21', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 1.356 (0.1413)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/22 (0.00%)', 'Adverse Events 2:', ' Total: 0/22 (0.00%)']}

{'Clinical Trial ID': 'NCT03167359', 'Intervention': ['INTERVENTION 1: ', ' Participants With Stage 0-III Breast Cancer', ' Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.', ' Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.'], 'Eligibility': ['Inclusion Criteria:', ' Participants must have one or more of the following characteristics and be eligible for breast or chest wall with or without regional nodal radiotherapy:', ' Prior Chemotherapy for Breast Cancer', ' Greater than 25 cm of breast separation (the largest distance on an axial slice of the planning CT simulation scan between the entry and exit points of the radiation beam on the body)', ' Non-Caucasian Race', ' Less than or equal to 50 years of age', ' Requiring regional nodal irradiation without evidence of N3 disease', 'Exclusion Criteria:', ' Males will be excluded', ' Women who are pregnant or nursing a child may not take part in this study'], 'Results': ['Outcome Measurement: ', ' Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4)', ' Cutaneous toxicity rate will be assessed by the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) v.3 grading scale. THe NCI CTCAE grades go from 0 to 4. Grade 0: none. Grade 1: Mild or localized; topical intervention indicated. Grade 2: Intense or widespread; intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); limiting instrumental ADLs. Grade 3-4: Severe or life-threatening. The higher the grade, the worse the outcome.', ' Time frame: Duration of Study (Up to 18 months)', 'Results 1: ', ' Arm/Group Title: Participants With Stage 0-III Breast Cancer', ' Arm/Group Description: Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.', ' Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.', ' Overall Number of Participants Analyzed: 71', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade 0: 60 84.5%', ' Grade 1: 11 15.5%', ' Grade 2: 0 0.0%', ' Grade 3: 0 0.0%', 'Grade 4: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/74 (4.05%)', ' Recurrance *3/74 (4.05%)']}

335936e4-9eaa-43b3-84fe-6f112c0d0226

Single

Results

NCT02622074

There was 38% more patients with DLT in cohort 2 of the primary trial than in cohort 1.

Contradiction

{'Clinical Trial ID': 'NCT02622074', 'Intervention': ['INTERVENTION 1: ', ' Cohort A: KNp / KAC', ' Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.', 'INTERVENTION 2: ', ' Cohort B: KNpCb (Regimen 1) / KAC', ' Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.'], 'Eligibility': ['Inclusion Criteria:', ' Has previously untreated, locally advanced TNBC.', ' Is able to provide 2 core needle biopsies from the primary tumor at screening to the central laboratory and agrees to have a core needle biopsy after single dose pembrolizumab treatment if tumor biopsy is feasible as judged by the investigator.', ' Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.', ' Has adequate organ function.', ' Females of childbearing potential must be willing to use adequate contraception for the course of the study through 12 months after the last dose of study drug for participants receiving cyclophosphamide and through 6 months after the last dose of study drug for participants who do not receive cyclophosphamide.', 'Exclusion Criteria:', ' Has evidence of metastatic breast cancer, concurrent bilateral invasive breast cancer, or inflammatory breast cancer.', ' Has another malignancy within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative surgery, or in situ cervical cancer.', ' Has received prior chemotherapy, targeted therapy, radiation therapy, immunotherapy that targets immune checkpoints, co-stimulatory or co-inhibitory pathways for T cell receptors within the past 12 months.', ' Is currently participating and receiving study therapy, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study drug.', ' Has received a live vaccine within 30 days of the first dose of study drug.', ' Has an active autoimmune disease that has required systemic treatment in past 2 years.', ' Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.', ' Has a known history of Human Immunodeficiency Virus (HIV).', ' Has known active Hepatitis B or Hepatitis C.', ' Has evidence of current pneumonitis.', ' Has a history of non-infectious pneumonitis requiring treatment with steroids or a history of interstitial lung disease.', ' Has an active infection requiring systemic therapy.', ' Has significant cardiovascular disease, such as: History of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months; Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA class III or IV', ' Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.', ' Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 12 months after the last dose of trial treatment for participants who have received cyclophosphamide, and for six months after the last dose of study medication for participants who have not.', ' Has a known hypersensitivity to the components of the study drug or its analogs.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)', ' The following events, if considered to be study-treatment-related by the Investigator, were considered a DLT:', ' Hematologic:', ' Grade 4 neutropenia lasting 8 days;', ' Febrile neutropenia Grade 3 or Grade 4; or', ' Grade 4 thrombocytopenia requiring platelet transfusion, or Grade 3 thrombocytopenia with bleeding', ' Non-hematologic:', ' Grade 4 toxicity;', ' Grade 3 symptomatic hepatic toxicities lasting >48 hours, or Grade 3 asymptomatic hepatic toxicities lasting 7 days; or', ' Grade 3 non-hematologic, non-hepatic organ toxicity, with exceptions', ' Other:', ' Any treatment delays for 14 days due to unresolved toxicity;', ' Grade 5 treatment-related adverse event (AE);', ' A dose reduction of study treatment during the DLT evaluation period.', ' Time frame: Cycle 1 Day 1 through end of Cycle 3 and Cycle 6 Day 1 through end of Cycle 7 (Up to ~150 days from first dose of first combination regimen); Each cycle was 21 days.', 'Results 1: ', ' Arm/Group Title: Cohort A: KNp / KAC', ' Arm/Group Description: Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 20.0%', 'Results 2: ', ' Arm/Group Title: Cohort B: KNpCb (Regimen 1) / KAC', ' Arm/Group Description: Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 4 40.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/10 (50.00%)', ' Anaemia 0/10 (0.00%)', ' Febrile neutropenia 1/10 (10.00%)', ' Lymphadenitis 0/10 (0.00%)', ' Neutropenia 0/10 (0.00%)', ' Abdominal pain upper 0/10 (0.00%)', ' Colitis 0/10 (0.00%)', ' Diarrhoea 0/10 (0.00%)', ' Nausea 1/10 (10.00%)', ' Oesophagitis 0/10 (0.00%)', ' Pyrexia 0/10 (0.00%)', ' Autoimmune hepatitis 0/10 (0.00%)', ' Influenza 0/10 (0.00%)', 'Adverse Events 2:', ' Total: 4/10 (40.00%)', ' Anaemia 0/10 (0.00%)', ' Febrile neutropenia 2/10 (20.00%)', ' Lymphadenitis 0/10 (0.00%)', ' Neutropenia 1/10 (10.00%)', ' Abdominal pain upper 0/10 (0.00%)', ' Colitis 0/10 (0.00%)', ' Diarrhoea 0/10 (0.00%)', ' Nausea 0/10 (0.00%)', ' Oesophagitis 0/10 (0.00%)', ' Pyrexia 1/10 (10.00%)', ' Autoimmune hepatitis 0/10 (0.00%)', ' Influenza 0/10 (0.00%)']}

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

19921113-538e-4fd2-81a6-6053f2dd6459

Single

Adverse Events

NCT00448279

In total there were 5x more adverse events in cohort 1 of the primary trial, than in cohort 2.

Contradiction

{'Clinical Trial ID': 'NCT00448279', 'Intervention': ['INTERVENTION 1: ', ' Chemotherapy Alone', " Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.", 'INTERVENTION 2: ', ' Chemotherapy + Trastuzumab', " Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death."], 'Eligibility': ['Inclusion Criteria:', ' female patients, >=18 years of age;', ' metastatic breast cancer;', ' HER2 overexpression (IHC 3+ and/or FISH positive);', ' disease progression during or after previous 1st line chemotherapy plus Herceptin;', ' scheduled to receive 2nd line chemotherapy.', 'Exclusion Criteria:', ' incompatibility with previous Herceptin therapy;', 'pregnancy.'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS) - Percentage of Participants With an Event', ' PFS was defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Participants were censored at the last tumour evaluation.', ' Time frame: Baseline (BL) and every 8 weeks thereafter', 'Results 1: ', ' Arm/Group Title: Chemotherapy Alone', " Arm/Group Description: Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.", ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: percentage of participants 58.6', 'Results 2: ', ' Arm/Group Title: Chemotherapy + Trastuzumab', " Arm/Group Description: Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator's discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.", ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: percentage of participants 58.6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/26 (15.38%)', ' Febrile neutropenia * 1/26 (3.85%)', ' Gastric volvulus * 20/26 (0.00%)', ' General Malaise * 21/26 (3.85%)', ' Hospitalisation for intrapleuric chemotherapy and thoracentesis * 21/26 (3.85%)', ' Acute renal failure * 21/26 (3.85%)', 'Adverse Events 2:', ' Total: 1/28 (3.57%)', ' Febrile neutropenia * 0/28 (0.00%)', ' Gastric volvulus * 21/28 (3.57%)', ' General Malaise * 20/28 (0.00%)', ' Hospitalisation for intrapleuric chemotherapy and thoracentesis * 20/28 (0.00%)', ' Acute renal failure * 20/28 (0.00%)']}

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

6a013bb4-0688-4f02-96c5-062f3ca67ae1

Comparison

Results

NCT01106040

NCT01441596

the primary trial and the secondary trial are not studying PFS, PBR or DLTs.

Contradiction

{'Clinical Trial ID': 'NCT01106040', 'Intervention': ['INTERVENTION 1: ', ' Intent-To-Treat', ' Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.'], 'Eligibility': ['Inclusion Criteria:', ' The patient has provided written informed consent with HIPAA authorization.', ' The patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan.', ' The patient is at least 18 years of age at the time of consent.', ' The patient has an ECOG performance status of Grade 0 - 2 (see Appendix A).', ' The patient has a clinical negative node status at the time of study entry (i.e. T0-4, N0, M0, see Appendix D and E).', ' If of childbearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.', ' Melanoma Patients', ' The patient has a diagnosis of primary melanoma. Breast Cancer Patients', ' The patient has a diagnosis of primary breast cancer.', ' Patients with pure ductal carcinoma in situ (DCIS) or non-invasive carcinoma if lymph node biopsy is part of the surgical plan.', 'Exclusion Criteria:', ' The patient is pregnant or lactating.', ' The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes (i.e., all patients should be any T,N0,M0, see Appendix D and E).', ' The patient has a known hypersensitivity to Lymphazurin.', ' The patient has participated in another investigational drug study within 30 days of scheduled surgery.', ' Melanoma Patients', ' The patient has a tumor with a Breslow depth less than 0.75mm.', ' Patient has had preoperative chemotherapy, immunotherapy, or radiation therapy.', ' Patient has been diagnosed with a prior invasive melanoma that would occur on the same body region or potentially draining to the same nodal basin or patients with truncal or extremity primary melanoma who has had a prior breast cancer potentially draining to the same axillary nodal basin.', ' Patient has undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary melanoma.', ' Patient has undergone a wide excision for their primary melanoma (>1 cm in dimension) or complex reconstruction (rotation, free flap, or skin graft of any type).', ' Breast Cancer Patients', ' The patient has bilateral primary breast cancers or multiple tumors within their breast.', ' Patient has had prior surgical procedures such as breast implants, reduction mammoplasty, or axillary surgery.', ' Patient is scheduled for bilateral mastectomy unless for cosmetic reasons and the contraindicated breast will not undergo lymph node mapping.', ' Patient has had preoperative radiation therapy to the affected breast or axilla.'], 'Results': ['Outcome Measurement: ', ' Concordance of Blue Dye and Lymphoseek', ' The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.', ' Time frame: Surgery after injections of Lymphoseek and blue dye', 'Results 1: ', ' Arm/Group Title: Intent-To-Treat', ' Arm/Group Description: Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.', ' Overall Number of Participants Analyzed: 133', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Lymph Nodes Measure Type: NumberNumber (95% Confidence Interval)Unit of Measure: Proportion of Lymph Nodes: 1.0000 (0.9840 to 1.0000)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/153 (5.23%)', ' Bradycardia [1]1/153 (0.65%)', ' Tachycardia [1]1/153 (0.65%)', ' Cellulitis [1]2/153 (1.31%)', ' Herpes Zoster Ophthalmic [1]1/153 (0.65%)', ' Seroma [1]1/153 (0.65%)', ' Syncope [1]1/153 (0.65%)', ' Asthma [1]1/153 (0.65%)']}

{'Clinical Trial ID': 'NCT01441596', 'Intervention': ['INTERVENTION 1: ', ' Afatinib Mono', ' Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.', 'INTERVENTION 2: ', ' Afatinib+Vino', ' Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.'], 'Eligibility': ['Inclusion criteria:', ' patients with HER2 positive breast cancer with a documented central nervous system (CNS) recurrence/progression (by imaging) during or after a HER2 inhibitor (Trastuzumab and/or Lapatinib) based therapy (no leptomeningeal carcinomatosis as the only site of CNS metastases)', ' at least one measurable and progressive lesion in the brain (=10 mm on T1-weighted, gadolinium-enhanced Magnetic Resonance Imaging). Measurable or non measurable extracranial metastases allowed.', ' previous treatment with HER2 inhibitors to be discontinued prior to first study treatment administration (at least 14 days for trastuzumab and other antibodies, at least 7 days for lapatinib).', ' previous chemotherapy and hormonal therapy (adjuvant and metastatic regimens) allowed, but chemotherapy must have been discontinued at least 14 days and hormonal therapy at least 7 days prior to first study treatment administration.', ' Patients must have recovered to baseline condition or to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade = 1 from any acute CTCAE v. 3.0 grade =2 side effects of previous treatments.', ' prior surgery, whole brain radiotherapy or stereotactic radiosurgery allowed provided that there is unequivocal evidence of one or more new and/or progressive brain metastases after completion of whole brain radiotherapy or stereotactic radiosurgery.', 'Exclusion criteria:', ' Prior treatment with HER2- tyrosine kinase inhibitor other than lapatinib', ' Any other current malignancy or malignancy diagnosed within the past five (5) years (other than bilateral primary breast cancer, metastases to the contralateral breast, non-melanomatous skin cancer and in situ cervical cancer).', " Significant chronic or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g. Crohn's disease, malabsorption or Common Terminology Criteria (CTC) grade =2 diarrhoea of any aetiology."], 'Results': ['Outcome Measurement: ', ' Patient Benefit Rate at 12 Weeks', ' Percentage of patients with patient benefit at week 12. Patient benefit was defined by the absence of central nervous system (CNS) disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in addition to no tumour-related worsening of the neurological signs and symptoms (NSS), no tumour-related increase in corticosteroid dosage and no progression of extra CNS disease according to RECIST 1.1', ' Time frame: 12 weeks from randomisation', 'Results 1: ', ' Arm/Group Title: Afatinib Mono', ' Arm/Group Description: Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.', ' Overall Number of Participants Analyzed: 40', ' Measure Type: Number', ' Unit of Measure: percentage of participants 30.0 (16.6 to 46.5)', 'Results 2: ', ' Arm/Group Title: Afatinib+Vino', ' Arm/Group Description: Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m administered intravenously on days 1, 8, 15 in a 3-weekly course.', ' Overall Number of Participants Analyzed: 38', ' Measure Type: Number', ' Unit of Measure: percentage of participants 34.2 (19.6 to 51.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/40 (45.00%)', ' Anaemia 0/40 (0.00%)', ' Febrile neutropenia 0/40 (0.00%)', ' Progressive cerebellar degeneration 0/40 (0.00%)', ' Vertigo 0/40 (0.00%)', ' Diarrhoea 3/40 (7.50%)', ' Dysphagia 0/40 (0.00%)', ' Enteritis 0/40 (0.00%)', ' Ileus 0/40 (0.00%)', ' Intestinal obstruction 0/40 (0.00%)', ' Nausea 1/40 (2.50%)', ' Stomatitis 1/40 (2.50%)', ' Subileus 0/40 (0.00%)', ' Vomiting 3/40 (7.50%)', 'Adverse Events 2:', ' Total: 24/37 (64.86%)', ' Anaemia 1/37 (2.70%)', ' Febrile neutropenia 3/37 (8.11%)', ' Progressive cerebellar degeneration 0/37 (0.00%)', ' Vertigo 0/37 (0.00%)', ' Diarrhoea 5/37 (13.51%)', ' Dysphagia 1/37 (2.70%)', ' Enteritis 1/37 (2.70%)', ' Ileus 1/37 (2.70%)', ' Intestinal obstruction 1/37 (2.70%)', ' Nausea 0/37 (0.00%)', ' Stomatitis 1/37 (2.70%)', ' Subileus 1/37 (2.70%)', ' Vomiting 2/37 (5.41%)']}

c103a786-0b1d-4124-aa5d-4945ded2c384

Comparison

Eligibility

NCT00274768

NCT00654836

Patients with at most stage 3 cancer are eligible for the secondary trial and the primary trial.

Contradiction

{'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%)']}

{'Clinical Trial ID': 'NCT00654836', 'Intervention': ['INTERVENTION 1: ', ' Carboplatin, ABI-007 and Bevacizumab', " Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15."], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed primary adenocarcinoma of the breast', ' Locally recurrent or metastatic disease', ' Must have HER-2-negative breast cancer or, if HER-2-positive, must be unable to receive trastuzumab (Herceptin®) or have previously received trastuzumab in the past', ' 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 by conventional techniques or as > 10 mm by spiral CT scan.', ' No known CNS disease', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', 'Inclusion criteria:', ' Postmenopausal status not specified', ' ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%', ' Life expectancy > 12 weeks', ' WBC 3,000/mcL', ' Absolute neutrophil count 1,500/mcL', ' Platelet count 100,000/mcL', ' Total bilirubin normal', ' AST and ALT 2.5 times upper limit of normal (ULN)', ' Alkaline phosphatase 2.5 times ULN (unless bone metastasis is present in the absence of liver metastasis)', ' Creatinine 1.5 mg/dL', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No other concurrent malignancies within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix', 'Exclusion criteria:', ' Pre-existing neuropathy grade 1', ' Uncontrolled intercurrent illness including, but not limited to, any of the following:', ' Ongoing or active infection', ' Symptomatic congestive heart failure', ' Unstable angina pectoris', ' Cardiac arrhythmia', ' Serious, non-healing wound, ulcer, or bone fracture', ' Psychiatric illness/social situations that would limit compliance with study requirements', ' Inadequately controlled hypertension (defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications)', ' History of hypertensive crisis or hypertensive encephalopathy', ' New York Heart Association class II-IV congestive heart failure', ' History of myocardial infarction or unstable angina within the past 6 months', ' History of stroke or transient ischemic attack within the past 6 months', ' Significant vascular disease (e.g., aortic aneurysm, aortic dissection)', ' Symptomatic peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Significant traumatic injury within the past 28 days', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months', ' Proteinuria, as demonstrated by either urine protein:creatinine ratio 1.0 OR urine dipstick for proteinuria 2+', ' Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline must demonstrate 24-hour urine protein 1g', ' History of allergy or hypersensitivity to paclitaxel albumin-stabilized nanoparticle formulation, paclitaxel, bevacizumab, carboplatin, albumin, drug product excipients, or chemically similar agents', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' Recovered from all prior therapy', ' No prior chemotherapy for locally recurrent or metastatic disease', ' Prior neoadjuvant or adjuvant chemotherapy allowed', ' More than 1 week since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device', ' More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy', ' More than 4 weeks since prior radiotherapy', ' More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)', ' At least 1 year since prior taxane regimen', ' No other concurrent investigational agents', ' Concurrent anticoagulation allowed, provided the following criteria are met:', ' Stable dose of warfarin or low molecular weight heparin', ' INR within desired range (2-3)', ' No evidence of active bleeding or coagulopathy', ' No concurrent combination antiretroviral therapy for HIV-positive patients', ' No other concurrent radiotherapy, chemotherapy, immunotherapy, or antitumor hormonal therapy'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' Progression-free survival was measured from treatment initiation to 30 months. 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: 30 Months', 'Results 1: ', ' Arm/Group Title: Carboplatin, ABI-007 and Bevacizumab', " Arm/Group Description: Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.", ' Overall Number of Participants Analyzed: 32', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 16 (9.80 to 22.20)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 24/32 (75.00%)', ' Disease Progression * [1]24/32 (75.00%)']}

2746a75c-7f01-4dc3-a05e-5c7499e75555

Single

Eligibility

NCT00416572

Patients with a prior malignancy of skin cancer are excluded from the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00416572', 'Intervention': ['INTERVENTION 1: ', ' Education Intervention', " Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.", 'INTERVENTION 2: ', ' Nutrition Education Intervention', ' Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.'], 'Eligibility': ['INCLUSION CRITERIA (Disease Characteristics):', ' Diagnosis of breast cancer', ' Stage I or II disease', ' No more than 10 positive lymph nodes', ' First-time diagnosis', ' Under the age of 50 at diagnosis', ' Finished active treatment within the past 2 months', ' English-speaking only', " Must live within 30 miles of Magee Women's Hospital, Pittsburgh, Pennsylvania", ' INCLUSION CRITERIA (Patient Characteristics):', ' Female patients only', ' Must be able to communicate', ' EXCLUSION CRITERIA (Patient Characteristics):', ' Other prior malignancies except skin cancer', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics'], 'Results': ['Outcome Measurement: ', ' Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention).', ' Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 24 (high levels of depressives symptoms) in the present sample.', ' Time frame: Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention).', 'Results 1: ', ' Arm/Group Title: Education Intervention', " Arm/Group Description: Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness/treatment, to enhance coping in productive ways.", ' Overall Number of Participants Analyzed: 70', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 5.83 (5.32)', ' Post-intervention: 5.65 (5.53)', ' Final follow-up: 5.07 (4.99)', 'Results 2: ', ' Arm/Group Title: Nutrition Education Intervention', ' Arm/Group Description: Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.', ' Overall Number of Participants Analyzed: 78', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 6.74 (5.94)', ' Post-intervention: 5.70 (5.45)', ' Final follow-up: 4.36 (4.49)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/83 (0.00%)', 'Adverse Events 2:', ' Total: 0/85 (0.00%)']}

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

df64a4c5-08f3-40c7-a4e7-2a6271bc9e53

Single

Adverse Events

NCT00193037

None of the patients in Cohort 1 of the primary trial suffered from Hypotension.

