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Single

Adverse Events

NCT00544167

Every adverse event in the primary trial occurred once.

Entailment

{'Clinical Trial ID': 'NCT00544167', 'Intervention': ['INTERVENTION 1: ', ' Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically-confirmed breast cancer with an interval between definitive surgery that includes axillary lymph node involvement assessment and initiation of study treatment of less than or equal to 84 days.', ' Definitive surgery - either mastectomy with axillary node involvement assessment, or breast conserving surgery with axillary node assessment. Margins of resected specimen must be free of invasive disease and/or ductal carcinoma in situ (DCIS).', ' Stage I, II, IIIA, and IIIC (T1-3, N3a only). Patients must be either lymph node positive or high-risk node negative.', ' Age > 18 years.', ' ECOG performance status 0 or 1.', ' Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) by Echocardiography or MUGA scan and electrocardiogram (ECG) within 35 days prior to initiation of study treatment.', ' Patients must have adequate bone marrow function', ' Patients must have normal liver function (', ' Serum creatinine <= 2mg/dl', ' INR < 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored.', 'Exclusion Criteria:', ' Prior systemic anticancer therapy for breast cancer (immunotherapy, chemotherapy, hormonal therapy).', ' Patients with HER2 positive breast cancer as determined by FISH or IHC3+ standing are ineligible for this trial.', ' Prior anthracycline or taxane therapy.', ' Prior radiation therapy for breast cancer.', ' Bilateral invasive disease.', ' Pre-existing motor or sensory neurotoxicity of a severity 2 by NCI CTCAE v 3.0 criteria.', ' Cardiac disease that includes: myocardial infarction; angina, congestive heart failure, arrhythmia; valvular heart disease; cardiomegaly on chest imaging or ventricular hypertrophy on ECG - unless the LVEF is within normal range for the institution; patients with poorly controlled hypertension (defined as systolic blood pressure > 150 and /or diastolic blood pressure > 100 mmHg on antihypertensive medications); patients who receive medications for angina, arrhythmias, or congestive heart failure.', ' Current therapy with raloxifene, tamoxifen or other selective estrogen receptor modulator', ' Concurrent treatment with ovarian hormonal replacement therapy.', ' History of prior malignancy within 5 years with the exception of skin cancer or cervical carcinoma in situ.', ' Women who are pregnant (positive pregnancy test) or breast feeding. Subjects of childbearing potential must use effective birth control measures during treatment.', ' Treatment with a non-approved or investigational drug within 30 days before day 1 of trial treatment.', ' Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.', ' Thrombotic or embolic events such as a stroke and transient ischemic attack within the past 6 months.', ' Pulmonary hemorrhage/bleeding event NCI CTCAE v3.0 Grade 2 within 4 weeks of first dose of study drug.', ' Any other hemorrhage/bleeding event NCI CTCAE v3.0 Grade 3 within 4 weeks of first dose of study drug.'], 'Results': ['Outcome Measurement: ', ' The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0.', ' [Not Specified]', ' Time frame: 18 Months', 'Results 1: ', ' Arm/Group Title: Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 45', ' Measure Type: Number', ' Unit of Measure: percentage of patients 40'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/45 (15.56%)', ' Febrile neutropenia 1/45 (2.22%)', ' Cardiac ischemia/infarction 1/45 (2.22%)', ' Ventricular arrhythmia - left ventricular systolic dysfunction 1/45 (2.22%)', ' Hemmorhage - GI 1/45 (2.22%)', ' Pancreatitis 1/45 (2.22%)', ' Infection - pneumonia 1/45 (2.22%)', ' Infection - Streptococcus 1/45 (2.22%)', " Abcess of Bartholin's cyst 1/45 (2.22%)"]}

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

ee2287bd-af76-4232-9575-d371fe3257dc

Comparison

Eligibility

NCT00675259

NCT01875367

Patients with an ImmunoHistoChemistry test result of 3+ are excluded from the primary trial and the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT00675259', 'Intervention': ['INTERVENTION 1: ', ' Neoadjuvant, Surgery, Adjuvant', " Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians' judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered 3 weeks after completing the regimen."], 'Eligibility': ['Inclusion:', ' Histologically confirmed breast cancer', ' Clinically or radiographically measurable residual tumor after core biopsy', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1', ' Age 18 yrs', ' Absolute neutrophil count 1,500/mm³', ' Hemoglobin 9 g/dL', ' Platelet count 100,000/ mm³', ' Creatinine 1.5 times upper limit of normal (ULN)', ' Urine protein:creatinine ratio < 1.0', ' AST (aspartate aminotransferase) and ALT 2.5 times ULN', ' Alkaline phosphatase 2.5 times ULN', ' Bilirubin normal', ' Women of childbearing potential must use effective contraception', ' Left ventricular ejection fraction (LVEF) normal by echocardiogram or MUGA', ' Exclusion:', ' No residual tumor after initial biopsy', ' Peripheral neuropathy of grade 2 or higher', ' HER-2 neu overexpression either by IHC 3+ or FISH+', ' No history of any prior treatment of breast cancer.', ' No history of unstable angina or myocardial infarction within the past 12 months', ' Pregnant or nursing women', ' Anticoagulation therapy within the last 6 months', ' History of gastrointestinal bleeding', ' Recent hemoptysis', ' No known hepatitis B or HIV seropositivity', ' No inadequately controlled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 100 mm Hg despite antihypertensive medications', ' History of hypertensive crisis or hypertensive encephalopathy', ' New York Heart Association class II-IV congestive heart failure', ' History of stroke or transient ischemic attack at any time', ' Significant vascular disease (e.g., aortic aneurysm or aortic dissection)', ' No symptomatic peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Significant traumatic injury within the past 28 days', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months', ' Serious, non-healing wound, ulcer, or bone fracture', ' Known hypersensitivity to any component of bevacizumab'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Pathologic Complete Response (pCR)', ' pCR was defined as the absence of viable invasive tumor cells in the surgical breast specimen and axillary lymph nodes.', ' Time frame: every 4 weeks', 'Results 1: ', ' Arm/Group Title: Neoadjuvant, Surgery, Adjuvant', " Arm/Group Description: Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians' judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered 3 weeks after completing the regimen.", ' Overall Number of Participants Analyzed: 33', ' Measure Type: Number', ' Unit of Measure: patients 6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/33 (0.00%)']}

{'Clinical Trial ID': 'NCT01875367', 'Intervention': ['INTERVENTION 1: ', ' Arm A: T-IV + T-SC Vial + T-SC Device', ' Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.', 'INTERVENTION 2: ', ' Arm B: T-IV + T-SC Device + T-SC Vial', ' Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Woman, 18 years old or upper.', ' Patient with advanced breast cancer with human epidermal growth factor receptor 2 (HER 2) positive histologically confirmed. The criteria for positivity HER 2 are:', ' immuno-histochemistry (IHC) 3+ (>10% of tumor cells with complete and intense membrane staining)', ' IHC 2+ with fluorescent in situ hybridization (FISH) / Chromogenic in situ hybridization (CISH) / silver-enhanced in situ hybridization (SISH) + for HER 2 amplification (*)', ' FISH / CISH / SISH + for HER 2 amplification (*) (*) Defined as the ratio of copies of HER 2/neu and copies of centromere of chromosome 17 (CEP17)> 2.2, or a number of copies of HER 2/neu> 6, as per local laboratory criteria.', ' Patient receiving trastuzumab with or without chemotherapy or hormonal therapy for at least 4 months.', ' No evidence of disease progression (clinical and / or radiological) for at least 4 months before inclusion in the study and with a life expectancy of at least 3 months.', ' Adequate performance status: Eastern Cooperative Oncology Group (ECOG) <2.', ' Adequate bone marrow function, liver and kidney', ' Proper cardiac function (LVEF within normal limits the center, measured by echocardiography or MUGA).', ' The patient must have been informed of the study and must sign and date informed consent document for entry into the trial.', ' The patient must be willing and able to comply with study procedures and be available to answer the study questionnaires.', 'Exclusion Criteria:', ' Patients with no advanced breast cancer.', ' Breast cancer patients with tumors HER 2-negative.', ' The patient has another active malignancy other than breast adenocarcinoma; are excluded the non-melanoma skin cancer or any other properly treated in situ neoplasia. Patients with a history of malignancy, if they bear> 5 years without evidence of disease could be included.', ' The patient has uncontrolled brain metastases.', ' Concomitant administration, or in the 4 weeks prior to study entry, of other experimental treatment.', ' Known hypersensitivity to trastuzumab or to any of its components.', ' Patients with severe dyspnea at rest or requiring supplemental oxygen.', ' Heart disease or serious medical pathological prevent trastuzumab administration: documented history of congestive cardiac insufficiency (CCI), high-risk arrhythmias uncontrolled angina requiring medication, clinically significant valvular disease, history of myocardial infarction or evidence of transmural infarction on ECG or hypertension poorly controlled.', ' Presence of any concomitant serious systemic disease that is incompatible with the study (at the discretion of the investigator).', ' The patient is pregnant or lactating. Women of childbearing potential should undergo pregnancy testing blood or urine within 14 days prior to inclusion as institutional rules and use a non-hormonal contraceptive suitable: intrauterine device, barrier method (condom or diaphragm) also used in conjunction with spermicidal cream, total abstinence or surgical sterilization, during treatment with the study drugs and for 6 months following the end of treatment.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Subcutaneous vs. Intravenous Treatment Preference', ' The percentage of patients who indicate a preference for the use of the intravenous vs subcutaneous administration of trastuzumab was analyzed with the answer to the questionnaire C2, question number 39 (All things considered, what method of administration do you prefer? Subcutaneous; Intravenous; No preference) of experiences and preferences of the patient.', ' Time frame: Up to 12 weeks', 'Results 1: ', ' Arm/Group Title: Arm A: T-IV + T-SC Vial + T-SC Device', ' Arm/Group Description: Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.', ' Overall Number of Participants Analyzed: 76', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Subcutaneous: 66 86.8%', ' Intravenous: 6 7.9%', ' No preference: 4 5.3%', 'Results 2: ', ' Arm/Group Title: Arm B: T-IV + T-SC Device + T-SC Vial', ' Arm/Group Description: Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.', ' Overall Number of Participants Analyzed: 83', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Subcutaneous: 71 85.5%', ' Intravenous: 5 6.0%', ' No preference: 7 8.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/81 (2.47%)', ' Heart failure 0/81 (0.00%)', ' Fever 1/81 (1.23%)', ' Cold 0/81 (0.00%)', ' Catheter related infection (Bacteriemia) 0/81 (0.00%)', ' Lack of strength in left leg 0/81 (0.00%)', ' Ostenecrosis produced by biphosphonates 0/81 (0.00%)', ' Gastric cancer 0/81 (0.00%)', ' Stroke 0/81 (0.00%)', ' Hematuria 1/81 (1.23%)', ' Nodule in left breast 0/81 (0.00%)', 'Adverse Events 2:', ' Total: 10/85 (11.76%)', ' Heart failure 1/85 (1.18%)', ' Fever 0/85 (0.00%)', ' Cold 1/85 (1.18%)', ' Catheter related infection (Bacteriemia) 1/85 (1.18%)', ' Lack of strength in left leg 1/85 (1.18%)', ' Ostenecrosis produced by biphosphonates 1/85 (1.18%)', ' Gastric cancer 1/85 (1.18%)', ' Stroke 1/85 (1.18%)', ' Hematuria 0/85 (0.00%)', ' Nodule in left breast 1/85 (1.18%)']}

e5495b51-5f42-4e97-80ec-c215652bd3ab

Single

Eligibility

NCT00612560

children and illiterate adults are able to take part in the primary trial, unless they are can read and write in italian.

Contradiction

{'Clinical Trial ID': 'NCT00612560', 'Intervention': ['INTERVENTION 1: ', ' Arm A - Flaxseed & Active Anastrazole', ' 25 mg flaxseed per day and 1 mg anastrozole pill per day', ' Anastrozole: 1 mg per day', ' flaxseed: 25 g per day ground', 'INTERVENTION 2: ', ' Arm B - Flaxseed', ' Flaxseed 25 mg per day and 1 placebo pill per day', ' flaxseed: 25 g per day ground'], 'Eligibility': ['Inclusion Criteria:', ' Age 18 and 85 years', ' Postmenopausal status defined as: no menstrual cycle in the past 12 months hysterectomy with bilateral oophorectomy hysterectomy with intact ovaries if age > 55 years', ' Newly diagnosed with incident, primary, invasive, estrogen receptor positive clinical stage II or lower breast cancer', ' ECOG performance status of 1 or less', ' Willingness to comply with study guidelines and procedures', ' Willingness and ability to provide informed consent', ' Usual consumption of soy no more than 1 time per week and willingness to avoid whole soy foods or concentrated soy sources (soy milk, tofu, substitute meat products, meal replacement bars) during the intervention period', ' Willingness to avoid herbal and dietary supplements (not including vitamins), aspirin, and ibuprofen during the intervention period', ' No competing neoadjuvant or chemotherapy treatment', ' Time between pre-surgical visit and surgery must be at least 2 weeks', ' No chemotherapy in the past 12 months', 'Exclusion Criteria:', ' Inability to read and write English', ' Previous invasive breast cancer', ' Insulin dependent Type I or II diabetes diagnosed by physician', ' History of coagulopathy, thrombocytopenia, or bleeding disorder', ' Current (past 30 days) regular (at least once per week) use of reproductive hormone therapy, Tamoxifen, aromatase inhibitors, or other estrogen inhibitors, flaxseed, or antibiotics', ' Current chemotherapy or neoadjuvant chemotherapy', ' Allergies to flaxseed, nuts, or other seeds', ' Renal dysfunction defined as creatinine > 1.5 mg/dl', " History of Crohns' disease, ulcerative colitis, irritable bowel syndrome, celiac sprue, or other malabsorption syndrome, diverticulitis, diverticulosis, or other bowel diagnosis which, in the opinion of the breast surgeon, would contraindicate large doses of dietary fiber or would impair nutrient absorption", ' Current, regular (more than once weekly) use of prescription blood-thinning agents including coumadin, heparin and heparin related drugs, clopidogrel bisulfate'], 'Results': ['Outcome Measurement: ', ' Expression of Estrogen Receptor (ER-beta)', ' Mean percentage of cells expressing estrogen receptor (ER-beta)', ' Time frame: Biopsy/Week 1 and Surgical Resection/Week 2', 'Results 1: ', ' Arm/Group Title: Arm A - Flaxseed & Active Anastrazole', ' Arm/Group Description: 25 mg flaxseed per day and 1 mg anastrozole pill per day', ' Anastrozole: 1 mg per day', ' flaxseed: 25 g per day ground', ' Overall Number of Participants Analyzed: 7', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of cells Biopsy: 7 participants', ' 67.1 (17.0)', 'Surgical resection: 7 participants', ' 45.7 (28.8)', 'Results 2: ', ' Arm/Group Title: Arm B - Flaxseed', ' Arm/Group Description: Flaxseed 25 mg per day and 1 placebo pill per day', ' flaxseed: 25 g per day ground', ' Overall Number of Participants Analyzed: 6', ' Mean (Standard Deviation)', ' Unit of Measure: percentage of cells Biopsy: 6 participants', ' 63.3 (10.3)', 'Surgical resection: 6 participants', ' 56.7 (23.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/7 (0.00%)', ' Breast haematoma 0/7 (0.00%)', 'Adverse Events 2:', ' Total: 0/7 (0.00%)', ' Breast haematoma 0/7 (0.00%)']}

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

9b6bd158-a66d-42b6-8fe6-843ff05e0c8d

Single

Results

NCT00452673

1/7 patients in cohort 1 of the primary trial suffered dose-limiting toxicities.

Entailment

{'Clinical Trial ID': 'NCT00452673', 'Intervention': ['INTERVENTION 1: ', ' 50 mg Dasatinib + 825 mg/m^2Capecitabine', ' Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.', 'INTERVENTION 2: ', ' 70 mg Dasatinib + 825 mg/m^2Capecitabine', ' Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.'], 'Eligibility': ['For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.', 'Inclusion Criteria:', ' Female with advanced breast cancer previously treated with a taxane and an anthracycline', ' No pleural or pericardial effusion', ' Not receiving anticoagulants'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population', ' Safety was assessed from first dose of study drug through at least 30 days after the last dose, until resolution of drug-related toxicity or when toxicity was deemed irreversible, whichever was longer. An adverse event (AE) was considered a dose limiting toxicity (DLT) if it occurred in the first 21 days and was at least possibly related to study drugs and were: Clinically-evident toxicity of Grade >= 3, or of Grade 2 which required interruption of treatment for >= 7 days (consecutive or non-consecutive); non-hematologic abnormal laboratory value of Grade >= 3, or hematologic toxicity of Grade 4, which persisted 7 days; any grade toxicity which in the judgment of the investigator required a dose reduction or removal from further study therapy.', ' Time frame: Day 1 to 30 days post last dose', 'Results 1: ', ' Arm/Group Title: 50 mg Dasatinib + 825 mg/m^2Capecitabine', ' Arm/Group Description: Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: participants 1', 'Results 2: ', ' Arm/Group Title: 70 mg Dasatinib + 825 mg/m^2Capecitabine', ' Arm/Group Description: Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/7 (28.57%)', ' Neutropenia 0/7 (0.00%)', ' Anaemia 0/7 (0.00%)', ' Pericardial effusion 0/7 (0.00%)', ' Melaena 0/7 (0.00%)', ' Vomiting 1/7 (14.29%)', ' Gastritis 0/7 (0.00%)', ' Diarrhoea 1/7 (14.29%)', ' Nausea 0/7 (0.00%)', ' Mucosal inflammation 0/7 (0.00%)', ' Asthenia 0/7 (0.00%)', ' Pyrexia 0/7 (0.00%)', ' Chest pain 0/7 (0.00%)', ' Pain 0/7 (0.00%)', 'Adverse Events 2:', ' Total: 2/9 (22.22%)', ' Neutropenia 0/9 (0.00%)', ' Anaemia 0/9 (0.00%)', ' Pericardial effusion 0/9 (0.00%)', ' Melaena 0/9 (0.00%)', ' Vomiting 0/9 (0.00%)', ' Gastritis 0/9 (0.00%)', ' Diarrhoea 0/9 (0.00%)', ' Nausea 0/9 (0.00%)', ' Mucosal inflammation 0/9 (0.00%)', ' Asthenia 0/9 (0.00%)', ' Pyrexia 0/9 (0.00%)', ' Chest pain 1/9 (11.11%)', ' Pain 0/9 (0.00%)']}

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

9ae51f9c-8544-4764-b731-e4efe9ae0ba6

Single

Adverse Events

NCT00320541

Cohort 2 of the primary trial recorded three times as many cases of Leukopenia as cohort 1.

Entailment

{'Clinical Trial ID': 'NCT00320541', 'Intervention': ['INTERVENTION 1: ', ' Paclitaxel Plus Bevacizumab (PB)', ' paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days', 'INTERVENTION 2: ', ' Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)', ' paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days'], 'Eligibility': ['Inclusion Criteria:', ' Females diagnosed with breast cancer and the cancer has spread to distant areas of the breast or organs.', ' Must be able to measure the disease by specific medical parameters', ' May have received breast cancer treatment in the early stage of the disease', ' May be restricted in physically strenuous activity but able to carry out light work.', ' Must have adequate organ function as seen in blood test results.', 'Exclusion', ' Criteria:', ' Cancer that has spread to the brain.', ' Unstable heart problems', ' Unstable high blood pressure.', ' Breast cancer treatment after the disease has considered to spread to other areas or organs.', ' Unable to agree with the requirements of the study'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR)', ' Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population).', ' Time frame: baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months)', 'Results 1: ', ' Arm/Group Title: Paclitaxel Plus Bevacizumab (PB)', ' Arm/Group Description: paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days', ' Overall Number of Participants Analyzed: 94', ' Mean (95% Confidence Interval)', ' Unit of Measure: proportion of responders 0.489 (0.385 to 0.595)', 'Results 2: ', ' Arm/Group Title: Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)', ' Arm/Group Description: paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days', ' Overall Number of Participants Analyzed: 92', ' Mean (95% Confidence Interval)', ' Unit of Measure: proportion of responders 0.587 (0.479 to 0.689)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 27/94 (28.72%)', ' Anaemia 2/94 (2.13%)', ' Febrile neutropenia 2/94 (2.13%)', ' Leukopenia 1/94 (1.06%)', ' Neutropenia 0/94 (0.00%)', ' Thrombocytopenia 1/94 (1.06%)', ' Arrhythmia 0/94 (0.00%)', ' Atrial fibrillation 0/94 (0.00%)', ' Cardiac failure congestive 0/94 (0.00%)', ' Cardiomyopathy 0/94 (0.00%)', ' Pericardial effusion 0/94 (0.00%)', ' Tachycardia 0/94 (0.00%)', 'Adverse Events 2:', ' Total: 36/93 (38.71%)', ' Anaemia 2/93 (2.15%)', ' Febrile neutropenia 9/93 (9.68%)', ' Leukopenia 3/93 (3.23%)', ' Neutropenia 4/93 (4.30%)', ' Thrombocytopenia 1/93 (1.08%)', ' Arrhythmia 1/93 (1.08%)', ' Atrial fibrillation 1/93 (1.08%)', ' Cardiac failure congestive 3/93 (3.23%)', ' Cardiomyopathy 2/93 (2.15%)', ' Pericardial effusion 1/93 (1.08%)', ' Tachycardia 1/93 (1.08%)']}

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

5b1915da-1819-4504-81bd-3f44a83b5e95

Single

Adverse Events

NCT00074152

Only 2 of the adverse event cases in the primary trial occurred in patients from cohort 1.

Contradiction

{'Clinical Trial ID': 'NCT00074152', 'Intervention': ['INTERVENTION 1: ', ' Arm I', ' Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.', ' radiation therapy: Given within 6 months after surgery', 'INTERVENTION 2: ', ' Arm II', ' Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.', ' chemotherapy: Given within 10 weeks after surgery.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed invasive breast cancer', ' First local and/or regional (i.e., ipsilateral axillary or internal mammary lymph node region) recurrence after primary treatment with mastectomy or lumpectomy/quadrantectomy with clear surgical margins', ' Local failure is defined as a tumor recurrence in any soft tissue of the ipsilateral conserved breast or the chest wall, mastectomy scar, and/or skin', ' Regional failure is defined as a tumor recurrence in the ipsilateral axillary lymph nodes, extranodal soft tissue of the ipsilateral axilla, and/or ipsilateral internal mammary. Regional failure does not include supraclavicular lymph nodes or tumor in the opposite breast', ' No other prior recurrence in any site, including local', ' Surgical resection of the recurrence meeting 1 of the following criteria:', ' Uninvolved ("clear") margins and planned radiotherapy with at least 40 Gy for patients who had no prior adjuvant radiotherapy', ' Mastectomy of the recurrence with uninvolved ("clear") margins after lumpectomy/quadrantectomy alone for the primary', ' Adjuvant trastuzumab (Herceptin®) therapy or other HER-2 directed therapies are allowed for patients with HER-2 positive tumors and must be declared prior to randomization', ' No evidence of distant metastasis, including ipsilateral supraclavicular lymph nodes, by x-ray or CT scan of the chest, ultrasound or CT scan of the abdomen and pelvis, or bone scintigraphy only if alkaline phosphatase is > 2 times normal or if medically indicated (e.g., bone pain)', ' No macroscopically incomplete surgery', ' No bilateral malignancy except carcinoma in situ', ' No suspicious mass in the opposite breast unless that mass has been proven by biopsy to be benign', ' No skeletal pain of unknown cause', ' No hot spots on bone scan for which metastases cannot be ruled out by x-ray, MRI, and/or CT scan', ' Hormone receptor status:', ' Determined in the recurrent tumor by immunohistochemistry and/or ligand-binding assay', ' Estrogen receptor positive or negative', ' Progesterone receptor positive or negative', ' PATIENT CHARACTERISTICS:', ' Age', ' Minimum 18 years', ' Sex', ' Female', ' Menopausal status', ' Not specified', ' Performance status', ' Not specified', ' Life expectancy', ' Not specified', ' Hematopoietic', ' Not specified', ' Hepatic', ' No elevated alkaline phosphatase', ' Renal', ' Not specified', ' Other', ' Fertile patients must use effective non-hormonal contraception', ' Medically suitable for chemotherapy of 3-6 months duration', ' No other primary malignant tumors except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer', ' No non-malignant systemic disease that would preclude study treatment or prolong follow-up', ' No psychiatric or addictive disorder that would preclude giving informed consent', ' No history of noncompliance to medical regimens or potential for being unreliable', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Not specified', ' Chemotherapy', ' See Disease Characteristics', ' Endocrine therapy', ' Not specified', ' Radiotherapy', ' See Disease Characteristics', ' Surgery', ' See Disease Characteristics'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival', ' [Not Specified]', ' Time frame: 5 years after randomization', 'Results 1: ', ' Arm/Group Title: Arm I', ' Arm/Group Description: Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.', ' radiation therapy: Given within 6 months after surgery', ' Overall Number of Participants Analyzed: 77', ' Measure Type: Number', ' Unit of Measure: percentage of participants 57 (44 to 67)', 'Results 2: ', ' Arm/Group Title: Arm II', ' Arm/Group Description: Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.', ' chemotherapy: Given within 10 weeks after surgery.', ' Overall Number of Participants Analyzed: 85', ' Measure Type: Number', ' Unit of Measure: percentage of participants 69 (56 to 79)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/77 (0.00%)', ' Neutropenia [1]0/77 (0.00%)', ' Left ventricular dysfunction 0/77 (0.00%)', ' Cardiac ischemia 0/77 (0.00%)', ' Gastrointestinal pain 0/77 (0.00%)', ' Colitis 0/77 (0.00%)', ' Febrile neutropenia 0/77 (0.00%)', ' Pulmonary/upper respiratory infection 0/77 (0.00%)', ' Diverticulitis 0/77 (0.00%)', ' Motor neuropathy 0/77 (0.00%)', ' Endometrial mucosa thinkening 0/77 (0.00%)', 'Adverse Events 2:', ' Total: 12/85 (14.12%)', ' Neutropenia [1]1/85 (1.18%)', ' Left ventricular dysfunction 1/85 (1.18%)', ' Cardiac ischemia 2/85 (2.35%)', ' Gastrointestinal pain 1/85 (1.18%)', ' Colitis 1/85 (1.18%)', ' Febrile neutropenia 3/85 (3.53%)', ' Pulmonary/upper respiratory infection 1/85 (1.18%)', ' Diverticulitis 1/85 (1.18%)', ' Motor neuropathy 1/85 (1.18%)', ' Endometrial mucosa thinkening 1/85 (1.18%)']}

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

edb1e4c0-7669-4b8c-878b-ea8ca060c350

Single

Intervention

NCT00429299

Only one cohort in the primary trial is administered trastuzumab 600 mg/m^2.

Contradiction

{'Clinical Trial ID': 'NCT00429299', 'Intervention': ['INTERVENTION 1: ', ' CT Plus Trastuzumab', ' Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.', 'INTERVENTION 2: ', ' CT Plus Lapatinib 1500 mg', ' Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.', ' Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.'], 'Eligibility': ['Inclusion criteria:', ' Histologically confirmed infiltrating primary breast cancer of > 2.0 cm in largest clinical diameter', ' HER2 positive tumor (either IHC 3+ or FISH+)', ' Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment', ' Age >18, < 65 years', ' ECOG PS 0-1', ' Normal organ and marrow function as defined below:', ' leukocytes ³ 3000/microL', ' absolute neutrophil count ³ 1,500/microL', ' platelets ³ 100,000/microL', " total bilirubin <= 1.5x ULN. In case of Gilbert's syndrome, <2 x ULN is allowed", ' AST (SGOT)/ALT(SGPT)<= 2.5 X institutional upper limit of normal', ' Alkaline phosphatase <= 2.5 x ULN', ' Creatinine within normal institutional limits', ' Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan', ' Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review of their use by the Principal Investigator. A list of medications and substances known or with the potential to interact with CYP450 isoenzymes is provided', ' The effects of lapatinib on the developing human fetus at the recommended therapeutic dose are unknown; women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately, the patient should be apprised of the potential hazard to the fetus and potential risk for loss of the pregnancy', ' Ability to understand and the willingness to sign a written informed consent document', ' Ability to swallow and retain oral medication', 'Exclusion criteria:', ' Stage IIIB, IIIC, and inflammatory breast cancer', ' Stage IV breast cancer', ' Contraindication to the treatment with anthracycline, paclitaxel and/or trastuzumab', ' Prior treatment with chemotherapy, endocrine therapy or radiotherapy. Prior treatment with EGFR targeting therapies', ' Treatment with any other investigational agents, or with all herbal (alternative) medicines', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib', ' Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Pregnancy or breastfeeding; (breast feeding should be discontinued to be enrolled in the study)', ' Women of childbearing potential that refusal to adopt adequate contraceptive measures', ' HIV-positive patients receiving combination anti-retroviral therapy', " GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)", ' Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Pathological Complete Response (pCR) in the Breast and in the Lymph Nodes', ' Pathological Complete Response (pCR) is defined by the complete absence of infiltrating tumor cells in the breast and in the lymph nodes. The pathological response in the breast was evaluated according to the criteria of Miller and Payne as follows: Grade 1, no change or some alteration to individual malignant cells, but no reduction in overall cellularity; Grade 2, a minor loss in tumor cells (up to 30%); Grade 3, between an estimated 30% and 90% reduction in tumor cells; Grade 4, marked disappearance of tumor cells, with only a small cluster or a dispersed cell remaining (more than 90% loss); Grade 5, no identifiable malignant cells. Ductal carcinoma in situ (DCIS) may be present. Grades were interpreted as follows: Grade 1-2=no response; Grade 3-4=partial response; Grade 5=complete response. pCR was defined by comparing specimens obtained at Baseline (biopsy) to those obtained upon surgery.', ' Time frame: At Baseline and surgery (within 5 weeks after the last chemotherapy administration) (assessed up to Study Week 29)', 'Results 1: ', ' Arm/Group Title: CT Plus Trastuzumab', ' Arm/Group Description: Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.', ' Overall Number of Participants Analyzed: 36', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 25', 'Results 2: ', ' Arm/Group Title: CT Plus Lapatinib 1500 mg', ' Arm/Group Description: Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.', ' Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.', ' Overall Number of Participants Analyzed: 38', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 26.3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/36 (38.89%)', ' Neutropenia 10/36 (27.78%)', ' Febrile neutropenia 1/36 (2.78%)', ' Diarrhoea 0/36 (0.00%)', ' Vomiting 1/36 (2.78%)', ' Abdominal pain 0/36 (0.00%)', ' Rectal haemorrhage 1/36 (2.78%)', ' Stomatitis 1/36 (2.78%)', ' Pyrexia 1/36 (2.78%)', ' Hyperpyrexia 0/36 (0.00%)', ' Drug hypersensitivity 0/36 (0.00%)', ' Device related infection 0/36 (0.00%)', 'Adverse Events 2:', ' Total: 13/39 (33.33%)', ' Neutropenia 7/39 (17.95%)', ' Febrile neutropenia 2/39 (5.13%)', ' Diarrhoea 3/39 (7.69%)', ' Vomiting 3/39 (7.69%)', ' Abdominal pain 1/39 (2.56%)', ' Rectal haemorrhage 0/39 (0.00%)', ' Stomatitis 0/39 (0.00%)', ' Pyrexia 1/39 (2.56%)', ' Hyperpyrexia 1/39 (2.56%)', ' Drug hypersensitivity 0/39 (0.00%)', ' Device related infection 0/39 (0.00%)']}

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

915939cf-7813-43e7-b503-e14a7eb4e568

Single

Adverse Events

NCT00856492

Cohort 1 of the primary trial recorded no deaths and no cases of Enterocolitis infectious.

Entailment

{'Clinical Trial ID': 'NCT00856492', 'Intervention': ['INTERVENTION 1: ', ' Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))', ' Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).', 'INTERVENTION 2: ', ' Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))', ' Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or pathologically confirmed breast cancer meeting one of the following criteria:', ' Locally advanced disease (stage IIIB disease, stage IIB/IIIA, or stage IIIC disease)', ' Inflammatory disease meeting the following two clinicopathologic criteria:', " Diffuse erythema AND edema (peau d'orange) of the breast involving the majority of the skin of the breast, i.e., more than 50%", ' A biopsy demonstrating cancer either within the dermal lymphatics OR in the breast parenchyma itself', ' HER2/neu-negative tumor as demonstrated by 0 or 1+ (weak or no staining) by DAKO, IHC, or equivalent test OR no gene amplification by FISH*', ' 2+ by DAKO or IHC allowed provided FISH* negative', ' NOTE: *A negative FISH test ratio is < 1.8 or FISH HER2 gene copy < 4.0; if only a positive or negative result is available from the FISH test, a negative result is acceptable for study entry', ' Hormone receptor status known', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' Zubrod performance status 0-2', ' Granulocyte count > 1,500/mm^3', ' ANC 1,500/mm^3', ' Platelet count > 100,000/mm^3', ' Hemoglobin 9.0 g/dL', ' Serum creatinine 1.5 times upper limit of normal (ULN)', ' Bilirubin 1.5 mg/dL', ' ALT and AST 3 times ULN', ' Alkaline phosphatase 2.5 ULN (unless bone metastasis is present in the absence of liver metastasis)', ' Urine protein:creatinine ratio 0.5 OR urine protein < 1,000 mg on 24-hour urine collection', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' Able to take oral medications (e.g., no uncontrolled nausea, vomiting, or diarrhea, lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome)', ' QTc < 500 msec by EKG', ' LVEF normal by MUGA or ECHO (for patients with hypertension or for patients > 60 years of age)', ' NYHA class II cardiac function by baseline ECHO/MUGA (for patients who have received central thoracic radiotherapy that included the heart in the radiotherapy port, or for patients who have a history of class II heart failure but are asymptomatic on treatment are eligible)', ' No history of stroke (cerebrovascular accident), transient ischemic attack, or cardiac event within the past 12 months, including any of the following:', ' Myocardial infarction (including severe/unstable angina)', ' Coronary/peripheral artery bypass graft', ' Symptomatic congestive heart failure', ' Pulmonary embolism', ' No poorly controlled hypertension, defined as recurrent or persistent ( 24 hours) elevated blood pressure (i.e., systolic blood pressure 140 mm Hg and/or diastolic blood pressure 90 mm Hg)', ' No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer', ' Peripheral neuropathy < grade 2', ' PRIOR CONCURRENT THERAPY:', ' No prior tyrosine kinase inhibitors', ' More than 5 years since prior chemotherapy, radiotherapy, or biologic therapy (e.g., trastuzumab or bevacizumab) for invasive breast cancer', ' At least 7 days since prior hormonal therapy', ' At least 7 days since prior and no concurrent strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or grapefruit juice', " No concurrent CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's wort)", ' No other concurrent therapy for the treatment of breast cancer except for bisphosphonates', ' No concurrent brachytherapy'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Pathological Complete Response Rate', ' Pathologic complete response (pCR), commonly defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes, has emerged as a surrogate endpoint for disease-free and overall survival, as the achievement of a pCR is associated with a favorable long-term prognosis in all breast cancer subtypes.', ' Time frame: pre-study pathology vs. post-chemo surgery pathology (approx. 39-42 weeks post-randomization)', 'Results 1: ', ' Arm/Group Title: Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G))', ' Arm/Group Description: Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).', ' Overall Number of Participants Analyzed: 98', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 35 35.7%', 'Results 2: ', ' Arm/Group Title: Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))', ' Arm/Group Description: Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab', ' Overall Number of Participants Analyzed: 113', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 24 21.2%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/96 (22.92%)', ' Anemia 1/96 (1.04%)', ' Febrile neutropenia 4/96 (4.17%)', ' Heart failure 1/96 (1.04%)', ' Abdominal pain 1/96 (1.04%)', ' Dysphagia 1/96 (1.04%)', ' Mucositis oral 1/96 (1.04%)', ' Nausea 1/96 (1.04%)', ' Vomiting 2/96 (2.08%)', ' Death NOS 0/96 (0.00%)', ' Pain 1/96 (1.04%)', ' Catheter related infection 1/96 (1.04%)', ' Enterocolitis infectious 0/96 (0.00%)', 'Adverse Events 2:', ' Total: 3/60 (5.00%)', ' Anemia 1/60 (1.67%)', ' Febrile neutropenia 1/60 (1.67%)', ' Heart failure 1/60 (1.67%)', ' Abdominal pain 0/60 (0.00%)', ' Dysphagia 0/60 (0.00%)', ' Mucositis oral 0/60 (0.00%)', ' Nausea 0/60 (0.00%)', ' Vomiting 0/60 (0.00%)', ' Death NOS 1/60 (1.67%)', ' Pain 0/60 (0.00%)', ' Catheter related infection 0/60 (0.00%)', ' Enterocolitis infectious 1/60 (1.67%)']}

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

126c1169-b375-4f89-95b2-52e971d19565

Single

Adverse Events

NCT00284180

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

Contradiction

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

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

11235250-3627-427e-aae9-099507484456

Comparison

Intervention

NCT00236899

NCT01153672

the primary trial and the secondary trial both administer Paclitaxel and Gemcitabine to their patients cohorts, but only the secondary trial utilises positron emission tomography.

