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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 | [
0,
1,
2,
3,
4,
5
] | [
0,
1,
2,
3,
4,
5
] | {'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 | [
18,
22,
23,
24
] | [] | {'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 | [
0,
3
] | [
0,
7,
8,
9,
10
] | {'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 | [
0,
1,
3,
4,
5
] | [] | {'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 | [
0,
1,
2,
3,
4,
5,
6,
7
] | [
0,
1,
2,
3,
4,
5,
6
] | {'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 | [
0,
1
] | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24
] | {'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 | [
0,
1,
4,
10
] | [] | {'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 | [
0,
1,
2,
3
] | [
0,
1,
2,
3,
4,
5
] | {'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 | [
0,
1,
2,
3,
4,
6
] | [] | {'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 | [
0,
1,
2,
3
] | [
0,
1,
2,
3
] | {'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 | [
0,
8
] | [] | {'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 | [
0,
6,
14,
20
] | [] | {'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 | [
19,
9
] | [] | {'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 | [
0,
1,
2,
3
] | [] | {'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 | [
0,
1,
2,
3
] | [
0,
1,
2,
3
] | {'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 | [
0,
1,
2,
3
] | [
0,
1,
2,
3,
4,
5
] | {'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 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25,
26,
27,
28,
29,
30,
31,
32,
33,
34,
35,
36,
37,
38,
39,
40,
41,
42,
43,
44,
45,
46,
47,
48,
49,
50,
51,
52,
53,
54,
55,
56,
57,
58,
59,
60,
61
] | [] | {'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 | [
0,
1,
2,
3,
4,
5,
6,
7
] | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] | {'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 | [
0,
1,
2,
3
] | [
0,
1,
2,
3,
4,
5
] | {'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 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16,
17,
18,
19,
20,
21,
22,
23,
24,
25
] | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10
] | {'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 | [
0,
1,
2,
3,
4,
5
] | [
0,
1,
2,
3,
4,
5,
6,
7
] | {'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 | [
0,
1,
2,
3,
4,
5,
6,
7,
8,
9,
10,
11,
12,
13,
14,
15,
16
] | [] | {'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 | [
0,
1
] | [] | {'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 | [
0,
1,
2,
3,
4,
5,
6,
7
] | [] | {'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 | [
17,
19
] | [] | {'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 |
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