Entailment

{'Clinical Trial ID': 'NCT00193037', 'Intervention': ['INTERVENTION 1: ', ' Arm A -Liposomal Doxorubicin Then Docetaxel', ' Liposomal doxorubicin (Arm A)', ' Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.', ' Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria.', 'INTERVENTION 2: ', ' Arm B - Docetaxel Then Liposomal Doxorubicin', ' Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.', ' Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria.'], 'Eligibility': ['Inclusion Criteria:', ' To be included in this study, you must meet the following criteria:', ' Metastatic breast cancer confirmed by biopsy', ' Prior adjuvant/neoadjuvant treatment allowed', ' Measurable disease', ' Able to perform activities of daily living with minimal assistance', ' Age 18 years or older', ' Adequate bone marrow, liver and kidney function', ' Normal heart function', ' Written informed consent', 'Exclusion Criteria:', ' You cannot participate in this study if any of the following apply to you:', ' Pre-existing moderate peripheral neuropathy', ' History of significant heart disease', ' Meningeal metastases.', ' Prior chemotherapy for metastatic breast cancer', ' No measurable disease (including bone only, pleural effusions, etc.)', ' Receiving Herceptin therapy.', ' Women who are pregnant or lactating.', ' 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: ', ' Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment', ' ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.', ' Time frame: 18 Months', 'Results 1: ', ' Arm/Group Title: Arm A -Liposomal Doxorubicin Then Docetaxel', ' Arm/Group Description: Liposomal doxorubicin (Arm A)', ' Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.', ' Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria.', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Number', ' Unit of Measure: percentage of patients 28 (16 to 42)', 'Results 2: ', ' Arm/Group Title: Arm B - Docetaxel Then Liposomal Doxorubicin', ' Arm/Group Description: Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.', ' Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria.', ' Overall Number of Participants Analyzed: 44', ' Measure Type: Number', ' Unit of Measure: percentage of patients 31 (18 to 45)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/50 (36.00%)', ' Hypotension 0/50 (0.00%)', ' Bradycardia 0/50 (0.00%)', ' Cardiac Arrest 1/50 (2.00%)', ' Diarrhea 2/50 (4.00%)', ' Pain - Abdominal 1/50 (2.00%)', ' Hemorrhage - GI 1/50 (2.00%)', ' Vomiting 0/50 (0.00%)', ' Nausea 0/50 (0.00%)', ' Dehydration 0/50 (0.00%)', ' Diverticular Abscess 1/50 (2.00%)', ' Failure to Thrive 1/50 (2.00%)', ' Fever 0/50 (0.00%)', 'Adverse Events 2:', ' Total: 22/52 (42.31%)', ' Hypotension 1/52 (1.92%)', ' Bradycardia 1/52 (1.92%)', ' Cardiac Arrest 0/52 (0.00%)', ' Diarrhea 0/52 (0.00%)', ' Pain - Abdominal 0/52 (0.00%)', ' Hemorrhage - GI 1/52 (1.92%)', ' Vomiting 1/52 (1.92%)', ' Nausea 1/52 (1.92%)', ' Dehydration 1/52 (1.92%)', ' Diverticular Abscess 0/52 (0.00%)', ' Failure to Thrive 0/52 (0.00%)', ' Fever 1/52 (1.92%)']}

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

682f5e80-75c4-4a36-9bc1-b389a98ad160

Comparison

Eligibility

NCT02673918

NCT01042938

Only White and Asian patients are eligible for both the primary trial and the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT02673918', 'Intervention': ['INTERVENTION 1: ', ' Part 1: Home-based Rehabilitation', ' Participants in part 1 and part 2 will receive home-based upper-body rehabilitation with online support: Participants will be given written educational material, in which the physiotherapist marks the exercises specifically recommended for the individual patient. In addition, participants will get a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.', ' On average, participants will complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.', 'INTERVENTION 2: ', ' Part 2: Home-based Rehabilitation', ' Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.', ' On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of breast cancer', ' Part 1 only: Surgery for breast cancer within the past eight weeks (mastectomy or lumpectomy with either sentinel or axillar dissection), including those women with a history of previous surgery for breast cancer, radiation therapy or chemotherapy', ' Part 2 only: Completion of surgery and radiation therapy for breast cancer within the past six weeks.', ' Home access to internet from stationary computer, lab top or tablet', ' Ability to use internet', ' Ability to read and understand Danish', 'Exclusion Criteria:', ' Surgery for breast cancer with immediate breast reconstruction', ' Diagnosis of primary lymphedema', ' Metastatic or inflammatory breast cancer', ' Planned use of chemotherapy within the next 6 weeks', ' Surgical complications: infection, drainage issues, seroma, hematoma', ' Severe physical, cognitive, or psychiatric illness causing inability to follow the study protocol: i.e. severe depression, anxiety, dementia, poor physical health with likely possibility of hospitalization within the next twelve weeks.', ' Planned hospitalization or surgery within the next twelve weeks', ' Participation in another clinical trial with a rehabilitation or exercise intervention'], 'Results': ['Outcome Measurement: ', ' Recruitment Rate', ' This outcome represent the number and proportion (%) of eligible patients who consented to participate in the study. Recruitment was open for 10 weeks for participants in Part 1 and for 20 weeks for participants in Part 2.', ' Time frame: 10 weeks for part 1 and 20 weeks for part 2', 'Results 1: ', ' Arm/Group Title: Part 1: Home-based Rehabilitation', ' Arm/Group Description: Participants in part 1 and part 2 will receive home-based upper-body rehabilitation with online support: Participants will be given written educational material, in which the physiotherapist marks the exercises specifically recommended for the individual patient. In addition, participants will get a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.', ' On average, participants will complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.', ' Overall Number of Participants Analyzed: 44', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 35 79.5%', 'Results 2: ', ' Arm/Group Title: Part 2: Home-based Rehabilitation', ' Arm/Group Description: Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.', ' On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 24 85.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/35 (0.00%)', 'Adverse Events 2:', ' Total: 0/24 (0.00%)']}

{'Clinical Trial ID': 'NCT01042938', 'Intervention': ['INTERVENTION 1: ', ' Curcumin C3 Complex', ' Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT) (~4-7 weeks).', 'INTERVENTION 2: ', ' Placebo', ' Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT)(~4-7 weeks).'], 'Eligibility': ['Inclusion Criteria:', ' Female with a diagnosis of, non-inflammatory breast adenocarcinoma and be referred for post-operative radiotherapy without concurrent chemotherapy.', ' Participants must be at least 21 years of age.', ' Participants must not be pregnant.', ' Participants can be from any racial or ethnic origin.', ' Breast adenocarcinoma could have been treated by either lumpectomy or mastectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment.', ' Participants with in situ breast cancer are eligible.', ' Participants who are prescribed concurrent hormone treatment with radiation treatment are eligible.', ' Participants must be scheduled to receive five sessions of radiation therapy per week (1 session per day) for at least four weeks using standard (1.8-2.0 Gy per session)or Canadian (2.2-2.5 Gy per session)irradiation fractionation.', ' A time period of three weeks must elapse after chemotherapy and surgery before beginning the study.', ' The total dose prescribed to the whole breast should be 50 Gy or greater.', ' Participants must be able to understand English and able to complete assessment forms (all assessment forms are in English).', ' Participants must be able to swallow medication.', ' Topical skin agents, e.g., Aquaphor, Cetaphil, or other emollients, are allowed either PRN or prophylactically.', ' Participant must give informed consent.', 'Exclusion Criteria:', ' Patients with bilateral breast cancer are not eligible.', ' Patients who have had previous radiation therapy to the breast or chest are not eligible.', ' Patients who are prescribed chemotherapy concurrently with radiation treatment are not eligible.', ' Patients who will be receiving treatment with Herceptin (trastuzumab), anti-coagulants, or anti-human epidermal growth factor receptor (EGFR) drugs, e.g. Iressa (gefitinib), Erbitux (cetuximab, C225), concurrently with their radiation therapy are not eligible.', ' Patients cannot have had breast reconstructions, implants, and/or expanders.', ' Patients with known radiosensitivity syndromes (e.g., Ataxia-telangiectasia) are not eligible.', ' Patients with collagen vascular disease, vasculitis, unhealed surgical sites, or breast infections are not eligible.', ' Patients whose baseline blood tests meet the following criteria are not eligible: greater than or equal to Grade 2 change Hemoglobin (i.e., 25% decrease from baseline); greater than or equal to Grade 1 change in Platelets (i.e., less than 75,000/mm3); greater than or equal to Grade 2 change in PT and PTT(i.e., 1.5-2x upper level normal (ULN)); greater than or equal to Grade 1 change in AST, ALT (i.e., greater than 2.5x ULN); greater than or equal to Grade 1 change in Bilirubin (i.e., greater than 1.5x ULN); greater than or equal to Grade 1 change in Creatinine (i.e., greater than 2x ULN).'], 'Results': ['Outcome Measurement: ', ' Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients', ' The severity of radiation dermatitis was measured using the Radiation Dermatitis Severity (RDS)Scale which ranges from 0.0 to 4.0 with increments of 0.5. The RDS scale is a revised form of the NIH Common Toxicity Criteria to account for color and subtle texture changes in the skin. The worst dermatitis (i.e., highest RDS score) at the end of treatment was used for the primary analysis of severity of radiation dermatitis in each treatment group. Additionally, we performed repeated measure analyses to examine the severity of dermatitis over time in each arm.', ' Time frame: 4-7 weeks (prescribed course of radiation)', 'Results 1: ', ' Arm/Group Title: Curcumin C3 Complex', ' Arm/Group Description: Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT) (~4-7 weeks).', ' Overall Number of Participants Analyzed: 14', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 2.6 (0.994)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT)(~4-7 weeks).', ' Overall Number of Participants Analyzed: 16', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 3.4 (0.554)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14 (0.00%)', 'Adverse Events 2:', ' Total: 0/16 (0.00%)']}

7028841e-28e6-4fd3-a27c-2ae2e7dc7b52

Single

Adverse Events

NCT00934856

In total, across both cohorts of the primary trial, there were at least 2 patients with a fever.

Entailment

{'Clinical Trial ID': 'NCT00934856', 'Intervention': ['INTERVENTION 1: ', ' MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)', ' Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.', 'INTERVENTION 2: ', ' MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)', ' Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.'], 'Eligibility': ['Inclusion Criteria:', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (ECOG performance status of 2 will be allowed if only due to debilitating bone disease)', ' HER2-positive metastatic or locally advanced breast cancer', ' For MBC participants:', ' Documented metastatic or inoperable locally advanced (without meeting LABC criteria) disease, amenable for treatment with docetaxel', ' History of disease progression within 3 months prior to study entry', ' For LABC participants:', ' Newly diagnosed locally advanced breast cancer, Stage IIA-IIIC (American Joint Committee on Cancer [AJCC] staging system)', 'Exclusion Criteria:', ' Significant cardiac disease', ' Inadequate bone marrow, liver or renal function', ' For MBC participants:', ' Participants must not have received radiotherapy for the treatment of metastatic or locally recurrent/advanced disease other than for the relief of pain in progressing metastatic bone lesions and/or brain metastases', ' Brain metastases that are untreated, symptomatic or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastasis within 2 months of the first study treatment.', ' For LABC participants:', ' Clinically or radiologically detectable metastasis (M1 disease)', ' Participants for whom surgery as primary intent procedure is the best option to treat their disease', ' Participants must not have received any systemic or loco-regional anti-cancer therapy for the treatment of locally advanced disease'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicity (DLT) - MBC and LABC Feasibility Population', ' DLTs included (as per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] grading): Grade 4 thrombocytopenia, thrombocytopenia of any grade with concurrent hemorrhage or requiring blood platelet transfusion, or thrombocytopenia not recovered by Day 21 to at least 100,000/microliter (mcL); Grade 4 neutropenia lasting for more than 7 days; Febrile neutropenia; Grade greater than or equal to (>/=) 3 neurotoxicity in the form of peripheral neuropathy or peripheral neurotoxicity not improving to baseline or Grade less than or equal to (</=) 1 by Day 21; Any non-hematological toxicity of Grade >/= 3 except for alopecia, fever, and chills, not improving to baseline or Grade </=1 by Day 21, despite adequate toxicity management; Any subjective intolerable toxicity felt by the investigator to be related to either study treatment; Any other treatment-related toxicity prohibiting the start of the Cycle 2 on Day 22; Fulminant skin rash.', ' Time frame: Cycle 1 (up to 21 days)', 'Results 1: ', ' Arm/Group Title: MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)', ' Arm/Group Description: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants 2', 'Results 2: ', ' Arm/Group Title: MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)', ' Arm/Group Description: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: participants 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/6 (33.33%)', ' Febrile neutropenia * 1/6 (16.67%)', ' Neutropenia * 0/6 (0.00%)', ' Thrombocytopenia * 1/6 (16.67%)', ' Diarrhoea * 0/6 (0.00%)', ' Pyrexia * 0/6 (0.00%)', ' Thrombosis in device * 1/6 (16.67%)', ' Fatigue * 0/6 (0.00%)', ' Mucosal inflammation * 0/6 (0.00%)', ' Device deployment issue * 0/6 (0.00%)', ' Hepatocellular injury * 1/6 (16.67%)', ' Cholecystitis * 1/6 (16.67%)', 'Adverse Events 2:', ' Total: 2/6 (33.33%)', ' Febrile neutropenia * 1/6 (16.67%)', ' Neutropenia * 1/6 (16.67%)', ' Thrombocytopenia * 0/6 (0.00%)', ' Diarrhoea * 0/6 (0.00%)', ' Pyrexia * 0/6 (0.00%)', ' Thrombosis in device * 1/6 (16.67%)', ' Fatigue * 0/6 (0.00%)', ' Mucosal inflammation * 0/6 (0.00%)', ' Device deployment issue * 0/6 (0.00%)', ' Hepatocellular injury * 0/6 (0.00%)', ' Cholecystitis * 0/6 (0.00%)']}

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

348c9273-6aa1-43a8-840d-3cf080874669

Single

Results

NCT00068588

We cannot compare results between the two Arms of the primary trial as there were no patients in cohort 1.

Entailment

{'Clinical Trial ID': 'NCT00068588', 'Intervention': ['INTERVENTION 1: ', ' Arm 1', ' Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,', 'INTERVENTION 2: ', ' Arm 2', ' Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed metastatic adenocarcinoma of the breast', ' Patients must have measurable disease, defined as lesions 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', ' Patients must have progressed on at least one but no more than two prior chemotherapy regimens for metastatic disease; patients must not have received prior capecitabine or 5-fluorouracil; patients with hormone-sensitive tumors should have received hormone treatment and any prior number of hormonal agents will be allowed; patients with tumors that overexpress HER-2/neu (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization) should have received herceptin, either in the adjuvant or metastatic setting, unless there is a contraindication to herceptin therapy; all prior therapies must have been completed 4 weeks before treatment', ' Life expectancy of greater than 3 months', ' ECOG performance status =< 2 (Karnofsky >= 50%)', ' Leukocytes >= 3,000/μL', ' Absolute neutrophil count >= 1,500/μL', ' Platelets >= 100,000/μL', ' Total bilirubin within normal institutional limits', ' AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal', ' Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min', ' Patients must have completed radiation treatment > 4 weeks prior to study entry; previously radiated area(s) must not be the only site of disease', ' All major surgical procedures must be completed > 4 weeks prior to study entry; placement of vascular access device or tissue biopsy will not be considered major surgery', ' 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; 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', ' Patients must agree to the placement of a central venous catheter in order to receive the continuous infusion treatment', 'Exclusion Criteria:', ' Patients with only non-measurable disease, defined as all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions, which include 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 who have had chemotherapy, hormone therapy, 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 earlier', ' Patients may not be receiving any other investigational agents; patients may not have received prior GTI-2040', ' Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to GTI-2040 or to capecitabine or 5-fluorouracil', ' Patients requiring anticoagulant therapy; low-dose anticoagulant (warfarin 1 mg per day) for the primary prophylaxis of venous catheter-associated thrombosis is permitted', ' 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 because GTI-2040 and capecitabine have the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with GTI-2040 and capecitabine, breastfeeding should be discontinued if the mother is treated', ' Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with GTI-2040 or other agents administered during the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated'], 'Results': ['Outcome Measurement: ', ' Maximum Tolerated Dose Determined by Dose-limiting Toxicities', ' 1st 3 pts will be treated on arm 2. If 0/3 DLTs observed, the dose will be escalated to arm 3. If 1/3 DLTs onserved on arm 2, 3 more pts will be treated on arm 2. If no additional DLTs are observed on arm 2, the dose will be escalated to arm 3. If at most 1/6 DLTs observed on arm 3, arm 3 will be considered the MTD. If more than 1/6 DLTs observed on arm 3, the dose will be de-escalated to arm 2. If at most 1/6 DLTs observed on arm 2, arm 2 will be considered the MTD. If more than 1/6 pts on arm 2 experience a DLT, the dose will be de-escalated to arm 1. The remaining pts will be treated on arm 1 as the MTD, unless more than 1/6 DLTs, in which case the study will stop. DLT is defined as any grade III or IV non-hematologic toxicity (incl. diarrhea w\\ adequate antidiarrheal treatment & hydration & nausea/vomiting w\\ maximal antiemetic prophylaxis, as per protocol) or grade IV hematologic toxicity. DLT will be based on the 1st course of treatment according to the revised NCI CTC v 2.0', ' Time frame: 21 days', 'Results 1: ', ' Arm/Group Title: Arm 1', ' Arm/Group Description: Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: Patients experiencing DLT ', 'Results 2: ', ' Arm/Group Title: Arm 2', ' Arm/Group Description: Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: Patients experiencing DLT 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/3 (66.67%)', ' Diarrhea * 0/3 (0.00%)', ' Nausea * 0/3 (0.00%)', ' Vomiting * 0/3 (0.00%)', ' Fatigue * 0/3 (0.00%)', ' Catheter related infection * 1/3 (33.33%)', ' Infection NOS * 1/3 (33.33%)', ' Aspartate aminotransferase increased * 1/3 (33.33%)', ' Dehydration * 0/3 (0.00%)', ' Hypercalcemia * 0/3 (0.00%)', ' Hypokalemia * 0/3 (0.00%)', ' Hypophosphatemia * 1/3 (33.33%)', 'Adverse Events 2:', ' Total: 6/21 (28.57%)', ' Diarrhea * 2/21 (9.52%)', ' Nausea * 1/21 (4.76%)', ' Vomiting * 1/21 (4.76%)', ' Fatigue * 1/21 (4.76%)', ' Catheter related infection * 0/21 (0.00%)', ' Infection NOS * 1/21 (4.76%)', ' Aspartate aminotransferase increased * 1/21 (4.76%)', ' Dehydration * 1/21 (4.76%)', ' Hypercalcemia * 1/21 (4.76%)', ' Hypokalemia * 2/21 (9.52%)', ' Hypophosphatemia * 2/21 (9.52%)']}

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

dfe6228e-6bfb-49d3-b0b4-397aab177bea

Single

Results

NCT01302379

Only one patient cohort of the primary trial had a positive median Insulin change from baseline.