Contradiction

{'Clinical Trial ID': 'NCT00236899', 'Intervention': ['INTERVENTION 1: ', ' Treatment Schedule (Weekly)', ' Arm C, Docetaxel and Gemcitabine (Weekly):', ' Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Arm D, Paclitaxel and Gemcitabine (Weekly):', ' Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', 'INTERVENTION 2: ', ' Treatment Schedule (3 Weekly)', ' Arm A, Docetaxel and Gemcitabine (3 Weekly):', ' Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Arm B, Paclitaxel and Gemcitabine (3 Weekly):', ' Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.'], 'Eligibility': ['Inclusion Criteria:', ' Histologic diagnosis of metastatic breast cancer (MBC).', ' Prior neoadjuvant or adjuvant taxanes regimen is allowed if 12 months since completion of the regimen.', ' Relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an anthracycline if not clinically contraindicated.', ' Patients with measurable disease.', ' Previous hormonal therapy for adjuvant setting or metastatic disease.', 'Exclusion Criteria:', ' Previous chemotherapy for MBC', ' Previous chemotherapy with gemcitabine in any setting of disease', ' Patient candidable to treatment with trastuzumab.'], 'Results': ['Outcome Measurement: ', ' Time to Progressive Disease (TTPD) by Treatment Schedule', ' TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a 20% increase in sum of longest diameter of target lesions.', ' Time frame: Baseline up to 49.84 months', 'Results 1: ', ' Arm/Group Title: Treatment Schedule (Weekly)', ' Arm/Group Description: Arm C, Docetaxel and Gemcitabine (Weekly):', ' Docetaxel: 30 mg/m , 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Gemcitabine: 800 mg/m , 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Arm D, Paclitaxel and Gemcitabine (Weekly):', ' Paclitaxel: 80 mg/m , IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Gemcitabine: 800 mg/m , 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Overall Number of Participants Analyzed: 117', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.33 (6.19 to 10.16)', 'Results 2: ', ' Arm/Group Title: Treatment Schedule (3 Weekly)', ' Arm/Group Description: Arm A, Docetaxel and Gemcitabine (3 Weekly):', ' Docetaxel: 75 mg/m , 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Gemcitabine: 1000 mg/m , 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Arm B, Paclitaxel and Gemcitabine (3 Weekly):', ' Paclitaxel: 175 mg/m , IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Gemcitabine: 1250 mg/m , 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.', ' Overall Number of Participants Analyzed: 124', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.51 (5.93 to 8.33)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/59 (15.25%)', ' Anaemia 0/59 (0.00%)', ' Febrile neutropenia 1/59 (1.69%)', ' Neutropenia 4/59 (6.78%)', ' Thrombocytopenia 0/59 (0.00%)', ' Cardiac failure 0/59 (0.00%)', ' Pericardial effusion 0/59 (0.00%)', ' Diarrhoea 2/59 (3.39%)', ' Intestinal obstruction 0/59 (0.00%)', ' Nausea 1/59 (1.69%)', ' Vomiting 1/59 (1.69%)', ' Asthenia 0/59 (0.00%)', ' Fatigue 1/59 (1.69%)', 'Adverse Events 2:', ' Total: 10/62 (16.13%)', ' Anaemia 1/62 (1.61%)', ' Febrile neutropenia 0/62 (0.00%)', ' Neutropenia 1/62 (1.61%)', ' Thrombocytopenia 1/62 (1.61%)', ' Cardiac failure 1/62 (1.61%)', ' Pericardial effusion 1/62 (1.61%)', ' Diarrhoea 0/62 (0.00%)', ' Intestinal obstruction 0/62 (0.00%)', ' Nausea 0/62 (0.00%)', ' Vomiting 0/62 (0.00%)', ' Asthenia 0/62 (0.00%)', ' Fatigue 0/62 (0.00%)']}

{'Clinical Trial ID': 'NCT01153672', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)', ' Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.', ' vorinostat: Given PO', ' laboratory biomarker analysis: Correlative studies', ' biopsy: Optional correlative studies', ' F-18 16 alpha-fluoroestradiol: Correlative studies', ' positron emission tomography: Correlative studies', ' anastrozole: Given PO', ' letrozole: Given PO', ' exemestane: Given PO', ' gene expression analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically proven diagnosis of breast cancer', ' Stage IV disease', ' Patient has previously derived clinical benefit from endocrine therapy, but is no longer deriving benefit to endocrine therapy in the opinion of the treating investigator; patients need to stop AI for at least one week prior to starting vorinostat treatment on this protocol', ' At least one site of measurable disease, as defined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2', ' Female patient is post menopausal as defined by one of the following; free from menses for > 2 years, surgically sterilized ,FSH and Estradiol in post-menopausal range AND surgical absence of uterus OR chemotherapy induced amenorrhea lasting > 1 year OR currently on ovarian suppression', ' Female patient of childbearing potential has a negative urine or serum (beta-human chorionic gonadotropin [hCG]) pregnancy test within 14 days prior to receiving the first dose of vorinostat', ' Male patient agrees to use two barrier methods of contraception or abstain from intercourse for the duration of the study', ' Absolute neutrophil count (ANC) >= 1,500/mcL', ' Platelets >= 100,000/mcL', ' Hemoglobin >= 9 g/dL', ' Prothrombin Time or international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN) unless receiving therapeutic anticoagulation', ' Partial thromboplastin time (PTT) =< 1.2 times the ULN unless the patient is receiving therapeutic anticoagulation', ' Potassium and magnesium levels within normal limits', ' Calculated creatinine clearance >= 30 mL/min', ' Serum total bilirubin =< 1.5 X ULN', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X ULN', ' Alkaline Phosphatase =< 2.5 X ULN', " Patient, or the patient's legal representative, has voluntarily agreed to participate by giving written informed consent", ' Patient has a life expectancy of at least 12 weeks in the opinion of the treating investigator', ' Patient is willing to continue on same AI therapy', ' Patient agrees to participate in imaging Protocol 7184 and is separately consented', 'Exclusion Criteria:', ' Patient has not derived clinical benefit from prior endocrine therapy', ' Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug(s) other than the imaging protocol 7184', ' Patient has received an ER blocking therapy (selective estrogen receptor modulating [SERM] or downregulating [SERD] i.e. tamoxifen or fulvestrant) within the past 6 weeks', ' Patient had prior treatment with an histone deacetylase (HDAC) inhibitor (e.g., romidespin [Depsipeptide], NSC-630176, MS 275, LAQ-824, belinostat [PXD-101], LBH589, MGCD0103, CRA024781, etc); patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid, as anti-tumor therapy should not enroll in this study; patients who have received such compounds for other indications, e.g. valproic acid for epilepsy, may enroll after a 30-day washout period', ' Patient is on any systemic steroids that have not been stabilized to the equivalent of =<10 mg/day prednisone during the 30 days prior to the start of the study drugs', ' Patient has known hypersensitivity to the components of study drug or its analogs', ' Patients with uncontrolled brain metastases', ' New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction within the previous 6 months, corrected QT interval (QTc) > 0.47 seconds, or uncontrolled arrhythmia.', ' Type I Diabetes Mellitus; patients with Type II Diabetes Mellitus will be included as long as their glucose can be controlled to under 200 mg/dL', ' Patient is pregnant or breast feeding, or expecting to conceive or father children within the projected duration of the study', ' Patient with a "currently active" second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled; patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for > 5 years or are considered by their physician to be at less than 30% risk of relapse', ' Patients with known active viral hepatitis', " Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study or is not in the best interest of the patient to participate"], 'Results': ['Outcome Measurement: ', ' Rate of Clinical Benefit According to RECIST', ' Conventional imaging (CT, bone scan) was performed at baseline and at week 8 and tumor response assessed by RECIST criteria', ' Time frame: Up to approximately 5 years', 'Results 1: ', ' Arm/Group Title: Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)', ' Arm/Group Description: Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.', ' vorinostat: Given PO', ' laboratory biomarker analysis: Correlative studies', ' biopsy: Optional correlative studies', ' F-18 16 alpha-fluoroestradiol: Correlative studies', ' positron emission tomography: Correlative studies', ' anastrozole: Given PO', ' letrozole: Given PO', ' exemestane: Given PO', ' gene expression analysis: Correlative studies', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Number', ' Unit of Measure: percentage of evaluable participants 15 (12 to 65)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/8 (25.00%)', ' pancreatitis [1]1/8 (12.50%)', ' Flu-like symptoms [1]1/8 (12.50%)']}

8a9f2247-7c51-44be-910b-5091d9abb2ea

Single

Intervention

NCT00038467

The patient groups in the primary trial each receive different oral medication, either Tamoxifen or Exemestane.

Entailment

{'Clinical Trial ID': 'NCT00038467', 'Intervention': ['INTERVENTION 1: ', ' Exemestane', ' Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.', 'INTERVENTION 2: ', ' Tamoxifen', ' Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.'], 'Eligibility': ['Inclusion Criteria:', ' postmenopausal women with histologically or cytologically confirmed primary breast adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously for between 2 and 3 years and one month, and still free of disease', 'Exclusion Criteria:', ' unresectable breast cancer', ' ER negative primary tumor'], 'Results': ['Outcome Measurement: ', ' Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study', ' DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.', ' Time frame: Baseline up to Month 36', 'Results 1: ', ' Arm/Group Title: Exemestane', ' Arm/Group Description: Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.', ' Overall Number of Participants Analyzed: 2352', ' Measure Type: Number', ' Unit of Measure: probability of DFS 0.90 (0.89 to 0.92)', 'Results 2: ', ' Arm/Group Title: Tamoxifen', ' Arm/Group Description: Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.', ' Overall Number of Participants Analyzed: 2372', ' Measure Type: Number', ' Unit of Measure: probability of DFS 0.86 (0.85 to 0.88)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 383/2320 (16.51%)', ' Anaemia * 2/2320 (0.09%)', ' Disseminated intravascular coagulation * 1/2320 (0.04%)', ' Granulocytopenia * 0/2320 (0.00%)', ' Hypofibrinogenaemia * 0/2320 (0.00%)', ' Iron deficiency anaemia * 1/2320 (0.04%)', ' Lymphadenitis * 1/2320 (0.04%)', ' Lymphadenopathy * 0/2320 (0.00%)', ' Thrombocytopenia * 1/2320 (0.04%)', ' Acute myocardial infarction * 5/2320 (0.22%)', 'Adverse Events 2:', ' Total: 439/2338 (18.78%)', ' Anaemia * 4/2338 (0.17%)', ' Disseminated intravascular coagulation * 0/2338 (0.00%)', ' Granulocytopenia * 1/2338 (0.04%)', ' Hypofibrinogenaemia * 1/2338 (0.04%)', ' Iron deficiency anaemia * 0/2338 (0.00%)', ' Lymphadenitis * 0/2338 (0.00%)', ' Lymphadenopathy * 1/2338 (0.04%)', ' Thrombocytopenia * 5/2338 (0.21%)', ' Acute myocardial infarction * 0/2338 (0.00%)']}

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

7e283897-4d9e-4353-8331-00f8db16cc7e

Comparison

Eligibility

NCT00847171

NCT01764022

Male patients with Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT00847171', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine', ' All patients receive weekly Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed adenocarcinoma of the breast, meeting one of the following criteria:', ' Metastatic disease', ' High-risk disease, defined as early-stage disease with pathologic involvement of locoregional lymph nodes', ' Patients who are/will be receiving standard adjuvant trastuzumab [Herceptin®] for high-risk disease will participate in this study during the single-agent trastuzumab portion of their therapy', ' No clinical or radiographical evidence of active disease', ' Not eligible for therapy of known curative potential for metastatic breast cancer', ' HER2/neu-overexpressing disease, defined as HER2/neu positive by IHC 3+ staining or by FISH+ amplification', ' Stable CNS disease allowed provided it has been adequately treated and is not under active treatment', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' ECOG performance status 0-1', ' ANC > 1,000/mm^3', ' Platelet count > 100,000/mm^3', ' Serum creatinine < 2.0 mg/dL', " Serum bilirubin 2.0 mg/dL (unless elevation is due to known Gilbert's syndrome)", ' AST/ALT 2 times upper limit of normal (ULN)', ' Alkaline phosphatase 5 times ULN', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' Cardiac ejection fraction normal by MUGA OR 45% by ECHO', ' No other malignancies within the past 5 years, except for carcinoma in situ of the cervix, superficial nonmelanoma skin cancer, or superficial bladder cancer', ' No prior or currently active autoimmune disease* requiring management with systemic immunosuppression, including any of the following:', ' Inflammatory bowel disease', ' Systemic vasculitis', ' Scleroderma', ' Psoriasis', ' Multiple sclerosis', ' Hemolytic anemia or immune-mediated thrombocytopenia', ' Rheumatoid arthritis', ' Systemic lupus erythematosus', ' Sjögren syndrome', ' Sarcoidosis', ' Other rheumatologic disease', ' No symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest', ' HIV-negative', ' No evidence of active acute or chronic infection', ' No uncontrolled medical problems', ' No active major medical or psychosocial problems that could be complicated by study participation', ' No corn allergy', ' No known severe hypersensitivity to trastuzumab (except for mild to moderate infusion reactions that are easily managed and do not recur) NOTE: *Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids allowed', ' PRIOR CONCURRENT THERAPY:', ' Any number of prior chemotherapy regimens for metastatic breast cancer allowed', ' Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed', ' More than 28 days since prior and no concurrent systemic oral steroids', ' Topical, ocular, or nasal steroids allowed', ' More than 28 days since prior and no concurrent chemotherapy, radiotherapy, or biologic therapy (except trastuzumab)', ' More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug', ' Concurrent endocrine therapy or bisphosphonates allowed'], 'Results': ['Outcome Measurement: ', ' Safety as Assessed by Number of Participants Experiencing Toxicity', ' Safety as assessed by number of participants who experienced drug-related local and systemic toxicity, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v3.0) in response to CY-modulated immunization with a novel breast cancer vaccine in the setting of weekly Trastuzumab therapy.', ' Time frame: 4 years', 'Results 1: ', ' Arm/Group Title: Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine', ' Arm/Group Description: All patients receive weekly Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Patients with drug-related toxicity: 20 100.0%', ' Patients with grade 3+ drug-related toxicity: 0 0.0%', ' Patients with serious drug-related toxicity: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/20 (0.00%)']}

{'Clinical Trial ID': 'NCT01764022', 'Intervention': ['INTERVENTION 1: ', ' BCD-022 (CJSC BIOCAD)', ' BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).', 'INTERVENTION 2: ', ' Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)', ' In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent and ability to follow the Protocol procedures;', ' Age from 18 years to 75 years inclusive;', ' Female gender;', ' Histologically confirmed breast cancer (BC);', ' Metastatic BC (stage IV according to TNM classification version 6);', ' Grade 3+ HER2 overexpression confirmed by immunohistochemical (IHC) staining or grade 2+ HER2 overexpression accompanied by HER2 gene amplification confirmed by fluorescent hybridization in situ (FISH) ;', ' Documented results of oestrogen and progesterone receptors expression analysis;', ' Eastern Cooperative Oncology Group (ECOG) status 0, 1 or 2, not increasing within 2 weeks prior to randomization;', ' Life expectancy - 20 weeks or more from the moment of randomization;', ' Presence of at least 1 tumour with a size not less than 1 cm (revealed with computed tomography (CT) slice thickness not more than 5 mm). Patients having bone metastasis as the only measurable tumour are not eligible for the trial;', ' Patients of childbearing potential must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior to inclusion into the trial and until 6 months after the last administration of the study drug.', 'Exclusion Criteria:', ' Previous anticancer therapy for metastatic BC, including cytotoxic chemotherapy, or previous anticancer therapy with signal transduction inhibitors (e.g. lapatinib), biological drugs (e.g. trastuzumab, bevacizumab), experimental (not approved for BC therapy) anticancer drugs. Any previous hormonal therapy is allowed;', ' Disease progression within 6 months after adjuvant and/or neoadjuvant anti BC therapy;', ' Surgery, radiation therapy, use of any experimental medications within 4 weeks (28 days) prior to randomization;', ' Hypersensitivity to paclitaxel and all medications containing polyoxyethylated castor oil, hypersensitivity to dexamethasone, diphenhydramine, ranitidine/cimetidine, recombinant murine proteins, contrast agents or excipients of study medications;', ' BC metastases in central nervous system, progressing or clinically manifested (e.g. cerebral oedema, spinal cord injury), with exception of non-progressing metastases not requiring treatment with glucocorticosteroids and/or anticonvulsants within 4 weeks prior to randomization;', ' Cardiovascular system pathology (congestive heart failure (CHF) stage III-IV according to New York Heart Association (NYHA) classification, unstable angina pectoris, myocardial infarction) within 12 months prior to randomization;', ' Uncontrolled hypertension comprising all cases of arterial hypertension when no decrease in blood pressure could be achieved despite treatment with a combination of 3 antihypertensive drugs including one diuretic and non-medicamental correction methods (low salt diet, physical exercise);', ' Left ventricular ejection fraction <50% according to electrocardiography;', ' Neutrophils 1500/mm3;', ' Platelets 100 000/mm3;', ' Hemoglobin 90 g/L;', ' Creatinine level 1.5 × upper limit of normal (ULN);', ' Bilirubin level 1.5 × ULN;', ' Asparagine transferase (AST) and alanine transferase (ALT) levels 2.5 × ULN (5 × ULN for patients with liver metastases);', ' Alkaline phosphatase level 5 × ULN;', ' Pregnancy or lactation;', ' Any other concomitant cancer including contralateral breast cancer revealed within 5 years prior to screening, except curatively treated intraductal carcinoma in situ, curatively treated cervical carcinoma in situ or curatively treated basal cell or squamous cell carcinoma;', " Conditions limiting patient's adherence to protocol requirements (dementia, neurologic or psychiatric disorders, drug addiction, alcoholism and others);", ' Stage II-IV neuropathy according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.0;', ' Concomitant participation in other clinical trials, previous participation in other clinical trials within 30 days before entering into the trial, previous participation in the same trial;', ' Acute or active chronic infections;', ' Hepatitis C virus, hepatitis B virus, HIV or syphilis infections;', ' Obstacles in intravenous administration of study drugs'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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.', ' The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed.', ' Time frame: Day 127', 'Results 1: ', ' Arm/Group Title: BCD-022 (CJSC BIOCAD)', ' Arm/Group Description: BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).', ' Overall Number of Participants Analyzed: 113', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 56 49.6%', 'Results 2: ', ' Arm/Group Title: Herceptin (F. Hoffmann-La Roche Ltd., Switzerland)', ' Arm/Group Description: In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).', ' Overall Number of Participants Analyzed: 110', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 48 43.6%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/113 (7.08%)', ' Febrile neutropenia [1]0/113 (0.00%)', ' Anemia with trombocytopenia 0/113 (0.00%)', ' Neutropenia 1/113 (0.88%)', ' Paroxism of atrial fibrillation 0/113 (0.00%)', ' Ventricular extrasystolone RYAN-1 0/113 (0.00%)', ' Gastrointestinal hemorrhage 1/113 (0.88%)', ' Death for unknown reason 1/113 (0.88%)', ' Diarrhea with vomiting and weakness 0/113 (0.00%)', 'Adverse Events 2:', ' Total: 13/110 (11.82%)', ' Febrile neutropenia [1]1/110 (0.91%)', ' Anemia with trombocytopenia 1/110 (0.91%)', ' Neutropenia 1/110 (0.91%)', ' Paroxism of atrial fibrillation 2/110 (1.82%)', ' Ventricular extrasystolone RYAN-1 1/110 (0.91%)', ' Gastrointestinal hemorrhage 0/110 (0.00%)', ' Death for unknown reason 1/110 (0.91%)', ' Diarrhea with vomiting and weakness 1/110 (0.91%)']}

54b15068-023b-4e60-bb82-2a22512fda62

Single

Intervention

NCT00900627

The two groups in the primary trial receive the same drug treatment, but different doses.

Entailment

{'Clinical Trial ID': 'NCT00900627', 'Intervention': ['INTERVENTION 1: ', ' AZD8931 160 mg bd', ' Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle', 'INTERVENTION 2: ', ' AZD8931 120 mg bd', ' Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle'], 'Eligibility': ['Inclusion Criteria:', ' Male/ female with solid, malignant tumour which is unresponsive to standard therapies (Phase I). Female patients with advanced breast cancer with low HER2 expression (Phase II)', ' Suitable for paclitaxel chemotherapy', ' Life expectancy more than 12 weeks', 'Exclusion Criteria:', ' Inadequate kidney, liver, heart, gastric, lung or eye function', ' Hypersensitive to paclitaxel', ' No symptomatic uncontrolled brain metastases', ' Previous taxane chemotherapy within 12 months (Phase II)'], 'Results': ['Outcome Measurement: ', ' Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel', ' DLT is an AE or laboratory abnormality related to AZD8931, starting during the DLT evaluation period and meeting any of the following criteria (further detail in protocol): Symptomatic ocular surface lesion; CTCAE grade 4 haematological AE; CTCAE grade 3 of febrile neutropenia / neutropenia / thrombocytopenia / hyperkalaemia / hyperglycaemia / hypotension / urological toxicity / ILD / pneumonitis; QTcF interval > 500 msec, two ECGs 30 minutes apart; Symptomatic congestive cardiac failure and a drop in LVEF; Decrease in LVEF of 20% to below the LLN; CS rash remaining CTCAE grade 3 for 5 days despite optimal treatment; CTCAE grade 3 nausea, vomiting or diarrhoea, despite optimal therapy; Other CTCAE grade 3 toxicity which, in the opinion of the investigator, is CS and related to AZD8931; Delay to the administration of paclitaxel on D1 of Cycle 2 by 7 days. Patients could have more than one DLT.', ' Time frame: Weekly visits for routine safety monitoring from Day 1 to Day 28 for each participant', 'Results 1: ', ' Arm/Group Title: AZD8931 160 mg bd', ' Arm/Group Description: Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: Number of Dose Limiting Toxicities Total: 2', ' Eye disorders: Keratitis: 1', ' Eye disorders: Photophobia: 1', ' Gastrointestinal disorders: Diarrhoea: 1', ' Gastrointestinal disorders: Oesophagitis: 0', ' Infections and infestations: Rash pustular: 0', 'Results 2: ', ' Arm/Group Title: AZD8931 120 mg bd', ' Arm/Group Description: Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle', ' Overall Number of Participants Analyzed: 2', ' Measure Type: Number', ' Unit of Measure: Number of Dose Limiting Toxicities Total: 1', ' Eye disorders: Keratitis: 0', ' Eye disorders: Photophobia: 0', ' Gastrointestinal disorders: Diarrhoea: 1', ' Gastrointestinal disorders: Oesophagitis: 0', ' Infections and infestations: Rash pustular: 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/6 (66.67%)', ' ANAEMIA 0/6 (0.00%)', ' FEBRILE NEUTROPENIA 0/6 (0.00%)', ' NEUTROPENIA 0/6 (0.00%)', ' PANCYTOPENIA 0/6 (0.00%)', ' CARDIAC FAILURE 0/6 (0.00%)', ' ATRIAL FIBRILLATION 0/6 (0.00%)', ' MYOCARDIAL INFARCTION 0/6 (0.00%)', ' SUPRAVENTRICULAR TACHYCARDIA 0/6 (0.00%)', ' KERATITIS 0/6 (0.00%)', ' DIARRHOEA 0/6 (0.00%)', ' NAUSEA 0/6 (0.00%)', ' OESOPHAGITIS 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 2/6 (33.33%)', ' ANAEMIA 0/6 (0.00%)', ' FEBRILE NEUTROPENIA 0/6 (0.00%)', ' NEUTROPENIA 0/6 (0.00%)', ' PANCYTOPENIA 0/6 (0.00%)', ' CARDIAC FAILURE 0/6 (0.00%)', ' ATRIAL FIBRILLATION 0/6 (0.00%)', ' MYOCARDIAL INFARCTION 0/6 (0.00%)', ' SUPRAVENTRICULAR TACHYCARDIA 0/6 (0.00%)', ' KERATITIS 0/6 (0.00%)', ' DIARRHOEA 0/6 (0.00%)', ' NAUSEA 0/6 (0.00%)', ' OESOPHAGITIS 1/6 (16.67%)']}

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

78764961-52be-4235-a2b7-e581497d0099

Comparison

Intervention

NCT03708393

NCT03456427

The interventions in the primary trial and the secondary trial require active participation from the patient to apply the treatment.

Contradiction

{'Clinical Trial ID': 'NCT03708393', 'Intervention': ['INTERVENTION 1: ', ' IUS Alone', 'IUS alone imaging', 'INTERVENTION 2: ', ' Imagio (IUS+OA)', 'IUS+OA imaging'], 'Eligibility': ['Inclusion Criteria:', ' - Female subjects participating in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status', 'Exclusion Criteria:', ' - Female subjects who did not have known clinical status in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status'], 'Results': ['Outcome Measurement: ', ' The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1', ' Primary effectiveness endpoint was the specificity of Imagio [IUS+OA] compared to IUS alone at fixed 95-99% sensitivity (fSp) interpolated from the area under the curve (AUC) of receiver operating characteristic (ROC) curves, averaged across all 10 independent readers. Both imaging modalities (IUS alone and IUS+OA) were read for each subject (subject as own control). Results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth).', ' Time frame: Baseline to 12 month follow-up', 'Results 1: ', ' Arm/Group Title: IUS Alone', ' Arm/Group Description: IUS alone imaging', ' Overall Number of Participants Analyzed: 120', ' Mean (95% Confidence Interval)', ' Unit of Measure: Percent of correct benign masses fSp (95.0%): 80.9 (69.1 to 92.7)', ' fSp (96.0%): 78.7 (65.7 to 91.7)', ' fSp (97.0%): 75.8 (61.4 to 90.3)', ' fSp (97.5%): 74 (58.7 to 89.4)', ' fSp (98.0%): 71.8 (55.4 to 88.3)', ' fSp (99.0%): 65.2 (45.8 to 84.6)', 'Results 2: ', ' Arm/Group Title: Imagio (IUS+OA)', ' Arm/Group Description: IUS+OA imaging', ' Overall Number of Participants Analyzed: 120', ' Mean (95% Confidence Interval)', ' Unit of Measure: Percent of correct benign masses fSp (95.0%): 75.4 (61.5 to 89.3)', ' fSp (96.0%): 71.4 (55.8 to 87.0)', ' fSp (97.0%): 66.1 (48.6 to 83.7)', ' fSp (97.5%): 62.8 (44.1 to 81.6)', ' fSp (98.0%): 58.9 (38.8 to 79)', ' fSp (99.0%): 47.7 (24.5 to 71.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/155 (0.00%)', 'Adverse Events 2:', ' ']}

{'Clinical Trial ID': 'NCT03456427', 'Intervention': ['INTERVENTION 1: ', ' All Study Participants: Patient Assisted Compression', ' All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', ' Patient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC & MLO.', 'INTERVENTION 2: ', ' All Study Participants: Technologist Compression', ' All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', ' Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site.'], 'Eligibility': ['Inclusion Criteria:', ' Are women aged 40 years or older;', ' Are asymptomatic and scheduled for screening mammography;', ' Have left and right breasts;', ' Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;', " Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;", ' Are able and willing to comply with study procedures; and', ' Are able and willing to provide written informed consent to participate.', 'Exclusion Criteria:', ' Are women aged 40 years or older;', ' Are asymptomatic and scheduled for screening mammography;', ' Have left and right breasts;', ' Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;', " Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;", ' Are able and willing to comply with study procedures; and', ' Are able and willing to provide written informed consent to participate.'], 'Results': ['Outcome Measurement: ', ' Percentage of Acceptable Overall Image Quality', ' The primary objective is to compare the percentage of acceptable overall image quality in unilateral two-view (CC and MLO) breast images acquired using Patient-Assisted Compression and Technologist Compression modes.', 'Time frame: 1 Day', 'Results 1: ', ' Arm/Group Title: All Study Participants: Patient Assisted Compression', ' Arm/Group Description: All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', ' Patient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC & MLO.', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Image Quality: Acceptable: 30 90.9%', ' Image Quality: Unacceptable: 3 9.1%', 'Results 2: ', ' Arm/Group Title: All Study Participants: Technologist Compression', ' Arm/Group Description: All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', ' Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site.', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Image Quality: Acceptable: 33 100.0%', ' Image Quality: Unacceptable: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/36 (0.00%)', 'Adverse Events 2:', ' ']}

e09fe98c-ec5c-49cf-9f49-92ba8824e82e

Single

Intervention

NCT01277757

the primary trial is not testing a novel Physiotherapy or radiotherapy intervention.

Entailment

{'Clinical Trial ID': 'NCT01277757', 'Intervention': ['INTERVENTION 1: ', ' Akt Inhibitor MK-2206', ' Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed breast cancer, with diagnosed or suspected metastatic, inoperable locally advanced breast cancer, or inoperable locally recurrent breast cancer', ' Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan', ' Patients who have failed to respond to at least one line of systemic therapy are eligible for MK2206 therapy; if the patient has a human epidermal growth factor receptor 2 (HER2) positive tumor, it is expected that they will have received at least one HER2-targeted therapy in the metastatic setting; if the patient has an estrogen receptor positive (ER+) tumor, it is expected that they will have received at least one ER-targeted therapy in the metastatic setting; patients can be enrolled for molecular screening while on another therapy if the patient is interested in MK2206 therapy upon progression', ' Archived primary tumor biopsies or surgical specimens, or biopsies of recurrence or metastasis, will be available for PIK3CA/Akt mutational analysis and PTEN analysis; patients with surgical samples, or core/punch biopsies available, will be eligible for testing for PIK3CA/Akt status as well as PTEN testing; the most recent sample will be preferred (i.e. in patients with metastatic disease, metastases samples are preferred over archival primary tumor and in patients with local recurrences a biopsy of the recurrence is preferred over archival primary tumor); NOTE: PIK3CA or Akt mutation status can be determined on fine needle aspirate (FNA) samples, but PTEN status cannot as stroma and endothelial cells are used as internal controls and PTEN testing has not been validated on FNA samples; thus patients with only FNA samples and no tissue blocks available will be considered to be eligible for screening for PIK3CA/Akt mutations and will be enrolled onto the study only if they are found to have PIK3CA mutations or Akt mutations; patients whose tumors have already been tested in the Clinical Laboratory Improvement Amendments (CLIA) environment and have been found to have a PIK3CA mutation or Akt mutation or PTEN loss by immunohistochemistry (IHC) or PTEN mutation will be eligible for treatment; patients whose tumors have been tested in the research environment and found to have a PIK3CA mutation or Akt mutation or PTEN loss or PTEN mutation will have their marker status confirmed in the CLIA environment', ' Patients whose tumors have already been tested in the CLIA environment and have been found to have a PIK3CA mutation or Akt mutation or PTEN loss or mutation will be eligible for treatment; patients whose tumors have been tested in the research environment and found to have a PIK3CA mutation or Akt mutation or PTEN loss or mutation will have their marker status confirmed in the CLIA environment.', ' Patient will have a tumor suitable for FNA and/or core/punch biopsy for research purposes', ' Patient must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1', ' Absolute neutrophil count (ANC) >= 1,000/uL', ' Platelets >= 100,000/uL', ' Hemoglobin (Hgb) >= 9 g/dL', ' Creatinine =< 1.5 X upper limit of normal (ULN)', ' Prothrombin time (PT), partial thromboplastin time (PTT) =< 1.2 X ULN', ' Total bilirubin =< 1.5 X ULN', ' Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 X ULN', ' Patients of childbearing potential must have a negative serum or urine pregnancy test beta-human chorionic gonadotropin (hCG) within 72 hours prior to study registration', ' Women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and also for 4 weeks after the end of therapy; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately', ' Patient must have completed any systemic therapy regimens and therapeutic radiation a minimum of 21 days prior to initiation of study therapy', ' Ability to understand and the willingness to sign a written informed consent document', ' >= 6 months life expectancy as documented in patient records', 'Exclusion Criteria:', ' Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events to grade 1 or less due to agents administered more than 3 weeks earlier', ' Patients may have received prior investigational therapies; however, they not be receiving any other investigational agents concurrent with MK2206; patients must have completed therapy a minimum of 21 days prior to initiation of study therapy', ' Patients may not have received treatment with another inhibitor of phosphatidylinositol 3 kinase (PI3K), Akt or mammalian target of rapamycin (mTOR) in the neoadjuvant, adjuvant or metastatic setting with the exception of rapalogs; patients with metastatic breast cancer, who received PI3K/Akt/mTOR inhibitors on short preoperative window trials (treatment for 4 weeks or less), will be eligible if the treatment was over 6 months prior to registration; patients must have completed therapies a minimum of 21 days prior to initiation of study therapy', ' Patients with known brain metastases should be excluded from this clinical trial; patients will not undergo pre-treatment imaging of the brain, unless clinically indicated', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK2206 or other agents used in the study', ' Patients receiving any medications or substances that are potent inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP 450 3A4) are ineligible; however, patients will be permitted regular dietary consumption of caffeine; glyburide will be allowed for the treatment of hyperglycemia', ' Patients with diabetes or in risk for hyperglycemia should not be excluded, but patients with poorly controlled diabetes (glycated hemoglobin [HBA1C] > 8%) should be excluded', " Baseline corrected QT by Fridericia's formula (QTcF) > 450 msec (male) or QTcF >b470 msec (female) will exclude patients from entry on study", ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Baseline bradycardia related to cardiac disease, or significant bundle branch block', ' Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MK2206', ' Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible', ' Patients at high risk for coagulopathy', ' Liver disease burden greater or equal to 50 percent', ' Need for blood or platelet transfusion within one month from baseline laboratory testing as well as within treatment initiation'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Response Defined Using Response Evaluation Criteria In Solid Tumors (RECIST)', ' Number of participants with response defined by RECIST version 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.', ' Time frame: Up to 3 weeks after completion of study treatment, for up to 1 year', 'Results 1: ', ' Arm/Group Title: Akt Inhibitor MK-2206', ' Arm/Group Description: Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: participants Complete Response (CR): 0', ' Partial Response (PR): 1', ' Progressive Disease (PD): 20', ' Stable Disease (SD): 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/28 (3.57%)', ' Hematocrit drop 1/28 (3.57%)']}

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

a83d98c9-e3da-4449-878b-5fa2f3bee8cf

Single

Eligibility

NCT01027416

To be eligible for the primary trial, patients must have an invasive carcinoma confirmed by core biopsy, and a -ive human chorionic gonadotropin urine test.

Contradiction

{'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%)']}

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

41db854e-1565-4eda-8236-550556043b47

Comparison

Adverse Events

NCT00493649

NCT01201265

There were no MRSA infections in either the secondary trial or the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00493649', 'Intervention': ['INTERVENTION 1: ', ' TOP2A-amplified Group', ' FISH ratio of TOP2A gene copy number was 2 or greater.', 'INTERVENTION 2: ', ' TOP2A-nonamplified Group', ' FISH ratio of TOP2A gene copy number was less than 2.'], 'Eligibility': ['Inclusion Criteria:', ' A woman will be eligible for inclusion in this study if she meets all of the following criteria:', ' Has HER2+ (IHC staining of 3+ [uniform, intense membrane staining of >30% of invasive tumor cells], or a FISH result of .6 HER2 gene copies per nucleus or a FISH ratio [HER2 gene signals to chromosome 17 signals] of >2.2; patients with equivocal FISH ratio results 1.8-2.2 are also eligible if 3+ IHC) (Appendix IX); Stage I, IIA, IIB, or IIIA T1-3N1-3M0 disease. At the discretion of the Treating Physician, patients with 4+ nodes with other factors such as patient choice, older age, preexisting cardiac disease with normal MUGA or ECHO may be enrolled into a separate subgroup.', ' Has operable, histologically confirmed, invasive carcinoma of the breast.', ' Has known ER and PR status', ' Has adequate tumor specimen available for FISH analysis of TOP2A status (See Appendix VII)', ' Has had no prior chemotherapy unless it was given >5 years ago for breast cancer or other cancer', ' Has an ECOG Performance Status (PS) 0-1', ' Age >18 to <70 years old.', ' Has laboratory values of: See protocol for specific details', ' Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase (ALP) within the ranges shown below. In determining eligibility the more abnormal of the 2 values (AST or ALT) should be used. See protocol for specific details', ' Has complete surgical resection of the primary breast tumor: either lumpectomy or mastectomy with sentinel lymph node or axillary dissection.', ' It has been <84 days since the date of definitive surgery, and there is adequate wound healing as determined by the Treating Physician', ' Has no evidence of metastatic disease by physical examination and x-ray; appropriate scans as needed by each individual patient (eg, bone scan; abdominal, chest CT; PET or PET/CT; ultrasound; or MRI should indicate no evidence of metastatic disease.', ' Has normal cardiac function as evidenced by a LVEF >50%, but must be within normal limits (WNL) by institutional standard, as determined by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO). The same modality must be used throughout the study to evaluate LVEF. Ejection fraction (EF) as determined by ECHO must be WNL by institutional standard.', ' Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential [not surgically sterilized and between menarche and 1 year postmenopause]).', ' If fertile, patient has agreed to use an acceptable method of birth control (barrier contraceptive) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter', ' Has signed a Patient Informed Consent Form', ' Has signed a Patient Authorization Form', 'Exclusion Criteria:', ' A woman will be excluded from this study if she meets any of the following criteria:', ' Has any evidence of disease following complete surgical resection of the primary tumor and metastatic workup', " Has Stage IIIB breast cancer (T4 disease; ie, patients with fixed tumors, peau d'orange skin changes, skin ulcerations, or inflammatory changes).", ' Has Stage IV breast cancer (M1 disease on TNM staging system)', ' Had prior chemotherapy for breast cancer or other cancer within the last 5 years (no neoadjuvant chemotherapy in this study is permitted)', ' Has a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80', ' Has had a myocardial infarction (MI) within 6 months of trial enrollment, or has New York Heart Association (NYHA) Class II or greater heart failure (see Appendix III), uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic changes', ' Has abnormal baseline MUGA (or ECHO) (<50%, or less than institutional LLN)', ' Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Adjuvant hormonal therapy, if needed, may be given during radiation therapy and during treatment with trastuzumab after completion of chemotherapy.', ' Is receiving concurrent investigational therapy or has received such therapy within the past 30 calendar days', ' Has peripheral neuropathy >Grade 1', ' Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious viral (including clinically defined AIDS), bacterial or fungal infection; or history of uncontrolled seizures, or diabetes, or CNS disorders deemed by the Treating Physician to be clinically significant, precluding informed consent', ' Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive', ' Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs', ' Is an obese patient to whom the Treating Physician would not be comfortable administering full doses of study drugs as calculated by the BSA. Obese patients will be treated based on actual body weight. Obese patients treated with full doses based on actual BSA are eligible', ' Is a pregnant or breastfeeding woman', ' Is deemed unable to comply with requirements of study'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival (DFS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.', ' DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: TOP2A-amplified Group', ' Arm/Group Description: FISH ratio of TOP2A gene copy number was 2 or greater.', ' Overall Number of Participants Analyzed: 190', ' Measure Type: Number', ' Unit of Measure: probability of disease-free survival 0.978 (0.942 to 0.992)', 'Results 2: ', ' Arm/Group Title: TOP2A-nonamplified Group', ' Arm/Group Description: FISH ratio of TOP2A gene copy number was less than 2.', ' Overall Number of Participants Analyzed: 248', ' Measure Type: Number', ' Unit of Measure: probability of disease-free survival 0.979 (0.949 to 0.991)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 51/486 (10.49%)', ' ANEMIA 1/486 (0.21%)', ' NEUTROPENIA 4/486 (0.82%)', ' FIBRILLATION ATRIAL 1/486 (0.21%)', ' ABDOMINAL PAIN 2/486 (0.41%)', ' BLOATING 1/486 (0.21%)', ' BOWEL PERFORATION 1/486 (0.21%)', ' COLITIS 1/486 (0.21%)', ' DEHYDRATION 5/486 (1.03%)', ' DIARRHEA 5/486 (1.03%)', ' GASTRIC INFLAMMATION 1/486 (0.21%)', ' NAUSEA 3/486 (0.62%)', ' NAUSEA AND VOMITING 1/486 (0.21%)', 'Adverse Events 2:', ' ']}

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

f559cacb-30e7-47cf-9ac6-5929c1a508f7

Comparison

Eligibility

NCT03096847

NCT01840163

Female Patients recently prescribed Rapamycin are not eligible for the primary trial, but may be eligible for the secondary trial unless they have a stage 1 to 2 Ductal carcinoma in situ and can speak english.

Contradiction

{'Clinical Trial ID': 'NCT03096847', 'Intervention': ['INTERVENTION 1: ', ' Ribociclib + Letrozole Cohort A', ' postmenopausal women, or men; naïve.', ' All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.', 'INTERVENTION 2: ', ' Ribociclib + Letrozole Cohort B1', ' premenopausal women or perimenopausal women; naïve All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly'], 'Eligibility': ['Inclusion Criteria:', ' Patient is an adult, 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines', ' Women and men with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.', ' Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive and HER2-negative breast cancer by local laboratory. Local pathology is sufficient for assessment.', ' Patient must have either:', ' Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria ).', ' Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease', ' Non-measurable disease', ' Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 2', ' Exclusion Criteria', ' Patient who received any CDK4/6 inhibitor or any mTOR inhibitor.', ' Patient has a known hypersensitivity to any of the excipients of ribociclib or letrozole', ' Patients with current inflammatory breast cancer.', ' Patient has received > 1 chemotherapy for the treatment of advanced/metastatic breast cancer', ' Patient has received > 2 endocrine therapies for the treatment of advanced/metastatic breast cancer', ' Patient has central nervous system (CNS) involvement. If patient is fulfilling the following 3 criteria she/he is eligible for the trial.', ' completed prior therapy (including radiation and/or surgery) for CNS metastases 28 days prior to the start of study and', ' CNS tumor is clinically stable at the time of screening and', ' Patient is not receiving steroids and enzyme inducing anti-epileptic medications for brain metastases', ' Patient has active cardiac disease or a history of cardiac dysfunction'], 'Results': ['Outcome Measurement: ', ' Clinical Benefit Rate (CBR) in Women and Men With Hormone Receptor Positiv, HER-2 Negative Breast Cancer Treated With Ribocilib and Letrozole', ' Clinical Benefit Rate (CBR) after 24 weeks of treatment as defined by RECIST 1.1 as percentage of patients with Complete Response (CR), Partial response (PR) or Stable disease (SD) lasting 24 weeks or longer as well as patients with Non-complete response, nonprogressive disease (NCRNPD).', ' Time frame: At 24 weeks after last patient enrolled in trial', 'Results 1: ', ' Arm/Group Title: Ribociclib + Letrozole Cohort A', ' Arm/Group Description: postmenopausal women, or men; naïve.', ' All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.', ' Overall Number of Participants Analyzed: 307', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants CBR by week 24 (= BOR of CR or PR or SD or NCRNPD(Confirmed Best Overall Response (BOR)): 63.2 (57.5 to 68.6)', ' CBR by week 24 (= BOR of CR or PR or SD or NCRNPD (non-confirmed BOR): 71.7 (66.3 to 76.6)', 'Results 2: ', ' Arm/Group Title: Ribociclib + Letrozole Cohort B1', ' Arm/Group Description: premenopausal women or perimenopausal women; naïve All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants CBR by week 24 (= BOR of CR or PR or SD or NCRNPD(Confirmed Best Overall Response (BOR)): 57.7 (36.9 to 76.6)', ' CBR by week 24 (= BOR of CR or PR or SD or NCRNPD (non-confirmed BOR): 69.2 (48.2 to 85.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 97/319 (30.41%)', ' ANAEMIA 4/319 (1.25%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 1/319 (0.31%)', ' FEBRILE NEUTROPENIA 0/319 (0.00%)', ' HYPERFIBRINOLYSIS 0/319 (0.00%)', ' LEUKOPENIA 2/319 (0.63%)', ' NEUTROPENIA 2/319 (0.63%)', ' PANCYTOPENIA 1/319 (0.31%)', ' THROMBOCYTOPENIA 3/319 (0.94%)', ' ATRIAL FIBRILLATION 2/319 (0.63%)', ' BRADYARRHYTHMIA 1/319 (0.31%)', ' CARDIAC ARREST 1/319 (0.31%)', 'Adverse Events 2:', ' Total: 50/183 (27.32%)', ' ANAEMIA 4/183 (2.19%)', ' DISSEMINATED INTRAVASCULAR COAGULATION 0/183 (0.00%)', ' FEBRILE NEUTROPENIA 3/183 (1.64%)', ' HYPERFIBRINOLYSIS 1/183 (0.55%)', ' LEUKOPENIA 0/183 (0.00%)', ' NEUTROPENIA 2/183 (1.09%)', ' PANCYTOPENIA 0/183 (0.00%)', ' THROMBOCYTOPENIA 0/183 (0.00%)', ' ATRIAL FIBRILLATION 2/183 (1.09%)', ' BRADYARRHYTHMIA 0/183 (0.00%)', ' CARDIAC ARREST 0/183 (0.00%)']}

{'Clinical Trial ID': 'NCT01840163', 'Intervention': ['INTERVENTION 1: ', ' CanSORT Online Tool (Intervention)', ' Comprehensive (interactive) version of decision tool', ' CanSORT Online Tool', 'INTERVENTION 2: ', ' Static Version of CanSORT Tool (Control)', ' Static version (non-interactive) version of CanSORT decision tool', ' Static version of CanSORT tool'], 'Eligibility': ['Inclusion Criteria:', ' Stage 1-2 invasive breast cancer diagnosis,', ' DCIS', ' Ability to read English', 'Exclusion Criteria:', 'Male'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Accurate Knowledge About Risks and Benefits of Treatment Options for Locoregional Breast Cancer.', ' Self reported knowledge about locoregional treatment using a 5 item Breast Cancer Knowledge Measure (adapted). A binary knowledge indicator was created for all patients whereby high knowledge indicated for patients scoring greater than 80% on the item scale. The binary knowledge variable was analyzed for intervention effect using both unadjusted and adjusted logistic mixed model regression.', ' Time frame: 4-5 weeks from date of enrollment', 'Results 1: ', ' Arm/Group Title: CanSORT Online Tool (Intervention)', ' Arm/Group Description: Comprehensive (interactive) version of decision tool', ' CanSORT Online Tool', ' Overall Number of Participants Analyzed: 251', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 148 59.0%', 'Results 2: ', ' Arm/Group Title: Static Version of CanSORT Tool (Control)', ' Arm/Group Description: Static version (non-interactive) version of CanSORT decision tool', ' Static version of CanSORT tool', ' Overall Number of Participants Analyzed: 245', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 105 42.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/267 (0.00%)', 'Adverse Events 2:', ' Total: 0/270 (0.00%)']}

79362f6d-ef2c-4b93-8719-be361d0b5acc

Comparison

Eligibility

NCT02650193

NCT00656669

Patients with Class III obesity cannot be included in the primary trial, but can be entered into the secondary trial, even if they have uncontrolled Hypertension.

Contradiction

{'Clinical Trial ID': 'NCT02650193', 'Intervention': ['INTERVENTION 1: ', ' Cycle 0: HSP-130 3mg', ' Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.', 'INTERVENTION 2: ', ' Cycles 0: HSP-130 6mg', ' Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.'], 'Eligibility': ['Inclusion Criteria:', ' A subject will be eligible for study participation if all of the following criteria are met at Screening:', ' Is informed, has been given ample time and opportunity to read about participation in the study and has signed and dated the written informed consent form approved by an Independent Ethics committee (IEC) prior to any study related activities', ' Females 18 years', ' Histologically confirmed and documented invasive breast cancer', ' Breast cancer without evidence of distant metastases (Stage 4) based on staging work-up', ' Chemotherapy naive, who have not received chemotherapy in the neoadjuvant setting and who are candidates for chemotherapy in the adjuvant setting of taxane/cyclophosphamide-based regimen, e.g., TAC, as background chemotherapy', ' Zubrod/WHO/ECOG performance status 2', ' Adequate bone marrow, hepatic, and renal function reserve as evidenced by:', ' Hemoglobin 10 mg/dl', ' ANC 1.5 x 10^9/L', ' Platelet count of 100 x 10^9/L', ' Total bilirubin 2 mg/dl', ' Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 3 x the upper limit of normal (ULN) of the reference lab', ' Serum creatinine of 1.5 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of 60 mg/min', ' Body mass index (BMI) of 19 to 40 kg/m^2 , inclusive', ' Subjects of childbearing potential, and their partners, agree to pregnancy prevention throughout the duration of the study (through the Follow-up Visit). Specific type of pregnancy prevention should be discussed with, and acceptable to, the treating oncologist in the context of the tumoral hormone receptor status. Subjects and their partners must agree to use of an effective method of contraception, to avoid impregnation of females throughout the course of the study', ' Medically acceptable forms of birth control can include, with approval of the treating physician:', ' Barrier methods (condom or diaphragm with spermicide)', ' Intrauterine device (IUD)', ' Hormone contraceptives (such as oral [pill], injection, skin patch, implant, cervical ring)', ' Subjects using oral contraceptives must be on a stable regimen for at least 3 months prior to Screening. Sexually active subjects must use contraception while on HSP-130 from admission to the final Follow-up Visit', ' Able to understand verbal or written instructions and comply with all study requirements, to communicate effectively with study personnel and is available for the planned duration of the study', 'Exclusion Criteria:', ' A subject will NOT be eligible for study participation if any of the following criteria are met at Screening:', ' Previous G-CSF exposure, including filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim, granulocyte/macrophage colony stimulating growth factor (GM-CSF), or any other branded or biosimilar G-CSF', ' Prior autologous stem cell harvest of any type', ' Drug sensitivity, allergic reaction, or known hypersensitivity or idiosyncratic reaction to E. coli - derived proteins, filgrastim, other G-CSFs, or pegylated agents', ' Known hypersensitivity to docetaxel, polysorbate 80, or doxorubicin', ' For subjects receiving doxorubicin, no concurrent use of inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp or with trastuzumab due to increased risk of cardiac dysfunction', ' Chemotherapy other than that included in this study (taxane/cyclophosphamide-based regimen, e.g., TAC or TC) or neoadjuvant chemotherapy; or known immunosuppressive agents including chronic oral corticosteroid use, or radiation therapy within 4 weeks of first dose of HSP-130, prior bone marrow or stem cell transplantation, or malignancy within 5 years', ' Known HER2 + ( overexpressing breast cancer)', ' Known triple negative (estrogen receptor-negative, progesterone receptor-negative and HER2-negative) breast cancer', ' Grade 2 underlying neuropathy', ' Current diagnosis of active tuberculosis or other severe infection, such as sepsis, abscesses or opportunistic infections', ' Treatment with systemically active antibiotics within 72 hours before chemotherapy', ' Known infection with HIV', ' Known sickle cell disease', ' Known severe persistent drug-induced myelosuppression', ' New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina, clinically significant ECG abnormalities) or MI within the previous 6 months before the first administration of HSP-130', ' Any malignancy other than breast cancer, with exception of adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ, within 5 years before the first administration of the HSP-130', ' Current or recent treatment (within 30 days before the first administration of the HSP-130) with any other investigational medicinal product', ' Pregnancy or lactation; Subjects planning to be pregnant or to breastfeed before, during, or within 12 months after administration of the HSP-130 are not permitted to enroll in the study', ' Received a live, live-attenuated, or non-live vaccine within 4 weeks before the first administration of the HSP-130', ' Patient has evidence of any other coexisting disease or medical or psychological condition, metabolic dysfunction, physical examination finding or clinical lab finding giving reasonable suspicion of a disease or condition that contraindicated the use of an HSP-130, or patient is high risk for treatment complication'], 'Results': ['Outcome Measurement: ', ' Area Under the Effect Curve for Absolute Neutrophil Count (AUECANC): Cycle 0', " Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.", ' Time frame: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose', 'Results 1: ', ' Arm/Group Title: Cycle 0: HSP-130 3mg', ' Arm/Group Description: Participants who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.', ' Overall Number of Participants Analyzed: 6', ' Mean (Standard Deviation)', ' Unit of Measure: hour*10^9 Neutrophils per Liter 3900.482 (683.6870)', 'Results 2: ', ' Arm/Group Title: Cycles 0: HSP-130 6mg', ' Arm/Group Description: Participants who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Participants were followed approximately 30 days after last dose of study treatment.', ' Overall Number of Participants Analyzed: 6', ' Mean (Standard Deviation)', ' Unit of Measure: hour*10^9 Neutrophils per Liter 5880.985 (1287.2887)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/6 (0.00%)', ' Febrile Neutropenia * 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 0/6 (0.00%)', ' Febrile Neutropenia * 0/6 (0.00%)']}

{'Clinical Trial ID': 'NCT00656669', 'Intervention': ['INTERVENTION 1: ', ' Sunitinib Monotherapy', ' Patients who completed the Sunitinib monotherapy segment'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically-confirmed adenocarcinoma of the breast with operable or inoperable stage 1c (primary tumor > 1.0 cm), II or III disease.', ' Measurable disease by physical examinations or diagnostic breast imaging (mammography, ultrasonography or MR).', ' Pre-treatment core or incisional biopsy. Patients may not have had definitive primary surgery.', ' Male or female, 18 years of age or older.', ' ECOG performance status 0 or 1.', ' Adequate organ function as defined in the protocol.', 'Exclusion Criteria:', ' Prior radiation therapy, cytotoxic therapy or systemic therapy for breast cancer. Prior use of tamoxifen or raloxifene as chemoprevention is allowed but must be discontinued prior to study entry.', ' Metastatic (Stage IV) breast cancer', ' Patients who have had only a pre-treatment fine needle aspiration (FNA) are excluded.', ' Current therapeutic treatment on another clinical trial with an investigational agent.', ' Any of the following within the 6 months prior to starting study treatment: -myocardial infarction -severe/unstable angina -coronary/peripheral artery bypass graft -congestive heart failure -cerebrovascular accident including transient ischemic attack -pulmonary embolus', ' Ongoing cardiac dysrhythmias of NCI CTCAE grade >=2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.', ' Hypertension that cannot be controlled by medications.', ' Current treatment with therapeutic doses of any anti-coagulant. Prophylactic use of anticoagulants is allowed.', ' Known human immunodeficiency virus (HIV) infection.', ' Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test prior to first day of study medication.', ' Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.'], 'Results': ['Outcome Measurement: ', ' Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy', ' Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value.', ' Time frame: baseline through end of segment 1 (2 weeks)', 'Results 1: ', ' Arm/Group Title: Sunitinib Monotherapy', ' Arm/Group Description: Patients who completed the Sunitinib monotherapy segment', ' Overall Number of Participants Analyzed: 19', ' Mean (Standard Deviation)', ' Unit of Measure: mm Hg 14.0 (12.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/23 (0.00%)', ' LEFT VENTRICULAR SYSTOLIC DYSFUNCTION *0/23 (0.00%)', ' NAUSEA *0/23 (0.00%)', ' VOMITING *0/23 (0.00%)', ' BILIRUBIN (HYPERBILIRUBINEMIA) *0/23 (0.00%)', ' INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E *0/23 (0.00%)', ' NEUTROPHILS/GRANULOCYTES (ANC/AGC) *0/23 (0.00%)']}

54918996-1b4d-48bd-a0ca-13d8e259767b

Comparison

Adverse Events

NCT00679341

NCT00201851

Patients in the secondary trial and those in the primary trial did not share any of the same adverse events.

Entailment

{'Clinical Trial ID': 'NCT00679341', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine', ' Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.', 'INTERVENTION 2: ', ' Trastuzumab + Docetaxel', ' Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease, and a candidate for chemotherapy.', ' Human epidermal growth factor receptor 2 (HER2)-positive.', ' No prior chemotherapy for their metastatic breast cancer (MBC).', ' Measurable disease.', ' Age 18 years.', ' For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the study.', 'Exclusion Criteria:', ' History of any chemotherapy for MBC.', ' An interval of < 6 months from the completion of cytotoxic chemotherapy in the neo-adjuvant or adjuvant setting until the time of metastatic diagnosis.', ' Trastuzumab 21 days prior to randomization.', ' Hormone therapy < 7 days prior to randomization.', ' Current peripheral neuropathy of Grade 3.', ' History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those previously mentioned.', ' Previous radiotherapy for the treatment of unresectable, locally advanced or metastatic breast cancer is not allowed if more than 25% of marrow-bearing bone has been irradiated or the last fraction of radiotherapy has been administered within approximately 3 weeks prior to randomization.', ' Brain metastases that are untreated, symptomatic, or require therapy to control symptoms or any radiation, surgery, or other therapy to control symptoms from brain metastases within 2 months prior to randomization.', ' History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin > 500 mg/m^2; epirubicin > 900 mg/m^2; mitoxantrone > 120mg/m^2 and idarubicin > 90 mg/m^2.', ' Current unstable angina.', ' History of symptomatic congestive heart failure, or ventricular arrhythmia requiring treatment.', ' History of myocardial infarction within 6 months prior to randomization.', ' Left ventricular ejection fraction (LVEF) below 50% within approximately 28 days prior to randomization.', ' History of decreased LVEF or symptomatic congestive heart failure (CHF) with previous adjuvant trastuzumab treatment.', ' Cardiac troponin I 0.2 ng/mL within 28 days of randomization.', ' Severe dyspnea at rest because of complications of advanced malignancy or requiring current continuous oxygen therapy.', ' Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).', ' Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment.', ' Current pregnancy or lactation.', ' History of receiving any investigational treatment within approximately 28 days prior to randomization.', ' Current known infection with human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C virus.', ' History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins, or docetaxel.', ' Known hypersensitivity to any of the study drugs, including the excipients, or any drugs formulated in polysorbate 80.', ' Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) by the Investigator Using Modified Response Evaluation Criteria In Solid Tumors (RECIST)', ' PFS was defined as the time from randomization (R) to first documented investigator-assessed radiographic or clinical disease progression (PD) or death due to any cause, whichever occurred first. For target lesions (TL), PD was defined as at least a 20% increase in the sum of the longest diameter (SLD) of TLs, taking as reference the SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Data for patients without PD or death were censored at the last date of tumor assessment prior to crossover (or, if no tumor assessment was performed after Baseline, at the R date +1 day). Data for patients who were lost to follow-up were censored at the last date of tumor assessment prior to crossover at which the patient was known to be progression free. Data for patients with no post-baseline tumor assessment were censored at the R date +1 day.', ' Time frame: Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine', ' Arm/Group Description: Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 67', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 14.2 [1] (10.6 to NA)', 'Results 2: ', ' Arm/Group Title: Trastuzumab + Docetaxel', ' Arm/Group Description: Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.', ' Overall Number of Participants Analyzed: 70', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.2 (8.2 to 11.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/69 (20.29%)', ' Febrile neutropenia 0/69 (0.00%)', ' Anaemia 0/69 (0.00%)', ' Atrial fibrillation 1/69 (1.45%)', ' Cardiopulmonary failure 0/69 (0.00%)', ' Supraventricular extrasystoles 1/69 (1.45%)', ' Abdominal pain 1/69 (1.45%)', ' Intestinal obstruction 0/69 (0.00%)', ' Vomiting 1/69 (1.45%)', ' Chills 1/69 (1.45%)', ' Oedema peripheral 0/69 (0.00%)', ' Pyrexia 1/69 (1.45%)', 'Adverse Events 2:', ' Total: 17/66 (25.76%)', ' Febrile neutropenia 6/66 (9.09%)', ' Anaemia 1/66 (1.52%)', ' Atrial fibrillation 1/66 (1.52%)', ' Cardiopulmonary failure 1/66 (1.52%)', ' Supraventricular extrasystoles 0/66 (0.00%)', ' Abdominal pain 0/66 (0.00%)', ' Intestinal obstruction 1/66 (1.52%)', ' Vomiting 0/66 (0.00%)', ' Chills 0/66 (0.00%)', ' Oedema peripheral 1/66 (1.52%)', ' Pyrexia 0/66 (0.00%)']}

{'Clinical Trial ID': 'NCT00201851', 'Intervention': ['INTERVENTION 1: ', ' A - Scheduled Surgery', ' Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen', ' Tamoxifen: 20 mg po daily x 5 years', ' Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)', 'INTERVENTION 2: ', ' B - Immediate Surgery', ' Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen', ' Tamoxifen: 20 mg po daily x 5 years', ' Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)'], 'Eligibility': ['Inclusion Criteria:', ' Open for accrual in Asia only', ' Female age 18-50,', ' premenopausal with regular cycles (>25-35 in length)', ' fine-needle aspiration diagnosis', ' Stage II-IIIA hormone receptor positive invasive breast cancer', ' No prior radiation or chemotherapy', ' Must be surgical candidate for bilateral oophorectomy'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival', ' 5-year disease-free survival', ' Time frame: two- to three-year accrual and initial two or more years of follow-up period', 'Results 1: ', ' Arm/Group Title: A - Scheduled Surgery', ' Arm/Group Description: Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen', ' Tamoxifen: 20 mg po daily x 5 years', ' Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)', ' Overall Number of Participants Analyzed: 244', ' Measure Type: Number', ' Unit of Measure: percentage of participants 64', 'Results 2: ', ' Arm/Group Title: B - Immediate Surgery', ' Arm/Group Description: Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen', ' Tamoxifen: 20 mg po daily x 5 years', ' Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)', ' Overall Number of Participants Analyzed: 255', ' Measure Type: Number', ' Unit of Measure: percentage of participants 71'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/244 (0.00%)', ' Pregnancy *0/244 (0.00%)', ' Endocervical cancer *0/244 (0.00%)', ' Nosocomial pneumonia *0/244 (0.00%)', ' Venous thrombosis *0/244 (0.00%)', 'Adverse Events 2:', ' Total: 5/255 (1.96%)', ' Pregnancy *1/255 (0.39%)', ' Endocervical cancer *1/255 (0.39%)', ' Nosocomial pneumonia *2/255 (0.78%)', ' Venous thrombosis *1/255 (0.39%)']}

a5a1c7f1-92f4-4436-9dcb-ab222ff1c8a5

Single

Adverse Events

NCT02015676

There are no recorded cases of thrombocytopenia in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT02015676', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab, Doxorubicin, Paclitaxel; Phase II', ' Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.'], 'Eligibility': ['Inclusion Criteria:', ' women 18-70 years of age;', ' metastatic or locally advanced breast cancer;', ' HER2 overexpression;', ' >= 1 measurable lesion.', 'Exclusion Criteria:', ' prior treatment for advanced breast cancer;', ' prior treatment with Herceptin;', ' bone or central nervous system metastasis as the only site of disease;', ' history of another malignancy (except basal cell skin cancer and cancer in situ of the uterine cervix, and contralateral breast cancer) within 5 years of study.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment', ' For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion. For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks.', ' Time frame: Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)', 'Results 1: ', ' Arm/Group Title: Trastuzumab, Doxorubicin, Paclitaxel; Phase II', ' Arm/Group Description: Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.', ' Overall Number of Participants Analyzed: 54', ' Measure Type: Number', ' Unit of Measure: percentage of participants CR: 51.85', 'PR: 46.30'], 'Adverse Events': ['Adverse Events 1:', ' Total: 26/69 (37.68%)', ' Thrombophlebitis * 1/69 (1.45%)', ' Anaemia NOS * 1/69 (1.45%)', ' Acute febrile neutrophilic dermatosis * 1/69 (1.45%)', ' Cardiac failure NOS * 2/69 (2.90%)', ' Ejection fraction decreased * 1/69 (1.45%)', ' Intestinal obstruction NOS * 1/69 (1.45%)', ' Diarrhoea NOS * 2/69 (2.90%)', ' Febrile neutropenia * 12/69 (17.39%)', ' Mucosal inflammation NOS * 1/69 (1.45%)']}

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

52c8361f-75dc-45f1-a35c-79180a22b931

Single

Results

NCT01091168

Patients in the control group of the primary trial had a median Overall Survival of less than a year, however several patients in arm B survived longer than a year.

Contradiction

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

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

f2f05760-cc22-4fe8-a24f-f6d43f9c9a86

Single

Results

NCT01271725

In the primary trial The Percentage of Participants With Objective Response (OR) for the Afatinib Monotherapy was 18% lower than the Afatinib and Paclitaxel or Vinorelbine Combination Therapy group.

Contradiction

{'Clinical Trial ID': 'NCT01271725', 'Intervention': ['INTERVENTION 1: ', ' Afatinib Monotherapy', ' Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.', 'INTERVENTION 2: ', ' Afatinib and Paclitaxel or Vinorelbine Combination Therapy', ' Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy'], 'Eligibility': ['Inclusion criteria:', ' Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer', ' Stage IV metastatic disease', ' At least one measurable lesion according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1). Skin, bone and brain lesions are considered non-target lesions', ' Must have failed or progressed on either trastuzumab or lapatinib or trastuzumab and lapatinib treatment in the neoadjuvant and/or adjuvant setting', 'Exclusion criteria:', ' Prior first line therapy for metastatic breast cancer', ' Known pre-existing interstitial lung disease', ' Active brain metastases', ' History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to trial treatment.', ' Cardiac left ventricular function with resting ejection fraction of less than 50%.', ' Prior treatment with Epidermal Growth Factor Receptor (EGFR)/HER2-targeted small molecules or antibodies other than trastuzumab and lapatinib in the neoadjuvant or adjuvant setting', ' Prior treatment with paclitaxel in the past 12 months', ' Must not have received prior vinorelbine treatment - Further exclusion criteria apply'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1', ' Objective response according to RECIST v1.1. Best overall response of confirmed complete response (CR) or confirmed partial response (PR) recorded since first administration of trial medication and until the earliest of disease progression, death or start of next treatment in each part separately. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of participants with OR along with exact 95% Confidence Interval by Clopper and Pearson is presented.', ' Time frame: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days', 'Results 1: ', ' Arm/Group Title: Afatinib Monotherapy', ' Arm/Group Description: Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.', ' Overall Number of Participants Analyzed: 74', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 18 (10 to 28)', 'Results 2: ', ' Arm/Group Title: Afatinib and Paclitaxel or Vinorelbine Combination Therapy', ' Arm/Group Description: Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 31 (17 to 48)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/74 (24.32%)', ' Anaemia 0/74 (0.00%)', ' Febrile neutropenia 0/74 (0.00%)', ' Cardio-respiratory arrest 1/74 (1.35%)', ' Abdominal pain 2/74 (2.70%)', ' Diarrhoea 3/74 (4.05%)', ' Nausea 0/74 (0.00%)', ' Vomiting 2/74 (2.70%)', ' Asthenia 3/74 (4.05%)', ' Chest pain 1/74 (1.35%)', ' Pain 0/74 (0.00%)', ' Pyrexia 0/74 (0.00%)', ' Hepatic function abnormal 1/74 (1.35%)', 'Adverse Events 2:', ' Total: 5/13 (38.46%)', ' Anaemia 1/13 (7.69%)', ' Febrile neutropenia 1/13 (7.69%)', ' Cardio-respiratory arrest 0/13 (0.00%)', ' Abdominal pain 2/13 (15.38%)', ' Diarrhoea 0/13 (0.00%)', ' Nausea 0/13 (0.00%)', ' Vomiting 1/13 (7.69%)', ' Asthenia 1/13 (7.69%)', ' Chest pain 0/13 (0.00%)', ' Pain 1/13 (7.69%)', ' Pyrexia 2/13 (15.38%)', ' Hepatic function abnormal 0/13 (0.00%)']}

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

db8ffa86-bf52-47bb-89f7-42e7ae47b84d

Single

Intervention

NCT02392611

the primary trial cohorts are not seperated based on patient characteristics.

Entailment

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

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

5a01d00f-8601-4c17-b814-be87e63b0d8a

Single

Eligibility

NCT01351376

Patients currently prescribed laxatives are not excluded from the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01351376', 'Intervention': ['INTERVENTION 1: ', ' Placebo', ' CDT + inactive LLL', ' Low Level Laser Therapy: Placebo LLL combined with CDT', 'INTERVENTION 2: ', ' LLL Combined With CDT', ' CDT + active LLL', ' Low Level Laser: Active LLL combined with CDT'], 'Eligibility': ['Inclusion Criteria:', ' unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection (sentinel biopsy or axillary dissection)', ' stage II or III unilateral secondary upper extremity lymphedema (as defined by the International Society of Lymphology)', ' girth 2 cm circumferential difference and/or volume 200 mL compared to the uninvolved upper extremity at any 4 cm segment', ' able to commit to a long term follow-up schedule', 'Exclusion Criteria:', ' active cancer/metastatic cancer', ' currently receiving or have plans for adjuvant radiation or chemotherapy', ' pregnant', ' presence of other extremity lymphedema (primary or secondary)', ' pacemaker', ' artificial joints in the upper quadrants', ' renal failure', ' arterial insufficiency', ' congestive heart failure', ' chronic inflammatory conditions', ' history of deep vein thrombosis (DVT) in the lymphedematous upper extremity', ' previous treatment with Low Level Laser (regardless of indication)', ' medication(s) known to affect body fluid balance', ' body mass index (BMI) > 40 (morbid obesity)'], 'Results': ['Outcome Measurement: ', ' Arm Volume', ' [Not Specified]', ' Time frame: 13 Months', 'Results 1: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: CDT + inactive LLL', ' Low Level Laser Therapy: Placebo LLL combined with CDT', ' Overall Number of Participants Analyzed: 10', ' Mean (Standard Deviation)', ' Unit of Measure: cm^3 1.48 (1.01)', 'Results 2: ', ' Arm/Group Title: LLL Combined With CDT', ' Arm/Group Description: CDT + active LLL', ' Low Level Laser: Active LLL combined with CDT', ' Overall Number of Participants Analyzed: 11', ' Mean (Standard Deviation)', ' Unit of Measure: cm^3 1.58 (1.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)', 'Adverse Events 2:', ' Total: 0/11 (0.00%)']}

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

7577f05f-04e9-44de-9e00-b7411ff4010f

Single

Adverse Events

NCT00191451

Patients in the primary trial experienced a only one type of Oesophageal adverse events and several types of cardiac adverse events.

Contradiction

{'Clinical Trial ID': 'NCT00191451', 'Intervention': ['INTERVENTION 1: ', ' HER2+', ' Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.', ' Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion).', 'INTERVENTION 2: ', ' HER2- (Taxane-)', ' Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).', ' Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of metastatic breast cancer', " Able to visit the doctor's office at least every 14 days during the actual treatment", ' Able to care for yourself, even if you cannot work or participate in other normal activities', ' Your blood results must be adequate for therapy.', ' If you are a female of childbearing potential and test negative for pregnancy, use a reliable method of birth control during and for three months following the last dose of study drug.', 'Exclusion Criteria:', ' Have received gemcitabine, paraplatin, or trastuzumab for your cancer.', ' Be pregnant or breastfeeding', ' Have cancer to the brain and has not been treated', ' Have another active cancer besides breast cancer', ' Have received stem cell or bone marrow transplant for hematologic (blood type) cancer'], 'Results': ['Outcome Measurement: ', ' Overall Tumor Response', ' Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.', ' Time frame: baseline to disease progression/recurrence (up to 3.5 years)', 'Results 1: ', ' Arm/Group Title: HER2+', ' Arm/Group Description: Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.', ' Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion).', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: participants Complete Response (CR): 6', ' Partial Response (PR): 26', ' Stable Disease (SD): 12', ' Progressive Disease (PD): 4', 'Not Evaluable (NE): 2', 'Results 2: ', ' Arm/Group Title: HER2- (Taxane-)', ' Arm/Group Description: Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).', ' Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).', ' Overall Number of Participants Analyzed: 47', ' Measure Type: Number', ' Unit of Measure: participants Complete Response (CR): 0', ' Partial Response (PR): 13', ' Stable Disease (SD): 20', ' Progressive Disease (PD): 12', 'Not Evaluable (NE): 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/50 (20.00%)', ' Anaemia 0/50 (0.00%)', ' Febrile neutropenia 0/50 (0.00%)', ' Neutropenia 0/50 (0.00%)', ' Thrombocytopenia 0/50 (0.00%)', ' Diastolic dysfunction 0/50 (0.00%)', ' Tachycardia 0/50 (0.00%)', ' Intestinal obstruction 0/50 (0.00%)', ' Nausea 1/50 (2.00%)', ' Oesophageal spasm 0/50 (0.00%)', ' Oesophagitis 0/50 (0.00%)', ' Retching 0/50 (0.00%)', 'Adverse Events 2:', ' Total: 11/48 (22.92%)', ' Anaemia 4/48 (8.33%)', ' Febrile neutropenia 0/48 (0.00%)', ' Neutropenia 2/48 (4.17%)', ' Thrombocytopenia 2/48 (4.17%)', ' Diastolic dysfunction 1/48 (2.08%)', ' Tachycardia 1/48 (2.08%)', ' Intestinal obstruction 0/48 (0.00%)', ' Nausea 0/48 (0.00%)', ' Oesophageal spasm 1/48 (2.08%)', ' Oesophagitis 0/48 (0.00%)', ' Retching 1/48 (2.08%)']}

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

3b0440e6-cf85-4236-8a1d-2e3572143946

Single

Eligibility

NCT00077857

Patients must be older than 18, female, have one or more target lesions and more than 2 regiments of chemotherapy to participate in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00077857', 'Intervention': ['INTERVENTION 1: ', ' 1250 mg/m^2 Capecitabine + Docetaxel', ' 1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.', 'INTERVENTION 2: ', ' 825 mg/m^2 Capecitabine + Docetaxel', ' 825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.'], 'Eligibility': ['Inclusion Criteria:', ' women >=18 years of age;', ' >=1 target lesion;', ' locally advanced or metastatic breast cancer;', ' demonstrated resistance to anthracycline;', ' >=2 regimens of chemotherapy for advanced/metastatic disease.', 'Exclusion Criteria:', ' previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;', ' previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.'], 'Results': ['Outcome Measurement: ', ' Time to Progression of Disease or Death', ' Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause.', ' Time frame: Event driven (after 350 events). Median observation time was approximately 16 months.', 'Results 1: ', ' Arm/Group Title: 1250 mg/m^2 Capecitabine + Docetaxel', ' Arm/Group Description: 1250 mg/m^2 capecitabine (Xeloda ) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere ) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.', ' Overall Number of Participants Analyzed: 230', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 7.9 (6.9 to 8.5)', 'Results 2: ', ' Arm/Group Title: 825 mg/m^2 Capecitabine + Docetaxel', ' Arm/Group Description: 825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.', ' Overall Number of Participants Analyzed: 229', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 5.8 (4.9 to 7.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 41/217 (18.89%)', ' Febrile neutropenia 13/217 (5.99%)', ' Neutropenia 6/217 (2.76%)', ' Leukopenia 2/217 (0.92%)', ' Anaemia 0/217 (0.00%)', ' Atrial flutter 0/217 (0.00%)', ' Cardiac failure 0/217 (0.00%)', ' Cardiogenic shock 1/217 (0.46%)', ' Cardiopulmonary failure 0/217 (0.00%)', ' Stomatitis all 5/217 (2.30%)', ' Diarrhoea 2/217 (0.92%)', ' Vomiting 2/217 (0.92%)', 'Adverse Events 2:', ' Total: 53/248 (21.37%)', ' Febrile neutropenia 14/248 (5.65%)', ' Neutropenia 4/248 (1.61%)', ' Leukopenia 0/248 (0.00%)', ' Anaemia 1/248 (0.40%)', ' Atrial flutter 1/248 (0.40%)', ' Cardiac failure 1/248 (0.40%)', ' Cardiogenic shock 0/248 (0.00%)', ' Cardiopulmonary failure 1/248 (0.40%)', ' Stomatitis all 0/248 (0.00%)', ' Diarrhoea 2/248 (0.81%)', ' Vomiting 2/248 (0.81%)']}

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

6f342205-ef33-482a-b74a-74644537538b

Single

Results

NCT00950742

100 participants in the Afatinib 20mg + Herceptin group of the primary trial suffer Dose Limiting Toxicities.

Contradiction

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

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

5b63fffb-0a75-414f-8744-5fea78395f28

Comparison

Eligibility

NCT02279108

NCT00943670

Adult Patients with Histologically proven HER2- infiltrating breast cancer that have had a Previous lumpectomy or same side mammary reduction are excluded from both the secondary trial and the primary trial.

Entailment

{'Clinical Trial ID': 'NCT02279108', 'Intervention': ['INTERVENTION 1: ', ' Double Detection Indocyanine + Isotope', ' intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery', ' indocyanine green: One injection, 2.5 milligrams per patient, intradermal use', ' isotope: One injection, 20 MBq techntium99, intradermal use', 'INTERVENTION 2: ', ' Isotope Detection Alone', ' intradermal injection of 20 MBq of technetium 99 before breast surgery', ' isotope: One injection, 20 MBq techntium99, intradermal use'], 'Eligibility': ['Inclusion Criteria:', ' Histologically proved infiltrating breast cancer (ductal, lobular carcinoma…) or a carcinoma in-situ with an elevated risk of micro-invasion. (High grade with necrosis, radiologically evaluated size more than 40mm, or immediate mastectomy…)', ' Unifocal or multifocal but in same quarter', ' Size < 5cm clinically palpable or not', ' Clinically or ultrasound axillary N0', ' Isotopic sentinel node detection', ' Adult patient', ' Signed informed consent by patient or legally responsable authority', ' Patient registered to a social security system', ' No surgical contra-indication', 'Exclusion Criteria:', ' Mammary carcinoma recurrence', ' Previous same side mammary reduction', ' Previous lumpectomy', ' Contra-indication to surgery', ' Pregnant or breast feeding patient', ' Denial of participation'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Less Than Two Lymph Nodes Detected', ' Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone', ' Time frame: peroperative', 'Results 1: ', ' Arm/Group Title: Double Detection Indocyanine + Isotope', ' Arm/Group Description: intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery', ' indocyanine green: One injection, 2.5 milligrams per patient, intradermal use', ' isotope: One injection, 20 MBq techntium99, intradermal use', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 22 44.0%', 'Results 2: ', ' Arm/Group Title: Isotope Detection Alone', ' Arm/Group Description: intradermal injection of 20 MBq of technetium 99 before breast surgery', ' isotope: One injection, 20 MBq techntium99, intradermal use', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 20 40.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/50 (0.00%)', 'Adverse Events 2:', ' Total: ']}

{'Clinical Trial ID': 'NCT00943670', 'Intervention': ['INTERVENTION 1: ', ' T-DM1', ' Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented, locally advanced, or metastatic breast cancer; measurable and/or non-measureable but evaluable disease is permitted', ' HER2-positive disease', ' History of prior trastuzumab therapy', ' Life expectancy 90 days as assessed by the investigator', ' Negative urine pregnancy test 72 hours prior to Cycle 1 Day 1 for all women of childbearing potential', ' For patients of childbearing potential, agreement to use one highly effective form of contraception or two effective forms of contraception for the duration of the study treatment(s) and for 4 months after the last dose of T-DM1 or 6 months after the last dose of pertuzumab, if applicable', 'Exclusion Criteria:', ' Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 2 weeks of the first study treatment', ' Prior T-DM1 or pertuzumab therapy', ' History of intolerance (such as Grade 3-4 infusion reaction) and/or adverse events related to trastuzumab', ' Grade 2 (based on National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v3) peripheral neuropathy at the time of or within 3 weeks prior to the first study treatment', ' Brain metastases that are untreated or progressive or have required any type of therapy, including radiation, surgery, and/or steroids, to control symptoms from brain metastases within 60 days prior to the first study treatment', ' History of cardiac disease, unstable angina, symptomatic congestive heart failure (CHF) (Class II per the New York Heart Associate [NYHA] guidelines), myocardial infarction, or ventricular arrhythmia 6 months prior to Cycle 1, Day 1', ' Implantable pacemaker or automatic implantable cardioverter defibrillator', ' Congenital long QT syndrome or family history of long QT syndrome', ' Current uncontrolled hypertension', ' Current treatment with medications that alter cardiac conduction (e.g., digitalis, beta-blockers, or calcium channel blockers) or medications that are generally accepted to have a risk of causing torsades de pointes (TdP)', ' Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus', ' Major surgical procedure or significant traumatic injury within 28 days prior to first study treatment, or anticipation of the need for major surgery during the course of study treatment'], 'Results': ['Outcome Measurement: ', ' Change From Baseline in Mean Duration of the QTc Interval', " The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The corrected QT interval was calculated using Fridericia's correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QTcF intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QTcF interval was subtracted from the average QTcF intervals to create a baseline-adjusted average QTcF interval.", ' Time frame: Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.', 'Results 1: ', ' Arm/Group Title: T-DM1', ' Arm/Group Description: Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.', ' Overall Number of Participants Analyzed: 51', ' Mean (Standard Deviation)', ' Unit of Measure: milliseconds Cycle 1, Day 1, 15 minutes post-dose [N=44]: 1.2 (8.3)', ' Cycle 1, Day 1, 60 minutes post-dose [N=45]: -1.0 (6.3)', ' Cycle 1, Day 8 [N=43]: -4.0 (13.4)', ' Cycle 3, Day 1, 15 minutes pre-dose [N=35]: -0.1 (10.1)', ' Cycle 3, Day 1, 15 minutes post-dose [N=37]: 4.7 (9.6)', ' Cycle 3, Day 1, 60 minutes post-dose [N=37]: 4.7 (10.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/51 (7.84%)', ' Thrombocytopenia 2/51 (3.92%)', ' Anaemia 0/51 (0.00%)', ' Cardiac arrest 0/51 (0.00%)', ' Gastrointestinal haemorrhage 0/51 (0.00%)', ' Generalised oedema 1/51 (1.96%)', ' Aspartate aminotransferase increased 0/51 (0.00%)', ' Hypokalaemia 0/51 (0.00%)', ' Convulsion 1/51 (1.96%)', ' Renal failure 1/51 (1.96%)', ' Dyspnoea 1/51 (1.96%)', ' Skin haemorrhage 0/51 (0.00%)']}

9e655973-7d1d-4528-8394-a9cbcf0b978f

Comparison

Intervention

NCT00073073

NCT00054028

There is no placebo or control group in the primary trial, in the secondary trial, Suramin acts as placebo.