Contradiction

{'Clinical Trial ID': 'NCT01302379', 'Intervention': ['INTERVENTION 1: ', ' Metformin + Lifestyle Intervention', ' Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time', ' Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.', 'INTERVENTION 2: ', ' Placebo + Lifestyle Intervention', ' Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time', ' Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.'], 'Eligibility': ['Inclusion Criteria:', ' BMI at least 25.0 kg/m2', ' Diagnosed with Stage I, II, or III breast cancer within past 5 years', ' Treatment with total mastectomy or breast-sparing surgical removal of cancer with clear macroscopic margins, and axillary dissection, followed by adjuvant breast radiation', ' Not scheduled for or currently undergoing chemotherapy', ' Accessible geographically and by telephone', ' Able to communicate dietary and physical activity data via telephone', ' If taking statins, tamoxifen, or aromatase inhibitors; able and willing to remain on treatment for 6-month study period', ' Post-menopausal at diagnosis', 'Exclusion Criteria:', ' Preliminary bloodwork outside of specified ranges', ' Evidence of renal insufficiency, liver disease, or congestive heart failure', ' Currently taking corticosteroid pills or steroid hormone therapy (including vaginal estrogen creams)', ' Recent initiation (< 3 months ago) of thiazides or β-blockers', ' Taking insulin or other antidiabetic drug', ' Other primary or recurrent invasive cancer in past 10 years', ' Unable to commit to study requirements'], 'Results': ['Outcome Measurement: ', ' Insulin', ' Insulin measured as percent change from baseline', ' Time frame: change from baseline to 6 months', 'Results 1: ', ' Arm/Group Title: Metformin + Lifestyle Intervention', ' Arm/Group Description: Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time', ' Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.', ' Overall Number of Participants Analyzed: 83', ' Least Squares Mean (95% Confidence Interval)', ' Unit of Measure: percent change from baseline -21.8 (-29.7 to -13.0)', 'Results 2: ', ' Arm/Group Title: Placebo + Lifestyle Intervention', ' Arm/Group Description: Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time', ' Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.', ' Overall Number of Participants Analyzed: 83', ' Least Squares Mean (95% Confidence Interval)', ' Unit of Measure: percent change from baseline -17.7 (-25.9 to -8.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/333 (1.50%)', ' transient ischemic attack1/333 (0.30%)', ' Injury due to fall1/333 (0.30%)', ' Abdominal pain1/333 (0.30%)', ' slurred speach1/333 (0.30%)', 'Adverse Events 2:', ' Total: 5/333 (1.50%)', ' transient ischemic attack1/333 (0.30%)', ' Injury due to fall1/333 (0.30%)', ' Abdominal pain1/333 (0.30%)', ' slurred speach1/333 (0.30%)']}

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

9f424ebb-63b8-4930-b2c1-cd46fff4d706

Single

Results

NCT00324259

Cohort 2 of the primary trial had one more patient with Stable disease than cohort 1.

Entailment

{'Clinical Trial ID': 'NCT00324259', 'Intervention': ['INTERVENTION 1: ', ' Arm 1 (6 mg Estradiol)', ' 6 mg of estradiol daily (2 mg tid).', 'INTERVENTION 2: ', ' Arm 2 (30 mg Estradiol)', ' 30 mg of estradiol. (10 mg tid)'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with advanced hormone receptor positive (ER and or PgR) breast cancer, has received prior treatment with an aromatase inhibitor in the advanced disease setting, and experienced at least 24 weeks of progression free survival. As long as the patient experienced an aromatase inhibitor response as defined this way, she is still eligible even if she has received further lines of endocrine therapy, which may include other aromatase inhibitors or tamoxifen, even if these subsequent lines of treatment were unsuccessful (see below for permitted chemotherapy and trastuzumab therapy).', ' OR', ' Postmenopausal women with systemic or unresectable local relapse after taking at least two years of adjuvant aromatase inhibitor therapy.', ' Clinical diagnosis of postmenopausal status is defined as either:', ' Age greater than 50 years and amenorrhea for 1 year', ' Bilateral Surgical ovariectomy', ' Serum FSH and estradiol level in the postmenopausal range before the initiation of AI therapy.', ' If the patient was receiving an LHRH agonist to maintain a postmenopausal state during AI therapy this should be continued since recovery of menses would lead to uncontrolled estrogen exposure and pregnancy during estrogen therapy is contraindicated.', ' Tumor cell expression of ER and/or PgR can be ascertained on either the primary or the metastatic site. However when both types of tissue are available, the metastatic site should be used to determine eligibility. ER and/or PgR positive are defined as at least 10% of malignant cells with positive nuclear staining.', ' The patients may have received adjuvant and/or neoadjuvant chemotherapy.', ' Prior radiotherapy is permitted as long as it was planned before the start of the study medication and is completed within 3 weeks of trial medication starting.', ' Prior tamoxifen therapy is also permitted as adjuvant or advanced disease therapy.', ' Patients with ER+ HER2+ disease are eligible even of they have received trastuzumab in the past (and even if it was administered in combination with endocrine treatment) as long as they meet all other eligibility criteria. Trastuzumab therapy must be held during estradiol treatment.', ' Use of prior experimental agents alone or in combination with endocrine therapy is also permissible, but a wash out of one month is required if the immediate prior therapy involved a study medication that had not been subject to regulatory approval.', ' Prior adjuvant chemotherapy is permitted as well as one line of chemotherapy for advanced disease.', ' Patient must have at least one measurable lesion defined by RECIST criteria. To be considered measurable, a baseline lesion must have a minimum diameter to compensate for measurement error: 1 cm for soft tissue lesions, 1 cm for lung lesions including pleural lesions measured by CT scan, 1 cm for liver lesions measured by CT scan.', ' Patients with bone only disease can also be enrolled if they meet the following criteria:', ' Four or more lesions more than one cm, measurable on CT scan bone windows.', ' At least one tumor marker that is elevated to at least two times the upper limit of normal.', ' All patients should have a baseline bone scan with X-ray evaluation of all hot spots, CT chest abdomen and pelvis (with bone windows), and tumor marker assessment. Also CT scan of the extremities should be done on suspicious areas seen on X-ray evaluation of all hot spots if these extremity lesions are to be followed for response.', ' The patient must have an ECOG performance status of 0-2', ' The patient should have a life expectancy of > 6 months.', ' The patient must have adequate hematologic function, defined as ANC >1000/mm3 and platelets > 75,000/mm3.', ' The patient must have adequate renal function, defined as serum creatinine less than or equal to 1.5 times the upper limit of normal.', ' The patient must have adequate liver function defined as serum bilirubin less than or equal to 1.5 times the upper limit of normal (three times the upper limit of normal for patients with hereditary benign hyperbilirubinaemia), transaminases (ALT, AST) less than or equal to 2.5 times the upper limit of normal in patients without liver metastasis or less than or equal to 5 times the upper limit of normal in patients with liver metastasis.', ' For patients with bone metastasis, treatment with i.v. bisphosphonates during the trial is mandatory because of the risk of hypercalcemia. Bisphosphonate therapy must be started before the patient begins protocol therapy.', ' Preexisting hypercalcemia should be treated and calcium normalized prior to study entry.', ' The patient must give written informed consent prior to initiation of any invasive study-related procedures that would otherwise not be performed, and must be able to comply with scheduled visits and evaluations.', ' Inclusion of Women and Minorities: Entry to this study is open to women of all racial and ethnic subgroups.', ' Patients with fasting blood glucose level 200 mg/dL. If greater, hyperglycemia must be treated before initiation of study investigations.', 'Exclusion Criteria:', ' Patients with CNS involvement with metastatic breast cancer or life threatening lymphangitic or large volume lung or liver disease that threatens organ function.', ' Patients with history of deep venous thrombosis, pulmonary embolism, stroke, acute myocardial infarction, congestive cardiac failure, untreated hypertension.', ' Ischemic changes on a baseline EKG or other evidence of ischemic heart disease.', ' Undiagnosed abnormal genital bleeding', ' Untreated cholelithiasis', ' Fasting serum triglycerides greater than 400. Patients should be treated and triglycerides controlled prior to study entry.', ' Treatment with fulvestrant within 12 months of study initiation (fulvestrant has been shown to antagonize estradiol induced apoptosis in preclinical models (5).', " The patient's only qualifying lesion (s) have been previously irradiated or are scheduled for irradiation following study entry.", ' Severe or uncontrolled concomitant disease from other causes.', ' EGOG Performance status 3 or 4.', ' The patient has previous malignancies other than breast cancer except a) adequately treated in situ carcinoma of the cervix, b) localized basal or squamous cell carcinoma of the skin c) any previous malignancy treated with curative intent with a recurrence risk of less than 30%.', ' The patient is unable to understand the informed consent or is unlikely to be compliant with the protocol.', ' More than one line of palliative chemotherapy for advanced disease.'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate (CR Plus PR Plus SD)', ' Complete response (CR) + partial response (PR) + stable disease (SD) using RECIST 1.0', ' CR = disappearance of all target lesions', ' PR = at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter', ' SD = neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for progressive disease', ' SD is defined as lack of disease progression by 24 weeks.', ' Time frame: 24 weeks after start of treatment', 'Results 1: ', ' Arm/Group Title: Arm 1 (6 mg Estradiol)', ' Arm/Group Description: 6 mg of estradiol daily (2 mg tid).', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Number', ' Unit of Measure: participants Complete response (CR): 0', ' Partial response (PR): 3', ' Stable disease (SD): 7', 'CR+PR+SD: 10', 'Results 2: ', ' Arm/Group Title: Arm 2 (30 mg Estradiol)', ' Arm/Group Description: 30 mg of estradiol. (10 mg tid)', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Number', ' Unit of Measure: participants Complete response (CR): 0', ' Partial response (PR): 1', ' Stable disease (SD): 8', 'CR+PR+SD: 9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/34 (23.53%)', ' Hemoglobin 0/34 (0.00%)', ' Eye pain 0/34 (0.00%)', ' Vison loss 0/34 (0.00%)', ' Abdominal pain 2/34 (5.88%)', ' Constipation 0/34 (0.00%)', ' Diarrhea 2/34 (5.88%)', ' GI hemorrhage 1/34 (2.94%)', ' Nausea 2/34 (5.88%)', ' Vomiting 2/34 (5.88%)', ' Fatigue 0/34 (0.00%)', ' Fever 2/34 (5.88%)', ' Pain 0/34 (0.00%)', ' Pneumonia 1/34 (2.94%)', ' Neutropenia 0/34 (0.00%)', 'Adverse Events 2:', ' Total: 8/32 (25.00%)', ' Hemoglobin 1/32 (3.13%)', ' Eye pain 1/32 (3.13%)', ' Vison loss 1/32 (3.13%)', ' Abdominal pain 1/32 (3.13%)', ' Constipation 2/32 (6.25%)', ' Diarrhea 1/32 (3.13%)', ' GI hemorrhage 0/32 (0.00%)', ' Nausea 3/32 (9.38%)', ' Vomiting 3/32 (9.38%)', ' Fatigue 1/32 (3.13%)', ' Fever 0/32 (0.00%)', ' Pain 1/32 (3.13%)', ' Pneumonia 0/32 (0.00%)', ' Neutropenia 1/32 (3.13%)']}

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

c1f8c7fb-22de-4501-af86-d9eb59542ae3

Single

Eligibility

NCT00331630

Left ventricular ejection fraction > 50% is required for participation in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00331630', 'Intervention': ['INTERVENTION 1: ', ' Treatment With Lapatinib and Abraxane', ' 30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast cancer', ' Clinical stage I-III disease', ' Measurable disease defined as 1 unidimensionally measurable lesion 20 mm by conventional techniques OR 10 mm with spiral CT scan', ' HER2/neu 3+ by immunohistochemistry or positive by fluorescent in situ hybridization', ' No known brain metastases', ' Hormone receptor status unspecified', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' Male or female', ' Life expectancy > 12 weeks', ' ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%', ' WBC 3,000/mm^3', ' Absolute neutrophil count 1,500 mm^3', ' Platelet count 100,000/mm^3', ' Total bilirubin normal', ' AST and ALT 2.5 times upper limit of normal', ' Creatinine normal OR creatinine clearance 60 mL/min', ' LVEF 50% as measured by echocardiogram or MUGA scan', ' No other malignancy within the past year', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' Able to swallow and retain oral medication', ' No history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib', ' No ongoing or active infection', ' No symptomatic congestive heart failure', ' No unstable angina pectoris', ' No cardiac arrhythmia', ' No psychiatric illness or social situation that would preclude study compliance', ' No other uncontrolled illness', ' No gastrointestinal (GI) tract disease that would preclude ability to take oral medication', ' No malabsorption syndrome', ' No requirement for IV alimentation', " No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)", ' PRIOR CONCURRENT THERAPY:', ' No prior chemotherapy, immunotherapy, radiotherapy, or hormonal therapy for breast cancer', ' No prior treatment with epidermal growth factor receptor targeting therapies', ' No prior surgical procedures affecting absorption', ' No prior surgery for breast cancer', ' At least 14 days since prior and no concurrent CYP3A4 inducers, including any of the following:', ' Dexamethasone or dexamethasone equivalent dose 1.5 mg/day, including any of the following:', ' Cortisone ( 50 mg/day)', ' Hydrocortisone ( 40 mg/day)', ' Prednisone ( 10 mg/day)', ' Methylprednisolone ( 8 mg/day)', ' Phenytoin', ' Carbamazepine', ' Phenobarbital', ' Efavirenz', ' Nevirapine', ' Rifampin', ' Rifabutin', ' Rifapentine', " Hypericum perforatum (St. John's wort)", ' Modafinil', ' At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:', ' Clarithromycin', ' Erythromycin', ' Troleandomycin', ' Delavirdine', ' Ritonavir', ' Indinavir', ' Saquinavir', ' Nelfinavir', ' Amprenavir', ' Lopinavir', ' Itraconazole', ' Ketoconazole', ' Voriconazole', ' Fluconazole (doses up to 150 mg/day are permitted)', ' Nefazodone', ' Fluvoxamine', ' Verapamil', ' Diltiazem', ' Cimetidine', ' Aprepitant', ' Grapefruit or its juice', ' At least 6 months since prior and no concurrent amiodarone', ' At least 2 days since prior and no concurrent gastric pH modifiers*, including any of the following:', ' Cimetidine', ' Ranitidine', ' Nizatidine', ' Famotidine', ' Omeprazole', ' Esomeprazole', ' Rabeprazole', ' Pantoprazole', ' Lansoprazole', ' NOTE: *Antacids are allowed within 1 hour before and after administration of study drug', ' No other concurrent investigational agents', ' No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or antitumor hormonal therapy', ' No concurrent herbal (alternative) medicines', ' No concurrent combination antiretroviral therapy for HIV-positive patients', ' Concurrent bisphosphonates allowed'], 'Results': ['Outcome Measurement: ', ' Clinical Response Rate (cRR)', " cRR measured by RECIST for target lesions assessed by clinical exam+ mammogram+ ultrasound (US). cRR is defined as number of patients who's best response in any of the assessments (clinical exam/mammogram/US) is CR+PR. Response will be defined as one of the following in either clinical exam, mammogram or US: Complete Response (CR)-Disappearance of all target lesions. Partial Response (PR)>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum.", ' Stable Disease-neither sufficient shrinkage to qualify for Partial disease nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD while on study.', ' Progressive Disease <=20% increase in the sum of the 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.', ' Time frame: At Baseline, then before each treatment cycle begins and after 4 cycles of study treatment (1 cycle = 21 days)', 'Results 1: ', ' Arm/Group Title: Treatment With Lapatinib and Abraxane', ' Arm/Group Description: 30 patients receive Abraxane IV over 30 minutes on day 1 and oral lapatinib once daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' lapatinib ditosylate: Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' paclitaxel albumin-stabilized nanoparticle formulation: 30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 6', ' Partial Response: 18', ' Stable Disease: 5', ' Progressive Disease: 0', ' Clinical Response Rate: 24'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/30 (6.67%)', ' Dry Eyes [1]1/30 (3.33%)', ' Diarrhea [2]1/30 (3.33%)']}

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

6630047b-7ebc-4435-8203-cf6bbe6b6ee7

Comparison

Eligibility

NCT00903162

NCT01674062

Patients with cancer in situ of the cervix are eligible for the primary trial and the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00903162', 'Intervention': ['INTERVENTION 1: ', ' Letrozole-Leuprolide', ' Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.', ' leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years', ' letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration', ' zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)'], 'Eligibility': ['Inclusion Criteria:', ' Women 18 years of age or older', ' History of invasive ER+ or PR+ breast cancer treated with at least 4.5 years of tamoxifen', ' No current evidence of recurrent invasive disease or metastatic disease. Patients may have a history of bilateral breast cancer', ' Premenopausal (estradiol level in premenopausal range, >20pg/ml, within the prior 28 days)', ' Liver function tests and creatinine <2.5 times the upper limit of normal within the 28 days prior to enrollment', ' ECOG Performance Status 0-1', ' Must agree to use non-hormonal contraception (condoms, diaphragm, IUD, sterilization, abstinence, etc) and no other hormonal therapy during trial and until 3 months after letrozole is stopped', ' Negative pregnancy test within 14 days prior to enrollment', ' Patient must be able to speak, read and write in English', 'Exclusion Criteria:', ' Previous treatment with an oral or IV bisphosphonate in the prior two years', ' History of cancer other than breast cancer within 5 years excluding basal/squamous cell skin carcinoma in situ of the cervix', ' Women with evidence of current local recurrence or metastatic breast cancer', ' Pregnant women', ' Nursing women', ' Women who are currently taking tamoxifen and are unwilling to stop this medication', ' Women with a known deleterious BRCA 1 or BRCA 2 mutation'], 'Results': ['Outcome Measurement: ', ' Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole.', ' The tolerability at one year of ovarian function suppression (OFS) using leuprolide and letrozole in this patient population. Specifically, the number of patients who discontinued treatment prior to one year due to toxicity.', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Letrozole-Leuprolide', ' Arm/Group Description: Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.', ' leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years', ' letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration', ' zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)', ' Overall Number of Participants Analyzed: 16', ' Measure Type: Number', ' Unit of Measure: participants 4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/17 (0.00%)']}

{'Clinical Trial ID': 'NCT01674062', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab + Trastuzumab (Cohorts 1 and 2)', ' Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.'], 'Eligibility': ['Inclusion Criteria:', ' Females greater than or equal to ( ) 18 years of age, with histologically-confirmed HER2-positive breast cancer', ' Metastatic breast cancer, with progression on trastuzumab-based therapy as last treatment for metastatic disease', ' Less than or equal to ( ) 3 chemotherapy regimens prior to study entry', ' Last trastuzumab dose 9 weeks before study entry for participants receiving pertuzumab + trastuzumab, and 4 weeks for participants receiving pertuzumab monotherapy', ' Left ventricular ejection fraction 55% at study entry', 'Exclusion Criteria:', ' Previous treatment with an anti-cancer vaccine or any targeted therapy other than trastuzumab', ' Brain metastases', ' History of any cardiac adverse event related to trastuzumab therapy', ' Any other malignancy in the last 5 years, except for basal cell cancer or cancer in situ of the cervix'], 'Results': ['Outcome Measurement: ', ' Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 During Dual-Agent Treatment', ' Tumor response was assessed using RECIST version 1.0 to determine the objective response (OR) rate, or the percentage of participants with either confirmed CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter compared to Baseline. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The OR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.', ' Time frame: Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)', 'Results 1: ', ' Arm/Group Title: Pertuzumab + Trastuzumab (Cohorts 1 and 2)', ' Arm/Group Description: Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.', ' Overall Number of Participants Analyzed: 66', ' Measure Type: Number', ' Unit of Measure: percentage of participants 24.2 (17.4 to 32.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/66 (18.18%)', ' Palpitations * 1/66 (1.52%)', ' Haematemesis * 1/66 (1.52%)', ' Performance status decreased * 1/66 (1.52%)', ' Hepatic failure * 1/66 (1.52%)', ' Cellulitis * 1/66 (1.52%)', ' Device related infection * 1/66 (1.52%)', ' Pneumonia * 1/66 (1.52%)', ' Pneumonia pneumococcal * 1/66 (1.52%)', ' Femur fracture * 0/66 (0.00%)', ' Hypokalaemia * 1/66 (1.52%)', ' Back pain * 2/66 (3.03%)']}

039c3fc2-f798-4d97-b904-9aa7d363eeef

Single

Eligibility

NCT00121134

the primary trial requires participants to have undergone PTR.