Contradiction

{'Clinical Trial ID': 'NCT00073073', 'Intervention': ['INTERVENTION 1: ', ' Exemestane', ' exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.', ' Exemestane: exemestane 25 mg by mouth (PO) every day for two years', ' Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years', ' Vitamin D: Vitamin D 400 international units PO every day x 2 years'], 'Eligibility': ['INCLUSION CRITERIA:', ' Postmenopausal female.', ' Postmenopausal defined as no menses for at least 12 months or bilateral oophorectomy. In unclear cases, (e.g. 50 year old who has had hysterectomy) chemical confirmation of postmenopausal status may be confirmed with follicle stimulating hormone (FSH) greater than 35 U/L.', ' Elevated risk for developing invasive breast cancer by virtue of one of the following criteria:', ' Gail Model risk of greater than or equal to 1.7% over 5 years from study entry. (This is the same minimum level of risk required for a subject to be eligible for the recently completed NSABP-P1 tamoxifen breast cancer prevention trial).', ' Lobular neoplasia.', ' Atypical ductal hyperplasia.', ' DCIS (ductal carcinoma in situ) that has been previously treated with mastectomy or lumpectomy and radiation, +/- tamoxifen.', ' Deleterious mutations in BRCA1 or 2 OR A priori risk assessment of 20% chance or greater of carrying BRCA1/2 gene mutation. The BRCAPRO and Couch model will both be used to asses this risk. If a woman has a 20% risk of carrying a BRCA1/2 mutation by either model, she will meet eligibility criteria.', ' Prior stage I or II breast cancer at least 2 years out from treatment for invasive disease and no prior use of aromatase inhibitors.', ' Subjects should be willing to abstain from use of hormonal therapies (e.g. tamoxifen, hormone replacement therapy, oral contraceptive pills, hormone-containing intrauterine devices (IUDs). E-string is acceptable). Venlafaxine will be offered as supportive care for women with menopausal symptoms.', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1.', ' Subject has been counseled regarding her options and has signed the informed consent document.', ' Baseline dual-emission x-ray absorptiometry (DEXA) scan with bone mineral density (BMD) T-score greater than or equal to 2.5 at antero posterior (AP) spine.', ' Hemoglobin greater than or equal to 11 g/dl.', ' Creatinine less than 1.5 times the upper limits of normal.', ' Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 2.5 times upper limit of normal.', ' No investigational agent for the past 30 days.', ' If history of cancer (other than squamous or basal cell skin cancers), subject must have no evidence of disease at time of enrollment AND no history of cancer directed treatment in the 2 years preceding enrollment.', 'EXCLUSION CRITERIA:', ' Current or recent chronic use (within 3 months) of hormonal medications, e.g. oral contraceptive pills, hormone replacement therapy, tamoxifen, raloxifene, IUD with progestins or corticosteroids. (Subjects on chronic topical or inhaled steroids will be eligible for the study.) Current use of phenytoin, carbamazepine, rifampin due to increased estrogen metabolism.', ' History of clotting or bleeding disorder.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to exemestane (e.g. anastrozole, letrozole, formestane).', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.'], 'Results': ['Outcome Measurement: ', ' Percent Change in Mammographic Density at 1 Year on Exemestane', ' [Not Specified]', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Exemestane', ' Arm/Group Description: exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.', ' Exemestane: exemestane 25 mg by mouth (PO) every day for two years', ' Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years', ' Vitamin D: Vitamin D 400 international units PO every day x 2 years', ' Overall Number of Participants Analyzed: 42', ' Mean (95% Confidence Interval)', ' Unit of Measure: percent change from baseline -2.4 (-5.0 to 0.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/42 (0.00%)']}

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

ea62355f-aab9-4796-8658-746c0b669ca7

Single

Adverse Events

NCT00454805

In the primary trial there were more cases of Intestinal Obstruction in cohort 1 than in cohort 2.

Contradiction

{'Clinical Trial ID': 'NCT00454805', 'Intervention': ['INTERVENTION 1: ', ' Cediranib 45 mg', ' Cediranib 45 mg+Fulvestrant 250 mg', ' Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:', ' Day 1: fulvestrant 500 mg im', ' Day 15: fulvestrant 250 mg im', ' Day 29, and every 28 days thereafter: fulvestrant 250 mg im', ' and daily: cediranib 45 mg (administered orally)', 'INTERVENTION 2: ', ' Placebo', ' Placebo+Fulvestrant 250 mg', ' Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:', ' Day 1: fulvestrant 500 mg im', ' Day 15: fulvestrant 250 mg im', ' Day 29, and every 28 days thereafter: fulvestrant 250 mg im', ' and daily: placebo to match cediranib (administered orally)'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent', ' Females with histological/cytological confirmation of hormone sensitive breast cancer with evidence of metastatic disease', ' One or more evaluable lesions', 'Exclusion Criteria:', ' Prior hormonal therapy with fulvestrant', ' More than one course of prior systemic cytotoxic chemotherapy for metastatic breast cancer', ' Prior biologic therapy for ABC including Anti-VEGF agents', ' Radiation therapy within 4 weeks prior to provision of consent'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival', ' Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.', ' Time frame: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.', 'Results 1: ', ' Arm/Group Title: Cediranib 45 mg', ' Arm/Group Description: Cediranib 45 mg+Fulvestrant 250 mg', ' Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:', ' Day 1: fulvestrant 500 mg im', ' Day 15: fulvestrant 250 mg im', ' Day 29, and every 28 days thereafter: fulvestrant 250 mg im', ' and daily: cediranib 45 mg (administered orally)', ' Overall Number of Participants Analyzed: 31', ' Median (95% Confidence Interval)', ' Unit of Measure: Days 223 (129 to 340)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Placebo+Fulvestrant 250 mg', ' Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:', ' Day 1: fulvestrant 500 mg im', ' Day 15: fulvestrant 250 mg im', ' Day 29, and every 28 days thereafter: fulvestrant 250 mg im', ' and daily: placebo to match cediranib (administered orally)', ' Overall Number of Participants Analyzed: 31', ' Median (95% Confidence Interval)', ' Unit of Measure: Days 112 (59 to 329)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/31 (48.39%)', ' Intracardiac Thrombus 1/31 (3.23%)', ' Diarrhoea 2/31 (6.45%)', ' Nausea 2/31 (6.45%)', ' Vomiting 2/31 (6.45%)', ' Ascites 0/31 (0.00%)', ' Ileus 1/31 (3.23%)', ' Small Intestinal Obstruction 1/31 (3.23%)', ' Multi-Organ Failure 0/31 (0.00%)', ' Sepsis 1/31 (3.23%)', ' Weight Decreased 1/31 (3.23%)', ' Dehydration 2/31 (6.45%)', ' Hypokalaemia 0/31 (0.00%)', 'Adverse Events 2:', ' Total: 4/31 (12.90%)', ' Intracardiac Thrombus 0/31 (0.00%)', ' Diarrhoea 0/31 (0.00%)', ' Nausea 0/31 (0.00%)', ' Vomiting 0/31 (0.00%)', ' Ascites 1/31 (3.23%)', ' Ileus 0/31 (0.00%)', ' Small Intestinal Obstruction 0/31 (0.00%)', ' Multi-Organ Failure 1/31 (3.23%)', ' Sepsis 0/31 (0.00%)', ' Weight Decreased 0/31 (0.00%)', ' Dehydration 0/31 (0.00%)', ' Hypokalaemia 1/31 (3.23%)']}

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

55eaae8d-611c-4dbb-b162-de664902e059

Comparison

Intervention

NCT00485953

NCT00068601

the cyclophosphamide dose in the secondary trial and the Placebo dose in the primary trial are not specified.

Entailment

{'Clinical Trial ID': 'NCT00485953', 'Intervention': ['INTERVENTION 1: ', ' Active Medicine Group', ' risedronate 35 mg weekly', 'INTERVENTION 2: ', ' Placebo Group', ' Received placebo medication once weekly'], 'Eligibility': ['Inclusion Criteria:', ' elderly postmenopausal women (ages 55 and older)', ' osteopenic (DXA T-score -1.0 to -2.5 SD). However, after full counseling about the risks, benefits, and options regarding therapy for osteoporosis and discussion with her PCP, an osteoporotic woman may enroll in the study.', ' with breast cancer on aromatase inhibitor therapy', ' with no evidence of distant metastatic disease or osteoporosis (by BMD or clinical history)', ' type of surgical procedure or addition of radiation therapy prior to this aromatase inhibitor therapy will not exclude patients', ' Participants must provide voluntary, written informed consent to participate in the study, which includes understanding of the procedures, medications, and risks and benefits', 'Exclusion Criteria:', ' Women with stage 4 breast cancer (presence of distant metastases)', ' Women with normal bone density by DXA (T-score > -1.0 SD)bone density by DXA, except in the instance of a fragility fracture.', ' Women with history of any illness known to affect bone and mineral metabolism, such as renal failure (estimated GFR <30), hepatic failure, malignancy (excluding breast cancer, treated superficial basal and squamous cell carcinoma and malignancies where the diagnosis itself or its treatment would not adversely affect bone metabolism), untreated primary hyperparathyroidism, and malabsorption.', ' Women being treated with oral glucocorticoid therapy >3 months for suppression therapy, and certain anti-seizure medications which may adversely affect bone metabolism (phenobarbital, phenytoin, carbamazepine).', ' Those with untreated active peptic ulcer disease', ' Those with osteoporosis by BMD (T-score -2.5 SD at the spine or total hip) or a history of fragility fracture as an adult. However, as discussed above, osteoporotic women may elect to enroll in the study.', ' Women treated with oral bisphosphonates or calcitonin for 3 months within the last year (3 month washout period)', ' Men and children will be excluded because they do not get postmenopausal osteoporosis following treatment with an aromatase inhibitor', ' Women with very poor dental hygiene (as assessed by the baseline dental exam) in need of dental extraction during the study', ' Use of fluoride for more than 1 month ever (except for dental treatment)', ' Less than 2 evaluable vertebrae', ' Distant metastatic disease'], 'Results': ['Outcome Measurement: ', ' BMD of Spine by DXA', ' BMD is the bone mineral density of the lumbar spine measured using the dual-energy x-ray absorptometry (DXA) scan.', ' Time frame: at 24 months', 'Results 1: ', ' Arm/Group Title: Active Medicine Group', ' Arm/Group Description: risedronate 35 mg weekly', ' Overall Number of Participants Analyzed: 55', ' Mean (Standard Error)', ' Unit of Measure: percentage change 2.269 (0.583)', 'Results 2: ', ' Arm/Group Title: Placebo Group', ' Arm/Group Description: Received placebo medication once weekly', ' Overall Number of Participants Analyzed: 54', ' Mean (Standard Error)', ' Unit of Measure: percentage change -1.735 (0.611)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/55 (18.18%)', ' Cardiovascular related events5/55 (9.09%)', ' Gastrointestinal Events0/55 (0.00%)', ' Other events0/55 (0.00%)', ' Infection related events2/55 (3.64%)', ' Musculoskeletal related events2/55 (3.64%)', ' Other cancers0/55 (0.00%)', ' Urogenital related events0/55 (0.00%)', ' Breast related events1/55 (1.82%)', 'Adverse Events 2:', ' Total: 16/54 (29.63%)', ' Cardiovascular related events2/54 (3.70%)', ' Gastrointestinal Events1/54 (1.85%)', ' Other events4/54 (7.41%)', ' Infection related events3/54 (5.56%)', ' Musculoskeletal related events5/54 (9.26%)', ' Other cancers2/54 (3.70%)', ' Urogenital related events1/54 (1.85%)', ' Breast related events2/54 (3.70%)']}

{'Clinical Trial ID': 'NCT00068601', 'Intervention': ['INTERVENTION 1: ', ' Standard Chemotherapy', ' Patients receive cyclophosphamide-containing chemotherapy alone.', ' cyclophosphamide: Part of planned chemotherapy regimen', 'INTERVENTION 2: ', ' Chemotherapy Plus Goserelin', ' Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.', ' cyclophosphamide: Part of planned chemotherapy regimen', ' goserelin acetate: Given subcutaneously'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed invasive breast cancer', ' Stage I-IIIA', ' Operable disease', ' Bilateral synchronous invasive breast cancer allowed provided primary tumors were diagnosed no more than 1 month apart and both tumors are hormone receptor negative', ' Must be planning to receive 3-8 months of a preoperative or postoperative chemotherapy regimen containing alkylating agents (anthracyclines or non-anthracyclines), meeting 1 of the following criteria:', ' 3-month/4-course anthracycline-based regimen', ' 6- to 8-month/course anthracycline-based regimen', ' 6- to 8-month/course non-anthracycline-based regimen', ' Hormone receptor status:', ' Estrogen receptor negative', ' Progesterone receptor negative', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 to 49', ' Sex', ' Female', ' Menopausal status', ' Premenopausal', ' Performance status', ' Zubrod 0-2', ' Life expectancy', ' Not specified', ' Hematopoietic', ' Not specified', ' Hepatic', ' Not specified', ' Renal', ' Not specified', ' Other', ' Not pregnant or nursing', ' Fertile patients must use effective barrier contraception', ' No other prior malignancy except adequately treated basal cell or squamous cell skin cancer or any in situ cancer from which the patient has been disease-free for at least 5 years after treatment with curative intent', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' Not specified', ' Chemotherapy', ' See Disease Characteristics', ' No prior cytotoxic chemotherapy', ' Endocrine therapy', ' No other concurrent hormonal therapy', ' Radiotherapy', ' Concurrent radiotherapy to the breast, chest wall, or lymph nodes allowed', ' Surgery', ' See Disease Characteristics', ' Other', ' Concurrent participation in other therapeutic clinical trials, including SWOG-S0221, allowed'], 'Results': ['Outcome Measurement: ', ' Rate of Premature Ovarian Failure at 2 Years', ' Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of follicle-stimulating hormone (FSH) in the post-menopausal range.', ' Time frame: 2 years', 'Results 1: ', ' Arm/Group Title: Standard Chemotherapy', ' Arm/Group Description: Patients receive cyclophosphamide-containing chemotherapy alone.', ' cyclophosphamide: Part of planned chemotherapy regimen', ' Overall Number of Participants Analyzed: 69', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 15 21.7%', 'Results 2: ', ' Arm/Group Title: Chemotherapy Plus Goserelin', ' Arm/Group Description: Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.', ' cyclophosphamide: Part of planned chemotherapy regimen', ' goserelin acetate: Given subcutaneously', ' Overall Number of Participants Analyzed: 66', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 5 7.6%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/111 (0.00%)', ' Thrombosis/thrombus/embolism 0/111 (0.00%)', 'Adverse Events 2:', ' Total: 1/103 (0.97%)', ' Thrombosis/thrombus/embolism 1/103 (0.97%)']}

c3438bb2-4a49-4f14-ae50-a46fb48d0208

Single

Intervention

NCT00821964

the primary trial participants apply topical imiquimod to cutaneous lesions once daily on days for a total of 13 days every 28 day cycle.

Entailment

{'Clinical Trial ID': 'NCT00821964', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Biological Therapy, Chemo)', ' Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.', ' imiquimod: Given topically', ' Abraxane: Given IV', ' laboratory biomarker analysis: Correlative studies', ' RNA analysis: Correlative studies', ' immunoenzyme technique: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Patients with advanced stage refractory breast cancer', ' Progressive or relapsed disease following standard therapy with chemotherapy and/or surgery, and/or radiation', ' Patients must have measurable (bi-dimensional) chest wall disease and/or cutaneous metastatic lesions', ' Patients must be at least 7 days from last chemotherapy and 30 days from local radiotherapy and/or systemic steroids', ' Patients on bisphosphonates, trastuzumab, lapatinib and/or hormonal therapy are eligible', ' White blood cell count >= 1000/ul', ' Absolute neutrophil count (ANC) >= 1200/ul', ' Platelets > 75,000/ul', ' Serum creatinine =< 2.0 mg/dL, a creatinine clearance > 60 ml/min', ' Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2 X upper limit normal (ULN)', ' Total bilirubin < 2 X ULN', ' Patients must have a Performance Status Score (Eastern Cooperative Oncology Group [ECOG] Scale) =< 2', ' Patients must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment', ' Men and women of reproductive ability must agree to contraceptive use during the study and for 1 month after imiquimod/Abraxane treatment is discontinued', 'Exclusion Criteria:', ' Patients with prior allergic reaction to taxanes', ' Patients with any clinically significant active autoimmune disease requiring active treatment with systemic steroids or other immunomodulators', ' Pregnant or breast-feeding women', ' Patients with peripheral neuropathy >= Grade 2'], 'Results': ['Outcome Measurement: ', ' Anti-tumor Effects of Imiquimod as Assessed by Modified World Health Organization (WHO) Criteria', ' Tumor responses will be determined using the sum of the products of the largest perpendicular dimensions. Target lesions will be evaluated by the following response criteria: complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).', ' Evaluation of target lesions per modified WHO response criteria:', ' Complete response (CR): complete clearance (100%) of target lesion(s)', ' Partial response (PR): 50% decrease in target lesion size', ' Stable disease (SD): < 50% decrease in target lesion size', ' Progressive (PD): 25% increase in target lesion size Overall Response Rate (ORR) determined at end of study treatment which was 1 week after cycle #3, unless patient was withdrawn from study. If patient was withdrawn from study, then ORR was determined after their last cycle of treatment received.', ' Time frame: Baseline and then every 4 weeks until week 24', 'Results 1: ', ' Arm/Group Title: Treatment (Biological Therapy, Chemo)', ' Arm/Group Description: Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.', ' imiquimod: Given topically', ' Abraxane: Given IV', ' laboratory biomarker analysis: Correlative studies', ' RNA analysis: Correlative studies', ' immunoenzyme technique: Correlative studies', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Total Evaluated in this Outcome Measure: 14 100.0%', ' Complete Response (CR): 5 35.7%', ' Partial Response (PR): 5 35.7%', ' Stable Disease (SD): 3 21.4%', ' Progressive Disease (PD): 1 7.1%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/15 (6.67%)', 'Pain 1/15 (6.67%)']}

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

8f505cec-6ad4-4142-a861-1771e3ae5cdd

Single

Eligibility

NCT00478257

Adequate Hematologic, Hepatic and renal function is not necessary for participating in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00478257', 'Intervention': ['INTERVENTION 1: ', ' Effect of Bright Light', ' Effect of bright light on fatigue in women with breast cancer', 'INTERVENTION 2: ', ' Effect of Red Light', ' effect of red light on fatigue in women with breast cancer'], 'Eligibility': ['Inclusion Criteria:', ' stage I-III breast cancer', ' adjuvant or neoadjuvant anthracycline-based chemotherapy', 'Exclusion Criteria:', ' under age 18', ' pregnancy', ' metastatic or inoperable (including inflammatory) breast cancer', ' confounding underlying medical illnesses', ' history of mania', ' history of other axis-I psychiatric disorder', ' other physical or psychological impairments -'], 'Results': ['Outcome Measurement: ', ' Fatigue', ' The Short Form of the Multidimensional Fatigue Symptom Inventory (MFSI-sf) was used to measure fatigue. The range of possible score for each subscale is 0 to 24, and the range for total score is -24 to 96, with a higher score indicating more severe fatigue, except for the Vigor subscale, where larger score indicates less fatigue.', ' Time frame: four cycles of chemotherapy', 'Results 1: ', ' Arm/Group Title: Effect of Bright Light', ' Arm/Group Description: Effect of bright light on fatigue in women with breast cancer', ' Overall Number of Participants Analyzed: 23', ' Mean (Standard Error)', ' Unit of Measure: units on a scale 15.25 (5.5)', 'Results 2: ', ' Arm/Group Title: Effect of Red Light', ' Arm/Group Description: effect of red light on fatigue in women with breast cancer', ' Overall Number of Participants Analyzed: 16', ' Mean (Standard Error)', ' Unit of Measure: units on a scale 21.6 (7.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/23 (0.00%)', 'Adverse Events 2:', ' Total: 0/16 (0.00%)']}

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

8f4f9793-041d-448b-9da8-b0c787a875bb

Comparison

Intervention

NCT01735175

NCT01216319

the secondary trial is testing a surgical intervention, unlike the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01735175', 'Intervention': ['INTERVENTION 1: ', ' LA-EP2006', ' During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.', ' LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.', 'INTERVENTION 2: ', ' Neulasta®', ' During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.', ' Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.'], 'Eligibility': ['Inclusion Criteria:', ' histologically proven breast cancer', ' eligible for six cycles of neoadjuvant or adjuvant chemotherapy', 'Exclusion Criteria:', ' concurrent or prior chemotherapy for breast cancer', ' concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy', ' concurrent prophylactic antibiotics', ' previous therapy with any G-CSF (granulocyte-colony stimulating factor) product', ' Other protocol-defined inclusion/exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy', ' Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9 cells/L (grade 4 neutropenia).', ' Time frame: 21 days (Cycle 1 of chemotherapy treatment)', 'Results 1: ', ' Arm/Group Title: LA-EP2006', ' Arm/Group Description: During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.', ' LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.', ' Overall Number of Participants Analyzed: 159', ' Mean (Standard Deviation)', ' Unit of Measure: days FAS: 155 participants', ' 0.75 (0.878)', ' PP: 146 participants', ' 0.75 (0.875)', 'Results 2: ', ' Arm/Group Title: Neulasta ', ' Arm/Group Description: During each chemotherapy cycle eligible patients receive Neulasta s.c. post chemotherapy application.', ' Neulasta : Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.', ' Overall Number of Participants Analyzed: 157', ' Mean (Standard Deviation)', ' Unit of Measure: days FAS: 155 participants', ' 0.83 (0.898)', ' PP: 149 participants', ' 0.79 (0.872)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/159 (10.06%)', ' Febrile neutropenia 9/159 (5.66%)', ' Neutropenia 3/159 (1.89%)', ' Anemia 1/159 (0.63%)', ' Leukopenia 0/159 (0.00%)', ' Pancytopenia 0/159 (0.00%)', ' Thrombocytopenia 0/159 (0.00%)', ' Cardio-respiratory arrest 2/159 (1.26%)', ' Cardiac arrest 1/159 (0.63%)', ' Diarrhea 0/159 (0.00%)', ' Gastritis 1/159 (0.63%)', ' Nausea 1/159 (0.63%)', ' Vomiting 0/159 (0.00%)', 'Adverse Events 2:', ' Total: 21/157 (13.38%)', ' Febrile neutropenia 12/157 (7.64%)', ' Neutropenia 6/157 (3.82%)', ' Anemia 2/157 (1.27%)', ' Leukopenia 1/157 (0.64%)', ' Pancytopenia 1/157 (0.64%)', ' Thrombocytopenia 1/157 (0.64%)', ' Cardio-respiratory arrest 0/157 (0.00%)', ' Cardiac arrest 0/157 (0.00%)', ' Diarrhea 1/157 (0.64%)', ' Gastritis 0/157 (0.00%)', ' Nausea 0/157 (0.00%)', ' Vomiting 1/157 (0.64%)']}

{'Clinical Trial ID': 'NCT01216319', 'Intervention': ['INTERVENTION 1: ', ' Nipple Reconstruction Cylinder', ' Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder'], 'Eligibility': ['Inclusion Criteria:', ' Patient presents with a history of breast cancer, having previously completed either uni- or bi-lateral breast removal and reconstruction.', ' Patient presents with a desire to obtain nipple reconstruction', ' Patient is at least 18 years of age', ' And other inclusion criteria', 'Exclusion Criteria:', ' Patient is not medically fit enough for surgery under local anesthesia', ' Patient is currently smoking, using tobacco products, or nicotine products (i.e. patch, gum, or nasal spray)', ' Patient is pregnant, breastfeeding or planning further pregnancy during the study period', ' Patient has physical allergies or cultural objections to the receipt of porcine products', ' And other exclusion criteria'], 'Results': ['Outcome Measurement: ', ' Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)', ' [Not Specified]', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Nipple Reconstruction Cylinder', ' Arm/Group Description: Nipple reconstruction: Biodesign Nipple Reconstruction Cylinder', ' Overall Number of Participants Analyzed: 44', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Nipples Mean (Standard Deviation)Unit of Measure: percentage of projection vs baseline: 37.3 (17.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/50 (2.00%)', ' Metastatic breast cancer 1/50 (2.00%)']}

d13e5689-2a9e-4295-b3f8-e4a18fe42bf1

Single

Intervention

NCT00376597

the primary trial do not receive any intervention by IV, orally or by surgery during the study.

Entailment

{'Clinical Trial ID': 'NCT00376597', 'Intervention': ['INTERVENTION 1: ', ' Arm I (Lymphedema Education)', ' Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.', 'INTERVENTION 2: ', ' Arm II (Lymphedema Education, Physical Therapy)', ' Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.'], 'Eligibility': ['Eligibility Criteria:', ' Newly diagnosed with stage I-III cancer of the female breast', ' No prior history of carcinoma in situ, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or invasive breast cancer', ' * Patients with a history of other invasive malignancies are eligible as long as they have completed treatment and are 5 years post-diagnosis; patients with basal cell and squamous cell cancer of the skin are eligible', ' Neoadjuvant therapy', ' Patients scheduled to receive any type of radiation therapy to the breast or axilla are eligible; however, they must be registered to this study with pre-surgery measures taken prior to receiving neoadjuvant therapy', ' Patients scheduled to receive neoadjuvant chemotherapy are also eligible; however, they must be registered to this study with pre-surgery measurements taken prior to receiving neoadjuvant therapy', ' Patients receiving no neoadjuvant therapy are eligible', ' May be enrolled on other treatment trials; however, patients enrolled on surgery trials where only one treatment arm is full axillary node dissection are not eligible; NOTE: Patients enrolled on American College of Surgeons Oncology Group (ACOSOG)-Z1071 are eligible to participate in this study; patients concurrently enrolled on this study and ACOSOG-Z1071, may not also be enrolled on the ACOSOG-Z1071 lymphedema sub-study', ' No documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease which, in the opinion of the treating physician, significantly increases mortality over the next 2 years', ' No diagnosed lymphedema', ' In order to be properly fitted for the elastic sleeve, eligible patients must have arm measurements for axilla, elbow, and wrist that fall within the ranges for one of the six sleeve sizes', ' Not currently homebound or dependent upon a walker or wheelchair for mobility', ' Able to participate in a mild exercise program', ' Willing to return to the study site for the duration of the study (18 months)', ' Sentinel (SND) or full axillary node dissection (AND) (no minimum number of nodes required)', ' Patients with double mastectomy, axillary node dissection and/or radiation on both arms are ineligible; patients who undergo these treatments (i.e., surgery and/or radiation) on the contralateral arm after registration to Step 2 are still eligible to remain in the study; however, it should be documented appropriately on form C-1628 at the conclusion of study participation'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Were Lymphedema-free 18 Months After Randomization', ' To test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema. Reported here is the proportion of patients who are lymphedema-free 18 months after randomization between the two arms', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: Arm I (Lymphedema Education)', ' Arm/Group Description: Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.', ' Overall Number of Participants Analyzed: 242', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 114 47.1%', 'Results 2: ', ' Arm/Group Title: Arm II (Lymphedema Education, Physical Therapy)', ' Arm/Group Description: Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.', ' Overall Number of Participants Analyzed: 312', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 135 43.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}

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

61d56c2a-089f-4fa3-9e97-3a9007576077

Single

Eligibility

NCT00411788

If Hannah has been taking ketoconazole to treat athlete's foot for 6 weeks, until today, she will not be eligible for the primary trial for the next month.

Entailment

{'Clinical Trial ID': 'NCT00411788', 'Intervention': ['INTERVENTION 1: ', ' Sirolimus and Trastuzumab', ' Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed HER2 overexpressing (IHC 3+ and/or FISH +) metastatic breast cancer with measurable disease. Patients with either HER2 3+ positive tumors by immunohistochemistry (Dako Herceptest®) or gene amplification (> 2 copies) by fluorescence in-situ hybridation (FISH) are eligible.', ' Progression following at least 8 weeks of standard doses of Herceptin or a Herceptin containing regimen.', ' Off Herceptin for a minimum of 2 weeks.', ' Patients must have measurable disease as defined by RECIST guidelines (the lesion that will be biopsied on study cannot be the only measurable lesion).', ' Life expectancy > 3 months', ' Age 18 years', ' ECOG performance status 2', ' Adequate bone marrow function as indicated by the following:', ' ANC 1500/µL', ' Platelets 100,000/µL', ' Hemoglobin 9 g/dL', ' Adequate liver function, as indicated by bilirubin 1.5 x ULN, AST or ALT <2x ULN.', ' Adequate renal function, as indicated by creatinine <1.5 x upper limit of normal (ULN)', ' Ability to understand and the willingness to sign a written informed consent.', ' Adequate birth control: Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Pregnant and nursing patients are excluded because the effects of the combination of Rapamycin on a fetus or nursing child are unknown. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.', ' Fasting serum cholesterol <350 mg/d L and triglycerides < 400 mg/ d L.', ' Biopsy is required but patients or physicians may opt out of this part of the trial if sufficient justification is provided. Justification must be provided to the PI in writing indicating excessive physical risk or psychological trauma if biopsy is undertaken.', 'Exclusion Criteria:', ' Active infection or treatment for systemic infections within 14 days of enrollment', ' Patients with active brain metastases requiring treatment, inclusive but not limited to surgery, radiation, and corticosteroids (patients with asymptomatic non- progressing brain metastasis who have completed treatment 30 days before enrollment and without evidence of progression on a post treatment MRI may be considered for the study).', ' Pregnant or lactating women', ' Prior chemotherapy within the last 4 weeks (last 6 weeks for nitrosureas/mitomycin)', ' Prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation).', ' Prior therapy with rapamycin, rapamycin analogs, or experimental agents targeting mTOR.', ' Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.', ' Ejection fraction <50% or below the lower limit of the institutional normal range, whichever is lower', ' Hypersensitivity to trial medications', ' Patients may not be receiving any other investigational agents within 30 days before enrollment.', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnant women are excluded from this study because the investigational agents may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated.', ' HIV-positive patients are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy and the potential pharmacokinetic interaction between antiretroviral therapy and the investigational agents.', " Use of all herbal and alternative medications within 4 weeks. All herbal and alternative medications should be discontinued while on study, these include but not limited to: Hydrastis canadensis (goldenseal) - Uncaria tomentosa (cat's claw) - Echinacea angustifolia roots - trifolium pratense (wild cherry) - matricaria chamomila (chamomile) - Glycyrrhiza glabra (licorice) - dillapiol - naringenim.", ' Use of any of these medications within 4 weeks; cyclosporine, diltiazen, ketoconazole, rifampin, fluconazole, delavirdine, nicardipine, pioglitazone, and sulfonamides, erythromycin, clarithromycin, itraconazole, erythromycin, metoclopramide, nevirapine, phenobarbital, phenytoin, indinavir, fosamprenavir, nefazadone, St Johns Wort.', ' Consumption of grapefruit juice is prohibited during the study.', ' Use of warfarin (Coumadin), immunosuppressive agents or chronic oral, intravenous or topical steroid'], 'Results': ['Outcome Measurement: ', ' Proportion of Patients Who Are Progression-free (CR, PR and Stable Disease)', ' To determine the clinical activity of oral daily rapamycin administered in combination with weekly intravenous trastuzumab in patients with HER2 overexpressing advanced breast cancer, the primary outcome is to determine the proportion of patients who are progression-free at 16 weeks, defined by complete response (CR), partial response (PR), or stable disease (SD).who are progression free at 16 weeks, defined by complete response (CR), partial response (PR), or stable disease (SD). Response objectives assessed using response evaluation criteria (RECIST) 1.0', ' This primary outcome was reworded from its original format when results were entered.', ' Time frame: 16 weeks', 'Results 1: ', ' Arm/Group Title: Sirolimus and Trastuzumab', ' Arm/Group Description: Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/9 (11.11%)', ' Cardiac Dysfunction *1/9 (11.11%)', ' Hyperglycemia *1/9 (11.11%)']}

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

5b90b8de-97b9-4ed7-b5a4-e3724fd38c41

Comparison

Intervention

NCT01712009

NCT00343382

Cohort 2 patients in the primary trial receive naproxen at the same frequency and dosage as cohort 2 patients in the secondary trial receive Pilocarpine.