Entailment

{'Clinical Trial ID': 'NCT00121134', 'Intervention': ['INTERVENTION 1: ', ' Group A- Bevacizumab Alone', ' Bevacizumab 15 mg/kg every 3 wks for 1 year', 'INTERVENTION 2: ', ' Group B-Bevacizumab+Cyclophosphamide+Methotrexate', ' Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast cancer, preoperative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging', ' Patients must have completed preoperative (neoadjuvant) chemotherapy with a standard chemotherapy regimen. No more chemotherapy should be planned.', ' Patients must have completed definitive resection of primary tumor with adequate excision of gross disease.', ' For patients receiving adjuvant radiation therapy, treatment must be completed prior to initiation of protocol therapy.', ' Patients must have the presence of significant residual invasive disease on pathologic review following their preoperative chemotherapy.', ' LVEF > institutional limits of normal after preoperative chemotherapy, as assessed by ECHO or nuclear medicine gated study, within 30 days prior to initiating protocol-based treatment.', ' ECOG performance status 0-1', 'Exclusion Criteria:', ' Inadequate organ function, as measured by laboratory assessment after preoperative chemotherapy and within 14 days of beginning protocol-based treatment', ' Patients with metastatic disease are ineligible.', ' Known HIV infection', ' Patients may not be pregnant, expect to become pregnant, plan to conceive a child while on study, or breastfeeding', ' Uncontrolled intercurrent illness', ' Non-healing wounds or major surgical procedures (such as breast surgery) other than that for venous access device or diagnostic study are not permitted within 28 day prior to enrollment', ' History of abdominal fistula, GI perforation, intra-abdominal abscess, or serious, non-healing wound, ulcer, or bone fracture within 6 months prior to initiating bevacizumab', ' Patients with any history of arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular event (CVA), unstable angina, or myocardial infarction (MI) within the past 6 months. Patients with clinically significant peripheral arterial disease should also be excluded', ' History of bleeding diathesis or coagulopathy', ' History of grade 3 or 4 allergic reactions to compounds of similar chemical or biologic composition to cyclophosphamide (such as other alkylating agents) or methotrexate (such as other antimetabolites)', ' Prior history of malignancy treated without curative intent, excluding nonmelanomatous skin cancer', ' Patients with large or rapidly accumulating pleural or abdominal effusions', ' Current use of anticoagulants is allowed as long as patients have been on a stable dose for more than two weeks with stable INR', ' Chronic therapy with full dose aspirin (< 325 mg/day) or standard non-steroidal anti-inflammatory agents is allowed', ' Patients may not receive other investigational agents while on study'], 'Results': ['Outcome Measurement: ', ' The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts', ' [Not Specified]', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Group A- Bevacizumab Alone', ' Arm/Group Description: Bevacizumab 15 mg/kg every 3 wks for 1 year', ' Overall Number of Participants Analyzed: 40', ' Measure Type: Number', ' Unit of Measure: percentage of participants 60', 'Results 2: ', ' Arm/Group Title: Group B-Bevacizumab+Cyclophosphamide+Methotrexate', ' Arm/Group Description: Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.', ' Overall Number of Participants Analyzed: 41', ' Measure Type: Number', ' Unit of Measure: percentage of participants 58'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/40 (2.50%)', ' Hypertension 0/40 (0.00%)', ' Lower GI bleed 1/40 (2.50%)', ' Death 0/40 (0.00%)', ' Headache 0/40 (0.00%)', ' Dyspnea 0/40 (0.00%)', ' Sinusitis 0/40 (0.00%)', ' Wound Dehiscence 0/40 (0.00%)', 'Adverse Events 2:', ' Total: 3/41 (7.32%)', ' Hypertension 1/41 (2.44%)', ' Lower GI bleed 0/41 (0.00%)', ' Death 0/41 (0.00%)', ' Headache 0/41 (0.00%)', ' Dyspnea 0/41 (0.00%)', ' Sinusitis 1/41 (2.44%)', ' Wound Dehiscence 1/41 (2.44%)']}

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

50a2a4a9-2b30-4901-b7bc-9c77b8ca870f

Comparison

Intervention

NCT00537771

NCT00354640

participants of cohort 1 in the primary trial and all participants of the secondary trial take 1 milligram of anastrozole and 40 milligrams of simvastatin PO QD.

Contradiction

{'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%)']}

f8028143-35d1-4cc3-895a-acb577db4715

Single

Eligibility

NCT00193180

A female patient over the age of 18 suffering from chronic viral hepatitis would be eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00193180', 'Intervention': ['INTERVENTION 1: ', ' Intervention', ' All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.'], 'Eligibility': ['Inclusion Criteria:', ' To be included in this study, you must meet the following criteria:', ' Metastatic breast cancer confirmed by biopsy', ' No more than one prior chemotherapy regimen for metastatic breast cancer', ' Able to perform activities of daily living with minimal assistance', ' Adequate bone marrow, liver and kidney function', ' Age 18 years or older', ' Give written informed consent', 'Exclusion Criteria:', ' You cannot participate in this study if any of the following apply to you:', ' Moderate to severe peripheral neuropathy', ' Uncontrolled blood pressure or uncontrolled heart beat irregularities', ' Diabetes Mellitus with fasting blood sugar greater than 200 mg %', ' Significant heart disease within the prior 6 months', ' Severe or uncontrolled medical disease', ' Active uncontrolled infection', ' Known chronic liver disease', ' Known diagnosis of HIV infection', ' Pregnant or breast feeding females', ' 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: ', ' Overall Response Rate (ORR)', ' Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1.', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: Intervention', ' Arm/Group Description: All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Number', ' Unit of Measure: percentage of participants 16 (4.3 to 28.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/37 (48.65%)', ' Febrile neutropenia 1/37 (2.70%)', ' Hemoglobin 1/37 (2.70%)', ' Leukocytes 1/37 (2.70%)', ' Neutrophils 1/37 (2.70%)', ' Cardiac ischemia/infarction 2/37 (5.41%)', ' Cardiac ischemia/infarction - rheumatic heart failure 1/37 (2.70%)', ' Dehydration 1/37 (2.70%)', ' Gastrointestinal - Other (diverticular abscess) 1/37 (2.70%)', ' Gastritis 1/37 (2.70%)', ' Mucositis 1/37 (2.70%)']}

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

907f7e56-b6ec-4a43-bf3a-14f93c644bc1

Single

Eligibility

NCT00853996

Women classified as high-risk of developing breast cancer within the next 5 years and within her lifetime by the Gail model are eligible for the primary trial.

Entailment

{'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': ''}

3fa58451-21ba-4ad9-8d13-6a9eefa17a5b

Single

Adverse Events

NCT01572727

Cohort 1 of the primary trial recorded more optical adversse events than cohort 2.

Contradiction

{'Clinical Trial ID': 'NCT01572727', 'Intervention': ['INTERVENTION 1: ', ' BKM120 and Paclitaxel', ' Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel', 'INTERVENTION 2: ', ' Placebo and Paclitaxel', ' Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel'], 'Eligibility': ['Inclusion Criteria:', ' Breast cancer that is locally advanced or metastatic', ' HER2 negative disease, and a known hormone receptor status - ER/PgR (common breast cancer classification tests)', ' A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization', ' Adequate bone marrow and organ function', ' Measurable or non-measurable disease', 'Exclusion Criteria:', ' Prior chemotherapy for locally advanced or metastatic disease', ' Previous treatment with PI3K or AKT inhibitors', ' Patient has symptomatic CNS metastases', ' Concurrent malignancy or malignancy within 3 years of study enrollment', ' Hematopoietic colony-stimulating growth factors or radiation within 2-4 weeks prior to starting study drug', ' Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent', ' Active heart (cardiac) disease as defined in the protocol', ' Known hypersensitivity or contraindications to use paclitaxel', ' Pregnant or nursing (lactating) woman', ' Certain scores on an anxiety and depression mood questionaire given at screening', ' Other protocol defined criteria may apply'], 'Results': ['Outcome Measurement: ', " Progression-free Survival (PFS)Assessed by Local Investigator's Assessment (Phase ll)", ' PFS was defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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: Every 8 weeks from randomization until disease progression up to 10 months after futility was analyzed', 'Results 1: ', ' Arm/Group Title: BKM120 and Paclitaxel', ' Arm/Group Description: Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel', ' Overall Number of Participants Analyzed: 168', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 8.0 (7.2 to 9.2)', 'Results 2: ', ' Arm/Group Title: Placebo and Paclitaxel', ' Arm/Group Description: Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel', ' Overall Number of Participants Analyzed: 170', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.2 (7.3 to 11.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 61/202 (30.20%)', ' FEBRILE NEUTROPENIA 1/202 (0.50%)', ' LEUKOPENIA 0/202 (0.00%)', ' NEUTROPENIA 2/202 (0.99%)', ' CARDIAC FAILURE CONGESTIVE 0/202 (0.00%)', ' CARDIO-RESPIRATORY ARREST 1/202 (0.50%)', ' PERICARDIAL EFFUSION 1/202 (0.50%)', ' CATARACT 1/202 (0.50%)', ' OPTIC NEUROPATHY 0/202 (0.00%)', ' ABDOMINAL PAIN 0/202 (0.00%)', ' CONSTIPATION 0/202 (0.00%)', ' DIARRHOEA 5/202 (2.48%)', 'Adverse Events 2:', ' Total: 42/201 (20.90%)', ' FEBRILE NEUTROPENIA 0/201 (0.00%)', ' LEUKOPENIA 1/201 (0.50%)', ' NEUTROPENIA 0/201 (0.00%)', ' CARDIAC FAILURE CONGESTIVE 1/201 (0.50%)', ' CARDIO-RESPIRATORY ARREST 0/201 (0.00%)', ' PERICARDIAL EFFUSION 0/201 (0.00%)', ' CATARACT 1/201 (0.50%)', ' OPTIC NEUROPATHY 1/201 (0.50%)', ' ABDOMINAL PAIN 1/201 (0.50%)', ' CONSTIPATION 1/201 (0.50%)', ' DIARRHOEA 3/201 (1.49%)']}

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

a41bf7b0-9a09-4ce0-8832-f13758581f20

Single

Adverse Events

NCT00130533

Less than 0.25% of patients in cohort 1 of the primary trial suffered from Hyperbilirrubinemia.

Entailment

{'Clinical Trial ID': 'NCT00130533', 'Intervention': ['INTERVENTION 1: ', ' Xeloda (Capecitabine)', ' 1000 mgrs/m2 twice a day, tablets, 8 cycles', 'Capecitabine', 'INTERVENTION 2: ', ' Observation', ' Observation. No intervention.'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent.', ' Histological diagnoses of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 negative. Time window between end of adjuvant chemotherapy and study randomization must be less than 8 weeks. In patients receiving adjuvant radiotherapy, time window allowed between last session and randomisation is 4 weeks.', ' Surgery must consist of mastectomy or conservative surgery with axillary lymph node dissection. Margins free of disease and ductal carcinoma in-situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.', ' Node negative patients with tumour size > 2 cm.', ' Positive axillary lymph nodes defined as at least 1 out of 6 nodes with presence of disease. If sentinel node technique is used, sentinel node can be the only node affected. Patients belonging to the following classifications are eligible: pN1a (Metastases in 1-3 axillary lymph nodes, at least one metastasis greater than 2.0 mm), pN2a (Metastases in 4-9 axillary lymph nodes (at least one tumor deposit greater than 2 mm)), pN3a (Metastases in 10 or more axillary lymph nodes [at least one tumor deposit greater than 2 mm]; or metastases to the infraclavicular [level III axillary lymph] nodes).', ' Status of hormone receptors in primary tumour. Negative results must be available before the end of adjuvant chemotherapy.', ' Patients must not present evidence of metastatic disease.', ' Negative status of HER2 in primary tumour, known before randomization.', ' Adjuvant chemotherapy consisting of a minimum of 6 courses with anthracyclines and/or taxanes.', ' Age >= 18 and <= 70 years old.', ' Performance status (Karnofsky index) >= 80.', ' Laboratory results (within 14 days prior to randomization):', ' Hematology:', ' neutrophils >= 1.5 x 10e9/l;', ' platelets >= 100x 10e9/l;', ' hemoglobin >= 10 mg/dl', ' Hepatic function:', ' total bilirubin <= 1 upper normal limit (UNL);', ' Aspartate aminotransferase (AST or SGOT) and Alanine aminotransferase (ALT or SGPT) <= 2.5 UNL;', ' alkaline phosphatase <= 2.5 UNL.', ' If values of SGOT and SGPT > 1.5 UNL are associated to alkaline phosphatase > 2.5 UNL, patient is not eligible.', ' Renal Function:', ' creatinine <= 175 µmol/l (2 mg/dl).', ' creatinine clearance >= 60 ml/min.', ' Pharmacogenetics:', ' one blood sample is needed for single nucleotide polymorphism (SNP) assessment.', ' Patients able to comply with treatment and study follow-up.', ' Negative pregnancy test done in the 14 previous days to randomization.', 'Exclusion Criteria:', ' Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.', ' Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments. Negative pregnancy test in the 14 previous days to randomization.', ' Bilateral invasive breast cancer.', ' Any T4 or M1 tumour.', ' Axillary lymph nodes: patients belonging to the following classifications are excluded: pN1b (Metastases in internal mammary nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected), pN1c (Metastases in 1-3 axillary lymph nodes and in internal mammary lymph nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected), pN2b (Metastases in clinically detected internal mammary lymph nodes in the absence of axillary lymph node metastases), pN3b (Metastases in clinically detected ipsilateral internal mammary lymph nodes in the presence of one or more positive axillary lymph nodes; or in more than three axillary lymph nodes and in internal mammary lymph nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected), pN3c (Metastases in ipsilateral supraclavicular lymph nodes).', ' Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled hypertension or high risk arrhythmias.', ' History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.', ' Active uncontrolled infection.', ' Active peptic ulcer, unstable diabetes mellitus.', ' Previous or current history of neoplasms different to breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumour curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.', ' History of hypersensitivity to capecitabine, fluorouracil.', ' Patients lacking physical integrity of upper gastrointestinal tract or with history of bad absorption syndrome.', ' History of dihydropyrimidine dehydrogenase (DPD) deficiency.', ' Anticoagulant treatment with coumadin anticoagulants.', ' Current treatment with sorivudine or its chemical family.', ' Concomitant treatment with other investigational products. Participation in other clinical trials with a non-marketed drug in the 30 previous days before randomization.', ' Concomitant treatment with other therapy for cancer.', 'Males.'], 'Results': ['Outcome Measurement: ', ' Disease Free Survival (DFS) Events', ' DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Xeloda (Capecitabine)', ' Arm/Group Description: 1000 mgrs/m2 twice a day, tablets, 8 cycles', ' Capecitabine', ' Overall Number of Participants Analyzed: 448', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 105 23.4%', 'Results 2: ', ' Arm/Group Title: Observation', ' Arm/Group Description: Observation. No intervention.', ' Overall Number of Participants Analyzed: 428', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 120 28.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 23/436 (5.28%)', ' Neutropenia G 3; Leucopenia G2 1/436 (0.23%)', ' Hyperbilirrubinemia [1]1/436 (0.23%)', ' Supraventricular arrhythmia NOS [2]1/436 (0.23%)', ' Heart failure [2]0/436 (0.00%)', ' Infarction and cardiac arrest 0/436 (0.00%)', ' Ischemia cardiac/Infarction [3]1/436 (0.23%)', ' Coronary vasospam [3]1/436 (0.23%)', ' Gastroenteritis and renal insuficience 1/436 (0.23%)', 'Adverse Events 2:', ' Total: 6/425 (1.41%)', ' Neutropenia G 3; Leucopenia G2 0/425 (0.00%)', ' Hyperbilirrubinemia [1]0/425 (0.00%)', ' Supraventricular arrhythmia NOS [2]0/425 (0.00%)', ' Heart failure [2]1/425 (0.24%)', ' Infarction and cardiac arrest 1/425 (0.24%)', ' Ischemia cardiac/Infarction [3]0/425 (0.00%)', ' Coronary vasospam [3]0/425 (0.00%)', ' Gastroenteritis and renal insuficience 0/425 (0.00%)']}

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

5f2d2015-eaf9-45a8-9583-fddbc9807287

Comparison

Eligibility

NCT03273426

NCT01091168

Patients with dementia or schizophrenia may be eligible for the primary trial and the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT03273426', 'Intervention': ['INTERVENTION 1: ', ' Core Needle Biopsy', ' Ultrasound-guided core needle biopsy (14G, 5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.', 'INTERVENTION 2: ', ' Vacuum-assisted Biopsy', ' Vacuum-assisted biopsy (10G, 5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.'], 'Eligibility': ['Inclusion Criteria:', ' Patients', ' with unilateral primary cancer pathologically confirmed before neoadjuvant chemotherapy (NAC)', ' who received NAC', ' with detectable lesion / clip marker on ultrasound', ' with cT1-T3 tumors', ' clinical and imaging complete or near-complete response on MRI', ' with informed consent', 'Exclusion Criteria:', ' Multifocal cancer', ' Residual microcalcification', ' Contralateral breast cancer'], 'Results': ['Outcome Measurement: ', ' Negative Predictive Value', ' Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR', ' Time frame: 2 weeks', 'Results 1: ', ' Arm/Group Title: Core Needle Biopsy', ' Arm/Group Description: Ultrasound-guided core needle biopsy (14G, 5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.', ' Overall Number of Participants Analyzed: 17', ' Measure Type: Number', ' Unit of Measure: percentage of participants 88.2 (71.94 to 95.64)', 'Results 2: ', ' Arm/Group Title: Vacuum-assisted Biopsy', ' Arm/Group Description: Vacuum-assisted biopsy (10G, 5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Number', ' Unit of Measure: percentage of participants 85.7 (64.37 to 95.22)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/20 (0.00%)', 'Adverse Events 2:', ' Total: ']}

{'Clinical Trial ID': 'NCT01091168', 'Intervention': ['INTERVENTION 1: ', ' Vinflunine', ' Patients randomised in the test arm (arm A) received VFL at the dose of 280 mg/m² on day 1 of each cycle every 3 weeks, over a 20-minute intravenous (IV) infusion. Cycles were repeated every 3 weeks.', ' vinflunine: 280 mg/m2 on day 1 of each cycle every 3 weeks', 'INTERVENTION 2: ', ' Alkylating Agent', ' Patients randomised in the control arm (arm B) received an alkylating agent used as a single agent which was available in the investigational center and was approved for the treatment of cancer in the country.', ' Alkylating agent of physician choice registered in cancer: cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin'], 'Eligibility': ['Inclusion Criteria:(main conditions)', ' Female patients 18 to 75 years of age with metastatic breast cancer histologically/cytologically confirmed not amenable to curative surgery or radiotherapy and who have received at least two prior chemotherapy regimens including anthracyclines,taxanes,antimetabolite and vinca-alkaloid and are no longer candidate for these drugs,', ' Karnofsky performance score of at least 70 %, adequate haematological, hepatic and renal functions and ECG without clinically relevant abnormality.', 'Exclusion Criteria:', ' Concurrent serious uncontrolled medical disorder,', ' known or clinical evidence of brain metastases or leptomeningeal involvement,', ' pulmonary lymphangitis or symptomatic pleural effusion or symptomatic ascites,', ' history of second primary malignancy,', ' HIV infection, preexisting neuropathy,', ' pregnancy or breast feeding.'], 'Results': ['Outcome Measurement: ', ' Overall Survival', ' The main endpoint of this study is overall survival defined as the time from randomisation to the date of death or last follow-up. For patients who have not died, survival duration will be censored at the date of last contact or last follow-up or the date of last news.', ' Time frame: From baseline up to 3 years 1 month', 'Results 1: ', ' Arm/Group Title: Vinflunine', ' Arm/Group Description: Patients randomised in the test arm (arm A) received VFL at the dose of 280 mg/m on day 1 of each cycle every 3 weeks, over a 20-minute intravenous (IV) infusion. Cycles were repeated every 3 weeks.', ' vinflunine: 280 mg/m2 on day 1 of each cycle every 3 weeks', ' Overall Number of Participants Analyzed: 298', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.1 (7.7 to 10.4)', 'Results 2: ', ' Arm/Group Title: Alkylating Agent', ' Arm/Group Description: Patients randomised in the control arm (arm B) received an alkylating agent used as a single agent which was available in the investigational center and was approved for the treatment of cancer in the country.', ' Alkylating agent of physician choice registered in cancer: cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin', ' Overall Number of Participants Analyzed: 296', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.3 (7.5 to 10.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 82/297 (27.61%)', ' Neutropenia 6/297 (2.02%)', ' Anaemia 6/297 (2.02%)', ' Febrile neutropenia 3/297 (1.01%)', ' Thrombocytopenia 1/297 (0.34%)', ' Endocardititis staphylococcal 1/297 (0.34%)', ' Arteriospasm coronary 1/297 (0.34%)', ' Atrial fibrillation 1/297 (0.34%)', ' Cardiac failure 0/297 (0.00%)', ' Constipation 5/297 (1.68%)', ' Vomiting 6/297 (2.02%)', ' Abdominal pain 4/297 (1.35%)', 'Adverse Events 2:', ' Total: 66/290 (22.76%)', ' Neutropenia 0/290 (0.00%)', ' Anaemia 0/290 (0.00%)', ' Febrile neutropenia 1/290 (0.34%)', ' Thrombocytopenia 2/290 (0.69%)', ' Endocardititis staphylococcal 0/290 (0.00%)', ' Arteriospasm coronary 0/290 (0.00%)', ' Atrial fibrillation 1/290 (0.34%)', ' Cardiac failure 1/290 (0.34%)', ' Constipation 0/290 (0.00%)', ' Vomiting 3/290 (1.03%)', ' Abdominal pain 1/290 (0.34%)']}

609ddd08-ebd5-4661-be43-874b65dbfe52

Comparison

Eligibility

NCT00322348

NCT00429572

the primary trial and the secondary trial use ECOG to evaluate potential candidates' performance status.

Contradiction

{'Clinical Trial ID': 'NCT00322348', 'Intervention': ['INTERVENTION 1: ', ' ZOLADEX 10.8 mg', ' ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks', 'INTERVENTION 2: ', ' ZOLADEX 3.6 mg', ' ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed oestrogen receptor positive (ER +ve) breast cancer', ' World Health Organization (WHO) performance status of 0, 1, or 2', ' Provided written informed consent', 'Exclusion Criteria:', ' Treatment with tamoxifen or other hormonal therapies as early breast cancer (EBC) adjuvant in the previous 24 weeks', ' Received radiotherapy within the past 4 weeks', ' History of systemic malignancy other than breast cancer within the previous 3 years', ' Estimated survival less than 24 weeks'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Progression Free Survival (PFS) at Week 24', ' The number of participants for whom neither objective disease progression or death (due to any cause) has been observed at Week 24 over the number of randomised participants x 100.', ' Time frame: Objective tumour assessments carried out every 12 weeks (+/- 7 days) until Week 24, and then every 24 weeks (+/- 14 days) until Week 96 or objective progression is confirmed according to Response Evaluation Criteria in Solid Tumours (RECIST).', 'Results 1: ', ' Arm/Group Title: ZOLADEX 10.8 mg', ' Arm/Group Description: ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 69.4', 'Results 2: ', ' Arm/Group Title: ZOLADEX 3.6 mg', ' Arm/Group Description: ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 73.5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/50 (4.00%)', ' Peritonsillar Abscess 0/50 (0.00%)', ' Humerus Fracture 1/50 (2.00%)', ' Endometrial Hyperplasia 1/50 (2.00%)', ' Haematoma 0/50 (0.00%)', 'Adverse Events 2:', ' Total: 3/48 (6.25%)', ' Peritonsillar Abscess 1/48 (2.08%)', ' Humerus Fracture 0/48 (0.00%)', ' Endometrial Hyperplasia 1/48 (2.08%)', ' Haematoma 1/48 (2.08%)']}

{'Clinical Trial ID': 'NCT00429572', 'Intervention': ['INTERVENTION 1: ', ' Allogeneic Transplantation', ' Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.'], 'Eligibility': ['Inclusion Criteria:', ' Recurrent or residual metastatic breast carcinoma', ' Zubrod performance status less than 2', ' 18-60 years old', ' Related donor human leukocyte antigen (HLA)-compatible for allogeneic transplantation or unrelated HLA-compatible donor.', ' No major organ dysfunction or active infection', 'Exclusion Criteria: None'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Tumor Response', ' Best response recorded from start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria of Complete Response: disappearance of all disease/symptoms > 4 weeks; Partial response, > 50% reduction in sum of products of diameters of each measurable lesion for more than 4 weeks; Stable Disease, no change in tumor size; and Progressive Disease, appearance of new lesions or > 25% increase in sum of products of diameters of any measurable lesions.', ' Time frame: Baseline to measured progressive disease (post study follow-up period 24 months starting from the date of the last drug administration). Data collected every 4 months.', 'Results 1: ', ' Arm/Group Title: Allogeneic Transplantation', ' Arm/Group Description: Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.', ' Overall Number of Participants Analyzed: 18', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 5', ' Stable Disease: 9', ' Partial Response: 1', ' Progressive Disease: 3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/19 (0.00%)']}

b6ac985d-87ae-4e0f-83e1-38033c1db5cc

Single

Results

NCT00431067

More than 5% of the primary trial participants achieved Objective Response (OR).

Entailment

{'Clinical Trial ID': 'NCT00431067', 'Intervention': ['INTERVENTION 1: ', ' Afatinib 50 mg', ' Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.'], 'Eligibility': ['Inclusion criteria:', 'Inclusion Criteria:', ' Male or female patients with confirmed diagnosis of Stage IIIB or IV HER2-positive metastatic breast cancer(HER2 2+ and FISH positive or HER2 3+).', ' Patients must have progressed following receipt of prior standard trastuzumab treatment or standard chemotherapy in conjunction with trastuzumab. Patients with visceral disease or rapid progression should not be included if they have not had previous chemotherapy in addition to trastuzumab. Patients who are intolerant to trastuzumab and who have received adequate chemotherapy and/or hormone therapy are eligible upon progression.', ' Age 18 years or older.', ' Life expectancy of at least four (4) months.', ' Written informed consent that is consistent with ICH-GCP guidelines.', ' Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2.', ' Patients should not have received treatment with chemotherapy or immune therapy within the last 4 weeks (2 weeks for trastuzumab). Patients should not have received treatment with hormone therapy within the last 2 weeks.', ' Patients must have recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC less than or equal to Grade 1.', ' Patients must have recovered from previous surgery.', ' Patients must have measurable disease as defined by RECIST criteria.', 'Exclusion criteria:', 'Exclusion Criteria:', ' Active infectious disease.', ' Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.', ' Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.', ' Patients with active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal MRI scan at screening and be at least three months post-radiation or surgery.', ' Cardiac left ventricular function with resting ejection fraction <50%.', ' Absolute neutrophil count (ANC) less than 1500 cells/mm3.', ' Platelet count less than 100 000 cells/mm3.', ' Bilirubin greater than 1.5 mg/dl (>26 micromol /L, SI unit equivalent).', ' Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than three times the upper limit of normal.', ' Serum creatinine greater than 1.5 mg/dl (>132 micromol/L, SI unit equivalent).', ' Women and men (and their partners) who are sexually active and unwilling to use a medically acceptable method of contraception.', ' Pregnancy or breast-feeding.', ' Treatment with other investigational drugs; chemotherapy, immunotherapy, radiotherapy or hormone therapy (including LHRH agonists, or other hormones taken for breast cancer), or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study. Treatment with bisphosphonates is allowed.', ' Prior treatment with an EGFR- or HER2 inhibiting drug (except trastuzumab).', ' Patients unable to comply with the protocol.', ' Active alcohol or drug abuse.', ' Patients with history of other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least 3 years.'], 'Results': ['Outcome Measurement: ', ' Objective Response (OR)', ' Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .', ' Time frame: From first dose of study medication to response measurement, up to 34 month', 'Results 1: ', ' Arm/Group Title: Afatinib 50 mg', ' Arm/Group Description: Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.', ' Overall Number of Participants Analyzed: 41', ' Measure Type: Number', ' Unit of Measure: Participants 4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/41 (19.51%)', ' Constipation 1/41 (2.44%)', ' Diarrhoea 1/41 (2.44%)', ' Nausea 2/41 (4.88%)', ' Vomiting 3/41 (7.32%)', ' Biliary colic 1/41 (2.44%)', ' Diarrhoea infectious 1/41 (2.44%)', ' International normalised ratio decreased 1/41 (2.44%)', ' Dehydration 2/41 (4.88%)', ' Hyponatraemia 1/41 (2.44%)', ' Malignant neoplasm progression 2/41 (4.88%)', ' Headache 1/41 (2.44%)']}

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

43ff9425-5e6e-4a85-a8ca-0c0c67a96623

Single

Intervention

NCT00470301

Every patient in the primary trial is given tipifarnib PO, along with paclitaxel, doxorubicin hydrochloride and acyclophosphamide IV, but only a subset of participants undergo axillary lymph node dissection.

Contradiction

{'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': ''}

b3ccde30-cdfc-4e18-aee0-8b3a921dde39

Comparison

Adverse Events

NCT00191815

NCT01301729

None of the patients in the primary trial or the secondary trial committed suicide.

Contradiction

{'Clinical Trial ID': 'NCT00191815', 'Intervention': ['INTERVENTION 1: ', ' Gemcitabine + Cisplatin', ' Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).', ' Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).'], 'Eligibility': ['Inclusion Criteria:', ' You are female in the age of 18 to 75 years old.', ' You have been diagnosed with the metastatic breast cancer.', ' You have desire and an opportunity to visit your doctor in medical site, both during realization of the active treatment program, and within 24 months of medical follow up.', ' You must sign this informed consent form', 'Exclusion Criteria:', ' You are pregnant or breastfeeding.', ' Your laboratory parameters fall outside the limits, admitted by requirements of the present clinical study.', ' You have been diagnosed with serious concomitant or acute infectious disease.', ' You have used experimental medications within the last month.'], 'Results': ['Outcome Measurement: ', ' Objective Tumor Response', ' Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.', ' Time frame: baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)', 'Results 1: ', ' Arm/Group Title: Gemcitabine + Cisplatin', ' Arm/Group Description: Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).', ' Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).', ' Overall Number of Participants Analyzed: 54', ' Measure Type: Number', ' Unit of Measure: participants Complete Response: 7', ' Partial Response: 19', ' Stable Disease: 19', ' Progressive Disease: 5', 'Not Assessable: 4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6', ' Atrial fibrillation 1/67 (1.49%)', ' Ventricular fibrillation 1/67 (1.49%)', ' Gastrointestinal perforation 1/67 (1.49%)', ' Periproctitis 1/67 (1.49%)', ' General physical health deterioration 1/67 (1.49%)', ' Escherichia sepsis 1/67 (1.49%)', ' Pneumonia 1/67 (1.49%)', ' Tumour pain 1/67 (1.49%)', ' Renal failure acute 1/67 (1.49%)', ' Pleurisy 1/67 (1.49%)']}

{'Clinical Trial ID': 'NCT01301729', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab', ' Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.'], 'Eligibility': ['Inclusion Criteria:', ' Female participants , >/= 18 years of age', ' Locally recurrent/metastatic breast cancer (relapse in supra- or infraclavicular lymph nodes is regarded as metastatic disease)', ' HER2-positive primary disease', ' Participants must have received Herceptin in the adjuvant and/or neoadjuvant setting', ' Relapsed breast cancer >/= 6 months after discontinuing last drugs of Herceptin and/or chemotherapy in the adjuvant and/or neoadjuvant setting for HER2-positive breast cancer', ' Measurable disease according to RECIST 1.0', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2', ' Maximum cumulative dose of doxorubicin </= 360 mg/m2 or of epirubicin </= 720 mg/m2 or no prior anthracyclines', ' At least 3 weeks after prior surgery or radiotherapy', 'Exclusion Criteria:', ' Pregnant or breastfeeding women', ' Previous chemotherapy for metastatic breast cancer (prior endocrine therapy till progressive disease is allowed)', ' Pleural effusions, ascites or bone lesions as only manifestation of disease', ' Brain metastases', ' Invasive malignancy other than metastatic breast cancer', ' Inadequate bone marrow, hepatic or renal function', ' Prior treatment with anti-HER therapies other than (neo)adjuvant Herceptin'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 and was defined as the time from the date when the participant signed the informed consent form (ICF) until death or progressive disease (PD). PD was defined as 20% increase in the sum of the longest diameter of target lesions. PFS and associated confidence intervals were calculated using the Kaplan-Meier method.', ' Time frame: From the date of informed consent to the date of death or progressive disease (up to 28 months)', 'Results 1: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.', ' Overall Number of Participants Analyzed: 32', ' Median (95% Confidence Interval)', ' Unit of Measure: months 9.9 (6.28 to 13.63)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/32 (15.63%)', ' Leukopenia 1/32 (3.13%)', ' Neutropenia 1/32 (3.13%)', ' Cataract 1/32 (3.13%)', ' Infection 1/32 (3.13%)', ' Upper respiratory tract infection 1/32 (3.13%)', ' Completed suicide 1/32 (3.13%)']}

8697a59e-0f1c-452a-b15a-6d24e2df387f

Single

Eligibility

NCT02721147

Stephanie has been living with her husband for 31 years, she is eligible for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT02721147', 'Intervention': ['INTERVENTION 1: ', ' Participants Eligible For Enrollment', ' Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.'], 'Eligibility': ['Inclusion Criteria:', ' Female', ' Age > 21 years', ' Has diagnosis of non-recurrent stage I-III breast cancer', ' Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)', ' Has a partner or spouse who is > 21', ' Lives with a romantic partner > 6 months', ' Score of > 3 on Patient Care Monitor Sexual Concerns screening item', ' No hearing impairment in patient or partner', 'Exclusion Criteria:', ' Not able to speak English, as stated in medical record or as observed by study team member', ' ECOG Performance score > 2 OR too ill to participate as judged by physician/in medical record', ' Overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, referring source, or other qualified observer.', ' Past history of any cancer other than non-melanoma skin cancer', ' Currently participating in couple/marital therapy', 'Currently pregnant'], 'Results': ['Outcome Measurement: ', ' Feasibility of the Treatment as Measured Through Study Accrual', ' Feasibility is measured through the percentage of study eligible individuals who enrolled in the intervention study (i.e., acceptance rate).', ' Time frame: Up to 8 weeks', 'Results 1: ', ' Arm/Group Title: Participants Eligible For Enrollment', ' Arm/Group Description: Feasibility is measured before randomization through the percentage of participants enrolled out of the number of individuals approached for the study.', ' Overall Number of Participants Analyzed: 182', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 62 34.1%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/40 (0.00%)']}

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

4ab74186-5f4e-4139-af05-d4a9871a251d

Single

Adverse Events

NCT00432172

All of the adverse events recorded in the primary trial were cardiac related.

Contradiction

{'Clinical Trial ID': 'NCT00432172', 'Intervention': ['INTERVENTION 1: ', ' Group 2 (Basal) Standard Treatment', ' Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.', 'INTERVENTION 2: ', ' Group 2 (Basal) Selective Treatment', ' Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent.', ' Breast cancer with histological diagnosis.', ' Negative Human Epidermal Growth Factor Receptor 2 (HER2) tumours defined as immunohistochemistry (IHQ) 0,1+.', ' No evidence of suspicion of metastatic disease.', ' Age >= 18 years old.', ' Performance status (Karnofsky index) >= 80 (ECOG 0,1).', ' Adequate cardiac function by ECG in the previous 12 weeks.', ' Hematology: neutrophils >= 1,5 x10^9/l; platelets >= 100 x10^9/l; hemoglobin >= 10 g/dl.', ' Adequate hepatic function: total bilirubin <= 1x Upper Normal Limit (UNL); Aspartate aminotransferase (AST) (SGOT) and Alanine aminotransferase (ALT) (SGPT) <= 2.5 x UNL; alkaline phosphatase <= 2.5 x UNL.', ' Adequate renal function: creatinine <= 1 x UNL; creatinine clearance >= 60 ml/min.', ' Patients able to comply with study treatment and follow-up.', ' Negative pregnancy test in the previous 14 days.', 'Exclusion Criteria:', ' HER2 positive tumours (defined as IHQ 3+ or positive fluorescence in situ hybridization [FISH]).', ' Prior systemic therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).', ' Prior treatment with anthracyclines or taxanes (paclitaxel, docetaxel) for any previous malignancy.', ' Prior radiotherapy for breast cancer.', ' Bilateral invasive breast cancer.', ' Pregnant or lactating women.', ' Previous grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria [NCICTC]).', ' Other serious comorbidities: congestive heart failure or unstable angina; prior history of myocardial infarction in previous year; uncontrolled hypertension (HT); high risk arrhythmias; history of significant neurological or psychiatric disorders; uncontrolled active infection; active peptic ulcer; unstable diabetes mellitus; dyspnea at rest; or chronic therapy with oxygen.', ' Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumor curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.', ' Chronic treatment with corticosteroids.', ' Contraindications for administration of corticosteroids.', ' Concomitant treatment with other therapy for cancer.', 'Males.'], 'Results': ['Outcome Measurement: ', ' Pathological Response for Basal Group 2', ' This primary outcome only applies for the basal group 2 as per protocol. The pathological response in luminal group 1 was not pre-specified even as a Secondary Outcome. Pathological response was assessed after surgery, according to the Miller & Payne criteria, which stratifies the responses based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in breast and axilla. Grades 1-4 are categorised as a partial pathological response (pPR) and grade 5 was a complete pathological response (cPR).', ' Time frame: Up to 24 weeks', 'Results 1: ', ' Arm/Group Title: Group 2 (Basal) Standard Treatment', ' Arm/Group Description: Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.', ' Overall Number of Participants Analyzed: 46', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade 5: 16 34.8%', ' Grade 4: 5 10.9%', ' Grade 3: 11 23.9%', ' Grade 2: 8 17.4%', ' Grade 1: 5 10.9%', ' Not available: 1 2.2%', 'Results 2: ', ' Arm/Group Title: Group 2 (Basal) Selective Treatment', ' Arm/Group Description: Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.', ' Overall Number of Participants Analyzed: 47', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Grade 5: 14 29.8%', ' Grade 4: 11 23.4%', ' Grade 3: 8 17.0%', ' Grade 2: 9 19.1%', ' Grade 1: 4 8.5%', ' Not available: 1 2.1%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/45 (11.11%)', ' Neutrophils/granulocytes (ANC/AGC) * [1]0/45 (0.00%)', ' Neutrophils/granulocytes (ANC/AGC) * [2]0/45 (0.00%)', ' Diabetes decompensation * 0/45 (0.00%)', ' Diarrhea * [2]0/45 (0.00%)', ' Mucositis/stomatitis and Vomiting * [3]0/45 (0.00%)', ' Pancreatitis * [4]1/45 (2.22%)', ' Febrile neutropenia * [2]3/45 (6.67%)', 'Adverse Events 2:', ' Total: 0/46 (0.00%)', ' Neutrophils/granulocytes (ANC/AGC) * [1]0/46 (0.00%)', ' Neutrophils/granulocytes (ANC/AGC) * [2]0/46 (0.00%)', ' Diabetes decompensation * 0/46 (0.00%)', ' Diarrhea * [2]0/46 (0.00%)', ' Mucositis/stomatitis and Vomiting * [3]0/46 (0.00%)', ' Pancreatitis * [4]0/46 (0.00%)', ' Febrile neutropenia * [2]0/46 (0.00%)', ' Infection pulmonary/ Upper airway NOS * [5]0/46 (0.00%)']}

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

082ee581-f420-4892-b098-ce82c6ad0210

Single

Eligibility

NCT00982319

Pre and Post menopausal women can enter the primary trial, as long as they do not have prior hormone replacement therapy.