Contradiction

{'Clinical Trial ID': 'NCT01712009', 'Intervention': ['INTERVENTION 1: ', ' No Prophylaxis', ' Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.', 'INTERVENTION 2: ', ' Naproxen 500 mg BID', ' Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.'], 'Eligibility': ['Age 18 years or over', ' Eastern cooperative oncology group (ECOG) performance status 0-2', ' Female with newly diagnosed, not previously treated with chemotherapy, stage I-III breast cancer', ' Medically eligible to safely receive adjuvant or neoadjuvant chemotherapy, pegfilgrastim, naproxen and loratadine as determined by the investigator', ' Creatinine 1.5 X upper limit of normal (ULN)', ' Planning to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy', ' Planning to receive prophylaxis with pegfilgrastim starting in the first cycle and continuing throughout each chemotherapy cycle of the treatment period', ' Subject has provided informed consent', ' Exclusion Criteria', ' History of other malignancy within the past 5 years, with the following exceptions:', ' Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease', ' Adequately treated cervical carcinoma in situ without evidence of disease', ' Planning to receive weekly chemotherapy', ' Ongoing chronic pain, or other painful conditions requiring treatment (including immediate post-operative treatment of surgical or procedural-associated pain) as determined by the investigator', ' Chronic oral steroid use. Premedication related to the administration of chemotherapy, and use of anti-emetics is allowed, per usual clinical practice', ' Chronic use of oral non-steroidal anti-inflammatory drug (NSAIDs) or oral antihistamines outside of those dictated by the randomization groups outlined in the protocol, with the following exception:', ' - Chronic oral aspirin use for cardiovascular-related indications', ' Prior chemotherapy treatment for cancer within 5 years of current breast cancer diagnosis', ' Prior use of granulocyte colony stimulating factor (G-CSF)', ' History of clinically significant gastrointestinal (GI) bleeding, history of GI ulcers or active GI bleeding within 6 months prior to randomization', ' History of clinically significant bleeding disorders, thromboembolism within 6 months prior to randomization', ' Currently enrolled in, or less than 30 days since ending, another clinical trial which includes language directing G-CSF (filgrastim, pegfilgrastim, other) or granulocyte-macrophage colony-stimulating factor (GM-CSF) (sargramostim) use', ' Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes a blinded treatment or blinded treatment arm (whether or not the subject is randomized to the blinded arm)', ' Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes the use of any agent not currently considered to be standard therapy for the adjuvant or neoadjuvant treatment of stage I-III breast cancer based on National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Breast Cancer', ' Currently enrolled in, or less than 30 days since ending, any pain intervention study', ' Female subjects who are pregnant or lactating or of reproductive potential not willing to employ an effective method of birth control during treatment and for 17 days after discontinuing study treatment', ' History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Bone Pain (All Grades) in Cycle 1', ' Bone pain data were captured as part of standard adverse event (AE) reporting.', ' Time frame: Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval)', 'Results 1: ', ' Arm/Group Title: No Prophylaxis', ' Arm/Group Description: Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.', ' Overall Number of Participants Analyzed: 191', ' Measure Type: Number', ' Unit of Measure: percentage of participants 46.6 (39.4 to 53.9)', 'Results 2: ', ' Arm/Group Title: Naproxen 500 mg BID', ' Arm/Group Description: Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.', ' Overall Number of Participants Analyzed: 196', ' Measure Type: Number', ' Unit of Measure: percentage of participants 40.3 (33.4 to 47.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 34/196 (17.35%)', ' Anaemia 1/196 (0.51%)', ' Febrile neutropenia 7/196 (3.57%)', ' Neutropenia 2/196 (1.02%)', ' Pancytopenia 1/196 (0.51%)', ' Angina pectoris 1/196 (0.51%)', ' Atrial fibrillation 0/196 (0.00%)', ' Cardiac failure congestive 0/196 (0.00%)', ' Pericarditis 1/196 (0.51%)', ' Colitis 2/196 (1.02%)', ' Colitis ischaemic 1/196 (0.51%)', ' Constipation 0/196 (0.00%)', 'Adverse Events 2:', ' Total: 30/193 (15.54%)', ' Anaemia 1/193 (0.52%)', ' Febrile neutropenia 6/193 (3.11%)', ' Neutropenia 0/193 (0.00%)', ' Pancytopenia 0/193 (0.00%)', ' Angina pectoris 0/193 (0.00%)', ' Atrial fibrillation 1/193 (0.52%)', ' Cardiac failure congestive 1/193 (0.52%)', ' Pericarditis 0/193 (0.00%)', ' Colitis 1/193 (0.52%)', ' Colitis ischaemic 0/193 (0.00%)', ' Constipation 1/193 (0.52%)']}

{'Clinical Trial ID': 'NCT00343382', 'Intervention': ['INTERVENTION 1: ', ' Collective Placebo', ' Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.', 'INTERVENTION 2: ', ' Pilocarpine 2 Times Per Day', ' Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.'], 'Eligibility': ['Required Characteristics:', ' Adult post menopausal women or women with no childbearing potential ( 18 years) with a history of breast cancer (currently no evidence of disease) or women who do not want to take vaginal estrogen for a fear of an increased risk of breast cancer. Postmenopausal status will be determined by the primary physician.', ' Significant vaginal complaints defined as persistent vaginal dryness and/or itching of sufficient severity to make a patient desire therapeutic intervention. Symptoms should have been present 2 months prior to randomization.', ' Life expectancy > 6 months', ' Ability to complete questionnaire(s) by themselves or with assistance.', ' Contraindications:', ' Initiation or discontinuation of tamoxifen or aromatase inhibitors 2 months prior to randomization or plans to initiate or discontinue any of these medications during the 6-week study.', ' Active vaginal infection', ' Concurrent chemotherapy', ' Acute iritis', ' Current or past use of pilocarpine (regardless of purpose)', ' Planned use of any vaginal preparations during the study period (including any over the counter or herbal preparations). Note: Lubricants used during sexual intercourse are permitted.', ' Use of any vaginal preparations 1 week prior to study entry (Exception: If patient has used vaginal preparations during the previous week but will stop, then they can be placed on study with plans to start with pretreatment questionnaire one week later). Note: Lubricants used during sexual intercourse are permitted.', ' Current ( 4weeks prior to randomization), or planned during the study period, use of any estrogen product.', ' A diagnosis of asthma, COPD, CAD or narrow angle glaucoma, or known cholelithiasis.', ' Hepatic or renal insufficiency defined as a history of an elevation of SGOT 1.5 x ULN or creatinine 1.5 x ULN within the past year.', ' Concurrent use of other anticholinergics', ' Use of pharmacologic soy preparations', " Known history of cardiac arrhythmia. (Patients with occasional PVC's or PAC's that do not require treatment are eligible.)", ' Prior or concurrent pelvic radiation therapy', ' Prior radical pelvic surgery (TAH/BSO is allowed)', ' Use of beta adrenergic antagonists', ' Diagnosis of any of the following conditions:', ' Vulvar and vaginal dysplasia', ' Essential vulvodynia', ' Vulvar vestibulitis', ' Vaginal prolapse', ' Bartholin cyst/abscess', ' History of Bartholin gland surgery', ' Lichen sclerosis', ' Lichen planus of the vulvovaginal region', ' Desquamative vaginitis'], 'Results': ['Outcome Measurement: ', ' Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics', ' Vaginal dryness was measured by the numerical analogue scale at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values * 6) / 3) / 6). The average pro-rated AUC for vaginal dryness scores was compared in each of the Pilocarpine arms against the collective placebo arm.', ' Time frame: Baseline to Week 6', 'Results 1: ', ' Arm/Group Title: Collective Placebo', ' Arm/Group Description: Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.', ' Overall Number of Participants Analyzed: 61', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 63.6 (24.04)', 'Results 2: ', ' Arm/Group Title: Pilocarpine 2 Times Per Day', ' Arm/Group Description: Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.', ' Overall Number of Participants Analyzed: 61', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 55.8 (27.69)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/65 (0.00%)', 'Adverse Events 2:', ' Total: ']}

bad4d3e7-a05a-44fd-937a-c94a23655c03

Comparison

Adverse Events

NCT00499122

NCT00454805

There were several cases of Multi-Organ Failure in both cohort 1 of the secondary trial and cohort 2 of the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00499122', 'Intervention': ['INTERVENTION 1: ', ' NOV-002 and Chemotherapy', ' NOV-002:', ' Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart', ' Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration', ' Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections', ' Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1', ' Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1', ' Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1'], 'Eligibility': ['Inclusion Criteria:', ' Females age 18 years or older.', ' The ability to provide written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time.', ' Histologically confirmed infiltrating (invasive) breast cancer by core needle biopsy, with no evidence of metastatic disease except to the ipsilateral axillary lymph nodes.', ' Clinical stage IIB - IIIC (T2-4, N0 or N1, M0 or - any T, N1-3, M0) breast cancer. The primary tumor must be greater than or equal to 2 cm (T2-4) or with pathologically proven axillary nodal involvement (N1-3).', ' Patients with inflammatory breast cancer (T4) are permitted into the study.', ' Clinically palpable tumor that meets the criteria of RECIST for palpable measurable disease. The primary tumor must be greater than or equal to 2 cm (T2-4) or with pathologically proven axillary nodal involvement (N1-3). Bilateral synchronic breast cancers are allowed but one of the primary tumors should be selected as the target tumor.', ' Primary tumor may be estrogen or progesterone receptor negative or positive, and human epidermal growth factor receptor 2 (HER-2/neu) negative as determined by either Fluorescent In Situ Hybridization (FISH) or 0-2+ staining by immunohistochemistry (IHC) (Hercept™).', ' Normal cardiac ejection fraction (EF 50%) as determined by screening multigated acquisition scan (MUGA) or echocardiogram.', ' No prior history of myocardial infarction, congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias.', ' Patients must be ambulatory with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.', ' The patient or her caregiver must be able to self administer daily subcutaneous injections.', ' Life expectancy greater than 6 months.', 'Exclusion Criteria:', ' Prior therapy of any modality for the treatment of breast cancer', ' Any prior therapy with an anthracycline or a taxane for any other indication', ' HER-2 positive breast cancer defined as either gene amplification by Fluorescent In Situ Hybridization (FISH) or 3+ staining by IHC (Hercept™).', ' Women who have a positive pregnancy test, no pregnancy test available, who are pregnant or who are lactating.', ' Women of childbearing potential must agree to use a reliable and appropriate contraceptive method, which could include a double barrier method (condom plus diaphragm), an intrauterine device or oral contraceptives. Women with ER or PR positive breast cancer, should not, however, use oral contraceptives as a method of contraception. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.', ' Women with breast cancer that do not have palpable breast tumors at screening.', ' History of another malignancy within the last 5 years except curatively treated basal cell carcinoma of the skin or cervical intraepithelial neoplasia.', ' Clinically significant (i.e. active) cardiac disease (NYHA Grade II or greater congestive heart failure, symptomatic coronary artery disease, unstable angina, and cardiac arrhythmia not well-controlled with medication), myocardial infarction within the last 6 months prior to study start, or screening ejection fraction of < 50%.', ' Any of the following abnormal laboratory values:', ' Absolute neutrophil count < 1.5 x 109/L', ' Platelet count < 100 x 109/L', ' Serum bilirubin > 1.5 x upper limit of normal (ULN)', ' Serum alanine transaminase (ALT), aspartate transaminase (AST) > 2.5 x ULN', ' Serum creatinine > 2.0 mg/dL or 177mmol/L or calculated creatinine clearance by the method of Cockcroft and Gault < 50mL/min).', ' Any severe or poorly controlled systemic disease (e.g., hypertension; clinically significant cardiovascular, pulmonary, or metabolic disease, disorders of wound-healing, ulcer or bone fracture).', ' Patients who have received any investigational treatment within 4 weeks of study start.', ' Known infection with HIV, Hepatitis B virus (HBV), or Hepatitis C virus (HCV).', ' Known hypersensitivity to any of the components of NOV-002 or to any of the study drugs.', ' Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.'], 'Results': ['Outcome Measurement: ', ' Rate of Pathologic Complete Response in the Affected Breast After Protocol Therapy', ' The primary objective of this study is to define the rate of pathologic complete response rate (pCR) in the affected breast after the preoperative administration of NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel in patients with stage IIB-IIIC breast cancer. Pathologic complete response (pCR) is defined according to Hankoop et al [41] as either: the absence of any histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast or the presence of invasive tumor equal to or less than 10mm after preoperative treatment, determined at definitive breast surgery.', ' Time frame: About 7 months', 'Results 1: ', ' Arm/Group Title: NOV-002 and Chemotherapy', ' Arm/Group Description: NOV-002:', ' Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart', ' Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration', ' Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections', ' Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1', ' Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1', ' Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1', ' Overall Number of Participants Analyzed: 39', ' Overall Number of Units Analyzed', ' Type of Units Analyzed: Tumors Median (95% Confidence Interval)Unit of Measure: percentage of tumors: 39 (25 to 45)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 27/41 (65.85%)', ' Febrile Neutropenia 4/41 (9.76%)', ' Neutropenia 1/41 (2.44%)', ' Deep Vein Thrombosis 1/41 (2.44%)', ' Pulmonary embolism 1/41 (2.44%)', ' Femoral Artery occlusion 1/41 (2.44%)', ' Abdominal Pain 2/41 (4.88%)', ' Constipation 1/41 (2.44%)', ' Fatigue 2/41 (4.88%)', ' Headache 1/41 (2.44%)', ' Nausea 1/41 (2.44%)', ' Cellulitis 1/41 (2.44%)', ' Muscular Weakness 1/41 (2.44%)']}

{'Clinical Trial ID': 'NCT00454805', 'Intervention': ['INTERVENTION 1: ', ' Cediranib 45 mg', ' Cediranib 45 mg+Fulvestrant 250 mg', ' Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:', ' Day 1: fulvestrant 500 mg im', ' Day 15: fulvestrant 250 mg im', ' Day 29, and every 28 days thereafter: fulvestrant 250 mg im', ' and daily: cediranib 45 mg (administered orally)', 'INTERVENTION 2: ', ' Placebo', ' Placebo+Fulvestrant 250 mg', ' Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:', ' Day 1: fulvestrant 500 mg im', ' Day 15: fulvestrant 250 mg im', ' Day 29, and every 28 days thereafter: fulvestrant 250 mg im', ' and daily: placebo to match cediranib (administered orally)'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent', ' Females with histological/cytological confirmation of hormone sensitive breast cancer with evidence of metastatic disease', ' One or more evaluable lesions', 'Exclusion Criteria:', ' Prior hormonal therapy with fulvestrant', ' More than one course of prior systemic cytotoxic chemotherapy for metastatic breast cancer', ' Prior biologic therapy for ABC including Anti-VEGF agents', ' Radiation therapy within 4 weeks prior to provision of consent'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival', ' Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.', ' Time frame: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.', 'Results 1: ', ' Arm/Group Title: Cediranib 45 mg', ' Arm/Group Description: Cediranib 45 mg+Fulvestrant 250 mg', ' Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:', ' Day 1: fulvestrant 500 mg im', ' Day 15: fulvestrant 250 mg im', ' Day 29, and every 28 days thereafter: fulvestrant 250 mg im', ' and daily: cediranib 45 mg (administered orally)', ' Overall Number of Participants Analyzed: 31', ' Median (95% Confidence Interval)', ' Unit of Measure: Days 223 (129 to 340)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Placebo+Fulvestrant 250 mg', ' Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:', ' Day 1: fulvestrant 500 mg im', ' Day 15: fulvestrant 250 mg im', ' Day 29, and every 28 days thereafter: fulvestrant 250 mg im', ' and daily: placebo to match cediranib (administered orally)', ' Overall Number of Participants Analyzed: 31', ' Median (95% Confidence Interval)', ' Unit of Measure: Days 112 (59 to 329)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/31 (48.39%)', ' Intracardiac Thrombus 1/31 (3.23%)', ' Diarrhoea 2/31 (6.45%)', ' Nausea 2/31 (6.45%)', ' Vomiting 2/31 (6.45%)', ' Ascites 0/31 (0.00%)', ' Ileus 1/31 (3.23%)', ' Small Intestinal Obstruction 1/31 (3.23%)', ' Multi-Organ Failure 0/31 (0.00%)', ' Sepsis 1/31 (3.23%)', ' Weight Decreased 1/31 (3.23%)', ' Dehydration 2/31 (6.45%)', ' Hypokalaemia 0/31 (0.00%)', 'Adverse Events 2:', ' Total: 4/31 (12.90%)', ' Intracardiac Thrombus 0/31 (0.00%)', ' Diarrhoea 0/31 (0.00%)', ' Nausea 0/31 (0.00%)', ' Vomiting 0/31 (0.00%)', ' Ascites 1/31 (3.23%)', ' Ileus 0/31 (0.00%)', ' Small Intestinal Obstruction 0/31 (0.00%)', ' Multi-Organ Failure 1/31 (3.23%)', ' Sepsis 0/31 (0.00%)', ' Weight Decreased 0/31 (0.00%)', ' Dehydration 0/31 (0.00%)', ' Hypokalaemia 1/31 (3.23%)']}

b88eaf78-957d-4b3d-bcb2-d029b7d7b7e2

Single

Adverse Events

NCT00191789

In the primary trial there was 1 case of jaundice.

Entailment

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

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

0c435231-a09c-4424-924a-13840c6b7068

Comparison

Eligibility

NCT01217385

NCT01202591

Prior exposure to exemestane is not allowed for patients in the secondary trial, however, the primary trial may accept patients despite this.

Entailment

{'Clinical Trial ID': 'NCT01217385', 'Intervention': ['INTERVENTION 1: ', ' Diffuse Optical Spectroscopy Imaging (DOSI', ' Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.', ' DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during NAC treatment.'], 'Eligibility': ['Inclusion Criteria', ' Pathologically confirmed diagnosis of invasive breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy;', ' Tumor size >2cm, measured on imaging or estimated by physical exam;', ' No contraindications for primary chemotherapy;', ' Planned definitive breast surgery (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant therapy;', ' Age 18 years or older;', ' ECOG Performance Status 2 (Karnofsky 60%; see Appendix II);', ' Normal organ and marrow function as follows:', ' leukocytes 3,000/μl;', ' absolute neutrophil count 1,500/μl;', ' platelets 100,000/μl;', ' total bilirubin within normal institutional limits;', ' AST(SGOT)/ALT(SGPT) 2.5 times the institutional upper limit of normal;', ' creatinine within normal institutional limits; OR', ' creatinine clearance 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal;', ' If female, postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, confirmed by a pregnancy test as per institutional Standard of Care (SOC), and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation;', ' Able to understand and willing to sign a written informed consent document and a HIPAA authorization in accordance with institutional guidelines;', ' Exclusion Criteria', ' Previous treatment (chemotherapy, radiation, or surgery) to involved breast; including hormone therapy;', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;', ' Medically unstable;', ' Under age 18;', ' Pregnant or nursing;', ' Previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years.'], 'Results': ['Outcome Measurement: ', ' Accuracy of %Change in TOI Between Baseline and Mid-therapy to Predict Pathologic Response (pCR +/-)', ' This measure will look at the Accuracy of % change in DOSI measured Tumor Optical Index (TOI) from baseline to mid therapy to predict pathologic response (pCR+ v pCR-) Pathologic response (dichotomized into responders (pCR+) and non-responders (pCR-) based pathologic assessment) will be used as the reference standard and Accuracy will be determined using receiver operating characteristic (ROC) analysis to determine the ROC Area Under the Curve (AUC).', ' Time frame: From baseline to mid-therapy', 'Results 1: ', ' Arm/Group Title: Diffuse Optical Spectroscopy Imaging (DOSI', ' Arm/Group Description: Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.', ' DOSI: Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during NAC treatment.', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Number', ' Unit of Measure: probability 0.60 (0.39 to 0.81)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/34 (0.00%)']}

{'Clinical Trial ID': 'NCT01202591', 'Intervention': ['INTERVENTION 1: ', ' AZD4547 80mg bd Cont + Ex 25mg', ' 80 mg AZD4547 BD continuous + 25 mg exemestane', 'INTERVENTION 2: ', ' AZD4547 40mg Cont + Ex 25mg', ' 40 mg AZD4547 BD continuous + 25 mg exemestane'], 'Eligibility': ['Inclusion Criteria:', ' Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)', ' Histological confirmation of Breast Cancer with documented ER+ receptor status', ' Safety run-in: Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal AL', ' Rand phase IIa: Received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both). Chemotherapy administered in the adjuvant setting is permitted.', ' Rand phase IIa: Mandatory provision of tumour sample to confirm FGFR1 polysomy or gene amplification. At least one measurable lesion that can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits', 'Exclusion Criteria:', ' Prior exposure to exemestane (safety run-in) / fulvestrant (randomized phase IIa), or any agent known to inhibit FGFRs.', ' More than 1 prior regimen of chemotherapy for breast cancer', ' ECG recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction', ' History of hypersensitivity to active or inactive excipients of AZD4547 or exemestane (safety run-in ) or fulvestrant (Randomized phase), including castor oil, or drugs with a similar chemical structure or class to AZD4547 or exemestane or fulvestrant.', ' Randomized phase IIa: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks'], 'Results': ['Outcome Measurement: ', ' Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)', ' [Not Specified]', ' Time frame: 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).', 'Results 1: ', ' Arm/Group Title: AZD4547 80mg bd Cont + Ex 25mg', ' Arm/Group Description: 80 mg AZD4547 BD continuous + 25 mg exemestane', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Number', ' Unit of Measure: Participants 5', 'Results 2: ', ' Arm/Group Title: AZD4547 40mg Cont + Ex 25mg', ' Arm/Group Description: 40 mg AZD4547 BD continuous + 25 mg exemestane', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Number', ' Unit of Measure: Participants 5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/5 (40.00%)', ' ANAEMIA 0/5 (0.00%)', ' DIARRHOEA 0/5 (0.00%)', ' OESOPHAGEAL ACHALASIA 0/5 (0.00%)', ' STOMATITIS 0/5 (0.00%)', ' DEVICE DEPOSIT ISSUE 0/5 (0.00%)', ' INFLAMMATION 0/5 (0.00%)', ' GAIT DISTURBANCE 0/5 (0.00%)', ' LOWER RESPIRATORY TRACT INFECTION VIRAL 0/5 (0.00%)', ' NEUTROPENIC SEPSIS 1/5 (20.00%)', ' PLEURAL INFECTION 1/5 (20.00%)', ' PYELONEPHRITIS 0/5 (0.00%)', 'Adverse Events 2:', ' Total: 2/5 (40.00%)', ' ANAEMIA 1/5 (20.00%)', ' DIARRHOEA 0/5 (0.00%)', ' OESOPHAGEAL ACHALASIA 0/5 (0.00%)', ' STOMATITIS 0/5 (0.00%)', ' DEVICE DEPOSIT ISSUE 0/5 (0.00%)', ' INFLAMMATION 0/5 (0.00%)', ' GAIT DISTURBANCE 0/5 (0.00%)', ' LOWER RESPIRATORY TRACT INFECTION VIRAL 0/5 (0.00%)', ' NEUTROPENIC SEPSIS 0/5 (0.00%)', ' PLEURAL INFECTION 0/5 (0.00%)', ' PYELONEPHRITIS 0/5 (0.00%)']}

0812dcc1-eab5-4d5f-9d51-934f9b1f05ca

Comparison

Adverse Events

NCT01252290

NCT00479674

Unlike the secondary trial, the primary trial does not record any instances of Anemia, Dyspepsia, Nausea or depression.

Contradiction

{'Clinical Trial ID': 'NCT01252290', 'Intervention': ['INTERVENTION 1: ', ' Lovaza™', ' Lovaza™: 4 capsules daily for 6 months'], 'Eligibility': ['Inclusion Criteria', ' Subjects must be postmenopausal and between the ages of 25 and 69 years. Menopause is defined by no menstrual period for more than one year and intact uterus and ovaries, or women with intact ovaries but without a uterus and age 50 and over, or a woman with both estradiol and follicle stimulating hormone (FSH) in the postmenopausal range or any woman who has had her ovaries removed.', ' Subjects must be at increased risk for breast cancer on the basis of at least one of the following criteria:', ' A five-year Gail risk of 1.67% or 2X the average risk for a woman of the same age using either the Surveillance Epidemiology and End Results (SEER, http://seer.cancer.gov) database, the NCI Breast Cancer Risk Assessment Tool (www.cancer.gov/bcrisktool), or the International Breast Cancer Intervention Study (IBIS) Risk Evaluator (http://www.emstrials.', ' org/riskevaluator/), or a ten-year Tyrer-Cuzick model risk of 2x that of the population risk.', ' A first degree relative with breast cancer under the age of 60 or multiple second degree relatives with breast cancer.', ' Multiple prior biopsies or at least one prior biopsy exhibiting atypical hyperplasia (AH), lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS).', ' Random periareolar fine needle aspiration (RPFNA) evidence of hyperplasia with atypia within the last three years;', ' Chest or neck radiation before age 30;', ' Mammographic breast density by visual estimate equals or exceeds 50%.', ' Subjects must be willing to continue the same hormonal milieu present at baseline throughout trial (Cannot start or stop any type of hormone replacement therapy with the exception of vagifem or estring).', ' Six months or more must have elapsed from completion of a prevention intervention trial (with exception of a weight reduction trial), ingestion of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) prior to baseline biomarker assessment. .', ' Subjects with a history of AH, LCIS, or ER-positive DCIS by diagnostic biopsy, must have been counseled about appropriate standard prevention therapies such as tamoxifen or raloxifene and are either not eligible or are not interested in standard prevention therapies. Women with DCIS must have had appropriate local therapy (lumpectomy plus radiation or mastectomy). If subject has had a DCIS, at least two months must have elapsed from surgery and/or radiation therapy to the involved breast. Only the contra-lateral (uninvolved breast) will be studied by RPFNA. The subject may not have had any radiation therapy to the contra-lateral breast to be studied', ' Subjects must have had a screening mammogram within 6 months of entering the interventional portion of the study and read as not suspicious for breast cancer or if suspicious must have completed all suggested tests including biopsy and found to have no evidence of cancer. Women must be willing to have an off-study mammogram performed 6 months after study entry.', ' Subjects must have had an RPFNA of the breast within six months prior to entering the intervention portion of the study and be willing to have another RPFNA at ~6.5 months after starting Lovaza™.', 'Tissue Eligibility: Subjects must have cytomorphologic evidence of hyperplasia with atypia or borderline atypia (Masood score > 13). There must be 500 epithelial cells on the slide for cytomorphology. There must be sufficient reserved methanol-formalin- fixed material for quantitative reverse transcription polymerase chain reaction (RT-qPCR). Frozen tissue must also have been obtained for fatty acid analysis, reverse phase proteomics, adipokines and cytokines, and RT-qPCR.', ' Subjects must be willing to undergo phlebotomy at baseline and 6 months and 6.5 months. Approximately 3 tablespoons of blood will be obtained at baseline and 6 months and 6.5 months or 6 tablespoons if the subject decides to participate in the optional monocyte cytokine release assay .', ' Subjects must produce a spot urine sample at baseline, 6 months, and at study conclusion', ' Subjects must be willing to undergo measurement of height, weight, and BMI and undergo body composite analysis (DEXA) at initiation and conclusion of intervention.', ' Subjects must be willing to complete questionnaires regarding diet and supplement use, quality of life as well as relevant family history personal health and reproductive history and medications at initiation and conclusion of the intervention. Subjects must be willing to sign an informed consent for the entire study and separate consent for repeat RPFNA.', ' Exclusion Criteria', ' Women that have had a metastatic malignancy of any kind.', ' Women that have had prior invasive breast cancer, diagnosed or treated within the past five years.', ' Women who are currently taking anticoagulants.', ' Women who have breast implants.', ' Women who have undergone change in their hormonal milieu in the past 6 months.', ' Women who have taken omega 3 fatty acid or flaxseed supplements within 3 weeks prior to their baseline RPFNA or women who have taken high dose omega 3 within the past three months.', ' Women who regularly take NSAIDS (>7 tablets weekly).', ' Women who have taken a SERM, aromatase inhibitor or participated in a chemoprevention or other investigational drug study within six months prior to baseline RPFNA.', ' Women who have abnormal renal or hepatic function at baseline, defined as blood chemistry values clinically significantly outside of normal institutional ranges.', ' Women who have a history of an allergy, including hives, to fish products.', ' Women who have a BMI of 40 kg/m^2 or greater.', ' Inclusion of Women and Minorities This study utilizes women at increased risk for breast cancer. Subjects recruited from an established cohort of women followed in the Breast Cancer Prevention Center. From previous trials we can expect 6% minority accrual which is similar to our hospital demographics. Males are not included due to the low absolute risk of breast cancer, and the difficulty of performing RPFNA on the male breast.'], 'Results': ['Outcome Measurement: ', ' The Proportion of Subjects That Complete Intervention of Lovaza™ 4 Grams Per Day', ' To determine the feasibility of an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to post-menopausal women under the age of 50.', ' Time frame: 6 month visit', 'Results 1: ', ' Arm/Group Title: Lovaza™', ' Arm/Group Description: Lovaza™: 4 capsules daily for 6 months', ' Overall Number of Participants Analyzed: 34', ' Measure Type: Number', ' Unit of Measure: proportion of enrolled participants 0.97'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/35 (5.71%)', ' Gastroesophageal reflux disease * 1/35 (2.86%)', ' Ductal carcinoma in situ * 1/35 (2.86%)']}

{'Clinical Trial ID': 'NCT00479674', 'Intervention': ['INTERVENTION 1: ', ' Abraxane, Carboplatin, Bevacizumab', ' Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15', ' Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..', ' Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.', ' Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.'], 'Eligibility': ['Inclusion Criteria:', ' Tissue block containing tumor to confirm metastatic breast cancer is required;', ' Measurable disease according to RECIST criteria', ' "Triple negative" disease defined as tumor demonstrating no expression for estrogen, progesterone or human epidermal growth factor receptor 2(HER2)receptors. "No expression" is categorized as 10% of cells staining or Allred 2;', ' Aged 18 years or older;', ' Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0 or 1; life expectancy 3 months;', ' Patients may have received 0 - 1 prior therapies (except taxanes in the metastatic setting). An interval of at least 1 week must have elapsed since prior chemotherapy or hormonal therapy for metastatic disease; at least 6 months must have elapsed since prior adjuvant therapy;', ' 2 weeks between surgery and study enrollment ( 4 weeks between major surgery (defined as open abdominal/thoracic/cardiac) and study enrollment;', ' Laboratory tests performed within 14 days of study entry:', ' Granulocytes 1,500/µL;', ' Platelets 100,000/µL;', ' Hemoglobin 9 gm/dL;', ' Total bilirubin institutional upper limit of normal (ULN);', ' Aspartate transaminase (AST) and alanine aminotransferase (ALT) 5 times ULN;', ' Alkaline phosphatase 2.5 times ULN;', ' Estimated creatinine clearance 60 mL/min.', ' left ventricular ejection fraction (LVEF) 50% by multigated acquisition (MUGA)/Echocardiogram;', ' Informed consent to receive protocol treatment, to provide biologic specimens, and to complete neurotoxicity questionnaires;', ' Cognitive and communication skills to comply with study and/or follow-up procedures;', ' No reproductive potential:', ' If pre-menopausal: Negative serum pregnancy test and patient agreement to use adequate contraceptive method (abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during and for 3 months after completion of treatment.', 'If post-menopausal: Amenorrhea for 12 months.', 'Exclusion Criteria:', ' Pregnant or breast feeding;', ' Prior treatment with Abraxane®, carboplatin or bevacizumab, or any taxane for metastatic breast cancer;', ' Known hypersensitivity to any component of any study drug;', ' Active infection;', ' Current neuropathy grade 2;', ' central nervous system (CNS) metastases as determined by head CT with contrast;', ' History of bleeding within the past 6 months or active bleeding disorder;', ' Serious non-healing wound, ulcer or bone fracture;', ' Uncontrolled congestive heart failure (CHF), or history of myocardial infarction(MI), unstable angina, stroke, or transient ischemia within previous 6 months;', ' Inadequately controlled hypertension (defined as systolic blood pressure < 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications; prior history of hypertensive crisis or hypertensive encephalopathy;', ' Proteinuria (defined as urine protein: creatinine (UPC) ratio 1.0 or urine dipstick 2+.', ' Significant vascular disease (aortic aneurysm, aortic dissection) or symptomatic peripheral vascular disease;', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within previous 6 months;', ' Uncontrolled serious contraindicated medical condition or psychiatric illness.'], 'Results': ['Outcome Measurement: ', ' Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III "Triple Negative" Metastatic Breast Cancer.', ' Best clinical response is based on RECIST criteria, the proportion in each response category along with the exact binomial confidence intervals are estimated. Toxicity summaries are also provided.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Abraxane, Carboplatin, Bevacizumab', ' Arm/Group Description: Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15', ' Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..', ' Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.', ' Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of participants Complete Response: 18 (8 to 34)', ' Partial Response: 69 (52 to 83)', ' Stable Disease: 8 (2 to 21)', ' Progressive Disease: 5 (1 to 17)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/41 (53.66%)', ' Anemia 1/41 (2.44%)', ' Dyspepsia 1/41 (2.44%)', ' Mucositis oral 1/41 (2.44%)', ' Nausea 3/41 (7.32%)', ' Vomiting 1/41 (2.44%)', ' Pain 3/41 (7.32%)', ' Allergic reaction 1/41 (2.44%)', ' Infections and infestations - Other, specify: [1]1/41 (2.44%)', ' Vascular access complication 3/41 (7.32%)', ' Alanine aminotransferase increased 1/41 (2.44%)']}

a29e6a86-65f3-4565-93e2-81f49fa837e4

Single

Eligibility

NCT00418457

Scheduled flap reconstruction within 10 days prior to beginning is acceptable for patients entering the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00418457', 'Intervention': ['INTERVENTION 1: ', ' General Anesthesia and Opioid', ' General anesthesia followed by opioid administration', ' General anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia', 'INTERVENTION 2: ', ' Regional Analgesia and Propofol', ' Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol', ' Regional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia'], 'Eligibility': ['Inclusion Criteria:', ' Primary breast cancer without known extension beyond the breast and axillary nodes (i.e. believed to be Tumor Stage 1-3, Nodes 0-2)', ' Scheduled for unilateral or bilateral mastectomy with or without implant (isolated "lumpectomy" will not qualify)', ' Isolated "lumpectomy" with axillary node dissection (anticipated removal of at least five nodes)', ' Written informed consent, including willingness to be randomized to morphine or regional analgesia', 'Exclusion Criteria:', ' Previous surgery for breast cancer (except diagnostic biopsies)', ' Inflammatory breast cancer', ' Age < 18 or > 85 years old', ' Scheduled free flap reconstruction', ' ASA Physical Status 4', ' Any contraindication to epidural or paravertebral anesthesia and analgesia (including coagulopathy, abnormal anatomy)', ' Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine', ' Other cancer not believed by the attending surgeon to be in long-term remission', ' Systemic disease believed by the attending surgeon to present 25% two-year mortality'], 'Results': ['Outcome Measurement: ', ' Number of Participants Who Had Breast Cancer Recurrence After Breast Cancer Surgery', ' time to breast cancer recurrence from the end of surgery.', ' Time frame: up to 10 years', 'Results 1: ', ' Arm/Group Title: General Anesthesia and Opioid', ' Arm/Group Description: General anesthesia followed by opioid administration', ' General anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia', ' Overall Number of Participants Analyzed: 1065', ' Measure Type: Number', ' Unit of Measure: participants 111', 'Results 2: ', ' Arm/Group Title: Regional Analgesia and Propofol', ' Arm/Group Description: Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol', ' Regional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia', ' Overall Number of Participants Analyzed: 1043', ' Measure Type: Number', ' Unit of Measure: participants 102'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/1065 (0.00%)', 'Adverse Events 2:', ' Total: 0/1043 (0.00%)']}

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

2470d8d1-27cd-41a5-9e5d-f62d4bbdd049

Comparison

Eligibility

NCT03190083

NCT01805089

All cancer stages are accepted for the primary trial and the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT03190083', 'Intervention': ['INTERVENTION 1: ', ' 3-dimensional Tomosynthesis Mammogram', ' The patients assigned a Breast imaging-reporting and data system (BIRADS) 5 category at the time of diagnosis and all new diagnosed breast cancer patients, will undergo a separate 2-D plus DBT in addition to the standard 2-D mammogram', ' 2-dimensional mammogram: This is standard of care for breast cancer diagnosis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.', ' digital breast tomosynthesis (DBT): The radiation dose from this/these procedure(s) will be no more than 0.4mSv for a bi-lateral breast tomosynthesis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.'], 'Eligibility': ['Inclusion Criteria:', ' New diagnosis of breast cancer', ' New diagnosis if a previous breast cancer patient with negative surgical margins', ' Patients willing to sign a written informed consent form', 'Exclusion Criteria:', ' High risk benign lesions as the primary pathology diagnosis'], 'Results': ['Outcome Measurement: ', ' Number of Participants for Which DBT Altered Surgical Plan', ' Only positive findings, like an additional site of cancer or atypical pathology like Atypical ductal/ lobular hyperplasia, papilloma, DCIS/LCIS (findings requiring surgical intervention), will be taken into account when estimating the frequency of changes to surgical management', ' Time frame: At completion of 3-Dimensional mammogram (1 day)', 'Results 1: ', ' Arm/Group Title: 3-dimensional Tomosynthesis Mammogram', ' Arm/Group Description: The patients assigned a Breast imaging-reporting and data system (BIRADS) 5 category at the time of diagnosis and all new diagnosed breast cancer patients, will undergo a separate 2-D plus DBT in addition to the standard 2-D mammogram', ' 2-dimensional mammogram: This is standard of care for breast cancer diagnosis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.', ' digital breast tomosynthesis (DBT): The radiation dose from this/these procedure(s) will be no more than 0.4mSv for a bi-lateral breast tomosynthesis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.', ' Overall Number of Participants Analyzed: 16', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/16 (0.00%)']}

{'Clinical Trial ID': 'NCT01805089', 'Intervention': ['INTERVENTION 1: ', ' Melatonin', ' Taken orally, once per day, at/around 9:00pm', 'Melatonin', 'INTERVENTION 2: ', ' Placebo', ' Taken orally, once per day, at/around 9:00pm', 'Placebo'], 'Eligibility': ['Inclusion Criteria:', ' History of ductal carcinoma in situ, lobular carcinoma in situ or stages 1-3 breast cancer', ' Not currently receiving chemotherapy or hormonal therapy', ' Postmenopausal', 'Exclusion Criteria:', ' Stage IV breast cancer or systemic recurrences', ' Prior malignancies of any type other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix', ' Use of adjuvant hormonal therapy, oral estrogen or progesterone replacement therapy, lutenizing hormone releasing hormone agonists currently or within the past 60 days', ' Concomitant use of beta-blockers', ' Concomitant nightly use of sleep aids at bedtime', ' Working more than one overnight shift per month on a regular basis', ' Concomitant use of postmenopausal hormone replacement therapy', ' Concomitant use of black cohosh, flaxseed or soy in pill or supplement form', ' Use of any type of oral melatonin supplementation within the past 30 days', ' Use of warfarin (coumadin) within the past 30 days', ' Active seizure disorder requiring the use of daily anti-epileptic medication'], 'Results': ['Outcome Measurement: ', ' Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo', ' Absolute plasma estradiol levels after 4 month course of melatonin or placebo, only 4 month level provided below.', ' Time frame: 4 months', 'Results 1: ', ' Arm/Group Title: Melatonin', ' Arm/Group Description: Taken orally, once per day, at/around 9:00pm', ' Melatonin', ' Overall Number of Participants Analyzed: 43', ' Mean (Standard Deviation)', ' Unit of Measure: pg/ml 4.59 (3.42)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Taken orally, once per day, at/around 9:00pm', ' Placebo', ' Overall Number of Participants Analyzed: 43', ' Mean (Standard Deviation)', ' Unit of Measure: pg/ml 3.39 (2.25)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/48 (0.00%)', 'Adverse Events 2:', ' Total: 0/47 (0.00%)']}

34bb7f09-3b2b-464f-96df-c8d80b1206fc

Single

Adverse Events

NCT00357110

Less than 20% of patients in cohort 1 of the primary trial had Varicose Veins.

Entailment

{'Clinical Trial ID': 'NCT00357110', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant + Anastrozole', ' fulvestrant 500 mg + anastrozole 1 mg', 'INTERVENTION 2: ', ' Anastrozole', 'anastrozole 1 mg'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with hormone receptor-positive early breast cancer and a positive Disseminated Tumour Cell immunocytochemical result from bone marrow aspiration prior to randomisation', 'Exclusion Criteria:', ' Inflammatory and/or metastatic breast cancer.', ' Current or previous malignancy within previous 5 years (other than Breast cancer or adequately treated non-melanoma skin cancer or in-situ cervical cancer).', ' History of bleeding diathesis.'], 'Results': ['Outcome Measurement: ', ' Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)', ' Number of patients event-free', ' Time frame: 12 month period following randomisation', 'Results 1: ', ' Arm/Group Title: Fulvestrant + Anastrozole', ' Arm/Group Description: fulvestrant 500 mg + anastrozole 1 mg', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: Participants 6', 'Results 2: ', ' Arm/Group Title: Anastrozole', ' Arm/Group Description: anastrozole 1 mg', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: Participants 7'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/6 (16.67%)', ' Goitre 0/6 (0.00%)', ' Haemorrhoid Operation 0/6 (0.00%)', ' Sciatica 0/6 (0.00%)', ' Renal Failure 0/6 (0.00%)', ' Varicose Vein 1/6 (16.67%)', 'Adverse Events 2:', ' Total: 2/7 (28.57%)', ' Goitre 1/7 (14.29%)', ' Haemorrhoid Operation 1/7 (14.29%)', ' Sciatica 1/7 (14.29%)', ' Renal Failure 1/7 (14.29%)', ' Varicose Vein 0/7 (0.00%)']}

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

e9824c27-bb70-4707-9599-ff20281f873e

Comparison

Results

NCT00320385

NCT00075270

The median time from randomization until the first documented sign of disease progression or death due to any cause for all participants in the primary trial, was lower than the median time for patients in the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00320385', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + Lapatinib', ' Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.', 'INTERVENTION 2: ', ' Lapatinib', ' Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent.', ' Female 18 years. Women of childbearing potential must have a negative serum pregnancy test at screening and must use an approved contraceptive method, if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product.', ' Metastatic breast cancer, histologically/cytologically confirmed. If the disease is restricted to a solitary lesion, its neoplastic nature must be confirmed by cytology or histology.', ' Subjects must have stage IV breast cancer whereby their disease has progressed in either the adjuvant or metastatic setting. Prior therapies must include, but are not limited to:', ' Taxane-containing regimen for at least 4 cycles, or 2 cycles provided disease progression occurred while on taxane.', ' Anthracycline-containing regimen for at least 4 cycles, or 2 cycles provided disease progression occurred while on anthracycline.', ' Subjects must have documented progression following at least ONE trastuzumab plus cytotoxic chemotherapy or anti-hormonal regimen in the metastatic setting.', ' Note: The most recent treatment must have contained trastuzumab, either alone or in combination with other therapy in the metastatic setting, and subjects must have progressed while on this regimen. Progression is defined as either new lesions or a 20% increase in the sum of longest diameter (LD) on the progression radiologic scan.', ' Subjects must have archived tumor tissue available for testing.', ' Documented amplification of the ErbB2 gene by fluorescence in situ hybridization (FISH) or documented overexpression of the ErbB2 protein by IHC in primary or metastatic tumor tissue. The IHC or FISH amplification may be documented by a local or central laboratory for randomization into the study. Subjects may be randomized on the basis of ErbB2 positivity by IHC 3+ overexpression or FISH amplification.', ' Lesion eligibility is as follows:', ' at least one measurable lesion(s) according to Response Evaluation Criteria in Solid Tumors [RECIST; Therasse, 2000], or', ' bone-only disease.', ' Note: Tumor lesions which are situated in a previously irradiated field, and have well-defined margins which are located in soft tissue will be defined as measurable disease.', ' Subjects with stable CNS metastases defined as asymptomatic and off systemic steroids and anticonvulsants for at least 1 month. Treatment with prophylactic anticonvulsants is permitted, unless listed within the Prohibited Medications (Section 8.2).', ' Radiotherapy if received within 2 weeks prior to initiation of investigational product to a limited area (e.g., palliative treatment for painful disease) other than the sole site of measurable disease is allowed; however, subject must have completed treatment and recovered from all treatment-related toxicities prior to administration of the first dose of investigational product.', ' With the single exception of prior trastuzumab treatment, all prior chemotherapy, immunotherapy, biologic therapy, or surgery (except for minor surgical procedures) must be discontinued at least 3 weeks prior to the first dose of investigational product. Subjects must have recovered or stabilized sufficiently from treatment-related toxicities prior to administration of the first dose of investigational product.', ' Bisphosphonate therapy for bone metastases is allowed; however, treatment must be initiated prior to the first dose of investigational product. Prophylactic use of bisphosphonates is permitted only for the treatment of osteoporosis.', ' ECOG Performance Status of 0 to 2.', ' Able to swallow and retain oral medication.', ' Cardiac ejection fraction within institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive. Same modality used at baseline must be used for repeat assessments throughout study.', ' Subject must have adequate organ function as defined in Table 1 :', ' Table 1 (Definitions for Adequate Hematologic and Hepatic Function)', ' SYSTEM (LABORATORY VALUES)', ' Hematologic:', ' ANC (absolute neutrophil count) ( 1x10^9/ L)', ' Hemoglobin ( 9 g / dL)', ' Platelets ( 75x10^9/ L)', ' Hepatic', ' Albumin ( 2.5 g / dL)', ' Serum bilirubin ( 2 mg / dL)', ' AST and ALT ( 3 x ULN without liver metastases) ( 5 xULN if documented liver metastases)', ' Renal', ' Serum Creatinine ( 1.5 mg / dL)', ' OR -', ' Calculated Creatinine Clearance1 ( 40 mL / min)', ' Calculated by the Cockcroft and Gault Method.', ' Subjects may continue anti-estrogen therapy only if treatment was initiated at least 1 month prior to the first dose of investigational product (IP). After randomization, no anti-hormonal therapy may be initiated.', 'Exclusion Criteria:', ' Pregnant or lactating females.', ' Prior therapy with an ErbB1 and/or ErbB2 inhibitor other than trastuzumab.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded.', ' History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.', " Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.", ' Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment.', ' Active or uncontrolled infection.', ' Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.', ' Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.', ' Known history or clinical evidence of leptomeningeal carcinomatosis.', ' Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy).', ' Concurrent treatment with an investigational agent or participation in another clinical trial.', ' Used an investigational drug within 3 weeks or 5 half-lives, whichever is longer, preceding the first dose of investigational product.', ' Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab or lapatinib or their excipients.', " Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)."], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS was defined as the time from randomization until the first documented sign of disease progression or death due to any cause.', ' Time frame: Baseline to disease progression or death due to any cause or 30 days after last dose (up to 216 weeks)', 'Results 1: ', ' Arm/Group Title: Trastuzumab + Lapatinib', ' Arm/Group Description: Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.', ' Overall Number of Participants Analyzed: 146', ' Median (95% Confidence Interval)', ' Unit of Measure: weeks 12.0 (8.1 to 16.0)', 'Results 2: ', ' Arm/Group Title: Lapatinib', ' Arm/Group Description: Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.', ' Overall Number of Participants Analyzed: 145', ' Median (95% Confidence Interval)', ' Unit of Measure: weeks 8.1 (7.6 to 9.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 40/149 (26.85%)', ' Febrile neutropenia * 2/149 (1.34%)', ' Anaemia * 1/149 (0.67%)', ' Thrombocytopenia * 1/149 (0.67%)', ' Left ventricular dysfunction * 1/149 (0.67%)', ' Cardiac failure * 1/149 (0.67%)', ' Myocardial infarction * 1/149 (0.67%)', ' Pericardial effusion * 0/149 (0.00%)', ' Vertigo * 1/149 (0.67%)', ' Diarrhoea * 2/149 (1.34%)', ' Vomiting * 3/149 (2.01%)', ' Nausea * 2/149 (1.34%)', 'Adverse Events 2:', ' Total: 24/146 (16.44%)', ' Febrile neutropenia * 0/146 (0.00%)', ' Anaemia * 0/146 (0.00%)', ' Thrombocytopenia * 0/146 (0.00%)', ' Left ventricular dysfunction * 2/146 (1.37%)', ' Cardiac failure * 0/146 (0.00%)', ' Myocardial infarction * 0/146 (0.00%)', ' Pericardial effusion * 1/146 (0.68%)', ' Vertigo * 0/146 (0.00%)', ' Diarrhoea * 3/146 (2.05%)', ' Vomiting * 2/146 (1.37%)', ' Nausea * 2/146 (1.37%)']}

{'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%)']}

43fcba9b-4edd-433d-86a7-370cbbf56853

Single

Results

NCT02555657

The Median time from randomization to death due to any cause was higher in cohort 1 of the primary trial, compared to cohort 2.