Entailment

{'Clinical Trial ID': 'NCT00982319', 'Intervention': ['INTERVENTION 1: ', ' Broccoli Sprout Extract and Mango Juice', ' Patients will be randomized to 14 day intervention of broccoli sprout extract consisting of a consistent dose of sulforaphane dissolved in mango juice. All women will be on a cruciferous free diet for the duration of the study (14 days).', 'INTERVENTION 2: ', ' Mango Juice Without Extract', ' Patients will be randomized to 14 day intervention of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days).'], 'Eligibility': ['Inclusion Criteria:', ' Female 18 + years of age', ' Confirmed diagnosis of DCIS on core or excisional/incisional biopsy and scheduled for definitive surgery', ' Pre or Post menopausal women reporting no use of hormone replacement therapy, tamoxifen or raloxifene within the prior 6 months to eligibility screening', ' Agree to avoid cruciferous vegetable/condiment intake for 14 days', ' Agree to sign an informed consent and allow use of some tissue (slides) from biopsy and definitive surgery for research purposes', 'Exclusion Criteria:', ' Prior cancer diagnosis other than non-melanomatous skin cancer or cervical carcinoma in-situ', ' Used hormone replacement therapy, tamoxifen or raloxifene within the past 6 months prior to eligibility screening', ' Used antibiotics within 10 days prior to beginning cruciferous free diet (day -14 prior to surgery)', ' Smoked within the past 12 months prior to eligibility screening;', ' Active infection or inflammation of the breast at time of eligibility screening', ' Has baseline comprehensive metabolic panel (CMP) [Glucose, Calcium, Albumin, Serum total protein (TP), Sodium, Potassium, Carbon dioxide, Chloride, Blood urea nitrogen (BUN), Creatinine, Alkaline phosphatase (ALP), Alanine amino transferase (AST), Aspartate amino transferase (SGOT), and Bilirubin], prothrombin time (PT) and , complete blood count (CBC) values that are 1.5 times in either direction the reported normal range'], 'Results': ['Outcome Measurement: ', ' Absolute Change in Mean Proliferative Rate Measured by Ki67%', ' Pathologists score the slides without knowledge of treatment assignment at the end of the study. All pre-post samples from one individual will be evaluated together. Quality control for these stains is performed routinely in the immunohistochemistry lab (using lymphoid tissue for Ki67). Initial scoring is performed where possible on a minimum of 3000 cells, by counting the number of positive cells divided by the total number of cells. DCIS lesions will be scored separately to adjacent normal tissue. The rationale for selecting Ki67 as a measure of cellular proliferation includes the robustness of the staining reaction, correlation with the S phase fraction of the cell cycle and mitotic index and that it can be successfully ascertained from core breast biopsies provided there is an adequate yield of epithelial cells. A negative value reflects a decrease in ki67 positive cells, therefore a decrease in cellular proliferation.', ' Time frame: Change from baseline to 14 days post-intervention', 'Results 1: ', ' Arm/Group Title: Broccoli Sprout Extract and Mango Juice', ' Arm/Group Description: Patients will be randomized to 14 day intervention of broccoli sprout extract consisting of a consistent dose of sulforaphane dissolved in mango juice. All women will be on a cruciferous free diet for the duration of the study (14 days).', ' Overall Number of Participants Analyzed: 15', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of Ki67 -1.15 (2.08)', 'Results 2: ', ' Arm/Group Title: Mango Juice Without Extract', ' Arm/Group Description: Patients will be randomized to 14 day intervention of mango juice alone. All women will be on a cruciferous free diet for the duration of the study (14 days).', ' Overall Number of Participants Analyzed: 15', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of Ki67 4 (17.08)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/15 (0.00%)', 'Adverse Events 2:', ' Total: ']}

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

7bf084eb-873a-4011-9b98-3a899ee582ee

Comparison

Intervention

NCT01575522

NCT00181363

the primary trial and the secondary trial are testing completely different modalities of interventions, but utilising the same 21 day cycle.

Contradiction

{'Clinical Trial ID': 'NCT01575522', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Tivantinib)', ' Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.', ' Laboratory Biomarker Analysis: Correlative studies', ' Tivantinib: Given PO'], 'Eligibility': ['Inclusion Criteria:', ' Participants must have histologically or cytologically confirmed invasive breast cancer, with recurrent or metastatic disease; participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation', ' Participants 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 for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan', ' Participants must have recent evidence of progressive disease', ' Participants must have received 1-3 prior chemotherapeutic regimens for metastatic breast cancer and must have been off treatment with chemotherapy for at least 14 days before enrollment in the study', ' Participants must have discontinued all biologic therapy (including vaccines) at least 14 days before enrollment in the study', ' Participants must have discontinued any investigational therapy at least 14 days before enrollment in the study', ' Participants may have received prior radiation therapy in either the metastatic or early-stage setting', ' Radiation therapy must be completed at least 14 days before enrollment in the study', ' Participant must not have received radiation to > 25% of his or her bone marrow within 30 days of starting study treatment', ' Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)', ' Hemoglobin >= 9.0 g/dL', ' Absolute neutrophil count >= 1,500/mcL', ' Platelets >= 100,000/mcL', ' Total bilirubin =< 1.5 times upper limit of normal (ULN)', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 times institutional ULN; for participants with documented liver metastases, AST/ALT =< 5.0 times ULN', ' Serum creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal', ' Either the primary tumor and/or the metastasis must be triple-negative; the invasive tumor must be hormone-receptor poor, defined as estrogen-receptor negative (ER-) and progesterone-receptor negative (PR-), or staining < 10% by immunohistochemistry (IHC)', ' Human epidermal growth factor receptor 2 (HER2) status: the invasive tumor must be HER2-negative, defined as 0 or 1+ by IHC, or FISH < 2.0', ' Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the study and for 90 days after the last investigational drug dose received', ' Female subjects of childbearing potential must have a negative serum pregnancy test within 21 days of cycle 1 day 1', ' Participants on bisphosphonates may continue receiving bisphosphonate therapy during study treatment; bisphosphonate therapy may also be initiated on study treatment if needed', ' Confirmed availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Participants who have received chemotherapy, biologic, investigational, or radiotherapy within 14 days prior to entering the study', ' Participants who are receiving any other investigational agents', ' Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms', ' Participants with a history of treated central nervous system (CNS) metastases are eligible', ' Treated brain metastases are defined as those having no evidence of progression or hemorrhage for >= 2 months after treatment, and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging or computed tomography [CT] scan) during the screening period', ' Treatment for brain metastases may include whole-brain radiotherapy, radiosurgery, or a combination as deemed appropriate by the treating physician', ' Participants may be taking anti-convulsant medications, which must be non-enzyme-inducing anti-epileptic drugs', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to ARQ 197', ' History of congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification; active coronary artery disease (CAD); clinically significant bradycardia or other uncontrolled, cardiac arrhythmia defined as >= grade 3 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, or uncontrolled hypertension; myocardial infarction occurring within 6 months prior to study entry (myocardial infarction occurring > 6 months prior to study entry is permitted)', ' 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', ' Human immunodeficiency virus (HIV)-positive participants on combination antiretroviral therapy are ineligible'], 'Results': ['Outcome Measurement: ', ' PFS Status', ' Analyzed using the Kaplan-Meier method. 95% confidence intervals (CI) will be determined. 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: Time from start of treatment to time of progression or death, assessed up to 6 months', 'Results 1: ', ' Arm/Group Title: Treatment (Tivantinib)', ' Arm/Group Description: Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.', ' Laboratory Biomarker Analysis: Correlative studies', ' Tivantinib: Given PO', ' Overall Number of Participants Analyzed: 22', ' Median (95% Confidence Interval)', ' Unit of Measure: months 1.2 (1.0 to 1.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/22 (59.09%)', ' Constipation 1/22 (4.55%)', ' Death [1]3/22 (13.64%)', ' Neutropenia 1/22 (4.55%)', ' Anxiety 1/22 (4.55%)', ' Pleural effusion 1/22 (4.55%)', ' Cough 1/22 (4.55%)', ' Dyspnea 3/22 (13.64%)', ' Cellulitis 1/22 (4.55%)', ' Thromboembolic event 1/22 (4.55%)']}

{'Clinical Trial ID': 'NCT00181363', 'Intervention': ['INTERVENTION 1: ', ' Prone', 'Prone position', 'INTERVENTION 2: ', ' Supine', 'Supine position'], 'Eligibility': ['Inclusion Criteria:', ' Patients should have had breast-conserving surgery for breast cancer or DCIS (Ductal Carcinoma in Situ)', ' No indication for radiotherapy of regional nodes', ' Large, pendulous breasts (bra size D and over)', 'Exclusion Criteria:', ' Regional radiotherapy is indicated', ' Unable to lie in prone position'], 'Results': ['Outcome Measurement: ', ' Dose Homogeneity 1: PTV', ' Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) and normal tissues in prone position versus supine position', ' Time frame: 1 day after treatment planning', 'Results 1: ', ' Arm/Group Title: Prone', ' Arm/Group Description: Prone position', ' Overall Number of Participants Analyzed: 10', ' Mean (Standard Deviation)', ' Unit of Measure: Gy Dmin (Gy) PTV: 9.8 (6.7)', ' Dmean (Gy) PTV: 48.2 (1.2)', ' Dmax (Gy) PTV: 53.6 (0.6)', 'Results 2: ', ' Arm/Group Title: Supine', ' Arm/Group Description: Supine position', ' Overall Number of Participants Analyzed: 10', ' Mean (Standard Deviation)', ' Unit of Measure: Gy Dmin (Gy) PTV: 8.2 (5.6)', ' Dmean (Gy) PTV: 49.8 (0.8)', ' Dmax (Gy) PTV: 54.8 (1.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)', 'Adverse Events 2:', ' ']}

ef0406b4-34ad-4cbd-83a4-dd0f118c4d5a

Single

Eligibility

NCT00741260

Patients with ERBB2 positive tumors are eligible for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00741260', 'Intervention': ['INTERVENTION 1: ', ' N160 + C1500', ' Neratinib 160 mg + Capecitabine 1500 mg/m2', 'INTERVENTION 2: ', ' N160 + C2000', ' Neratinib 160 mg + Capecitabine 2000 mg/m2'], 'Eligibility': ['INCLUSION CRITERIA', ' PART 1:', ' confirmed pathologic diagnosis of a solid tumor not curable with available therapies for which neratinib plus capecitabine is a reasonable treatment option.', ' PART 2:', ' confirmed histologically and/or cytologically confirmed diagnosis of breast cancer, metastatic or locally advanced.', ' erbB-2 gene amplified tumor (FISH or CISH) or erbB-2 overexpression (IHC 3+, or IHC2+ with FISH or CISH confirmation), based on local testing, or based on centralized FISH testing prior to day 1.', ' disease progression on or following at least 1 prior trastuzumab containing treatment regimen (at least 6 weeks) for metastatic or locally advanced disease. (Prior adjuvant trastuzumab is allowed but not required). A 2 week period is required between the last dose of trastuzumab treatment and first dose of the test article.', ' Prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, and/or metastatic disease treatment setting.', ' PARTS 1 and 2:', ' At least 1 measurable lesion as defined by RECIST criteria.', ' LVEF within institutional range of normal as measured by multi-gated acquisition (MUGA) or echocardiogram (ECHO).', ' EXCLUSION CRITERIA', ' PART 2:', ' prior treatment with capecitabine, lapatinib (20 subjects with prior lapatinib exposure will be enrolled) or any erbB-2 targeted agents except trastuzumab. Treatment with erbB-2 targeted therapy must exceed 2 weeks (14 days) in order to be exclusionary.', ' prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m², epirubicin dose of greater than 800 mg/m², or the equivalent dose for other anthracyclines.', ' PARTS 1 and 2:', ' Subjects with bone as the only site of disease.', ' Active uncontrolled or symptomatic central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Subjects with a history of CNS metastases or cord compression are allowable if they have been considered definitively treated and are off anticonvulsants and steroids for at least 4 weeks before the first dose of test article.', ' Any other cancer within 5 years prior to screening with the exception of adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicities', ' Number of participants reporting Adverse Events Causing Dose Limiting Toxicities (DLT).', ' Time frame: From first dose date to day 21', 'Results 1: ', ' Arm/Group Title: N160 + C1500', ' Arm/Group Description: Neratinib 160 mg + Capecitabine 1500 mg/m2', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%', 'Results 2: ', ' Arm/Group Title: N160 + C2000', ' Arm/Group Description: Neratinib 160 mg + Capecitabine 2000 mg/m2', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 22.2%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/6 (83.33%)', ' Anaemia 0/6 (0.00%)', ' Febrile neutropenia 0/6 (0.00%)', ' Thrombocytopenia 0/6 (0.00%)', ' Pericardial effusion 1/6 (16.67%)', ' Tachycardia 0/6 (0.00%)', ' Vertigo 0/6 (0.00%)', ' Abdominal pain 0/6 (0.00%)', ' Ascites 0/6 (0.00%)', ' Diarrhoea 0/6 (0.00%)', ' Melaena 0/6 (0.00%)', ' Nausea 1/6 (16.67%)', ' Proctitis 0/6 (0.00%)', ' Small intestinal obstruction 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 4/8 (50.00%)', ' Anaemia 0/8 (0.00%)', ' Febrile neutropenia 0/8 (0.00%)', ' Thrombocytopenia 0/8 (0.00%)', ' Pericardial effusion 0/8 (0.00%)', ' Tachycardia 0/8 (0.00%)', ' Vertigo 0/8 (0.00%)', ' Abdominal pain 1/8 (12.50%)', ' Ascites 1/8 (12.50%)', ' Diarrhoea 0/8 (0.00%)', ' Melaena 0/8 (0.00%)', ' Nausea 0/8 (0.00%)', ' Proctitis 0/8 (0.00%)', ' Small intestinal obstruction 1/8 (12.50%)']}

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

06bc9cff-e9fc-42c7-a2a3-c01a036e04c6

Single

Results

NCT01268150

Most patients in the primary trial treated with Eribulin Mesylate did not achieve complete response (CR) or partial response (PR).

Entailment

{'Clinical Trial ID': 'NCT01268150', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate', ' Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.'], 'Eligibility': ['Key Inclusion Criteria', ' Females age 18 years or older at the time of informed consent', ' Have histologically or cytologically proven adenocarcinoma of the breast', ' Subjects with locally recurrent or metastatic disease with at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors', ' (RECIST) criteria v 1.1', ' Human epidermal growth factor receptor (HER2)-negative disease as determined by fluorescence in situ hybridization (FISH) or 0 or 1+ by immunohistochemical (IHC) staining.', ' Life expectancy of greater than 24 weeks', ' Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2', ' At least 12 months since prior neoadjuvant or adjuvant chemotherapy', ' At least 2 weeks since prior radiotherapy or endocrine therapy, with complete recovery from the effects of these interventions', ' Adequate renal function', ' Adequate bone marrow function', ' Adequate liver function', ' Key Exclusion Criteria', ' Subjects who meet any of the following criteria will be excluded from participation in this study:', ' Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic breast cancer', ' Subjects who have had a prior malignancy other than carcinoma in situ of the cervix or nonmelanoma skin cancer', ' Prior exposure of greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than720 mg/m2 epirubicin', ' Inflammatory breast cancer', ' Clinically significant cardiovascular impairment', ' Subjects with known CNS disease are not eligible, except for those with treated brain metastasis.', ' Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen', ' Currently pregnant or breast-feeding.', ' Subjects with pre-existing Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade 2 before enrollment.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' The ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Targeted lesions were assessed by computed tomography (CT) and magnetic resonance imaging (MRI) which were then assessed by the investigator based on RECIST. CR was defined as the disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters. Possible CR and PR had to be confirmed no fewer than 4 weeks after the initial response assessment. A brain and bone scan was performed by CT/MRI within 1 week after confirmation of a response to ensure no new metastases. To be assigned a status of CR or PR, changes in tumor measurements had to be confirmed by repeat evaluations, to be performed not fewer than 4 weeks after the response criteria were first met. ORR = CR + PR', ' Time frame: Cycle 1 (Day 1) until first evidence of disease progression, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate', ' Arm/Group Description: Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 28.6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/56 (30.36%)', ' Febrile neutropenia 3/56 (5.36%)', ' Leukopenia 1/56 (1.79%)', ' Neutropenia 3/56 (5.36%)', ' Pericardial effusion 1/56 (1.79%)', ' Supraventricular tachycardia 1/56 (1.79%)', ' Intestinal perforation 1/56 (1.79%)', ' Small intestinal obstruction 1/56 (1.79%)', ' Bronchitis 1/56 (1.79%)', ' Pyelonephritis 1/56 (1.79%)', ' Sepsis 1/56 (1.79%)', ' Urinary tract infection 1/56 (1.79%)']}

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

f6c85ce8-e0fc-4186-a961-6207dd4cacd2

Single

Eligibility

NCT02321527

Patients with invasive breast cancer with a diameter of less than 4 cm are included in the primary trial.