Entailment

{'Clinical Trial ID': 'NCT02555657', 'Intervention': ['INTERVENTION 1: ', ' Pembrolizumab', ' Participants received pembrolizumab 200 mg IV every Q3W for up to 35 administrations (up to ~2 years).', 'INTERVENTION 2: ', ' Chemotherapy', " Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines."], 'Eligibility': ['Inclusion Criteria:', ' Centrally confirmed Stage IV/M1 mTNBC', ' Newly obtained tumor biopsy from metastatic site', ' Central determination of programmed cell death ligand 1 (PD-L1) tumor status', ' Received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on or after the most recent therapy', ' Previously treated with an anthracycline and/or taxane in the neoadjuvant/adjuvant or metastatic setting', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to study start', ' Adequate organ function', 'Exclusion Criteria:', ' Participation in another clinical trial within 4 weeks', ' Monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks', ' Chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks', ' Active autoimmune disease that required systemic treatment in the past 2 years', ' Diagnosed with immunodeficiency or receiving systemic steroid therapy or another form of immunosuppressive therapy within 7 days', ' Known additional malignancy that required treatment or progressed in last 5 years', ' Known active brain metastases and/or carcinomatous meningitis', ' Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand-1 (anti-PD-L1), anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte associated protein 4 [CTLA-4], OX-40, CD137) or previously participated in any pembrolizumab (MK-3475) clinical studies'], 'Results': ['Outcome Measurement: ', ' Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) 10', ' Overall survival (OS) was defined as the time from randomization to death due to any cause.', ' Time frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)', 'Results 1: ', ' Arm/Group Title: Pembrolizumab', ' Arm/Group Description: Participants received pembrolizumab 200 mg IV every Q3W for up to 35 administrations (up to ~2 years).', ' Overall Number of Participants Analyzed: 96', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 12.7 (9.9 to 16.3)', 'Results 2: ', ' Arm/Group Title: Chemotherapy', " Arm/Group Description: Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines.", ' Overall Number of Participants Analyzed: 98', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 11.6 (8.3 to 13.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 65/309 (21.04%)', ' Anaemia 2/309 (0.65%)', ' Febrile neutropenia 1/309 (0.32%)', ' Neutropenia 1/309 (0.32%)', ' Pancytopenia 0/309 (0.00%)', ' Thrombocytopenia 0/309 (0.00%)', ' Cardiac arrest 1/309 (0.32%)', ' Cardio-respiratory arrest 2/309 (0.65%)', ' Cardiogenic shock 1/309 (0.32%)', ' Sinus tachycardia 1/309 (0.32%)', ' Secondary adrenocortical insufficiency 1/309 (0.32%)', 'Adverse Events 2:', ' Total: 60/292 (20.55%)', ' Anaemia 2/292 (0.68%)', ' Febrile neutropenia 5/292 (1.71%)', ' Neutropenia 4/292 (1.37%)', ' Pancytopenia 1/292 (0.34%)', ' Thrombocytopenia 1/292 (0.34%)', ' Cardiac arrest 0/292 (0.00%)', ' Cardio-respiratory arrest 0/292 (0.00%)', ' Cardiogenic shock 0/292 (0.00%)', ' Sinus tachycardia 0/292 (0.00%)', ' Secondary adrenocortical insufficiency 0/292 (0.00%)']}

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

196c7a35-58a0-4d2d-a0a6-e9e3de077fb1

Single

Adverse Events

NCT00398567

3/4 patients in the primary trial did not suffer any adverse events.

Entailment

{'Clinical Trial ID': 'NCT00398567', 'Intervention': ['INTERVENTION 1: ', ' Part 2 - Expanded MTD Cohort', ' All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter'], 'Eligibility': ['Inclusion Criteria:', ' Pathologic diagnosis of breast cancer with current stage IIIB, IIIC or IV not curable by available therapy', ' Progression following at least one Herceptin-containing cytotoxic chemotherapy regimen (neoadjuvant, adjuvant, or metastatic setting)', ' HER2 positive breast cancer', ' At least one measurable target lesion', ' Adequate performance status', ' Adequate cardiac, kidney, and liver function', ' Adequate blood counts', ' Willingness of all subjects who are not surgically sterile or post menopausal to use acceptable methods of birth control', 'Exclusion Criteria:', ' More than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease', ' Major surgery, chemotherapy, radiotherapy, investigational agents, Herceptin or other cancer therapy within 2 weeks of treatment day 1', ' Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2', ' Extensive visceral disease', ' Active central nervous system metastases', ' Pregnant or breast feeding women', ' Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom', ' Prior exposure to HKI-272 or other HER2 targeted agents (except Herceptin and Tykerb)', ' Significant cardiac disease or dysfunction', ' History of life-threatening hypersensitivity to Herceptin', ' Inability or unwillingness to swallow HKI-272 capsules', ' Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin'], 'Results': ['Outcome Measurement: ', ' 16-week Progression-free Survival (PFS) Rate', ' 16-week progression-free survival (PFS) rate for subjects with advanced breast cancer who receive neratinib at the maximum tolerated dose (MTD) in combination with trastuzumab, evaluable population.', ' Time frame: From first dose date to progression status (PD or death) at 16-week', 'Results 1: ', ' Arm/Group Title: Part 2 - Expanded MTD Cohort', ' Arm/Group Description: All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: percentage of population 44.8 (25.9 to 62.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/4 (25.00%)', ' Vertigo 0/4 (0.00%)', ' Abdominal adhesions 0/4 (0.00%)', ' Abdominal distension 0/4 (0.00%)', ' Abdominal pain 0/4 (0.00%)', ' Diarrhoea 0/4 (0.00%)', ' Nausea 0/4 (0.00%)', ' Vomiting 0/4 (0.00%)', ' Disease progression 0/4 (0.00%)', ' Influenza 0/4 (0.00%)', ' Nasopharyngitis 0/4 (0.00%)', ' Lumbar vertebral fracture 0/4 (0.00%)', ' Hyponatraemia 0/4 (0.00%)', ' Ataxia 0/4 (0.00%)']}

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

27e0b995-b3d1-46a6-900a-d6e513504ff3

Comparison

Intervention

NCT01727011

NCT01420146

the primary trial and the secondary trial interventions involve a variety of scans, such as CT, PET and dosimetry

Entailment

{'Clinical Trial ID': 'NCT01727011', 'Intervention': ['INTERVENTION 1: ', ' IPAS', ' Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction', 'IPAS'], 'Eligibility': ['Inclusion Criteria:', ' Patient WITHinvasive breast cancer histologically proved: ductal, lobular, medullary, papillary, tubular or colloid:', ' All grades histo-prognostic', ' pT1 tumor size (<20 mm),', ' healthy Margins surgical', ' unifocal lesion', ' Any hormone receptor,', ' Any Her2 status,', ' No lymph node (sentinel lymphadenectomy or) or micrometastases (pN0, pN1mic)', ' Age greater than or equal to 70 years', ' Score Balducci I or II,', ' Karnofsky index greater than or equal to 70%', ' Time between lumpectomy and radiation less than 2 weeks', ' Implementation of clips in the tumor bed intraoperatively,', ' Patient having taken note of the information note and who signed the informed consent', ' Patient receiving social security coverage.', 'Exclusion Criteria:', ' Lobular carcinoma in situ or pure ductal carcinoma in situ or non-epithelial tumor type sarcoma or lymphoma,', ' Component extensive ductal in situ associated', ' Peritumoral lymphatic emboli,', ' Distance Metastasis', ' Inflammatory Breast Cancer,', ' Multifocal tumor (covering a total distance inter-end of 40 mm or more)', ' Previous treatment for this tumor including breast radiotherapy and / or chemotherapy neoadjuvant or adjuvant', ' History of plastic surgery breast', ' Unknown or safety margins positive for invasive carcinoma', ' Absence of clips in the tumor bed,', ' Time between lumpectomy and radiation greater than or equal to 2 weeks', ' Active infection or other serious comorbidity that could prevent the patient receiving the treatment,', ' History of cancer other than a basal cell skin or carcinoma in situ of the cervix or other cancer in complete remission for more than 5 years', ' Psychiatric illness'], 'Results': ['Outcome Measurement: ', ' Rate of Acute Toxicity Within 180 Days of IPAS Mono Split Postoperatively in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence (Low Risk Group of ESTRO IPAS Classification ESTRO)', ' Rate of acute toxicity evaluated by a clinical examination, in consultation with the radiotherapist to 30, 90 days and 180 days.', ' Common Toxicity Criteria classification for Adverse Events (CTCAE) in its fourth version is used.', ' Time frame: 180 days', 'Results 1: ', ' Arm/Group Title: IPAS', ' Arm/Group Description: Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction', ' IPAS', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: percentage of participants 70'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/26 (11.54%)', ' tacchycardia 1/26 (3.85%)', ' left breast painful inflammatory syndroma 1/26 (3.85%)', ' right breast haematoma 1/26 (3.85%)']}

{'Clinical Trial ID': 'NCT01420146', 'Intervention': ['INTERVENTION 1: ', ' Zr89-trastuzumab PET/CT', ' Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm'], 'Eligibility': ['Inclusion criteria:', ' All patients selected for this imaging study are patients scheduled to start trastuzumab-based therapy for advanced HER2 positive breast cancer (This includes trastuzumab alone, trastuzumab + chemotherapy, trastuzumab + endocrine therapy).', ' Histologically confirmed HER 2 positive (defined as FISH amplification ratio more than 2.2) invasive carcinoma of the breast (primary tumor at diagnosis) with locally recurrent or metastatic disease.', ' Patients with FDG-PET positive metastatic lesions.', ' Brain metastases are allowed provided they are controlled and they are not the sole site of metastatic disease.', ' Patient planned to have metastatic site biopsy for HER2 status control.', ' Age 18 years', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1', ' For women of childbearing potential a pregnancy test will be done and an agreement to use a highly-effective non hormonal form of contraception.', ' Agreement from the patient to participate in this imaging study and if indicated agreement to biopsy one or two accessible lesions.', ' Signed written informed consent (approved by the Ethics Committee) obtained prior to any study procedure', 'Exclusion criteria:', ' Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)', ' Pregnant or lactating women', ' Current known infection with HIV, HBV, or HCV', ' Known severe hypersensitivity to trastuzumab', ' Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol', ' Patients with bone only metastases are not eligible', ' Psychiatric illness/social situations that would limit compliance with study requirements', ' Patients who received lapatinib within the 7 days prior to HER immunoPET/CT.'], 'Results': ['Outcome Measurement: ', ' Test the Diagnostic Accuracy of the HER2 Imaging Using the Labelled Monoclonal Antibody Trastuzumab by Correlating the HER2 PET/CT Imaging With the FDG-PET/CT and Molecular Characterization of Tumor Samples With Discordant Image Findings', ' A visual \'patient-based\' classification capturing the whole disease burden was developed by using a side-by-side display, comparing baseline FDG-PET/CT(showing all FDG-positive mets independent of their HER2-imaging status) & day4 HER2-PET/CT. Pts were grouped into 4 HER2-PET/CT patterns according to the proportion of FDG avid tumour load showing relevant 89Zr-T uptake. Pattern A: entire tumor load showed pertinent tracer uptake; B: dominant part of tumour load showed tracer uptake; C: minor part of tumor load showed tracer uptake; D: entire tumor load lacked tracer uptake. Patterns A+B=\'HER2-positive\' & C+D=\'HER2-negative\'. In the 20 pts: 4 pts were classified "A", 5"B", 1"C" & 10"D". This classification indicates substantial heterogeneity of 89Zr-T uptake within this so called \'HER2-positive\' pt population. After dichotomization, 11(55%) pts were considered as HER2-PET/CT negative. Furthermore, HER2-PET/CT revealed intrapatient heterogeneity of tumour uptake(pts classified B or C).', ' Time frame: 4 years', 'Results 1: ', ' Arm/Group Title: Zr89-trastuzumab PET/CT', ' Arm/Group Description: Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Pattern A: 4 20.0%', ' Pattern B: 5 25.0%', ' Pattern C: 1 5.0%', ' Pattern D: 10 50.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/20 (5.00%)', ' Nausea - Pyrexia - Myalgia [1]1/20 (5.00%)']}

36a5357f-0c5f-4c64-a56a-a84aab165a16

Single

Adverse Events

NCT00024102

A patient in cohort 2 of the primary trial received a Packed red blood cell transfusion.

Entailment

{'Clinical Trial ID': 'NCT00024102', 'Intervention': ['INTERVENTION 1: ', ' Standard Chemotherapy', ' Patient/Physician choice of:', ' CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR', ' AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles', 'INTERVENTION 2: ', ' Capecitabine', ' Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.'], 'Eligibility': ['Patients with operable, histologically confirmed adenocarcinoma of the female breast.', ' TNM Stage per AJCC Cancer Staging Manual 6th edition:', ' T1-4 (Tumor size > 1 cm), N0, M0 or T1-4, N1-3, M0', ' Patients with bilateral, synchronous breast cancer are eligible as long as one primary tumor meets the criteria above.', ' Patients with HER2/neu positive, negative or unknown disease are eligible for this trial.', ' Patients whose tumors are HER2 positive by either immunohistochemistry 3+ staining or demonstrate gene amplification by FISH will be eligible to receive trastuzumab, as outlined in the protocol.', ' Age 65 years or older', ' Performance status 0-2 (Common Toxicity Criteria).', ' Prior treatment:', ' Surgical resection -', " All tumor should be removed by either a modified radical mastectomy or a lumpectomy. Patients must be registered 84 days from mastectomy or within 84 days of axillary dissection if patient's most extensive breast surgery was a breast sparing procedure.", ' Node dissection: Axillary node dissection is not required. Management of the axilla is at the discretion of the treating physician. There is no restriction on eligibility based on the number of nodes removed.', ' Mastectomy: There should be no evidence of gross or microscopic invasive tumor at the surgical resection margins noted in the final surgery or pathology reports for patients who have had a modified radical mastectomy. Patients with close margins (tumor < 1 mm from margin) are eligible.', ' Segmental mastectomy (lumpectomy): Although clear margins are preferable, DCIS or LCIS at the surgical resection margin will not render a patient who has undergone a segmental mastectomy ineligible for this study. Invasive tumor at the final resection margin will render a patient ineligible.', ' No prior chemotherapy for this malignancy.', ' Patients with a history of hypersensitivity to 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency are not eligible to participate.', ' Patients may receive up to four weeks of tamoxifen therapy for this malignancy and still be eligible for study entry. Patients who received tamoxifen or raloxifene for purposes of chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy should be discontinued before the patient is enrolled on this study.', ' Required Initial Laboratory Data:', ' Granulocytes > 1,500/µl', ' Platelet count 100,000/µl', ' Calculated Creatinine Clearance > 30 mL/min', ' Total bilirubin ULN'], 'Results': ['Outcome Measurement: ', ' Relapse-free Survival Rates at 2.4 Years', ' Percentage of participants who were alive and relapse-free at time of analysis were counted as "Alive without relapse" at 2.4 years. Participants who had a first local recurrence, first distant metastasis or death from any cause were counted as "relapse, first occurrence". These rates were estimated using the Kaplan Meier method', ' Time frame: randomization until date of first event, or date last known to be event free if no event was reported (up to 5 years)', 'Results 1: ', ' Arm/Group Title: Standard Chemotherapy', ' Arm/Group Description: Patient/Physician choice of:', ' CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR', ' AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles', ' Overall Number of Participants Analyzed: 326', ' Measure Type: Number', ' Unit of Measure: percentage of participants Relapse, first occurrence: 11', ' Alive without relapse: 89', 'Results 2: ', ' Arm/Group Title: Capecitabine', ' Arm/Group Description: Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.', ' Overall Number of Participants Analyzed: 307', ' Measure Type: Number', ' Unit of Measure: percentage of participants Relapse, first occurrence: 20', ' Alive without relapse: 80'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/131 (11.45%)', ' Disseminated intravascular coagulation 1/131 (0.76%)', ' Febrile neutropenia 5/131 (3.82%)', ' Hemoglobin decreased 7/131 (5.34%)', ' Lymphatics 1/131 (0.76%)', ' Transfusion: pRBCs 0/131 (0.00%)', ' Arrhythmia supraventricular 0/131 (0.00%)', ' Cardiac disorder 1/131 (0.76%)', ' Edema 0/131 (0.00%)', ' Left ventricular failure 0/131 (0.00%)', ' Myocardial ischemia 1/131 (0.76%)', 'Adverse Events 2:', ' Total: 17/181 (9.39%)', ' Disseminated intravascular coagulation 0/181 (0.00%)', ' Febrile neutropenia 1/181 (0.55%)', ' Hemoglobin decreased 13/181 (7.18%)', ' Lymphatics 0/181 (0.00%)', ' Transfusion: pRBCs 1/181 (0.55%)', ' Arrhythmia supraventricular 1/181 (0.55%)', ' Cardiac disorder 0/181 (0.00%)', ' Edema 0/181 (0.00%)', ' Left ventricular failure 1/181 (0.55%)', ' Myocardial ischemia 0/181 (0.00%)']}

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

c876167f-fe1e-4c3b-9183-dd3c1069ed0b

Single

Results

NCT00191152

The longest Time to Disease Progression the primary trial was over 11 months in the Docetaxel Plus Capecitabine group.

Entailment

{'Clinical Trial ID': 'NCT00191152', 'Intervention': ['INTERVENTION 1: ', ' Gemcitabine Plus Docetaxel', ' gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days.', ' Treatment continues until progression of disease at which time crossover treatment begins.', 'INTERVENTION 2: ', ' Docetaxel Plus Capecitabine', ' docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins.'], 'Eligibility': ['Inclusion Criteria:', ' Histologic or cytologic confirmation of breast cancer with locally advanced and/or metastatic disease', ' Patients may have received prior neo-adjuvant or adjuvant taxane regimen as long as it has been greater than or equal to 6 months since completion of the regimen', ' Patients may have had 0-1, but no more than one prior course of chemotherapy for metastatic disease', ' Patients must have either measurable or non-measurable (evaluable) disease', ' Prior radiation therapy allowed of less than 25% of the bone marrow', 'Exclusion Criteria:', ' Second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)', ' Parenchymal or leptomeningeal brain metastases', ' Peripheral neuropathy greater than or equal to grade 2', ' Prior treatment with gemcitabine and capecitabine will not be allowed. Prior treatment with a taxane in the metastatic setting will not be allowed. Prior taxane therapy in the neo-adjuvant or adjuvant setting is allowed if completion of therapy greater than or equal to 6 months prior to enrollment.', ' Active cardiac disease not controlled by therapy and/or myocardial infarction within the preceding 6 months.', ' Concomitant Herceptin is not allowed'], 'Results': ['Outcome Measurement: ', ' Time to Disease Progression (Initial Treatment)', ' Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.', ' Time frame: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)', 'Results 1: ', ' Arm/Group Title: Gemcitabine Plus Docetaxel', ' Arm/Group Description: gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days.', ' Treatment continues until progression of disease at which time crossover treatment begins.', ' Overall Number of Participants Analyzed: 239', ' Median (95% Confidence Interval)', ' Unit of Measure: months 9.28 (7.73 to 10.79)', 'Results 2: ', ' Arm/Group Title: Docetaxel Plus Capecitabine', ' Arm/Group Description: docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins.', ' Overall Number of Participants Analyzed: 236', ' Median (95% Confidence Interval)', ' Unit of Measure: months 8.88 (7.37 to 11.05)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 72/237 (30.38%)', ' Anaemia 2/237 (0.84%)', ' Disseminated intravascular coagulation 1/237 (0.42%)', ' Febrile neutropenia 9/237 (3.80%)', ' Leukocytosis 1/237 (0.42%)', ' Leukopenia 6/237 (2.53%)', ' Lymphopenia 1/237 (0.42%)', ' Neutropenia 25/237 (10.55%)', ' Thrombocytopenia 2/237 (0.84%)', ' Atrial fibrillation 0/237 (0.00%)', ' Cardiac failure congestive 2/237 (0.84%)', 'Adverse Events 2:', ' Total: 55/226 (24.34%)', ' Anaemia 1/226 (0.44%)', ' Disseminated intravascular coagulation 0/226 (0.00%)', ' Febrile neutropenia 9/226 (3.98%)', ' Leukocytosis 0/226 (0.00%)', ' Leukopenia 2/226 (0.88%)', ' Lymphopenia 0/226 (0.00%)', ' Neutropenia 7/226 (3.10%)', ' Thrombocytopenia 0/226 (0.00%)', ' Atrial fibrillation 1/226 (0.44%)', ' Cardiac failure congestive 0/226 (0.00%)']}

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

d6989b67-ae99-4c2a-a67d-c2285cc57058

Comparison

Results

NCT00320385

NCT00075270

Both cohorts in the primary trial outperformed cohort 1 of the secondary trial in median PFS.

Contradiction

{'Clinical Trial ID': 'NCT00320385', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + Lapatinib', ' Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.', 'INTERVENTION 2: ', ' Lapatinib', ' Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.'], 'Eligibility': ['Inclusion Criteria:', ' Signed informed consent.', ' Female 18 years. Women of childbearing potential must have a negative serum pregnancy test at screening and must use an approved contraceptive method, if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product.', ' Metastatic breast cancer, histologically/cytologically confirmed. If the disease is restricted to a solitary lesion, its neoplastic nature must be confirmed by cytology or histology.', ' Subjects must have stage IV breast cancer whereby their disease has progressed in either the adjuvant or metastatic setting. Prior therapies must include, but are not limited to:', ' Taxane-containing regimen for at least 4 cycles, or 2 cycles provided disease progression occurred while on taxane.', ' Anthracycline-containing regimen for at least 4 cycles, or 2 cycles provided disease progression occurred while on anthracycline.', ' Subjects must have documented progression following at least ONE trastuzumab plus cytotoxic chemotherapy or anti-hormonal regimen in the metastatic setting.', ' Note: The most recent treatment must have contained trastuzumab, either alone or in combination with other therapy in the metastatic setting, and subjects must have progressed while on this regimen. Progression is defined as either new lesions or a 20% increase in the sum of longest diameter (LD) on the progression radiologic scan.', ' Subjects must have archived tumor tissue available for testing.', ' Documented amplification of the ErbB2 gene by fluorescence in situ hybridization (FISH) or documented overexpression of the ErbB2 protein by IHC in primary or metastatic tumor tissue. The IHC or FISH amplification may be documented by a local or central laboratory for randomization into the study. Subjects may be randomized on the basis of ErbB2 positivity by IHC 3+ overexpression or FISH amplification.', ' Lesion eligibility is as follows:', ' at least one measurable lesion(s) according to Response Evaluation Criteria in Solid Tumors [RECIST; Therasse, 2000], or', ' bone-only disease.', ' Note: Tumor lesions which are situated in a previously irradiated field, and have well-defined margins which are located in soft tissue will be defined as measurable disease.', ' Subjects with stable CNS metastases defined as asymptomatic and off systemic steroids and anticonvulsants for at least 1 month. Treatment with prophylactic anticonvulsants is permitted, unless listed within the Prohibited Medications (Section 8.2).', ' Radiotherapy if received within 2 weeks prior to initiation of investigational product to a limited area (e.g., palliative treatment for painful disease) other than the sole site of measurable disease is allowed; however, subject must have completed treatment and recovered from all treatment-related toxicities prior to administration of the first dose of investigational product.', ' With the single exception of prior trastuzumab treatment, all prior chemotherapy, immunotherapy, biologic therapy, or surgery (except for minor surgical procedures) must be discontinued at least 3 weeks prior to the first dose of investigational product. Subjects must have recovered or stabilized sufficiently from treatment-related toxicities prior to administration of the first dose of investigational product.', ' Bisphosphonate therapy for bone metastases is allowed; however, treatment must be initiated prior to the first dose of investigational product. Prophylactic use of bisphosphonates is permitted only for the treatment of osteoporosis.', ' ECOG Performance Status of 0 to 2.', ' Able to swallow and retain oral medication.', ' Cardiac ejection fraction within institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive. Same modality used at baseline must be used for repeat assessments throughout study.', ' Subject must have adequate organ function as defined in Table 1 :', ' Table 1 (Definitions for Adequate Hematologic and Hepatic Function)', ' SYSTEM (LABORATORY VALUES)', ' Hematologic:', ' ANC (absolute neutrophil count) ( 1x10^9/ L)', ' Hemoglobin ( 9 g / dL)', ' Platelets ( 75x10^9/ L)', ' Hepatic', ' Albumin ( 2.5 g / dL)', ' Serum bilirubin ( 2 mg / dL)', ' AST and ALT ( 3 x ULN without liver metastases) ( 5 xULN if documented liver metastases)', ' Renal', ' Serum Creatinine ( 1.5 mg / dL)', ' OR -', ' Calculated Creatinine Clearance1 ( 40 mL / min)', ' Calculated by the Cockcroft and Gault Method.', ' Subjects may continue anti-estrogen therapy only if treatment was initiated at least 1 month prior to the first dose of investigational product (IP). After randomization, no anti-hormonal therapy may be initiated.', 'Exclusion Criteria:', ' Pregnant or lactating females.', ' Prior therapy with an ErbB1 and/or ErbB2 inhibitor other than trastuzumab.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded.', ' History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.', " Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.", ' Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment.', ' Active or uncontrolled infection.', ' Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.', ' Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.', ' Known history or clinical evidence of leptomeningeal carcinomatosis.', ' Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy).', ' Concurrent treatment with an investigational agent or participation in another clinical trial.', ' Used an investigational drug within 3 weeks or 5 half-lives, whichever is longer, preceding the first dose of investigational product.', ' Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab or lapatinib or their excipients.', " Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)."], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' PFS was defined as the time from randomization until the first documented sign of disease progression or death due to any cause.', ' Time frame: Baseline to disease progression or death due to any cause or 30 days after last dose (up to 216 weeks)', 'Results 1: ', ' Arm/Group Title: Trastuzumab + Lapatinib', ' Arm/Group Description: Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.', ' Overall Number of Participants Analyzed: 146', ' Median (95% Confidence Interval)', ' Unit of Measure: weeks 12.0 (8.1 to 16.0)', 'Results 2: ', ' Arm/Group Title: Lapatinib', ' Arm/Group Description: Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.', ' Overall Number of Participants Analyzed: 145', ' Median (95% Confidence Interval)', ' Unit of Measure: weeks 8.1 (7.6 to 9.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 40/149 (26.85%)', ' Febrile neutropenia * 2/149 (1.34%)', ' Anaemia * 1/149 (0.67%)', ' Thrombocytopenia * 1/149 (0.67%)', ' Left ventricular dysfunction * 1/149 (0.67%)', ' Cardiac failure * 1/149 (0.67%)', ' Myocardial infarction * 1/149 (0.67%)', ' Pericardial effusion * 0/149 (0.00%)', ' Vertigo * 1/149 (0.67%)', ' Diarrhoea * 2/149 (1.34%)', ' Vomiting * 3/149 (2.01%)', ' Nausea * 2/149 (1.34%)', 'Adverse Events 2:', ' Total: 24/146 (16.44%)', ' Febrile neutropenia * 0/146 (0.00%)', ' Anaemia * 0/146 (0.00%)', ' Thrombocytopenia * 0/146 (0.00%)', ' Left ventricular dysfunction * 2/146 (1.37%)', ' Cardiac failure * 0/146 (0.00%)', ' Myocardial infarction * 0/146 (0.00%)', ' Pericardial effusion * 1/146 (0.68%)', ' Vertigo * 0/146 (0.00%)', ' Diarrhoea * 3/146 (2.05%)', ' Vomiting * 2/146 (1.37%)', ' Nausea * 2/146 (1.37%)']}

{'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%)']}

90dfb0bd-e0a0-47a9-945b-fd8ec8faaaa1

Single

Results

NCT00076024

The minimum period of time from start of study treatment to first documentation of objective tumor progression or death due to cancer for any patient in the primary trial, was just over a year.

Contradiction

{'Clinical Trial ID': 'NCT00076024', 'Intervention': ['INTERVENTION 1: ', ' Axitinib + Docetaxel (Phase 2, Double-blind)', ' Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.', 'INTERVENTION 2: ', ' Docetaxel + Placebo (Phase 2, Double-blind)', ' Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.'], 'Eligibility': ['Inclusion Criteria:', ' Female patients with histologically/cytologically proven metastatic breast carcinoma (stage IV, or recurrent with local or regional spread or distant metastatic disease)', ' Adequate bone marrow, liver, and renal function', 'Exclusion Criteria:', ' Adjuvant chemotherapy given in the past 12 months', ' Uncontrolled brain metastases'], 'Results': ['Outcome Measurement: ', ' Time to Tumor Progression (TTP)', ' Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).', ' Time frame: Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks', 'Results 1: ', ' Arm/Group Title: Axitinib + Docetaxel (Phase 2, Double-blind)', ' Arm/Group Description: Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.', ' Overall Number of Participants Analyzed: 112', ' Median (95% Confidence Interval)', ' Unit of Measure: days 247 (208 to 265)', 'Results 2: ', ' Arm/Group Title: Docetaxel + Placebo (Phase 2, Double-blind)', ' Arm/Group Description: Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.', ' Overall Number of Participants Analyzed: 55', ' Median (95% Confidence Interval)', ' Unit of Measure: days 215 (191 to 247)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/6 (16.67%)', ' Agranulocytosis * 0/6 (0.00%)', ' Febrile neutropenia * 1/6 (16.67%)', ' Neutropenia * 0/6 (0.00%)', ' Arrhythmia supraventricular * 0/6 (0.00%)', ' Left ventricular dysfunction * 0/6 (0.00%)', ' Palpitations * 0/6 (0.00%)', ' Pericardial effusion * 0/6 (0.00%)', ' Restrictive cardiomyopathy * 0/6 (0.00%)', ' Hypothyroidism * 0/6 (0.00%)', ' Angle closure glaucoma * 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 54/111 (48.65%)', ' Agranulocytosis * 0/111 (0.00%)', ' Febrile neutropenia * 9/111 (8.11%)', ' Neutropenia * 10/111 (9.01%)', ' Arrhythmia supraventricular * 1/111 (0.90%)', ' Left ventricular dysfunction * 1/111 (0.90%)', ' Palpitations * 1/111 (0.90%)', ' Pericardial effusion * 1/111 (0.90%)', ' Restrictive cardiomyopathy * 1/111 (0.90%)', ' Hypothyroidism * 0/111 (0.00%)']}

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

886d3280-bc44-4a58-a5ba-66b018210332

Comparison

Adverse Events

NCT00323479

NCT03078751

There were more cases of deteriorating mental health in the primary trial than the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00323479', 'Intervention': ['INTERVENTION 1: ', ' Anastrozole 1 mg', ' Anastrozole 1 mg once daily'], 'Eligibility': ['Inclusion Criteria:', ' Post menopausal woman with a breast cancer and scheduled for an adjuvant treatment with anastrozole', ' WHO performance status 0, 1 or 2', ' Provision of written informed consent', 'Exclusion Criteria:', ' Recurrence of breast cancer, inflammatory rheumatism', ' treatment by chondromodulator, oral glucocorticoid, aromatase inhibitor, anti estrogen, Herceptin', ' Diabetes treated by insulin', ' Severe renal or hepatic disease', ' Known hypersensitivity to anastrozole'], 'Results': ['Outcome Measurement: ', ' Number of Participants With New Events of Arthralgia', ' [Not Specified]', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Anastrozole 1 mg', ' Arm/Group Description: Anastrozole 1 mg once daily', ' Overall Number of Participants Analyzed: 106', ' Measure Type: Number', ' Unit of Measure: Participants 37'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/110 (5.45%)', ' Sudden death unexplained 1/110 (0.91%)', ' General body pain 1/110 (0.91%)', ' Lymphangitis 1/110 (0.91%)', ' Femur fracture 1/110 (0.91%)', ' Parathyroid adenoma 1/110 (0.91%)', ' Depression worsened 1/110 (0.91%)', ' Calculus urinary bladder 1/110 (0.91%)', ' Pneumopathy 1/110 (0.91%)']}

{'Clinical Trial ID': 'NCT03078751', 'Intervention': ['INTERVENTION 1: ', ' Ribociclib + Adjuvant Endocrine Therapy (ET)', ' Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)', 'INTERVENTION 2: ', ' Placebo + Adjuvant Endocrine Therapy (ET)', ' Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen'], 'Eligibility': ['Key Inclusion Criteria:', ' Histologically confirmed unilateral primary invasive adenocarcinoma of the breast', ' Estrogen receptor-positive and/or progesterone receptor-positive, HER2-negative breast cancer', ' Patient is after surgical resection of the tumor where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor and with available archival tumor tissue from the surgical specimen', ' Patient who received adjuvant chemotherapy and have AJCC 8th edition Prognostic Stage Group III tumor; or patient who received neoadjuvant chemotherapy and have 1 or more ipsilateral axillary lymph nodes with residual tumor metastases greater than 2.0 mm in lymph node(-s) and residual tumor greater than 10.0 mm in breast tissue', ' Patient has completed multi-agent adjuvant or neoadjuvant chemotherapy of 4 cycles or 12 weeks which included taxanes prior to screening', ' Patient has completed adjuvant radiotherapy (if indicated) prior to screening', ' Patient may already have initiated adjuvant endocrine therapy (ET) at the time of randomization, but randomization must take place within 52 weeks of date of initial histological diagnosis of breast cancer and within 12 weeks of initiating ET', ' ECOG Performance Status 0 or 1', ' Adequate bone marrow and organ function', ' Sodium, potassium, phosphorus, magnesium and total calcium laboratory values within normal limits', ' QTcF interval < 450 msec and mean resting heart rate 50-90 bpm', ' Key Exclusion Criteria:', ' Prior treatment with CDK4/6 inhibitor', ' Prior treatment with tamoxifen, raloxifen or aromatase inhibitors for reduction in risk (chemoprevention) of breast cancer and/or treatment for osteoporosis within last 2 years', ' Prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin or 900 mg/m² or more for epirubicin', ' Distant metastases of breast cancer beyond regional lymph nodes', ' Patient has not recovered from clinical and laboratory acute toxicities of chemotherapy, radiotherapy and surgery', ' Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, or clinically significant cardiac arrhythmias', ' Uncontrolled hypertension with systolic blood pressure >160 mmHg', ' Patient is currently receiving any of the prohibited substances that cannot be discontinued 7 days prior to Cycle 1 Day 1: concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5; medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5; systemic corticosteroids 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment; concomitant medications with a known risk to prolong the QT interval and/or known to cause torsades de points that cannot be discontinued or replaced by safe alternative medication.', ' Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the study', ' Women of child-bearing potential unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the study treatment.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adverse Events and Serious Adverse Events', ' These are the number of participants who had adverse events or serious adverse events regardless of whether is was suspected to be drug-related or not', ' Time frame: Up to 26 months', 'Results 1: ', ' Arm/Group Title: Ribociclib + Adjuvant Endocrine Therapy (ET)', ' Arm/Group Description: Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: Participants Adverse Events: 25', ' Serious Adverse Events: 4', 'Results 2: ', ' Arm/Group Title: Placebo + Adjuvant Endocrine Therapy (ET)', ' Arm/Group Description: Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen', ' Overall Number of Participants Analyzed: 24', ' Measure Type: Number', ' Unit of Measure: Participants Adverse Events: 21', ' Serious Adverse Events: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/26 (15.38%)', ' Disseminated intravascular coagulation 1/26 (3.85%)', ' Cardiac failure congestive 1/26 (3.85%)', ' Breast cellulitis 1/26 (3.85%)', ' Cellulitis 1/26 (3.85%)', ' Acute myeloid leukaemia 1/26 (3.85%)', ' Seizure 0/26 (0.00%)', ' Pulmonary embolism 1/26 (3.85%)', 'Adverse Events 2:', ' Total: 2/24 (8.33%)', ' Disseminated intravascular coagulation 0/24 (0.00%)', ' Cardiac failure congestive 0/24 (0.00%)', ' Breast cellulitis 0/24 (0.00%)', ' Cellulitis 1/24 (4.17%)', ' Acute myeloid leukaemia 0/24 (0.00%)', ' Seizure 1/24 (4.17%)', ' Pulmonary embolism 0/24 (0.00%)']}

03dcb6d9-efae-40ec-87ee-68ef89424498

Single

Adverse Events

NCT00193206

the primary trial records a total of 7 patients suffering from various infections.