Entailment

{'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': ''}

5bdd61d9-aadf-4944-afe3-a04242d9c2b2

Single

Eligibility

NCT01252277

Fiona's sister, who is 34 years old was diagnosed with a ductal carcinoma, therefore fiona may be eligible for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01252277', 'Intervention': ['INTERVENTION 1: ', ' Lovaza™', ' Lovaza™: 4 capsules daily for 6 months'], 'Eligibility': ['Inclusion Criteria', ' Subjects must be premenopausal and between the ages of 25 and 54 and must have had a menstrual period within the past 12 months. Women who are not menstruating regularly due to use of certain types of contraceptives may be entered with restrictions. Their estrogen progesterone, and follicle stimulating hormone (FSH) levels must be documented at baseline random periareolar fine needle aspiration (RPFNA) and their off study RPFNA must take place at a similar portion of their cycle (high or low progesterone levels). In order to do this a serum progesterone will have to be obtained ~ 4 weeks before planned RPFNA and again 2 weeks later such that the RPFNA can be performed in the same phase of the "cycle" as baseline.', ' Subjects must be at increased risk for breast cancer on the basis of at least one of the following criteria:', ' A five-year Gail risk of 1.67% or three times the average risk for a woman of the same age using either the Surveillance Epidemiology and End Results (SEER, http://seer.cancer.gov) database or the NCI Breast Cancer Risk Assessment Tool (www.cancer.gov/bcrisktool)., or 10 yr Tyrer-Cuzick risk twice that of the population risk as listed in model, or RPFNA atypia', ' BMI <40 Kg/m3', ' A first degree relative with breast cancer under the age of 60 or multiple second degree relatives with breast cancer.', ' Multiple prior biopsies or at least one prior biopsy exhibiting atypical hyperplasia (AH), lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS).', ' RPFNA evidence of hyperplasia with atypia within the last three years;', ' Chest or neck radiation before age 30;', ' Mammographic breast density by visual estimate equals or exceeds 50%.', ' Subjects must be willing to continue the same hormonal milieu present at baseline throughout trial. If not using an oral, vaginal, or topical contraceptive, must be willing to actively use barrier methods of contraception to prevent pregnancy.', ' Six months or more must have elapsed from completion of a prevention intervention trial (with exception of a weight reduction trial), ingestion of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) prior to baseline biomarker assessment.', ' Subjects must be willing to undergo measurement of height, weight, and BMI and undergo body composite analysis (DEXA) at initiation and conclusion of intervention.', ' Subjects with a history of AH, LCIS, or ER-positive DCIS by diagnostic biopsy, must have been counseled about appropriate standard prevention therapies such as tamoxifen and are either not eligible or are not interested in standard prevention therapies. Women with DCIS must have had appropriate local therapy (lumpectomy plus radiation or mastectomy). If subject has had a DCIS, at least two months must have elapsed from surgery and/or radiation therapy to the involved breast. Only the contralateral (uninvolved breast) will be studied by RPFNA. The subject may not have had any radiation therapy to the contralateral breast to be studied', ' Subjects > 40 must have had a screening mammogram within 6 months of entering the interventional portion of the study and read as not suspicious for breast cancer or if suspicious must have completed all suggested tests including biopsy and found to have no evidence of cancer. Subjects of sufficient age and/or risk for a baseline mammogram must be willing to have an off-study mammogram performed 6 months after study entry.', ' Subjects must have had an RPFNA of the breast within six months prior to entering the intervention portion of the study and be willing to have another RPFNA at ~6.5 months after starting Lovaza™.', 'Tissue Eligibility: Subjects must have cytomorphologic evidence of hyperplasia with atypia or borderline atypia (Masood score 14 or higher). There must be 500 epithelial cells on the slide for cytomorphology and evidence of proliferation by Ki-67 staining. There must be sufficient reserved methanol- formalin-fixed material for real time quantitative polymerase chain reaction (RT-qPCR). Frozen tissue must also have been obtained for fatty acid analysis, reverse phase proteomics, adipokines and cytokines, and RT-qPCR.', ' Subjects must be willing to undergo phlebotomy at baseline, and 6 months and 6.5 months approximately 3 tablespoons of blood will be obtained at baseline, and 6 months and 6.5 months or 6 tablespoons if the subject decides to participate in the optional monocyte cytokine release assay .', ' Subjects must produce a spot urine sample at baseline, 6 months and at study conclusion. Baseline urine sample will in part be used to document that subject is not pregnant.', ' Subjects must be willing to complete questionnaires regarding diet and supplement use, quality of life, relevant family history, personal health and reproductive history and medications at initiation and conclusion of the intervention.', ' Subjects must be willing to sign an informed consent for the entire study and separate consent for repeat RPFNA', ' Exclusion Criteria', ' Women that have had a metastatic malignancy of any kind.', ' Women that have had prior invasive breast cancer, diagnosed or treated within the past five years.', ' Women who are currently taking anticoagulants.', ' Women who have breast implants.', ' Women who have undergone change in their hormonal milieu in the past 6 months this includes pregnancy, lactation, or stopping or starting hormonal contraceptives..', ' Women who have taken omega 3 fatty acid supplements within 3 weeks prior to their baseline RPFNA.', ' Women who regularly take NSAIDS (>7 tablets weekly).', ' Inclusion of Women and Minorities', ' -This study utilizes women at increased risk for breast cancer. Subjects recruited from an established cohort of women followed in the Breast Cancer Prevention Center. From previous trials we can expect 6% minority accrual which is similar to our hospital demographics. Males are not included due to the low absolute risk of breast cancer, and the difficulty of performing RPFNA on the male breast.'], 'Results': ['Outcome Measurement: ', ' The Proportion of Subjects That Complete an Intervention of Lovaza™ 4 Grams Per Day', ' The proportion of subjects that complete an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to premenopausal women under age 55.', ' Time frame: 6 month visit', 'Results 1: ', ' Arm/Group Title: Lovaza™', ' Arm/Group Description: Lovaza™: 4 capsules daily for 6 months', ' Overall Number of Participants Analyzed: 36', ' Measure Type: Number', ' Unit of Measure: proportion of enrolled participants 0.94'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/36 (0.00%)']}

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

b8ce7d6a-d707-48e0-816c-de7ac3a63823

Single

Adverse Events

NCT01498458

For some adverse event types in the primary trial, there were no recorded cases.

Contradiction

{'Clinical Trial ID': 'NCT01498458', 'Intervention': ['INTERVENTION 1: ', ' Pazopanib Plus Capecitabine', ' A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.', ' Complete baseline documentation must be submitted via the web-based data collection system MedCODES to the GBG Forschungs GmbH.', ' Diagnosis of advanced or metastatic HER2-negative breast cancer. HER2-negative is defined as HercepTest IHC 0-2+ or FISH negative (ratio < 2.2).', ' At least one prior endocrine or one non-capecitabine-containing chemotherapy treatment for metastatic/advanced disease.', ' Documented progression of either a measurable, or a non-measurable lesion according to the RECIST criteria, or a new lesion.', ' Complete radiological and clinical tumor assessment within 4 weeks prior to registration performed as clinically indicated.', ' Age => 18 years.', ' Karnofsky Performance Status index => 60%.', ' Laboratory requirements: Absolute neutrophil count (ANC) => 1.5 x 109/L, Platelets => 100 x 109/L, Hemoglobin => 9 g/dL (=> 5.6 mmol/L), Prothrombin time (PT) or international normalised ratio (INR) =< 1.2x UNL (upper normal limit), Partial thromboplastin time (PTT) =< 1.2x UNL, Total bilirubin < 1.5x UNL, ASAT (SGOT) and ALAT (SGPT) =< 2.5x UNL (concomitant elevations in serum bilirubin and ASAT/ALAT above 1.0x UNL are not permitted), The calculated creatinine clearance should be => 50 mL/min), Urine Protein to Creatinine Ratio (UPC) < 1 (if UPC => 1, then 24-hour urine protein must be < 1 g).', " Normal cardiac function confirmed by ECG; corrected QT interval (QTc) < 480 msec using Bazett's formula.", 'A female either of:Non-childbearing potential i.e., physiologically incapable of becoming pregnant because of history of hysterectomy, bilateral oophorectomy (ovariectomy), bilateral tubal ligation or postmenopausal status.', " Childbearing potential with a negative serum pregnancy test within 2 weeks prior to registration, preferably as close to the first dose as possible, and agrees to use adequate contraception. 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, Vasectomised partner who is sterile prior to the female subject'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).", ' Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.', 'Exclusion Criteria:', ' Known or suspected hypersensitivity reaction to the investigational compounds or incorporated substances.', ' Last metastatic treatment with capecitabine, 5-FU, bevacizumab, sunitinib, sorafenib, or other antibodies or tyrosine kinase inhibitors with anti-angiogenic activity. Investigational therapies within 14 days or five half-lives of the drug (whichever is longer) prior to first dose of pazopanib.', ' Any ongoing toxicity from prior anti-cancer therapy that is grade >1 and/or that is progressing in severity, except alopecia.', ' Surgery or tumor embolisation within 28 days prior to the first dose of pazopanib. At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiated field or there must be pathological proof of progressive disease.', ' Concurrent immuno-biological or hormonal therapy for cancer.', ' 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 6 months prior to first dose of study drug.', ' Life expectancy less than 3 months.', ' History of thyroid autoimmune disease or thyroid disorders with thyroid values out of standard range', " Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to: Active peptic ulcer disease, Known intraluminal metastatic lesion/s with risk of bleeding, Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), 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.", ' Severe liver dysfunction', ' Grade 3 or 4 diarrhea.', ' Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to: Malabsorption syndrome, Major resection of the stomach or small bowel.', ' Presence of uncontrolled infection.', ' History of any one or more of the following cardiovascular conditions within the past 6 months: Cardiac angioplasty or stenting, Myocardial infarction, Unstable angina, Coronary artery bypass graft surgery, Symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA), Poorly controlled hypertension (defined as systolic blood pressure [SBP] of 160 mmHg or diastolic blood pressure [DBP] of 90 mmHg).', ' Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry.', ' BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP/DBP values from each BP assessment must be < 160/95 mmHg in order for a subject to be eligible for the study (see Section 9.6.1 for details on BP control and re-assessment prior to study enrollment).', ' History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible.', ' Evidence of active bleeding or bleeding diathesis including, but not limited to: Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major), Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels, Hemoptysis prior to 6 weeks of first dose of study drug, Blood transfusion within 7 days of study entry.', " Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures."], 'Results': ['Outcome Measurement: ', ' Maximum Tolerable Dose (MTD) of Pazopanib', ' The maximum tolerated dose (MTD) is defined as the highest dose level with DLT in no more than 1 out of 6 patients. A maximal tolerated dose (MTD) could not be established.', ' Time frame: 3 years', 'Results 1: ', ' Arm/Group Title: Pazopanib Plus Capecitabine', ' Arm/Group Description: A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Number', ' Unit of Measure: mg NA [1]'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/8 (75.00%)', ' Thrombocytopenia 1/8 (12.50%)', ' Hypertension 1/8 (12.50%)', ' Hepatotoxicity 3/8 (37.50%)', ' Pancreatectomy * 1/8 (12.50%)']}

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

53d88010-e7d7-41c7-b20d-6328c8e507d1

Single

Adverse Events

NCT01416389

Cohort 1 of the primary trial had more cases of Hepatic encephalopathy and Pneumonia than cohort 2.

Contradiction

{'Clinical Trial ID': 'NCT01416389', 'Intervention': ['INTERVENTION 1: ', ' LY2523355 + Pegfilgrastim or Filgrastim', " LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]).", ' Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.', ' If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.', 'INTERVENTION 2: ', ' Ixabepilone', ' Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.', " Dosage determined by calculating participant's body surface area (40 mg/m^2).", ' If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.'], 'Eligibility': ['Inclusion Criteria:', ' Have histologic or cytologic diagnosis of metastatic or locally recurrent breast cancer that is not amenable to therapy given with curative intent.', ' Have measurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 guidelines.', ' Have received 2 or more prior standard cytotoxic chemotherapy regimens for metastatic breast cancer and be, in the opinion of the investigator, an appropriate candidate for experimental therapy. Regimens received in the neoadjuvant or adjuvant setting are not counted as prior regimens.', ' Have received a prior taxane in the neoadjuvant, adjuvant, or metastatic setting.', ' Have recovered from the acute effects of prior chemotherapy, hormonal therapy, and radiation prior to study enrollment.', ' Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.', ' Have adequate organ function.', 'Exclusion Criteria:', ' Have Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater (moderate or worse) peripheral neuropathy', ' Have a second primary malignancy.', ' Have symptomatic, untreated, or uncontrolled central nervous system metastases.', ' Have received autologous stem cell transplant following high-dose chemotherapy.', ' Have serious preexisting medical conditions that in the opinion of the investigator would preclude participation in this study.', ' Have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (HIV) or viral hepatitis.', ' Have previously received LY2523355 in another study investigating this agent or therapy with ixabepilone or an ixabepilone-containing regimen.', ' Have a history of radiation therapy involving more than 25 percent of the bone marrow.', ' Have a Fridericia corrected QT (QTcF) interval of >470 milliseconds (msec) on screening electrocardiogram (ECG).', ' Have QRS widening of >120 msec on screening ECG.', ' Cannot change or stop taking a strong Cytochrome P450 3A4 (CYP3A4) inhibitor or CYP3A4 inducer per the ixabepilone label.', ' Have hypersensitivity to drugs formulated with Cremophor® EL per the ixabepilone label.'], 'Results': ['Outcome Measurement: ', ' Change in Tumor Size (CTS) From Baseline to the End of Cycle 2', ' The log ratio of tumor size at Cycle 2 to tumor size at baseline is calculated for each participant, where the tumor size is the sum of the target lesion measurements at each assessment.', ' Time frame: Baseline up to end of Cycle 2 (Day 42)', 'Results 1: ', ' Arm/Group Title: LY2523355 + Pegfilgrastim or Filgrastim', " Arm/Group Description: LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]).", ' Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.', ' If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.', ' Overall Number of Participants Analyzed: 17', ' Mean (Standard Deviation)', ' Unit of Measure: log ratio of end of Cycle 2 to baseline -0.0 (0.08)', 'Results 2: ', ' Arm/Group Title: Ixabepilone', ' Arm/Group Description: Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.', " Dosage determined by calculating participant's body surface area (40 mg/m^2).", ' If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.', ' Overall Number of Participants Analyzed: 11', ' Mean (Standard Deviation)', ' Unit of Measure: log ratio of end of Cycle 2 to baseline -0.1 (0.37)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/26 (19.23%)', ' Febrile neutropenia 1/26 (3.85%)', ' Abdominal pain 0/26 (0.00%)', ' Constipation 0/26 (0.00%)', ' Nausea 1/26 (3.85%)', ' Pancreatitis 1/26 (3.85%)', ' Vomiting 2/26 (7.69%)', ' Pain 0/26 (0.00%)', ' Pneumonia 0/26 (0.00%)', ' Urinary tract infection 1/26 (3.85%)', ' Lumbar vertebral fracture 1/26 (3.85%)', ' Ammonia increased 1/26 (3.85%)', ' Hepatic encephalopathy 1/26 (3.85%)', 'Adverse Events 2:', ' Total: 4/13 (30.77%)', ' Febrile neutropenia 1/13 (7.69%)', ' Abdominal pain 1/13 (7.69%)', ' Constipation 1/13 (7.69%)', ' Nausea 0/13 (0.00%)', ' Pancreatitis 0/13 (0.00%)', ' Vomiting 0/13 (0.00%)', ' Pain 1/13 (7.69%)', ' Pneumonia 1/13 (7.69%)', ' Urinary tract infection 0/13 (0.00%)', ' Lumbar vertebral fracture 0/13 (0.00%)', ' Ammonia increased 0/13 (0.00%)', ' Hepatic encephalopathy 0/13 (0.00%)']}

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

8257bf5c-fae6-44c0-a86d-293746fdc468

Comparison

Eligibility

NCT00372424

NCT00041067

Patients with HER2 positive breast tumors are eligible for the primary trial, but excluded from the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT00372424', 'Intervention': ['INTERVENTION 1: ', ' Sunitinib + Docetaxel + Trastuzumab', ' Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.', ' Tumors over-expressing Her-2', ' Candidate for treatment with docetaxel/trastuzumab', 'Exclusion Criteria:', ' Histology of inflammatory carcinoma', ' AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)', ' An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of 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. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.', ' Time frame: From screening until 28 days post last dose of study drug', 'Results 1: ', ' Arm/Group Title: Sunitinib + Docetaxel + Trastuzumab', ' Arm/Group Description: Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: participants AEs: 24', 'SAEs: 11'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/25 (44.00%)', ' Febrile neutropenia * 4/25 (16.00%)', ' Neutropenia * 3/25 (12.00%)', ' Diarrhoea * 1/25 (4.00%)', ' Intestinal perforation * 1/25 (4.00%)', ' Rectal haemorrhage * 1/25 (4.00%)', ' Stomatitis * 1/25 (4.00%)', ' Vomiting * 1/25 (4.00%)', ' Fatigue * 1/25 (4.00%)', ' Multi-organ failure * 1/25 (4.00%)', ' Erysipelas * 1/25 (4.00%)', ' Pseudomembranous colitis * 1/25 (4.00%)']}

{'Clinical Trial ID': 'NCT00041067', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab, Docetaxel, Vinorelbine and Filgrastim', ' Trastuzumab, docetaxel, vinorelbine and filgrastim', ' docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles', ' vinorelbine : 27.5 mg/m^2 on Days 8 and 15', ' filgrastim : 5 microg/kg/day on Days 2 to 21', ' trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed stage IV breast cancer', ' Metastasis to the ipsilateral supraclavicular lymph nodes allowed', ' HER2-positive by fluorescence in situ hybridization (FISH) or immunohistochemistry 3+ staining confirmed in the adjuvant or metastatic setting', ' No effusions or ascites as only sites of disease', ' No primary or metastatic brain or central nervous system tumor', ' 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:', ' Absolute neutrophil count at least 1,500/mm^3', ' Platelet count at least 100,000/mm^3', ' Hepatic:', ' Bilirubin normal', ' aspartate aminotransferase or Alanine aminotranferease no greater than 1.5 times upper limit of normal (ULN)', ' Alkaline phosphatase no greater than 2.5 times ULN', ' Renal:', ' Not specified', ' Cardiovascular:', ' left ventricular ejection fraction normal by multigated radionuclide angiography or echocardiogram (patients who have received prior anthracycline therapy)', ' No clinical evidence or history of cardiomyopathy', ' Other:', ' No pre-existing grade 2 or greater motor or sensory peripheral neuropathy except abnormalities due to cancer', ' No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80', ' No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer currently in complete remission', ' No known sensitivity to E. coli-derived proteins', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy:', ' Not specified', ' Chemotherapy:', ' At least 6 months since prior chemotherapy', ' Prior anthracycline as adjuvant therapy allowed', ' No prior cumulative dose of doxorubicin more than 360 mg/m^2', ' No prior cumulative dose of epirubicin more than 720 mg/m^2', ' No more than 1 prior adjuvant or neoadjuvant chemotherapy regimen for primary disease', ' No prior docetaxel', ' No prior vinorelbine', ' Prior paclitaxel allowed', ' Endocrine therapy:', ' Prior hormonal therapy as adjuvant therapy or for metastatic breast cancer allowed', ' No concurrent hormonal therapy', ' Radiotherapy:', ' At least 3 weeks since prior radiotherapy', ' Surgery:', ' At least 2 weeks since prior surgery and recovered'], 'Results': ['Outcome Measurement: ', ' Survival at 1 Year', ' [Not Specified]', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Trastuzumab, Docetaxel, Vinorelbine and Filgrastim', ' Arm/Group Description: Trastuzumab, docetaxel, vinorelbine and filgrastim', ' docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles', ' vinorelbine : 27.5 mg/m^2 on Days 8 and 15', ' filgrastim : 5 microg/kg/day on Days 2 to 21', ' trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period', ' Overall Number of Participants Analyzed: 74', ' Measure Type: Number', ' Unit of Measure: percentage of patients 93 (84 to 97)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/73 (0.00%)']}

7ea00c54-b4a1-427b-8ef7-a8b3cb96e8c2

Comparison

Intervention

NCT03346161

NCT01000662

The intervention for the primary trial does not require patients to undergo any medical treatment during the study, whereas in the secondary trial, all patients receive Radiation Therapy.