Entailment

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

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

b881b717-1c8a-41b8-9554-6ed9e8ee7c77

Single

Adverse Events

NCT01439282

In total cohort 1 of the primary trial recorded 20% more adverse events than cohort 2.

Contradiction

{'Clinical Trial ID': 'NCT01439282', 'Intervention': ['INTERVENTION 1: ', ' Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine', ' Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.', 'INTERVENTION 2: ', ' Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine', ' Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.'], 'Eligibility': ['Inclusion Criteria:', ' Male subjects aged greater than or equal to 18 years and female subjects who must be postmenopausal (at least 12 months consecutive amenorrheic or have had a bilateral oophorectomy or, if they have had a hysterectomy but with ovaries intact, then females must be age 55 or older and with postmenopausal follicle-stimulating hormone [FSH] levels).', ' Subject is a candidate for chemotherapy in the adjuvant setting.', ' Adjuvant therapy must begin within 84 days of the final surgical procedure for breast cancer.', ' Histologically confirmed Stage I to II invasive breast cancer. Subjects may have more than one synchronous primary breast tumor.', ' Receptor Status:', ' HER2-normal as determined by a negative fluorescence in situ hybridization (FISH) result or 0 to 1+ by immunohistochemistry (IHC) staining result', ' ER-positive, node-negative or ER-positive Grade 1 or 2 node-positive breast cancer', ' ECOG performance status of 0 or 1', ' Adequate renal function as evidenced by serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than or equal to 50 mL/min per the Cockcroft and Gault formula', ' Adequate bone marrow function as evidenced by ANC greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10.0 g/dL, and platelet count greater than or equal to 100 x 10^9/L', ' Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limits of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 x ULN', ' Male subjects must have had a successful vasectomy (confirmed azoospermia), or their female partners must not be of childbearing potential, or male subjects must agree to use and have their female partners use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide] throughout the entire study period and for 30 days after study drug discontinuation..', ' Voluntary agreement to provide written informed consent and willingness and ability to comply with all aspects of the protocol', 'Exclusion Criteria:', ' Stage III and IV invasive breast cancer', ' Prior chemotherapy, radiation therapy, immunotherapy or biotherapy for current breast cancer', ' Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc) that would preclude any of the study therapy drugs', ' Subjects with a concurrently active second malignancy other than adequately treated nonmelanoma skin cancers or in situ cervical cancer', ' Subjects with pre-existing neuropathy greater than Grade 2', ' Subjects with known positive human immunodeficiency virus (HIV) status', ' Females of childbearing potential. Females will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrheic or have had a bilateral oophorectomy or, if they have had a hysterectomy but with ovaries intact, then females must be age 55 or older and with postmenopausal FSH levels).', ' Subjects with current gastrointestinal disease or other condition resulting in an inability to take or absorb oral medications', ' Subjects with known allergy or hypersensitivity to eribulin mesylate or its excipients, or to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase [DPD] deficiency)', ' A clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolongation of QT/QTc interval (time between the start of the Q wave and the end of the T wave/QT interval corrected for heart rate) (e.g., repeated demonstration of a QTc interval greater than 500 ms)', ' Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Who Achieved the Target Relative Dose Intensity (RDI) of 85%', " Relative Dose Intensity (RDI) is defined as the amount of drug administered over a specific time and is expressed as the fraction of that recommended for standard of care. The RDI for each participant was calculated as follows: (1) based on each participant's body surface area (BSA), a total planned dose for both eribulin (Dep) and capecitabine (Dcp) calculated for a full 4-cycle regimen; (2) actual total dose of eribulin (Dea) and capecitabine (Dca) for the full 4-cycle regimen as collected on the case report form; (3) overall RDI = (Dea/Dep + Dca/Dcp)/2. For each individual participant, the regimen was considered feasible if that participant was able to achieve an RDI of at least 85% of the 4 cycles of eribulin plus capecitabine treatment. Missing doses due to any reason was counted as zero in the RDI calculation.", ' Time frame: 21-Day Cycle 1 through 21-Day Cycle 4', 'Results 1: ', ' Arm/Group Title: Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine', ' Arm/Group Description: Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.', ' Overall Number of Participants Analyzed: 67', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 77.6 (67.6 to 100)', 'Results 2: ', ' Arm/Group Title: Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine', ' Arm/Group Description: Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 90.0 (60.6 to 99.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/67 (20.90%)', ' Febrile neutropenia 21/67 (1.49%)', ' Leukopenia 21/67 (1.49%)', ' Neutropenia 21/67 (1.49%)', ' Macular hole 21/67 (1.49%)', ' Diarrhoea 22/67 (2.99%)', ' Abdominal pain 21/67 (1.49%)', ' Abdominal pain upper 21/67 (1.49%)', ' Enteritis 21/67 (1.49%)', ' Gastritis 21/67 (1.49%)', ' Nausea 21/67 (1.49%)', ' Vomiting 21/67 (1.49%)', ' Pneumonia 21/67 (1.49%)', 'Adverse Events 2:', ' Total: 1/10 (10.00%)', ' Febrile neutropenia 20/10 (0.00%)', ' Leukopenia 20/10 (0.00%)', ' Neutropenia 20/10 (0.00%)', ' Macular hole 20/10 (0.00%)', ' Diarrhoea 20/10 (0.00%)', ' Abdominal pain 20/10 (0.00%)', ' Abdominal pain upper 20/10 (0.00%)', ' Enteritis 20/10 (0.00%)', ' Gastritis 20/10 (0.00%)', ' Nausea 20/10 (0.00%)', ' Vomiting 20/10 (0.00%)', ' Pneumonia 20/10 (0.00%)']}

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

20530faf-addb-47bf-896d-b9666e149223

Comparison

Eligibility

NCT00041067

NCT01273896

Patients with ER positive, PR positive or HER2 positive stage 4 tumors may be eligible for the secondary trial or the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00041067', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab, Docetaxel, Vinorelbine and Filgrastim', ' Trastuzumab, docetaxel, vinorelbine and filgrastim', ' docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles', ' vinorelbine : 27.5 mg/m^2 on Days 8 and 15', ' filgrastim : 5 microg/kg/day on Days 2 to 21', ' trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed stage IV breast cancer', ' Metastasis to the ipsilateral supraclavicular lymph nodes allowed', ' HER2-positive by fluorescence in situ hybridization (FISH) or immunohistochemistry 3+ staining confirmed in the adjuvant or metastatic setting', ' No effusions or ascites as only sites of disease', ' No primary or metastatic brain or central nervous system tumor', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age:', ' 18 and over', ' Sex:', ' Female', ' Menopausal status:', ' Not specified', 'Performance status:', ' Zubrod 0-2', ' Life expectancy:', ' Not specified', ' Hematopoietic:', ' Absolute neutrophil count at least 1,500/mm^3', ' Platelet count at least 100,000/mm^3', ' Hepatic:', ' Bilirubin normal', ' aspartate aminotransferase or Alanine aminotranferease no greater than 1.5 times upper limit of normal (ULN)', ' Alkaline phosphatase no greater than 2.5 times ULN', ' Renal:', ' Not specified', ' Cardiovascular:', ' left ventricular ejection fraction normal by multigated radionuclide angiography or echocardiogram (patients who have received prior anthracycline therapy)', ' No clinical evidence or history of cardiomyopathy', ' Other:', ' No pre-existing grade 2 or greater motor or sensory peripheral neuropathy except abnormalities due to cancer', ' No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80', ' No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer currently in complete remission', ' No known sensitivity to E. coli-derived proteins', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy:', ' Not specified', ' Chemotherapy:', ' At least 6 months since prior chemotherapy', ' Prior anthracycline as adjuvant therapy allowed', ' No prior cumulative dose of doxorubicin more than 360 mg/m^2', ' No prior cumulative dose of epirubicin more than 720 mg/m^2', ' No more than 1 prior adjuvant or neoadjuvant chemotherapy regimen for primary disease', ' No prior docetaxel', ' No prior vinorelbine', ' Prior paclitaxel allowed', ' Endocrine therapy:', ' Prior hormonal therapy as adjuvant therapy or for metastatic breast cancer allowed', ' No concurrent hormonal therapy', ' Radiotherapy:', ' At least 3 weeks since prior radiotherapy', ' Surgery:', ' At least 2 weeks since prior surgery and recovered'], 'Results': ['Outcome Measurement: ', ' Survival at 1 Year', ' [Not Specified]', 'Time frame: 1 year', 'Results 1: ', ' Arm/Group Title: Trastuzumab, Docetaxel, Vinorelbine and Filgrastim', ' Arm/Group Description: Trastuzumab, docetaxel, vinorelbine and filgrastim', ' docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles', ' vinorelbine : 27.5 mg/m^2 on Days 8 and 15', ' filgrastim : 5 microg/kg/day on Days 2 to 21', ' trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period', ' Overall Number of Participants Analyzed: 74', ' Measure Type: Number', ' Unit of Measure: percentage of patients 93 (84 to 97)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/73 (0.00%)']}

{'Clinical Trial ID': 'NCT01273896', 'Intervention': ['INTERVENTION 1: ', ' STA-9090', ' This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.', ' STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression.'], 'Eligibility': ['Inclusion Criteria:', ' Male and Female patients must be at least 18 years of age', ' Pathologically confirmed diagnosis of breast cancer', ' Metastatic or advanced stage breast cancer', ' Prior treatment with at least one and no more than three lines of biologic and/or chemotherapy for metastatic breast cancer (excluding hormonal therapy)', ' Patients with HER2+ disease must have received prior treatment with Trastuzumab', ' Patients with ER and/or PR+ disease must have received prior treatment with hormonal therapy', ' Off cytotoxic chemotherapy or biologic therapy (excluding Hormonal therapy) 3 weeks', ' Measurable disease by RECIST 1.1', ' Central nervous system metastases are permitted if treated and radiographically and clinically stable for at least 4 weeks prior to first dose of STA-9090', ' Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1', ' Life expectancy of at least 3 months', ' Adequate hematologic function as defined by:', ' Absolute neutrophil count 1,500 cells/μL', ' Platelets 100,000/μL', ' Hemoglobin 9.0g/dL', ' Adequate hepatic function as defined by:', ' Serum bilirubin 1.5 X upper limit of normal (ULN);', ' Adequate renal function as defined by a serum creatinine 1.5 x ULN', ' AST, ALT, and alkaline phosphatase 3 × ULN except for:', ' Patients with hepatic metastases: ALT and AST 5 × ULN', ' Patients with hepatic and/or bone metastases: alkaline phosphatase 5 × ULN', " Patients with Gilbert's disease: serum bilirubin < 5 mg/dL", ' Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures', ' Female subjects of childbearing potential and males must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment', ' Female subjects of childbearing age must have a negative serum pregnancy test at study entry.', 'Exclusion Criteria:', ' Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease', ' Major surgery within 4 weeks prior to first dose of STA-9090', ' Poor peripheral venous access for study drug administration. Study drug administration via indwelling catheters allowed only if the catheter is made of silicone material.', ' History of severe (grade 3 or 4) allergic or hypersensitivity reactions to excipients (e.g., Polyethylene glycol [PEG] 300 and Polysorbate 80)', ' Baseline QTc > 470 msec', ' Ventricular ejection fraction (EF) <50% at baseline', ' Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)', ' Women who are pregnant or lactating', ' Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results in the judgment of the investigator', ' Seizure disorder or requirement for seizure medication', ' Prior treatment with an HSP90 inhibitor', ' persistent adverse events of prior therapies that are > 1 grade 1 in severity', ' history of or current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery', ' history of or current uncontrolled dysrhythmias, or requirement for antiarrhythmic medications, or Grade 2 or greater left bundle branch block', ' New York Heart Association class II/III/IV congestive heart failure with a history of dyspnea, orthopnea, or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta blockers or diuretics'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate', ' To determine the overall response rate using RECIST v 1.1 criteria, defined as PR +CR.using RECIST v 1.1 criteria, defined as Partial response + complete response', ' Time frame: Radiological imaging studies to evaluate tumor status will be repeated during the rest week (Days 22 to 28) of every third cycle', 'Results 1: ', ' Arm/Group Title: STA-9090', ' Arm/Group Description: This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.', ' STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression.', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: participants 20'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/22 (27.27%)', ' Cardiac General, other1/22 (4.55%)', ' Pain - Abdomen NOS1/22 (4.55%)', ' Death not assoc w CTCAE term- Death NOS1/22 (4.55%)', ' Death not assoc w CTCAE term-Disease prog NOS1/22 (4.55%)', ' Liver dysfunction/failure1/22 (4.55%)', ' Sodium, low (hyponatremia)1/22 (4.55%)', ' Dyspnea (shortness of breath)2/22 (9.09%)']}

52557c9f-f771-4f31-bb71-01f87f9f5821

Single

Results

NCT00373256

Cohort 1 of the primary trial included over 200 patients being treated with Sunitinib and Paclitaxel for a duration of 18 months or until death, and the median PFS for this group was just under 7 and a half months.

Entailment

{'Clinical Trial ID': 'NCT00373256', 'Intervention': ['INTERVENTION 1: ', ' Sunitinib + Paclitaxel', ' Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.', 'INTERVENTION 2: ', ' Bevacizumab + Paclitaxel', ' Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of advanced breast cancer.', ' Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease.', ' ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.', 'Exclusion Criteria:', ' No prior treatment with cytotoxics in the advanced disease setting.', ' HER2/neu positive disease unless trastuzumab was previously received or is contraindicated.', ' Treatment with a taxane in the adjuvant setting unless disease free interval >12 months after end of treatment.'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS)', ' Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4', ' Time frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death', 'Results 1: ', ' Arm/Group Title: Sunitinib + Paclitaxel', ' Arm/Group Description: Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.', ' Overall Number of Participants Analyzed: 242', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 7.4 (6.9 to 8.5)', 'Results 2: ', ' Arm/Group Title: Bevacizumab + Paclitaxel', ' Arm/Group Description: Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.', ' Overall Number of Participants Analyzed: 243', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 9.2 (7.7 to 13.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 89/235 (37.87%)', ' Anaemia 3/235 (1.28%)', ' Febrile neutropenia 12/235 (5.11%)', ' Leukopenia 1/235 (0.43%)', ' Neutropenia 6/235 (2.55%)', ' Pancytopenia 2/235 (0.85%)', ' Thrombocytopenia 2/235 (0.85%)', ' Atrial fibrillation 1/235 (0.43%)', ' Cardiac failure congestive 1/235 (0.43%)', ' Cardiogenic shock 1/235 (0.43%)', ' Cardiovascular disorder 0/235 (0.00%)', 'Adverse Events 2:', ' Total: 85/242 (35.12%)', ' Anaemia 1/242 (0.41%)', ' Febrile neutropenia 3/242 (1.24%)', ' Leukopenia 0/242 (0.00%)', ' Neutropenia 2/242 (0.83%)', ' Pancytopenia 0/242 (0.00%)', ' Thrombocytopenia 0/242 (0.00%)', ' Atrial fibrillation 2/242 (0.83%)', ' Cardiac failure congestive 1/242 (0.41%)', ' Cardiogenic shock 0/242 (0.00%)', ' Cardiovascular disorder 1/242 (0.41%)']}

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

11472413-533f-45f9-9aac-c46bca318aab

Single

Eligibility

NCT00191854

Patients do not need to have a Her2neu positive tumours or a measurable indicator lesion to be included in the primary trial

Entailment

{'Clinical Trial ID': 'NCT00191854', 'Intervention': ['INTERVENTION 1: ', ' Gemcitabine + Paclitaxel', ' Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.', ' Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles', 'INTERVENTION 2: ', ' Gemcitabine + Carboplatin', ' Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.', ' Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles'], 'Eligibility': ['Inclusion Criteria:', ' Female patients with histological or cytological proven diagnosis of breast cancer', ' Stage IV disease', ' Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale', ' Patients had to have previously received anthracycline based regimens as a adjuvant therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic disease', ' Adequate organ function', 'Exclusion Criteria:', ' Prior chemotherapy for metastatic disease', ' Previous radiation therapy is allowed but must not have included whole pelvis radiation', " Known or suspected brain metastasis. Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator", ' Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (Herceptin))', ' Peripheral neuropathy of Common Toxicity Criteria (CTC) Grade greater than 1. History of significant neurological or mental disorder, including seizures or dementia'], 'Results': ['Outcome Measurement: ', ' Best Overall Response', ' Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.', ' Time frame: baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization)', 'Results 1: ', ' Arm/Group Title: Gemcitabine + Paclitaxel', ' Arm/Group Description: Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.', ' Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Number', ' Unit of Measure: participants Complete Response (CR): 1', ' Partial Response (PR): 12', ' Stable Disease (SD): 17', ' Progressive Disease (PD): 14', ' Early Death from Other Causes: 1', 'Unknown: 4', 'Results 2: ', ' Arm/Group Title: Gemcitabine + Carboplatin', ' Arm/Group Description: Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.', ' Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles', ' Overall Number of Participants Analyzed: 47', ' Measure Type: Number', ' Unit of Measure: participants Complete Response (CR): 0', ' Partial Response (PR): 8', ' Stable Disease (SD): 25', ' Progressive Disease (PD): 11', ' Early Death from Other Causes: 2', 'Unknown: 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/49 (10.20%)', ' Anaemia 1/49 (2.04%)', ' Leukopenia 21/49 (2.04%)', ' Neutropenia 30/49 (0.00%)', ' Thrombocytopenia 31/49 (2.04%)', ' Pyrexia 1/49 (2.04%)', ' Sudden death 31/49 (2.04%)', ' Hepatic failure 0/49 (0.00%)', ' Anaphylactic reaction 1/49 (2.04%)', ' Cystitis 31/49 (2.04%)', ' Pneumonia 40/49 (0.00%)', ' Pyelonephritis 0/49 (0.00%)', ' Sepsis 30/49 (0.00%)', 'Adverse Events 2:', ' Total: 3/47 (6.38%)', ' Anaemia 0/47 (0.00%)', ' Leukopenia 20/47 (0.00%)', ' Neutropenia 31/47 (2.13%)', ' Thrombocytopenia 31/47 (2.13%)', ' Pyrexia 0/47 (0.00%)', ' Sudden death 30/47 (0.00%)', ' Hepatic failure 1/47 (2.13%)', ' Anaphylactic reaction 0/47 (0.00%)', ' Cystitis 30/47 (0.00%)', ' Pneumonia 41/47 (2.13%)', ' Pyelonephritis 1/47 (2.13%)', ' Sepsis 31/47 (2.13%)']}

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

3b8f5ef2-b0bb-42e8-a165-45a2d35780e0

Comparison

Intervention

NCT00880022

NCT00916578

Only patients in cohort 2 of the primary trial undergo Trunk compression. However all patients in the secondary trial are treated with Trunk compression.

Contradiction

{'Clinical Trial ID': 'NCT00880022', 'Intervention': ['INTERVENTION 1: ', ' Arm Compression Only', '[Not Specified]', 'INTERVENTION 2: ', ' Arm, Trunck and Chest Compression', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' Individuals at least six months post- surgery and/or radiation treatment for breast cancer', ' At least 21 years of age', ' Lymphedema in one arm subsequent to breast cancer treatment with coexisting truncal swelling ** (Part One) and *lymphedema in one arm subsequent to breast cancer treatment without coexisting truncal swelling (Part Two)', ' Willing and able to drive to the study site as needed', ' Currently not using a compression pump or undergoing manual lymphatic drainage by a therapist', 'Exclusion Criteria:', ' Actively undergoing or less than six months post intravenous chemotherapy or radiation therapy', ' Individuals with congestive heart failure, chronic/acute renal disease, cor pulmonal, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, thrombophlebitis, deep vein thrombosis, infection of any kind and inflammation (redness) in the trunk or arms', ' History of bilateral breast cancer', ' Metastatic cancer', ' Inability to stand upright', ' Metal implants that would interfere with bioimpedance measurement equipment', ' Pregnancy', ' Pacemaker and internally implanted defibrillators'], 'Results': ['Outcome Measurement: ', ' Arm Volume at End of Study', ' measured by tape and then volume was calculated.', ' Time frame: end of scheduled treatments-day 30 of treatment', 'Results 1: ', ' Arm/Group Title: Arm Compression Only', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 21', ' Median (Inter-Quartile Range)', ' Unit of Measure: ml 2376.52 (1934.68 to 2622.99)', 'Results 2: ', ' Arm/Group Title: Arm, Trunck and Chest Compression', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 21', ' Median (Inter-Quartile Range)', ' Unit of Measure: ml 2539.93 (2168.28 to 3295.97)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/21 (0.00%)', 'Adverse Events 2:', ' Total: 0/21 (0.00%)']}

{'Clinical Trial ID': 'NCT00916578', 'Intervention': ['INTERVENTION 1: ', ' Single Arm Institution, Open Label, Phase II', ' Patients will received 825 mg/m2 bid of capecitabine. One of the two daily doses of capecitabine will be taken 2 hours before receiving radiotherapy. Capecitabine will be administered when patients receives radiation therapy. Radiation therapy doses will be 50-57 Gy to the initial clinical target volume.'], 'Eligibility': ['Inclusion Criteria:', ' Histological confirmation of invasive breast cancer', ' No contraindications to receiving a course of radiation treatment (pregnancy, prior radiation to the volume with disease, or systemic disease in which radiation therapy is an absolute contraindication)', ' Patients who have chemo-refractory gross disease in the breast causing symptoms (pain, drainage, duress) OR gross disease in the breast (greater than or equal to T3) and/or lymph node(s) progressive, persistent, or minimally responsive to chemotherapy deemed inoperable or questionable inoperable OR Recurrent gross disease in a previously unirradiated breast or on the chest wall or in the regional lymphatics (core biopsy will not be offered to patients without gross disease in the breast).', ' Are able to swallow and retain oral medication (intact pill)', ' Age over 18', ' Female gender', 'Exclusion Criteria:', ' Have an active or uncontrolled infection', ' Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent', ' Have used an investigational drug within 21 days preceding the first dose of study medication', ' Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin)', ' Uncontrolled arrhythmia or congestive heart failure (CHF) based on clinical history or physical exam', ' Patient cannot receive whole brain irradiation concurrently with Xeloda treatment.'], 'Results': ['Outcome Measurement: ', ' Response Rate of Patients Who Receive Pre-operative or Palliative Concurrent Radiation w/ Capecitabine to the Breast & at Risk or Involved Regional Lymph Nodes Basins.', ' The response by RECIST was assessed after 45 Gy of radiation for patients with breast cancer treated with concurrent capecitabine and radiation therapy.', ' Time frame: Participants were monitored from 2009 to 2012.', 'Results 1: ', ' Arm/Group Title: Single Arm Institution, Open Label, Phase II', ' Arm/Group Description: Patients will received 825 mg/m2 bid of capecitabine. One of the two daily doses of capecitabine will be taken 2 hours before receiving radiotherapy. Capecitabine will be administered when patients receives radiation therapy. Radiation therapy doses will be 50-57 Gy to the initial clinical target volume.', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Number', ' Unit of Measure: participants 26'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/26 (0.00%)']}

6446f085-c6b0-43ce-82ed-16d6952b549e

Single

Intervention

NCT01104584

the primary trial participants receive either 50mg/m2 trastuzumab, Tamoxifen or Exemestane.

Contradiction

{'Clinical Trial ID': 'NCT01104584', 'Intervention': ['INTERVENTION 1: ', ' CMRM Versus UMRM', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology [ACR] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.', ' if female, a digital XRM is required if any of the following criteria is met:', ' a. patient is younger than 50 years;', ' b. patient has heterogeneously or extremely dense breasts;', ' c. is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).', ' if female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.', ' has an estimated glomerular filtration rate (eGFR) value >/= 60 mL/min/1.73m^2 derived from a serum creatinine result within 2 weeks prior to study enrollment.', 'Exclusion Criteria:', ' is a female patient who is pregnant or lactating', ' has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.', ' has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.', ' has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)).', ' has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate < 60 mL/min/1.73m^2).', ' has received chemotherapy or hormonal therapy for breast cancer within 6 months.', ' has received hormone replacement therapy within 4 weeks prior to study drug administration.', ' is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application', ' has prior excisional biopsy or breast surgery less than 6 months before enrollment and between XRM and study MRM'], 'Results': ['Outcome Measurement: ', ' Difference of Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader', ' For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value. For ease of expression, the following abbreviations will be used: Magnetic Resonance Mammography (MRM), Unenhanced MRM (UMRM), combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM), X-ray mammography (XRM).', ' Time frame: Immediately before injection and after injection', 'Results 1: ', ' Arm/Group Title: CMRM Versus UMRM', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 390', ' Mean (95% Confidence Interval)', ' Unit of Measure: difference in sensitivity (%) Reader 1: 15.2 (11.8 to 18.7)', ' Reader 2: 31.9 (27.3 to 36.6)', ' Reader 3: 30.4 (25.8 to 34.9)', ' Investigator: 15.9 (12.4 to 19.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/439 (0.00%)']}

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

7348c2e8-9eb5-4ed6-9a5d-bcb02a5c3a0a

Comparison

Adverse Events

NCT00110084

NCT01961544

the primary trial and the secondary trial both reported cases of sepsis in their patients.

Entailment

{'Clinical Trial ID': 'NCT00110084', 'Intervention': ['INTERVENTION 1: ', ' Nab-paclitaxel/Gemcitabine', ' Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed invasive breast cancer', ' - Clinical evidence of metastatic disease', ' + No bone metastases or other non-measurable disease as the only evidence of metastasis', ' Measurable disease, defined as at least 1 measurable lesion', ' - The following are considered non-measurable disease:', ' Small lesions (< 2 cm)', ' Bone lesions', ' Leptomeningeal disease', ' Ascites', ' Pleural or pericardial effusions', ' Inflammatory breast disease', ' Lymphangitis cutis or pulmonis', ' Abdominal masses that are not confirmed and followed by imaging techniques', ' Cystic lesions', ' HER2(human epidermal growth factor receptor 2)-positive disease allowed provided patient has received prior treatment with trastuzumab', ' No evidence of active brain metastasis, including leptomeningeal involvement', ' Hormone receptor status:', ' Not specified', ' PATIENT CHARACTERISTICS:', ' Age', ' 18 and over Sex', ' Female Menopausal status', ' Not specified Performance status', ' ECOG 0-1 Life expectancy', ' At least 12 weeks Hematopoietic', ' Absolute neutrophil count 1,500/mm^3', ' Platelet count 100,000/mm^3', ' Hemoglobin 9 g/dL Hepatic', ' AST and ALT 2.5 times upper limit of normal (ULN)', ' Bilirubin 1.5 times ULN Renal', ' Creatinine 1.5 mg/dL Other', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for 30 days after completion of study treatment', ' No pre-existing peripheral neuropathy > grade 1', ' No other clinically significant illness or significant medical condition that would preclude study participation', ' No history of allergy or hypersensitivity to paclitaxel protein-bound particles in an injectable suspension, paclitaxel, gemcitabine, albumin, drug product excipients, or agents that are chemically similar to study drugs', ' No serious medical risk factors involving any of the major organ systems that would preclude study participation', ' No active stage III or IV invasive non-breast malignancy within the past 5 years', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy', ' See Disease Characteristics Chemotherapy', ' No more than 1 prior adjuvant chemotherapy regimen', ' No prior chemotherapy for metastatic disease', ' At least 6 months since prior adjuvant or neoadjuvant taxane', ' More than 2 weeks since prior cytotoxic chemotherapy', ' Prior neoadjuvant chemotherapy allowed', ' No other concurrent chemotherapy Endocrine therapy', ' Prior hormonal treatment as adjuvant therapy or for metastatic disease allowed Radiotherapy', ' Prior radiotherapy to target lesion allowed provided there is evidence of disease progression after completion of treatment', ' More than 2 weeks since prior radiotherapy, except radiotherapy to a non-target lesion only or single-dose palliative radiotherapy', ' No concurrent radiotherapy Surgery', ' Not specified Other', ' More than 2 weeks since prior investigational drugs', ' No concurrent participation in another clinical trial that is studying investigational procedures or therapies', ' Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed for palliation of pain or lytic lesions from breast cancer'], 'Results': ['Outcome Measurement: ', ' Proportion of Patients With Confirmed Responses', ' Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.', ' Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.', ' Time frame: Two consecutive evaluations at least 6 weeks apart', 'Results 1: ', ' Arm/Group Title: Nab-paclitaxel/Gemcitabine', ' Arm/Group Description: Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle', ' Overall Number of Participants Analyzed: 50', ' Measure Type: Number', ' Unit of Measure: participants Confirmed response: 25', 'Assessable: 50'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/50 (22.00%)', ' Anemia 3/50 (6.00%)', ' Febrile neutropenia 1/50 (2.00%)', ' Arrythmia 1/50 (2.00%)', ' Ileus 1/50 (2.00%)', ' Nausea 1/50 (2.00%)', ' Pain-Abdominal 1/50 (2.00%)', ' Vomiting 1/50 (2.00%)', ' Bronchial infection 1/50 (2.00%)', ' Sepsis 1/50 (2.00%)', ' Neutropenia 2/50 (4.00%)', ' Platelet count decreased 1/50 (2.00%)', ' Dehydration 1/50 (2.00%)', ' Arthralgia 1/50 (2.00%)']}

{'Clinical Trial ID': 'NCT01961544', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate 1.4 mg/m^2', ' Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Female, Age greater or equal to 20 years', ' Patients with histologically or cytologically confirmed carcinoma of the breast', ' Patients with locally advance or metastatic carcinoma of the breast', ' Patients who have received two to five prior chemotherapeutic regimens including an antracycline and a taxane and 2 or more regimens for locally recurrent and/or metastatic disease', ' Patients must have proved refractory to the most recent chemotherapy on or within six (6) months of therapy', ' Patients who have assessable lesion according to RECIST v 1.1', ' Adequately maintained bone marrow function', ' absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9 /L', ' hemoglobin greater than or equal to 10.0 g/dl (a hemoglobin less than 10.0 g/dL is acceptable if it is corrected by erythropoietin or transfusion)', ' Platelet count greater than or equal to 100 x 10^9 /L', ' Adequately maintained liver function', ' Total bilirubin: less than or equal to 1.5 times the upper limits of normal (ULN) and', ' Alkaline phosphatase(ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 x ULN (in the case of liver metastases less than or equal to 5 x ULN)', ' Adequately maintained renal function', ' Serum creatinine less than or equal to 2.0 mg/dl or', ' Calculated creatinine clearance greater than or equal to 40 ml/min (Cockcroft and Gault formula)', ' Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for', ' alopecia', ' stable sensory neuropathy less than or equal to Grade 2', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2', ' Life expectancy of greater than or equal to 3 months', ' Patients willing and able to comply with the study protocol for the duration of the study', ' Patients who have provided written consent to participate in this study', ' Exclusion Criteria', ' Patients who have received a chemotherapy, radiation, biologics, immunotherapy or hormonal therapy within three weeks before treatment start (but, palliative radiation can be enrolled)', ' Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen', ' Patients 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 four weeks before starting treatment in this study. Any signs and/or symptoms of brain metastases must be stable for at least four weeks before starting study treatment', ' Patients with meningeal carcinomatosis', ' Significant cardiovascular impairment', ' Myocardial infarction within the past six months, unstable angina, history of congestive heart failure NYHA class III or IV, or serious cardiac arrhythmia', " QTc prolongation (Bazett's Formula greater than 480 msec) or congenital long QT syndrome", ' Severe/uncontrolled intercurrent illness/infection required administration of antibiotic injection', ' Patients who have processed a major surgery within four weeks before participation in this clinical trial', ' Patients who have had a prior malignancy within the past five years other than breast cancer (but, treated non-melanoma skin cancer and carcinoma in situ of the cervix will not be excluded)', ' Patients with known positive HIV status', ' Patients who have received genetic therapy or other investigational drug within 4 weeks before treatment start or expected to receive prohibited medication', ' Patients with prior allergies to Halichondrin B, its derivatives, active ingredient, or other diluting agent', ' Patients who have received this investigational product before registration for this study', ' Patients who are pregnant, who may possibly be pregnant, or are lactating', ' Patients who do not agree to practice contraception for the study periods', ' Patients who have participated in other clinical trial within 4 weeks before screening', ' Patients otherwise judged by investigator or sub investigator to be unsuitable for inclusion'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-emergent Serious Adverse Event (SAE)', " An AE is defined as any harmful, untoward sign (including abnormal laboratory value, etc.), symptom, or disease in a participant administered investigational product that does not necessarily have a causal relationship with treatment. An SAE is defined as an AE that is life threatening or results in death, results in hospitalization (initial or prolonged), results in a disability (significant, persistent, or permanent change, impairment, damage or disruption in the participant's body function/structure, physical activities, or quality of life), results in a congenital anomaly, or requires intervention to prevent permanent impairment or damage. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.", ' Time frame: mean of 3.76 months', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate 1.4 mg/m^2', ' Arm/Group Description: Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 101', ' Measure Type: Number', ' Unit of Measure: Participants TEAE: 101', ' Treatment-emergent SAE: 20'], 'Adverse Events': ['Adverse Events 1:', ' Total: 20/101 (19.80%)', ' Neutropenia * 2/101 (1.98%)', ' Febrile neutropenia * 1/101 (0.99%)', ' Pericardial effusion * 2/101 (1.98%)', ' Abdominal distension * 1/101 (0.99%)', ' Abdominal pain * 1/101 (0.99%)', ' Ascites * 1/101 (0.99%)', ' Gastritis * 1/101 (0.99%)', ' Asthenia * 1/101 (0.99%)', ' Pyrexia * 1/101 (0.99%)', ' Pneumonia * 1/101 (0.99%)', ' Pseudomonal sepsis * 1/101 (0.99%)']}

db90c9d8-b289-48e2-a7df-f41620b3feab

Single

Adverse Events

NCT01419197

There are no cases of agranulocytosis in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01419197', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine', ' Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.', 'INTERVENTION 2: ', " Treatment of Physician's Choice", " Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy."], 'Eligibility': ['Inclusion Criteria:', ' Adult participants 18 years of age.', ' Histologically or cytologically documented breast cancer.', ' Metastatic or unresectable locally advanced/recurrent breast cancer.', ' HER2-positive disease by prospective laboratory confirmation.', ' Disease progression on the last regimen received as defined by the investigator.', ' Prior treatment with an trastuzumab, a taxane, and lapatinib.', ' Disease progression after at least two regimens of HER2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting.', ' Adequate organ function, as evidenced by laboratory results.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.', ' Left ventricular ejection fraction (LVEF) 50% by echocardiogram or multi gated acquisition scan.', 'Exclusion Criteria:', ' Chemotherapy 21 days before first study treatment.', ' Trastuzumab 21 days before first study treatment.', ' Lapatinib 14 days before first study treatment.', ' Prior enrollment in a trastuzumab emtansine containing study, regardless whether the patient received prior trastuzumab emtansine.', ' Brain metastases that are untreated or symptomatic, or require any radiation, surgery or corticosteroid therapy to control symptoms within 1 month of randomization.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' Progression-free survival was defined as the time from randomization to the first documented disease progression by investigator assessment using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurred first. Progression-free survival was a co-primary endpoint.', ' Time frame: Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine', ' Arm/Group Description: Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.', ' Overall Number of Participants Analyzed: 404', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 6.2 (5.59 to 6.87)', 'Results 2: ', " Arm/Group Title: Treatment of Physician's Choice", " Arm/Group Description: Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.", ' Overall Number of Participants Analyzed: 198', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 3.3 (2.89 to 4.14)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 102/403 (25.31%)', ' Anaemia 1/403 (0.25%)', ' Febrile neutropenia 1/403 (0.25%)', ' Granulocytopenia 0/403 (0.00%)', ' Neutropenia 1/403 (0.25%)', ' Thrombocytopenia 1/403 (0.25%)', ' Cardiac failure 1/403 (0.25%)', ' Vertigo 1/403 (0.25%)', ' Hypercalcaemia of malignancy 0/403 (0.00%)', ' Vision blurred 1/403 (0.25%)', ' Abdominal discomfort 0/403 (0.00%)', ' Abdominal pain 4/403 (0.99%)', 'Adverse Events 2:', ' Total: 41/184 (22.28%)', ' Anaemia 2/184 (1.09%)', ' Febrile neutropenia 7/184 (3.80%)', ' Granulocytopenia 1/184 (0.54%)', ' Neutropenia 2/184 (1.09%)', ' Thrombocytopenia 1/184 (0.54%)', ' Cardiac failure 0/184 (0.00%)', ' Vertigo 0/184 (0.00%)', ' Hypercalcaemia of malignancy 1/184 (0.54%)', ' Vision blurred 0/184 (0.00%)', ' Abdominal discomfort 1/184 (0.54%)', ' Abdominal pain 3/184 (1.63%)']}

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

f2533676-1e72-444e-8aef-1fa826ceb804

Comparison

Intervention

NCT03708393

NCT03456427

The intervention in the primary trial is carried out by either a doctor, radiographer or a sonographer, whereas one of the interventions in the secondary trial requires active participation from the patient.