Entailment

{'Clinical Trial ID': 'NCT03346161', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: BREASTChoice (Decision Tool)', " Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.", 'INTERVENTION 2: ', ' Arm 2: Enhanced Usual Care (Surgical Care Booklet)', ' Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn\'t have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn\'t have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet "Breast Reconstruction." They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.'], 'Eligibility': ['Newly diagnosed or recurrent breast cancer', ' Considering a referral or already referred to a plastic surgeon by their surgical oncologist for possible reconstruction', ' Considering or completing a mastectomy.', ' Does not have known distant metastatic disease (stage IV disease) at the time of recruitment', ' Female.', ' English-speaking.', ' At least 18 years of age.', ' Able to understand and willing to sign an IRB-approved written informed consent document.'], 'Results': ['Outcome Measurement: ', ' Percent Correct on the Knowledge Measure (Objective Knowledge Score)', ' To determine whether the CDT increases knowledge about their choice, the investigators will compare objective knowledge scores between participants using the CDT and those who received usual care', ' Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)', 'Results 1: ', ' Arm/Group Title: Arm 1: BREASTChoice (Decision Tool)', " Arm/Group Description: Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.", ' Overall Number of Participants Analyzed: 60', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of answers correct 84.6 (14.2)', 'Results 2: ', ' Arm/Group Title: Arm 2: Enhanced Usual Care (Surgical Care Booklet)', ' Arm/Group Description: Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn\'t have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn\'t have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet "Breast Reconstruction." They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.', ' Overall Number of Participants Analyzed: 60', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of answers correct 59.7 (18.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/60 (0.00%)', 'Adverse Events 2:', ' Total: 0/60 (0.00%)']}

{'Clinical Trial ID': 'NCT01000662', 'Intervention': ['INTERVENTION 1: ', ' ARM 1 Daily Boost', ' Radiation Therapy', ' Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.', ' Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.', 'INTERVENTION 2: ', ' ARM 2 Weekly Boost', ' Radiation Therapy', ' Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.', ' Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.'], 'Eligibility': ['Inclusion Criteria:', ' Pre or post-menopausal women with stage 0,I, and II breast cancer', ' Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm', ' Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (DCIS and Tumors <5mm do not require nodal assessment)', ' At least 2 weeks from last chemotherapy', ' Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Previous radiation therapy to the ipsilateral breast', ' More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation', ' Active connective tissue disorders, such as lupus or scleroderma', ' Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free >3 years', ' Pregnant or lactating women'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)', ' Number of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost: 0 - no symptoms, 5 - death directly related to radiation effects', 'Time frame: Day 60', 'Results 1: ', ' Arm/Group Title: ARM 1 Daily Boost', ' Arm/Group Description: Radiation Therapy', ' Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.', ' Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.', ' Overall Number of Participants Analyzed: 202', ' Measure Type: Number', ' Unit of Measure: participants 22', 'Results 2: ', ' Arm/Group Title: ARM 2 Weekly Boost', ' Arm/Group Description: Radiation Therapy', ' Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.', ' Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.', ' Overall Number of Participants Analyzed: 198', ' Measure Type: Number', ' Unit of Measure: participants 16'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/202 (0.00%)', 'Adverse Events 2:', ' Total: ']}

974225b7-9089-499c-9550-0a7207fd28b2

Single

Eligibility

NCT01506609

Patients with cytologically confirmed breast cancer, who's Locally recurrent disease is amenable to radiation with curative intent are not eligible for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01506609', 'Intervention': ['INTERVENTION 1: ', ' Group 2 Placebo + Carboplatin/Paclitaxel', ' Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.', 'INTERVENTION 2: ', ' Group 2 Veliparib + Carboplatin/Paclitaxel', ' Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.', ' Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.', ' Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.', ' If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.', ' Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.', ' Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.', ' Subject must have adequate bone marrow, renal and hepatic function.', ' Subject must not be pregnant or plan to conceive a child.', 'Exclusion Criteria:', ' Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1.', ' More than 2 prior lines of cytotoxic chemotherapy.', ' Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor.', ' Prior taxane therapy for metastatic breast cancer.', ' A history of or evidence of brain metastases or leptomeningeal disease.', ' A history of uncontrolled seizure disorder.', ' Pre-existing neuropathy from any cause in excess of Grade 1.', ' Known history of allergic reaction to cremophor/paclitaxel.', ' Clinical significant uncontrolled conditions, active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.', ' Pregnant or breastfeeding.'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS is defined as the number of months from the date the participant was randomized to the date of radiographic progression as determined by the central imaging center, or to the date of all cause deaths within 63 days of last tumor assessment if disease progression was not reached.', ' Time frame: Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for PFS was 34 months.', 'Results 1: ', ' Arm/Group Title: Group 2 Placebo + Carboplatin/Paclitaxel', ' Arm/Group Description: Placebo BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 98', ' Median (95% Confidence Interval)', ' Unit of Measure: months 12.3 (9.3 to 14.5)', 'Results 2: ', ' Arm/Group Title: Group 2 Veliparib + Carboplatin/Paclitaxel', ' Arm/Group Description: Veliparib 120 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 95', ' Median (95% Confidence Interval)', ' Unit of Measure: months 14.1 (11.5 to 16.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/2 (0.00%)', ' ANAEMIA 0/2 (0.00%)', ' FEBRILE NEUTROPENIA 0/2 (0.00%)', ' LYMPHADENOPATHY 0/2 (0.00%)', ' NEUTROPENIA 0/2 (0.00%)', ' PANCYTOPENIA 0/2 (0.00%)', ' THROMBOCYTOPENIA 0/2 (0.00%)', ' ATRIAL FIBRILLATION 0/2 (0.00%)', ' CARDIAC TAMPONADE 0/2 (0.00%)', ' PERICARDIAL EFFUSION 0/2 (0.00%)', ' TACHYCARDIA 0/2 (0.00%)', ' ABDOMINAL PAIN 0/2 (0.00%)', ' ABDOMINAL PAIN UPPER 0/2 (0.00%)', 'Adverse Events 2:', ' Total: 0/1 (0.00%)', ' ANAEMIA 0/1 (0.00%)', ' FEBRILE NEUTROPENIA 0/1 (0.00%)', ' LYMPHADENOPATHY 0/1 (0.00%)', ' NEUTROPENIA 0/1 (0.00%)', ' PANCYTOPENIA 0/1 (0.00%)', ' THROMBOCYTOPENIA 0/1 (0.00%)', ' ATRIAL FIBRILLATION 0/1 (0.00%)', ' CARDIAC TAMPONADE 0/1 (0.00%)', ' PERICARDIAL EFFUSION 0/1 (0.00%)', ' TACHYCARDIA 0/1 (0.00%)', ' ABDOMINAL PAIN 0/1 (0.00%)', ' ABDOMINAL PAIN UPPER 0/1 (0.00%)']}

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

6f533f52-c8e4-4983-8968-69af03a9e34a

Single

Intervention

NCT00591864

the primary trial does not have an intervention section.

Entailment

{'Clinical Trial ID': 'NCT00591864', 'Intervention': ['INTERVENTION 1: ', ' Study Participants', ' There are no arms or subgroups in this study.'], 'Eligibility': ['Inclusion Criteria:', ' This study will include a population of women aged 25 or older who are scheduled for a breast MRI examination at MAYO CLINIC ROCHESTER.', ' Patients must not be lactating or pregnant.', ' All women of child-bearing potential must have had a negative urine pregnancy test result within 2 days prior to the MBI study.', ' women who are scheduled for a breast MRI examination for a clinical concern, problem solving or for further evaluation of invasive breast cancer (e.g. pre-operative staging of known 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.', ' The breast MRI is for screening purposes or to determine the status of breast augmentation.', ' They have undergone breast surgery within the previous year'], 'Results': ['Outcome Measurement: ', ' Sensitivity on the Per Patient Level', ' Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy.', ' Time frame: within 1 week of surgery or biopsy', 'Results 1: ', ' Arm/Group Title: Study Participants', ' Arm/Group Description: There are no arms or subgroups in this study.', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: participants Sensitivity by MBI: 25', 'Sensitivity by MRI: 27'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/89 (0.00%)']}

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

690b8562-7d68-4642-bacb-601f227bb763

Single

Intervention

NCT03618017

the primary trial's intervention section does not describe the intervention dosage, frequency or duration for cohort 2, however cohort 1 recieves placebo twice daily for two months.

Contradiction

{'Clinical Trial ID': 'NCT03618017', 'Intervention': ['INTERVENTION 1: ', ' Recruitment Population', ' Pre-randomization recruitment and enrollment'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosed with early Stage (0-IIB) breast cancer', ' Must be a patient of a University of Michigan Breast Cancer Oncologist', ' Must be completing primary cancer treatment and transitioning into survivorship', ' Must be able to speak, read and write in English', ' Must have access and the ability to use the internet', 'Exclusion Criteria:', ' Diagnosed with stage III or IV breast cancer', ' Unable to speak, read, and write in English'], 'Results': ['Outcome Measurement: ', ' Number of Breast Cancer Patients Successfully Recruited to Participate in the Study', ' We anticipate a response rate of 80% enrollment (n=60). We will assess the number of patients successfully recruited who enroll and complete the baseline survey.', ' Time frame: At baseline survey', 'Results 1: ', ' Arm/Group Title: Recruitment Population', ' Arm/Group Description: Pre-randomization recruitment and enrollment', ' Overall Number of Participants Analyzed: 160', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 66 41.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/33 (0.00%)']}

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

75f94edd-dbde-4a19-be18-e67c767f6d8f

Comparison

Results

NCT00687440

NCT01307891

the primary trial had a higher percentage of patients with at least partial response than either cohort of the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00687440', 'Intervention': ['INTERVENTION 1: ', ' Caelyx, Docetaxel, Trastuzumab', ' Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.', ' Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must fulfill all the following criteria:', ' Females aged 18 to 70 years-old.', ' Willingness to participate in the study and comply with its procedures.', ' Documented diagnosis of metastatic breast carcinoma (stage IV) Human Epidermal Growth Factor Receptor 2 (HER2) overexpressing (Immunohistochemistry (IHC) 3+ or Fluorescence In Situ Hybridization(FISH) +).', ' No prior chemotherapy for metastatic breast cancer.', ' Adjuvant or neo-adjuvant chemotherapy is allowed according to the following rules:', ' patients treated with anthracyclines if all the following conditions are met:', ' Doxorubicin total dose <= 300 mg/m^2', ' Epirubicin total dose <= 480 mg/m^2', ' Chemotherapy-free interval of > 12 months', ' no taxane-based adjuvant or neo-adjuvant chemotherapy is allowed;', ' patients treated with non-anthracycline/taxane adjuvant or neo-adjuvant chemotherapy regimens are freely eligible (i.e. cyclophosphamide/methotrexate/fluorouracil (CMF) or similar regimens).', ' At least one measurable lesion according to RECIST criteria.', ' Complete hematologic and biologic baseline evaluation within 2 weeks prior to start of treatment.', ' Complete Tumor baseline evaluation including a total body computed tomography (CT) scan within 4 weeks prior to start of treatment.', ' Left ventricular ejection fraction (LVEF) >= 50% as determined by echocardiogram or Multi Gated Acquisition (MUGA) scan.', ' World Health Organization (WHO) performance status 0,1.', ' Life expectancy > 3 months.', ' Laboratory requirements :', ' Hematology :', ' Neutrophils > 1.5 x 10^9/L', ' Platelets > 100 x 10^9/L', ' Hemoglobin > 10 g/dL', ' Hepatic function:', ' Total bilirubin <= 1.25 x the upper-normal limits (UNL);', ' ASAT (Aspartate Aminotransferase or SGOT), ALAT (Alanine aminotransferase or SGPT) <= 2.5 x the upper-normal limits;', ' For patients with liver metastases:', ' Total bilirubin < 1.5 x the UNL (Upper limit of normal) ;', ' ASAT and/or ALAT < 3 x the UNL;', ' Renal function :', ' Serum Creatinine < 1.5 x the UNL.', ' Women of child bearing potential must have a negative serum pregnancy test and be using adequate contraception.', ' Patients must be accessible for treatment and follow-up.', 'Exclusion Criteria:', ' Patients will not be enrolled if any of the following criteria apply:', ' Prior chemotherapy for metastatic disease.', ' History of prior malignancy in the last 10 years (other than non melanoma skin cancer or excised cervical carcinoma in situ).', ' Radiation to disease areas within 3 weeks of study initiation.', ' Symptomatic peripheral neuropathy > grade 2 according to the National Cancer Institute (NCI) Common Toxicity Criteria.', ' Other serious illness or medical condition.', ' LVEF < 50% as determined by echocardiogram or MUGA scan.', ' Congestive hearth failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia.', ' History of significant neurologic or psychiatric disorders including dementia or seizures.', ' Active infection.', ' Active peptic ulcer, unstable diabetes mellitus or other contraindications for the use of dexamethasone.', ' Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.', ' Concurrent treatment with corticosteroids used for reasons other than for premedication. However patients receiving chronic treatment with corticosteroids (> 6 months) at low dose (< 20 mg of methylprednisolone or equivalent dose of other corticosteroids) for whichever reason are eligible.', ' Taxane-based adjuvant or neo-adjuvant chemotherapy < 12 months.', ' Other concurrent chemotherapy, immunotherapy, radiotherapy or any other investigational medication, for the treatment of the tumor.', ' Pregnant or breast-feeding women.'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria', ' Those who achieved either complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) response.', " Time frame: Week 09, Week 18, at the end of each patient's treatment, and at 3, 6, 9, and 12 months after end of treatment.", 'Results 1: ', ' Arm/Group Title: Caelyx, Docetaxel, Trastuzumab', ' Arm/Group Description: Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.', ' Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab.', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: Participants Participants who had a complete tumor response: 2', ' Participants who had a partial tumor response: 13', ' Participants who did not have a tumor response: 11'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/27 (22.22%)', ' NEUTROPENIA 1/27 (3.70%)', ' STOMATITIS 1/27 (3.70%)', ' VOMITING 1/27 (3.70%)', ' MUCOSAL INFLAMMATION 1/27 (3.70%)', ' PYREXIA 1/27 (3.70%)', ' SEPSIS 1/27 (3.70%)', ' EJECTION FRACTION DECREASED 1/27 (3.70%)', ' METASTASES TO MENINGES 1/27 (3.70%)', ' COMA 1/27 (3.70%)', ' PULMONARY OEDEMA 1/27 (3.70%)', ' PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME 2/27 (7.41%)']}

{'Clinical Trial ID': 'NCT01307891', 'Intervention': ['INTERVENTION 1: ', ' Abraxane + Tigatuzumab', ' Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.', 'INTERVENTION 2: ', ' Abraxane Alone', ' Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have pathologically documented Stage IV breast cancer. If blocks (paraffin-embedded tissue) from original diagnosis are available, they will be obtained to confirm the diagnosis and for correlative studies. Fifteen slides can be obtained from the block if the block is not available to be sent or released.', ' Tumor must be HER-2-neu negative (defined as 0 or 1+ staining by immunohistochemistry or gene amplification ratio less than or equal to 2.0, by fluorescent in situ hybridization - FISH), estrogen and progesterone receptors negative (<10%).', ' 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)', ' Biopsy of a metastatic lesion is not required for protocol entry but all patients with reasonably accessible lesions (chest wall, breast, skin, subcutaneous, superficial lymph nodes, bones and liver metastases) must agree to biopsy.', ' Biopsies may be done with local anesthesia or intravenous conscious sedation, according to standard institutional guidelines.', ' If a biopsy requires general anesthesia, then it is only allowed if acquisition of tissue is necessary for clinical reasons and excess tissue that would otherwise have been discarded is then used for research purposes. If a biopsy requires general anesthesia, then a biopsy of that site for research purposes only, without a coexisting clinical indication is not allowed on this protocol.', ' Patients with reasonably accessible lesions as described above, who will not agree with the biopsy, will not be enrolled in the trial.', ' Patients with NO reasonably accessible lesions as described above can be enrolled in the trial.', ' Prior Therapy:', ' There is no restriction as to the number of prior regimens for metastatic disease as long as patients have adequate performance status. Patients with no prior chemotherapy for metastatic disease and patients who have received prior therapy with taxanes for metastatic disease (taxol or taxotere) are eligible. Stratification will be used for randomization of these two categories (no prior chemotherapy for metastatic disease or prior taxane therapy for metastatic disease).', ' Chemotherapy treatment prior to enrollment must be discontinued for at least 3 weeks prior to study entry.', ' Patients must have completed radiation therapy at least 7 days prior to beginning protocol treatment.', ' Patients must have recovered from all reversible toxicities related to prior therapy before beginning protocol treatment, and may not have any pre- existing treatment-related toxicities in excess of grade 1. Patients must have < grade 2 pre-existing peripheral neuropathy.', ' Patients may receive bisphosphonates; however, if used, bone lesions may not be used for progression or response.', ' At least 18 years of age (19 in Alabama).', ' Life expectancy of greater than 12 weeks.', ' ECOG performance status < or equal to 2.', ' Patients must have normal organ and marrow function as defined below:', ' Absolute neutrophil count: > or equal to 1,500/mcL,', ' Hemoglobin: > or equal to 9 mg/dL,', ' Platelets: > or equal to 100,000/mcL,', ' Total bilirubin: < or equal to 1.5 X institutional upper limit of normal,', ' AST(SGOT)/ALT(SGPT): < or equal to 2.5 X institutional upper limit of normal without liver metastases, OR < or equal to 5 X institutional upper limit of normal if documented liver metastases,', ' Creatinine: < or equal to 2.0 mg/dL, OR calculated creatinine clearance greater than or equal to 50 mL/min (calculated by the Cockcroft and Gault method).', ' Ability to understand and the willingness to sign a written informed consent document.', ' Both men and women are eligible.', ' Use of an effective means of contraception in subjects of child-bearing potential.', ' Negative serum or urine beta-HCG pregnancy test at screening for patients with childbearing potential.', 'Exclusion Criteria:', ' Patients may not be receiving any other investigational agents.', ' Prior use of Abraxane for metastatic disease or in the adjuvant setting.', ' Metastatic lesions identifiable only by PET.', ' Patients may not be receiving concurrent chemotherapy for treatment of metastatic disease.', ' Active brain metastases: evidence of progression < or equal to 3 months after local therapy (patients should be asymptomatic and off corticosteroids and anticonvulsants for at least 3 months prior to study entry).', ' Patients with brain metastases must have at least one site of measurable disease outside of the central nervous system.', ' Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, history of recent myocardial infarction, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnant or lactating women are excluded. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated. These potential risks may also apply to other agents used in this study.', ' A prior invasive malignant disease within five years except for skin cancer (squamous cell or basal cell carcinoma).', ' Patients with known history of HIV or Hepatitis B because of potential for added toxicity from treatment regimen.', ' Dementia or altered mental status that would prohibit the understanding of informed consent.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate', ' Patient response rates will be measured by the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI. Responses include the following: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) best response from the start of treatment until disease progression.', ' Time frame: Baseline to 6 months', 'Results 1: ', ' Arm/Group Title: Abraxane + Tigatuzumab', ' Arm/Group Description: Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of patients 28 (14.9 to 45.0)', 'Results 2: ', ' Arm/Group Title: Abraxane Alone', ' Arm/Group Description: Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: percentage of patients 38 (18 to 61.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/39 (7.69%)', ' Neutropenia 1/39 (2.56%)', ' Bilateral Pulmonary Thromboembolism 0/39 (0.00%)', ' Fever 1/39 (2.56%)', ' Empyema associated with a permanent thoracic catheter 1/39 (2.56%)', 'Adverse Events 2:', ' Total: 3/21 (14.29%)', ' Neutropenia 1/21 (4.76%)', ' Bilateral Pulmonary Thromboembolism 1/21 (4.76%)', ' Fever 1/21 (4.76%)', ' Empyema associated with a permanent thoracic catheter 0/21 (0.00%)']}

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