Entailment

{'Clinical Trial ID': 'NCT03708393', 'Intervention': ['INTERVENTION 1: ', ' IUS Alone', 'IUS alone imaging', 'INTERVENTION 2: ', ' Imagio (IUS+OA)', 'IUS+OA imaging'], 'Eligibility': ['Inclusion Criteria:', ' - Female subjects participating in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status', 'Exclusion Criteria:', ' - Female subjects who did not have known clinical status in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status'], 'Results': ['Outcome Measurement: ', ' The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1', ' Primary effectiveness endpoint was the specificity of Imagio [IUS+OA] compared to IUS alone at fixed 95-99% sensitivity (fSp) interpolated from the area under the curve (AUC) of receiver operating characteristic (ROC) curves, averaged across all 10 independent readers. Both imaging modalities (IUS alone and IUS+OA) were read for each subject (subject as own control). Results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth).', ' Time frame: Baseline to 12 month follow-up', 'Results 1: ', ' Arm/Group Title: IUS Alone', ' Arm/Group Description: IUS alone imaging', ' Overall Number of Participants Analyzed: 120', ' Mean (95% Confidence Interval)', ' Unit of Measure: Percent of correct benign masses fSp (95.0%): 80.9 (69.1 to 92.7)', ' fSp (96.0%): 78.7 (65.7 to 91.7)', ' fSp (97.0%): 75.8 (61.4 to 90.3)', ' fSp (97.5%): 74 (58.7 to 89.4)', ' fSp (98.0%): 71.8 (55.4 to 88.3)', ' fSp (99.0%): 65.2 (45.8 to 84.6)', 'Results 2: ', ' Arm/Group Title: Imagio (IUS+OA)', ' Arm/Group Description: IUS+OA imaging', ' Overall Number of Participants Analyzed: 120', ' Mean (95% Confidence Interval)', ' Unit of Measure: Percent of correct benign masses fSp (95.0%): 75.4 (61.5 to 89.3)', ' fSp (96.0%): 71.4 (55.8 to 87.0)', ' fSp (97.0%): 66.1 (48.6 to 83.7)', ' fSp (97.5%): 62.8 (44.1 to 81.6)', ' fSp (98.0%): 58.9 (38.8 to 79)', ' fSp (99.0%): 47.7 (24.5 to 71.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/155 (0.00%)', 'Adverse Events 2:', ' ']}

{'Clinical Trial ID': 'NCT03456427', 'Intervention': ['INTERVENTION 1: ', ' All Study Participants: Patient Assisted Compression', ' All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', ' Patient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC & MLO.', 'INTERVENTION 2: ', ' All Study Participants: Technologist Compression', ' All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', ' Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site.'], 'Eligibility': ['Inclusion Criteria:', ' Are women aged 40 years or older;', ' Are asymptomatic and scheduled for screening mammography;', ' Have left and right breasts;', ' Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;', " Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;", ' Are able and willing to comply with study procedures; and', ' Are able and willing to provide written informed consent to participate.', 'Exclusion Criteria:', ' Are women aged 40 years or older;', ' Are asymptomatic and scheduled for screening mammography;', ' Have left and right breasts;', ' Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;', " Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;", ' Are able and willing to comply with study procedures; and', ' Are able and willing to provide written informed consent to participate.'], 'Results': ['Outcome Measurement: ', ' Percentage of Acceptable Overall Image Quality', ' The primary objective is to compare the percentage of acceptable overall image quality in unilateral two-view (CC and MLO) breast images acquired using Patient-Assisted Compression and Technologist Compression modes.', 'Time frame: 1 Day', 'Results 1: ', ' Arm/Group Title: All Study Participants: Patient Assisted Compression', ' Arm/Group Description: All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', ' Patient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC & MLO.', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Image Quality: Acceptable: 30 90.9%', ' Image Quality: Unacceptable: 3 9.1%', 'Results 2: ', ' Arm/Group Title: All Study Participants: Technologist Compression', ' Arm/Group Description: All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.', ' Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site.', ' Overall Number of Participants Analyzed: 33', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Image Quality: Acceptable: 33 100.0%', ' Image Quality: Unacceptable: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/36 (0.00%)', 'Adverse Events 2:', ' ']}

c15309b3-eb08-4d46-94ef-e4a504a111db

Comparison

Eligibility

NCT02964234

NCT00246090

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

Contradiction

{'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': 'NCT00246090', 'Intervention': ['INTERVENTION 1: ', ' E7389 1.4 mg/m^2', ' E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.'], 'Eligibility': ['Inclusion Criteria:', ' Female patients with histologically or cytologically confirmed carcinoma of the breast. Every effort should be made to make paraffin embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis.', ' Patients with locally advanced or metastatic disease who have received at least two (and not more than five) prior chemotherapeutic regimens for breast cancer, at least one of which was administered for treatment of locally advanced or metastatic disease.', ' Prior therapy must be documented by the following criteria prior to entry onto study:', ' Regimens must have included an anthracycline (eg, doxorubicin, epirubicin), a taxane (eg, paclitaxel, docetaxel) and capecitabine in any combination or order.', ' One or two of these regimens may have been administered as adjuvant and/or neoadjuvant therapy.', ' Patients with human epidermal growth factor receptor 2 (HER2/neu) over-expressing tumors must additionally have been treated with trastuzumab.', ' Patients with estrogen receptor-expressing tumors may have additionally been treated with estrogen-specific therapy.', ' Prior hormonal therapy, biological therapy, (eg, trastuzumab, bevacizumab), or immunotherapy, is not to be counted as one of the 2 to 5 prior chemotherapy regimens allowed. However, hormonal therapy must be discontinued one week before administration of E7389, and biological therapy must be discontinued two weeks before E7389 administration.', ' Patients who are being treated with bisphosphonates when they enter the study are allowed to continue the medication as long as the dosing does not change. In case a change in dosing is deemed necessary, the case needs to be discussed with the Sponsor.', ' Progression on or within six months of the last regimen for advanced disease, documented by the following:', ' The dates of treatment, doses, outcome of therapy and the reason for discontinuation of prior anthracycline, taxane, capecitabine, and trastuzumab therapy must be provided.', ' Prior to entry onto the study, information ensuring that the last therapy fulfills eligibility criteria is required, which includes progression while receiving this last prior chemotherapy regimen, or within six months of receiving that therapy.', " Chemotherapy medication administration sheets or other official medical/hospital records indicating type and dates of chemotherapy must be available for inspection, and one of the following as a reason for discontinuation of medication is required: radiographic evidence of progression, or doctor's office or hospitalization notes documenting radiologic progression, clinically documented increase in tumor burden, and/or increase in tumor-specific markers.", ' Patients with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, defined as at least one lesion that can be accurately measured in at least one diameter (at least 10 mm in longest diameter [LD] by spiral computer tomography [CT] scan), or at least 20 mm by standard techniques. If the only measurable lesion is a lymph node, it must measure at least 20 mm in LD. If a single lesion is identified as the target lesion, a biopsy or aspiration with cytological or histological confirmation of the diagnosis of breast carcinoma is required.', ' Resolution of all chemotherapy or radiation-related toxicities to less than Grade 2 severity, except for stable sensory neuropathy Grade 2 and alopecia.', ' Age >= 18 years.', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.', ' Life expectancy of 3 months.', ' Adequate renal function as evidenced by serum creatinine 2.0 mg/dL or calculated creatinine clearance 40 mL/minute (min) per the Cockcroft and Gault formula.', ' Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) 1.5 x 10^9/L hemoglobin 10.0 g/dL (acceptable if it is corrected by therapeutic intervention or transfusional support), and platelet count 100 x 10^9/L.', ' Adequate liver function as evidenced by bilirubin 1.5 mg/dL and alkaline phosphatase, alanine transaminase (ALT), and aspartate transaminase (AST) 3 times the upper limits of normal (ULN) (in the case of liver metastases 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.', ' Willing and able to complete the European Organization for Research on the Treatment of Cancer (EORTC) quality of life assessment, Analgesic Diary, and Pain Visual Analog Scale (VAS).', ' Willing and able to comply with the study protocol for the duration of the study.', ' Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.', 'Exclusion Criteria:', ' Patients must not have received chemotherapy, radiation, or biologic therapy within two weeks, hormonal therapy within one week, or trastuzumab within three weeks, before E7389 treatment start.', ' Patients must not have received radiation therapy encompassing > 30% of marrow (a lesion that has been irradiated cannot be used as a target lesion, unless it has progressed after the irradiation).', ' Patients must not have pre-existing neuropathy > Grade 2.', ' Patients must not have participated in a prior E7389 clinical trial.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate', ' Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).', ' Time frame: Every two cycles', 'Results 1: ', ' Arm/Group Title: E7389 1.4 mg/m^2', ' Arm/Group Description: E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.', ' Overall Number of Participants Analyzed: 269', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 14.1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 88/291 (30.24%)', ' Anemia3/291 (1.03%)', ' Febrile Neutropenia11/291 (3.78%)', ' Leukopenia1/291 (0.34%)', ' Neutropenia7/291 (2.41%)', ' Thrombocytopenia2/291 (0.69%)', ' Cardiac Arrest1/291 (0.34%)', ' Pericardial Effusion1/291 (0.34%)', ' Pericarditis1/291 (0.34%)', ' Tachycardia2/291 (0.69%)', ' Diplopia1/291 (0.34%)', ' Macular Hole1/291 (0.34%)', ' Abdominal Pain3/291 (1.03%)']}

4885cd77-628c-4b8f-8345-6bce2165938c

Single

Adverse Events

NCT00759785

Only one adverse event, a Breast abscess, is observed in patients from cohort 1 of the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00759785', 'Intervention': ['INTERVENTION 1: ', ' ER-positive Luminal B (ER+)', ' ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.', 'INTERVENTION 2: ', ' Triple Negative (TN)', ' Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.'], 'Eligibility': ['Inclusion Criteria:', ' Participant has operable stage I-IIIa breast cancer of the following subtypes: (1) estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer; (2) ER-positive tumor meeting one of the following criteria: histologic grade 3; histologic grade 2 and PR-negative; histologic grade 2 and Ki67 antigen 10%. Tumor is at least 2 cm in diameter as assessed by physical or radiographic exam', ' Participant is female and 18 years of age', 'Exclusion Criteria:', ' Participant is pregnant, breastfeeding or planning to become pregnant while in the study', ' Participant has received prior chemotherapy, biological therapy or radiation', ' Participant has participated in a clinical trial in the last 30 days', ' Participant has a history of drug or alcohol abuse in the last year', ' Participant is human immunodeficiency virus (HIV) positive. Patient has a history of Hepatitis B or C', ' Participant has poorly controlled diabetes mellitus'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Demonstrating a Decrease in the Growth Factor Signature (GFS)', " GFS was measured by microarray analysis of the entire 101 gene signature expression. The GFS is quantified as the change in gene expression between two separate samples collected from the same participant. A log (base 10) ratio of expression in the post-dose sample was generated relative to the reference in both the Up and DOWN arms of the gene signature. A log ratio value of zero indicated no change in the expression between the two samples. GFS was calculated as the mean log ratio of genes in the UP arm minus mean log ratio of genes in the Down arm. GFS was compared for paired samples (pre-dose and post-dose) by a T-statistic calculated as the GFS divided by its standard error. Responders to therapy had a T-statistic that was smaller than the threshold 1st percentile of student's T-distribution and were counted as having a decrease in GFS.", ' Time frame: Up to 12 Days Post-dose', 'Results 1: ', ' Arm/Group Title: ER-positive Luminal B (ER+)', ' Arm/Group Description: ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 28.6 (13.1 to 49.2)', 'Results 2: ', ' Arm/Group Title: Triple Negative (TN)', ' Arm/Group Description: Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.', ' Overall Number of Participants Analyzed: 17', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 17.6 (6.7 to 35.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/25 (4.00%)', ' Diarrhoea 0/25 (0.00%)', ' Breast abscess 0/25 (0.00%)', ' Breast cellulitis 0/25 (0.00%)', ' Syncope 1/25 (4.00%)', 'Adverse Events 2:', ' Total: 1/20 (5.00%)', ' Diarrhoea 1/20 (5.00%)', ' Breast abscess 1/20 (5.00%)', ' Breast cellulitis 1/20 (5.00%)', ' Syncope 0/20 (0.00%)']}

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

8809cc5e-36d5-4f7e-b06d-b1915a421f71

Comparison

Eligibility

NCT00908791

NCT00297596

Female patients over the age of 60, with Histologically confirmed breast cancer and advanced Alzheimer's disease are ineligible for both the secondary trial and the primary trial, unless they have an ECOG>2.

Contradiction

{'Clinical Trial ID': 'NCT00908791', 'Intervention': ['INTERVENTION 1: ', ' Pre CLA', ' Women with histologically proven invasive non-metastatic breast cancer.', 'INTERVENTION 2: ', ' Post CLA', ' Women with histologically proven invasive non-metastatic breast cancer.'], 'Eligibility': ['Inclusion Criteria:', ' All study patients must have histologically confirmed invasive adenocarcinoma of the breast. Their breast cancer must be resectable clinical stage I or II breast cancer as defined by the current AJCC TNM Staging System (Greene FL, Page DL, Fleming ID, et al.: editors. AJCC cancer staging manual, 6th edition. New York: Springer; 2002).', ' All patients must be able to and give informed consent indicating they are aware of the investigational nature of this treatment, prior to entry into the study.', ' All subjects must be Age >18 years.', ' All subject must have adequate hepatic and renal function documented prior to study entry to include: hepatic transaminases (AST or ALT) 1.5 times the upper limits of normal, total bilirubin 1.5 times the upper limits of normal, serum creatinine 1.5 times the upper limit of normal or eCRCl 60 mL/min.', 'Exclusion criteria:', ' Patients who have received prior or be receiving radiation therapy for their breast cancer will be excluded.', ' Patients who have received prior chemotherapy or receiving chemotherapy or hormonal therapy for their breast cancer will not be included.', ' Women must be surgically sterilized or post-menopausal or women of childbearing potential must be using an adequate method of contraception. Women of childbearing potential must be using at least one of the following: oral, implanted, injectable contraceptive hormones, or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or have a partner that is sterile (e.g., vasectomy). Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study therapy. Women who are pregnant or breast-feeding and women of childbearing potential not using an adequate method of birth control will be excluded.', ' Patients with gastrointestinal abnormalities including: inability to take oral medication, requirement for intravenous alimentation, or prior surgical procedures affecting nutrient /drug absorption will be excluded.', ' A serious uncontrolled medical disorder or active infection which would impair their ability to receive study treatment will be excluded. Significant cardiac disease, including uncontrolled high blood pressure, unstable angina, and congestive heart failure, myocardial infarction within the previous 3 months or serious cardiac arrhythmias will be excluded. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol will be excluded.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Spot 14 Expression Pre and Post CLA as Assessed by Quantitative Immunohistochemistry and Staining Intensities Scored at 0, 1, or 2', ' To determine whether 10 days of CLA consumption suppresses Spot 14 expression in breast cancer tissue in vivo. The staining intensities scoring system used is: no immuostaining (0), weak staining (1), and strong staining (2). The scoring system used objectively and quantitatively assesses the expression of Spot 14, fatty acid synthase, and lipoprotein lipase using the image processing and analysis software Image-Pro Plus™ (MediaCybernetics).', ' Time frame: Up to 28 days', 'Results 1: ', ' Arm/Group Title: Pre CLA', ' Arm/Group Description: Women with histologically proven invasive non-metastatic breast cancer.', ' Overall Number of Participants Analyzed: 24', ' Measure Type: Number', ' Unit of Measure: participants Spot 14 Expression Grade 0: 0', ' Spot 14 Expression Grade 1: 10', ' Spot 14 Expression Grade 2: 14', 'Results 2: ', ' Arm/Group Title: Post CLA', ' Arm/Group Description: Women with histologically proven invasive non-metastatic breast cancer.', ' Overall Number of Participants Analyzed: 24', ' Measure Type: Number', ' Unit of Measure: participants Spot 14 Expression Grade 0: 0', ' Spot 14 Expression Grade 1: 22', ' Spot 14 Expression Grade 2: 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/24 (0.00%)', 'Adverse Events 2:', ' ']}

{'Clinical Trial ID': 'NCT00297596', 'Intervention': ['INTERVENTION 1: ', ' Oxaliplatin/Trastuzumab', ' Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.'], 'Eligibility': ['Inclusion Criteria:', ' Females 18 years of age', ' Histologically confirmed breast cancer that is HER2/neu positive (3+ by IHC or FISH +) and evidence of metastatic disease. Tumor may be of any estrogen and progesterone receptor type', ' Measurable disease by RECIST and an ECOG 2', ' Patients with known evidence of brain metastases are eligible if they are asymptomatic and have completed all therapy (surgery, radiotherapy, and/or steroids)', ' Baseline LVEF value within the institutional normal range', ' Any number of prior hormonal therapy treatments in the adjuvant setting or for metastatic disease. A subject must have progressed on hormonal therapy and all hormonal therapy (including birth control pills) must be discontinued at study entry.', ' Prior chemotherapy in the adjuvant setting and up to one prior chemotherapy regimen for metastatic disease is allowed.', ' Patients may have received one prior trastuzumab/chemotherapy containing regimen or prior single agent trastuzumab.', ' Prior radiation therapy in the adjuvant setting or for metastatic disease, provided it was not to the only site of evaluable disease.', ' All prior chemotherapy, trastuzumab and radiation therapy should be completed > 2 weeks before enrollment.', ' Patients receiving bisphosphonate therapy are eligible. However, if bisphosphonate were started within < 2 months prior to enrollment, the bone lesions will not be evaluated for response and the patient must have another site of metastatic disease that is either measurable or evaluable for response.', ' Patients must have recovered from toxicities due to prior therapy.', ' Lab values in accordance with the protocol', ' Patients must be nonpregnant and nonlactating. Patients of childbearing potential must implement an effective method of contraception during the study (birth control pills are not allowed).', 'Exclusion Criteria:', ' Bone only disease are ineligible', ' Patients who received more than 1 prior chemotherapy regimen for metastatic disease are ineligible.', ' Patients with a history of other cancers except curatively-treated carcinoma of the cervix in situ or non-melanomatous skin cancer.', ' Active serious infection or other underlying medical condition that would impair their ability to receive protocol treatment.', ' Uncontrolled nervous system metastases', ' Dementia or significantly altered mental status that would interfere with proper consenting.', ' Receiving other investigational therapy.'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', ' Time frame: 18 months', 'Results 1: ', ' Arm/Group Title: Oxaliplatin/Trastuzumab', ' Arm/Group Description: Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.', ' Overall Number of Participants Analyzed: 25', ' Measure Type: Number', ' Unit of Measure: percentage of participants 20 (4.3 to 35.7)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/25 (28.00%)', ' Perforated appendix 1/25 (4.00%)', ' Allergic reaction 1/25 (4.00%)', ' Pathologic fracture of let proximal humeral diaphysis 1/25 (4.00%)', ' Pathologic fracture of right proximal humeral diaphysis 1/25 (4.00%)', ' Respiratory failure secondary to metastatic disease 1/25 (4.00%)', ' Breast cancer 1/25 (4.00%)', ' Progressive disease 1/25 (4.00%)']}

f0f7241c-0c2d-47cb-8b42-6e5d7494b2b1

Comparison

Adverse Events

NCT00623233

NCT01525589

More patients with a Low Platelet Count where found in the primary trial than in the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT00623233', 'Intervention': ['INTERVENTION 1: ', ' Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg', ' Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.', ' Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Must be female and greater than or equal to 18 yrs of age', ' Participants must have confirmed cancer with measurable or evaluable, locally recurrent or metastatic disease.', ' Participants must have received a taxane as neo-adjuvant and/or adjuvant therapy', ' Participants may have received prior hormone therapy for locally recurrent or metastatic disease', 'Exclusion Criteria:', ' Participants with breast cancer overexpressing Human Epidermal growth factor Receptor 2 (HER2) gene amplification', ' Prior chemotherapy or targeted therapy for metastatic breast cancer', ' Prior treatment with gemcitabine, trastuzumab, lapatinib or bevacizumab in any setting', ' History of, or active brain mets', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, or anticipation of need for major surgical procedure during course of study', ' Prior history of high blood pressure crisis', ' Have a serious, nonhealing wound, ulcer, or bone fracture'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS) Time', " PFS was measured from date of first dose to first date of progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had PD as of the data inclusion cut-off date for a particular analysis, PFS duration was censored for that analysis at the date of the participant's last progression-free tumor assessment before that cut-off date.", ' Time frame: Baseline to measured PD or death from any cause. Tumor assessments were performed every 8 weeks during therapy and every 2 months during post-therapy until documented PD (up to 34 months).', 'Results 1: ', ' Arm/Group Title: Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg', ' Arm/Group Description: Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.', ' Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 52', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.80 (3.42 to 7.56)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/52 (34.62%)', ' Anaemia 2/52 (3.85%)', ' Febrile Neutropenia 1/52 (1.92%)', ' Haemolytic Uraemic Syndrome 1/52 (1.92%)', ' Leukopenia 1/52 (1.92%)', ' Neutropenia 1/52 (1.92%)', ' Thrombocytopenia 1/52 (1.92%)', ' Cardiac Failure Congestive 1/52 (1.92%)', ' Cardio-Respiratory Arrest 1/52 (1.92%)', ' Abdominal Pain 1/52 (1.92%)', ' Constipation 1/52 (1.92%)', ' Diarrhoea 1/52 (1.92%)']}

{'Clinical Trial ID': 'NCT01525589', 'Intervention': ['INTERVENTION 1: ', ' Cohort A (BRCA+)', ' Patients with known deleterious BRCA1/2 mutation status at study entry', 'INTERVENTION 2: ', ' Cohort A1 (BRCA+/PARPi)', ' Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.'], 'Eligibility': ['Inclusion Criteria:', ' Women 18 and 75 years of age.', ' Voluntary signed informed consent form (ICF).', ' Proven diagnosis of metastatic breast cancer (MBC).', ' At least one, but no more than three, prior chemotherapy regimens for MBC.', ' Patients with known HER-2 overexpressing MBC must have failed at least one prior trastuzumab-containing regimen for metastatic disease.', ' Disease evaluable for response by specific appropriate criteria.', ' No or minimal disease-related symptoms not affecting patient daily activities.', ' Adequate major organ function (normal or minimal alteration in liver, kidney, hematological, metabolic and cardiac function)', ' Wash out periods prior to Day 1 of Cycle 1:', ' At least three weeks since the last chemotherapy (six weeks in some particular cases) and At least four weeks since the last radiotherapy (RT) > 30 Gy) and At least one week since the last hormonal therapy and At least two weeks since the last biological/investigational therapy', ' Minimal or no ongoing toxicity from immediately prior therapy according to specific appropriate criteria. Mild ongoing toxicity is allowed in case of alopecia, skin toxicity, fatigue and/or finger numbness or tumbling.', ' Patients of child-bearing potential must agree to use a medically approved contraception method until at least six weeks after the last study drug administration.', ' Known deleterious germline mutation of BRCA1/2 (Patients in Cohorts A and A1)', ' Prior treatment with PARP inhibitors (Patients in Cohort A1)', 'Exclusion Criteria:', ' Prior treatment with PM01183 or trabectedin.', ' Extensive prior RT.', ' Prior or concurrent malignant disease unless cured for more than five years.', ' Exceptions are breast cancer in the other breast.', ' Uncommon or rare subtypes of breast cancer.', ' Symptomatic or progressive brain metastases.', ' Bone-limited and exclusively metastases.', " Relevant diseases or clinical situations which may increase patient's risk:", ' History of cardiac disease. Moderate breathing difficulties or oxygen requirement Active uncontrolled infection. Unhealed wound or presence of any external drainage. Chronically active viral hepatitis. Immunocompromised patients, including those known to be infected by human immunodeficiency virus (HIV).', ' Known muscular disease or functional alteration', ' Pregnant or breastfeeding women.', ' Impending need for immediate RT for symptomatic relief.', " Limitation of the patient's ability to comply with the treatment or to follow-up the protocol."], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR)', ' The overall response rate is defined as the percentage of patients with a confirmed response, either complete response (CR) or partial response (PR), according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; PR >=30% decrease in the sum of the longest diameter of target lesions.', ' Time frame: Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment', 'Results 1: ', ' Arm/Group Title: Cohort A (BRCA+)', ' Arm/Group Description: Patients with known deleterious BRCA1/2 mutation status at study entry', ' Overall Number of Participants Analyzed: 54', ' Measure Type: Number', ' Unit of Measure: percentage 40.7 (27.6 to 55.0)', 'Results 2: ', ' Arm/Group Title: Cohort A1 (BRCA+/PARPi)', ' Arm/Group Description: Patients with known deleterious BRCA1/2 mutation status and prior treatment with PARPi.', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: percentage 5.0 (0.1 to 24.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/54 (25.93%)', ' anaemia 2/54 (3.70%)', ' Febrile neutropenia 7/54 (12.96%)', ' Neutropenia 2/54 (3.70%)', ' Thrombocytopenia 6/54 (11.11%)', ' Atrial fibrillation 1/54 (1.85%)', ' Cardiac failure congestive 1/54 (1.85%)', ' Pericardial effusion 1/54 (1.85%)', ' Nausea 2/54 (3.70%)', ' Vomiting 3/54 (5.56%)', ' Catheter site erythema 1/54 (1.85%)', ' Chest discomfort 1/54 (1.85%)', 'Adverse Events 2:', ' Total: 5/20 (25.00%)', ' anaemia 0/20 (0.00%)', ' Febrile neutropenia 2/20 (10.00%)', ' Neutropenia 0/20 (0.00%)', ' Thrombocytopenia 0/20 (0.00%)', ' Atrial fibrillation 0/20 (0.00%)', ' Cardiac failure congestive 0/20 (0.00%)', ' Pericardial effusion 0/20 (0.00%)', ' Nausea 0/20 (0.00%)', ' Vomiting 0/20 (0.00%)', ' Catheter site erythema 0/20 (0.00%)', ' Chest discomfort 0/20 (0.00%)']}

ca27db58-14c4-4889-95b1-69be9c10a07a

Single

Eligibility

NCT03190083

All cancer stages are accepted for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT03190083', 'Intervention': ['INTERVENTION 1: ', ' 3-dimensional Tomosynthesis Mammogram', ' The patients assigned a Breast imaging-reporting and data system (BIRADS) 5 category at the time of diagnosis and all new diagnosed breast cancer patients, will undergo a separate 2-D plus DBT in addition to the standard 2-D mammogram', ' 2-dimensional mammogram: This is standard of care for breast cancer diagnosis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.', ' digital breast tomosynthesis (DBT): The radiation dose from this/these procedure(s) will be no more than 0.4mSv for a bi-lateral breast tomosynthesis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.'], 'Eligibility': ['Inclusion Criteria:', ' New diagnosis of breast cancer', ' New diagnosis if a previous breast cancer patient with negative surgical margins', ' Patients willing to sign a written informed consent form', 'Exclusion Criteria:', ' High risk benign lesions as the primary pathology diagnosis'], 'Results': ['Outcome Measurement: ', ' Number of Participants for Which DBT Altered Surgical Plan', ' Only positive findings, like an additional site of cancer or atypical pathology like Atypical ductal/ lobular hyperplasia, papilloma, DCIS/LCIS (findings requiring surgical intervention), will be taken into account when estimating the frequency of changes to surgical management', ' Time frame: At completion of 3-Dimensional mammogram (1 day)', 'Results 1: ', ' Arm/Group Title: 3-dimensional Tomosynthesis Mammogram', ' Arm/Group Description: The patients assigned a Breast imaging-reporting and data system (BIRADS) 5 category at the time of diagnosis and all new diagnosed breast cancer patients, will undergo a separate 2-D plus DBT in addition to the standard 2-D mammogram', ' 2-dimensional mammogram: This is standard of care for breast cancer diagnosis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.', ' digital breast tomosynthesis (DBT): The radiation dose from this/these procedure(s) will be no more than 0.4mSv for a bi-lateral breast tomosynthesis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.', ' Overall Number of Participants Analyzed: 16', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/16 (0.00%)']}

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

5147b171-b5dc-46d6-a153-1a6d9a062ef1

Single

Adverse Events

NCT00656669

the primary trial did not record any adverse events.

Entailment

{'Clinical Trial ID': 'NCT00656669', 'Intervention': ['INTERVENTION 1: ', ' Sunitinib Monotherapy', ' Patients who completed the Sunitinib monotherapy segment'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically-confirmed adenocarcinoma of the breast with operable or inoperable stage 1c (primary tumor > 1.0 cm), II or III disease.', ' Measurable disease by physical examinations or diagnostic breast imaging (mammography, ultrasonography or MR).', ' Pre-treatment core or incisional biopsy. Patients may not have had definitive primary surgery.', ' Male or female, 18 years of age or older.', ' ECOG performance status 0 or 1.', ' Adequate organ function as defined in the protocol.', 'Exclusion Criteria:', ' Prior radiation therapy, cytotoxic therapy or systemic therapy for breast cancer. Prior use of tamoxifen or raloxifene as chemoprevention is allowed but must be discontinued prior to study entry.', ' Metastatic (Stage IV) breast cancer', ' Patients who have had only a pre-treatment fine needle aspiration (FNA) are excluded.', ' Current therapeutic treatment on another clinical trial with an investigational agent.', ' Any of the following within the 6 months prior to starting study treatment: -myocardial infarction -severe/unstable angina -coronary/peripheral artery bypass graft -congestive heart failure -cerebrovascular accident including transient ischemic attack -pulmonary embolus', ' Ongoing cardiac dysrhythmias of NCI CTCAE grade >=2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.', ' Hypertension that cannot be controlled by medications.', ' Current treatment with therapeutic doses of any anti-coagulant. Prophylactic use of anticoagulants is allowed.', ' Known human immunodeficiency virus (HIV) infection.', ' Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test prior to first day of study medication.', ' Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.'], 'Results': ['Outcome Measurement: ', ' Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy', ' Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value.', ' Time frame: baseline through end of segment 1 (2 weeks)', 'Results 1: ', ' Arm/Group Title: Sunitinib Monotherapy', ' Arm/Group Description: Patients who completed the Sunitinib monotherapy segment', ' Overall Number of Participants Analyzed: 19', ' Mean (Standard Deviation)', ' Unit of Measure: mm Hg 14.0 (12.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/23 (0.00%)', ' LEFT VENTRICULAR SYSTOLIC DYSFUNCTION *0/23 (0.00%)', ' NAUSEA *0/23 (0.00%)', ' VOMITING *0/23 (0.00%)', ' BILIRUBIN (HYPERBILIRUBINEMIA) *0/23 (0.00%)', ' INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E *0/23 (0.00%)', ' NEUTROPHILS/GRANULOCYTES (ANC/AGC) *0/23 (0.00%)']}

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

a5ed3500-1ea1-40b6-b1cb-3d5ae776f713

Comparison

Eligibility

NCT00903162

NCT01674062

Patients with BCC are excluded from the primary trial and the secondary trial.

Contradiction

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

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

3c482d5e-bfad-4a46-9e98-ba9967f2d900

Single

Eligibility

NCT00654836

Patients with metastatic HER-2-negative adenocarcinoma of the breast may be eligible for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00654836', 'Intervention': ['INTERVENTION 1: ', ' Carboplatin, ABI-007 and Bevacizumab', " Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15."], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed primary adenocarcinoma of the breast', ' Locally recurrent or metastatic disease', ' Must have HER-2-negative breast cancer or, if HER-2-positive, must be unable to receive trastuzumab (Herceptin®) or have previously received trastuzumab in the past', ' Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm by conventional techniques or as > 10 mm by spiral CT scan.', ' No known CNS disease', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', 'Inclusion criteria:', ' Postmenopausal status not specified', ' ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%', ' Life expectancy > 12 weeks', ' WBC 3,000/mcL', ' Absolute neutrophil count 1,500/mcL', ' Platelet count 100,000/mcL', ' Total bilirubin normal', ' AST and ALT 2.5 times upper limit of normal (ULN)', ' Alkaline phosphatase 2.5 times ULN (unless bone metastasis is present in the absence of liver metastasis)', ' Creatinine 1.5 mg/dL', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No other concurrent malignancies within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix', 'Exclusion criteria:', ' Pre-existing neuropathy grade 1', ' Uncontrolled intercurrent illness including, but not limited to, any of the following:', ' Ongoing or active infection', ' Symptomatic congestive heart failure', ' Unstable angina pectoris', ' Cardiac arrhythmia', ' Serious, non-healing wound, ulcer, or bone fracture', ' Psychiatric illness/social situations that would limit compliance with study requirements', ' Inadequately controlled hypertension (defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications)', ' History of hypertensive crisis or hypertensive encephalopathy', ' New York Heart Association class II-IV congestive heart failure', ' History of myocardial infarction or unstable angina within the past 6 months', ' History of stroke or transient ischemic attack within the past 6 months', ' Significant vascular disease (e.g., aortic aneurysm, aortic dissection)', ' Symptomatic peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Significant traumatic injury within the past 28 days', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months', ' Proteinuria, as demonstrated by either urine protein:creatinine ratio 1.0 OR urine dipstick for proteinuria 2+', ' Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline must demonstrate 24-hour urine protein 1g', ' History of allergy or hypersensitivity to paclitaxel albumin-stabilized nanoparticle formulation, paclitaxel, bevacizumab, carboplatin, albumin, drug product excipients, or chemically similar agents', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' Recovered from all prior therapy', ' No prior chemotherapy for locally recurrent or metastatic disease', ' Prior neoadjuvant or adjuvant chemotherapy allowed', ' More than 1 week since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device', ' More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy', ' More than 4 weeks since prior radiotherapy', ' More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)', ' At least 1 year since prior taxane regimen', ' No other concurrent investigational agents', ' Concurrent anticoagulation allowed, provided the following criteria are met:', ' Stable dose of warfarin or low molecular weight heparin', ' INR within desired range (2-3)', ' No evidence of active bleeding or coagulopathy', ' No concurrent combination antiretroviral therapy for HIV-positive patients', ' No other concurrent radiotherapy, chemotherapy, immunotherapy, or antitumor hormonal therapy'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' Progression-free survival was measured from treatment initiation to 30 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', ' Time frame: 30 Months', 'Results 1: ', ' Arm/Group Title: Carboplatin, ABI-007 and Bevacizumab', " Arm/Group Description: Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.", ' Overall Number of Participants Analyzed: 32', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 16 (9.80 to 22.20)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 24/32 (75.00%)', ' Disease Progression * [1]24/32 (75.00%)']}

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

48ccd744-abf1-4e98-bc86-8ecd625e6279

Single

Eligibility

NCT01783444

Women of any age can participate in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01783444', 'Intervention': ['INTERVENTION 1: ', ' Everolimus 10 mg + Exemestane 25 mg', ' Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).', 'INTERVENTION 2: ', ' Everolimus 10 mg', ' Everolimus (10 mg daily) (investigational arm).'], 'Eligibility': ['Key Inclusion Criteria:', ' - Women with locally advanced, recurrent, or metastatic breast cancer along with confirmation of estrogen-receptor positive (ER+). Measurable disease defined as at least one lesion 10 mm by CT or MRI that can be accurately measured in at least one dimension (CT scan slice thickness 5 mm) OR Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.', ' Key Exclusion Criteria:', ' - Patients who received more than one chemotherapy line. Patients with only non-measurable lesions other than lytic or mixed (lytic and blastic) bone metastasis.Previous treatment with exemestane, mTOR inhibitors, PI3K inhibitors or AKT inhibitors.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Everolimus Alone', ' Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was compared between the everolimus + exemestane combination therapy with the everolimus monotherapy.', ' Time frame: Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to 39 months', 'Results 1: ', ' Arm/Group Title: Everolimus 10 mg + Exemestane 25 mg', ' Arm/Group Description: Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).', ' Overall Number of Participants Analyzed: 104', ' Median (90% Confidence Interval)', ' Unit of Measure: Months 8.41 (6.60 to 9.72)', 'Results 2: ', ' Arm/Group Title: Everolimus 10 mg', ' Arm/Group Description: Everolimus (10 mg daily) (investigational arm).', ' Overall Number of Participants Analyzed: 103', ' Median (90% Confidence Interval)', ' Unit of Measure: Months 6.77 (5.52 to 7.20)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 37/104 (35.58%)', ' Anaemia 1/104 (0.96%)', ' Febrile neutropenia 0/104 (0.00%)', ' Leukopenia 0/104 (0.00%)', ' Neutropenia 0/104 (0.00%)', ' Pancytopenia 0/104 (0.00%)', ' Thrombocytopenia 0/104 (0.00%)', ' Atrial fibrillation 1/104 (0.96%)', ' Cardiac arrest 1/104 (0.96%)', ' Cardiac failure 1/104 (0.96%)', ' Cardiac failure acute 1/104 (0.96%)', ' Cardiac failure congestive 0/104 (0.00%)', 'Adverse Events 2:', ' Total: 30/103 (29.13%)', ' Anaemia 3/103 (2.91%)', ' Febrile neutropenia 0/103 (0.00%)', ' Leukopenia 0/103 (0.00%)', ' Neutropenia 0/103 (0.00%)', ' Pancytopenia 0/103 (0.00%)', ' Thrombocytopenia 0/103 (0.00%)', ' Atrial fibrillation 0/103 (0.00%)', ' Cardiac arrest 0/103 (0.00%)', ' Cardiac failure 0/103 (0.00%)', ' Cardiac failure acute 0/103 (0.00%)', ' Cardiac failure congestive 1/103 (0.97%)']}

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

dce5d9c8-7da6-4732-b969-c492c876cdca

Single

Results

NCT01106898

2% of the primary trial patients were diagnosed with Fatty Liver Disease after 3 years of Treatment with Chemotherapy or Maintenance Therapy.

Contradiction

{'Clinical Trial ID': 'NCT01106898', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Chemotherapy With or Without Maintenance Therapy)', ' SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.', ' MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.', ' cyclophosphamide, paclitaxel, trastuzumab: Given IV'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed newly diagnosed stage I-II breast cancer', ' Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment', ' Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' Absolute neutrophil count greater than or equal to 1,500/mcl', ' Platelet count equal to or greater than 150,000/mcl', ' Hemoglobin > 11 gm/dl', ' Alkaline phosphatase equal or less than 1.5 times the upper limit of normal (ULN)', ' Total bilirubin equal to or less than 1.5 times the ULN', ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no greater than 1.5 times the ULN', ' Creatinine less than 1.5 times the ULN', ' Able to give informed consent', ' All included patients must have normal cardiac function as defined by an ejection fraction of > 50% by echocardiogram', ' Able to return for treatment and follow-up on the specified days', 'Exclusion Criteria:', ' Prior malignancy; except for adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas', ' Patients with preexisting grade II peripheral neuropathy', ' Patients with prior chemotherapy', ' Stage IV or metastatic breast cancer', ' Pregnant or nursing women', ' Inability to cooperate with treatment protocol', ' No active serious infections or other conditions precluding chemotherapy', ' Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol (e.g. unstable angina, myocardial infarction within 6 months, severe infection, etc.)', ' Known hypersensitivity to any component of required drugs in the study', ' Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C or active hepatitis', ' Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form', ' Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiograph (ECG) abnormality at screening has to be documented by the investigator as not medically relevant'], 'Results': ['Outcome Measurement: ', ' Recurrence-free Survival', ' Recurrence-free survival curves will be plotted for subjects treated with stage I and II disease.', ' Time frame: Time from the start of treatment to recurrence, second malignancy, or death as a first event, assessed up to 3 years', 'Results 1: ', ' Arm/Group Title: Treatment (Chemotherapy With or Without Maintenance Therapy)', ' Arm/Group Description: SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.', ' MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.', ' cyclophosphamide, paclitaxel, trastuzumab: Given IV', ' Overall Number of Participants Analyzed: 100', ' Measure Type: Number', ' Unit of Measure: percentage of subjects 98 (92.2 to 99.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/102 (15.69%)', ' Febrile Neutropenia 3/102 (2.94%)', ' SinusTachycardia 1/102 (0.98%)', ' Abdominal pain 2/102 (1.96%)', ' Duodenal perforation 1/102 (0.98%)', ' Constipation 1/102 (0.98%)', ' Diarrhea 1/102 (0.98%)', ' Fever 1/102 (0.98%)', ' Anaphylaxis 1/102 (0.98%)', ' Skin Infection [1]1/102 (0.98%)', ' Urinary Tract Infection 1/102 (0.98%)', ' Sepsis 1/102 (0.98%)']}

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

1882de62-2df2-4b73-a3d2-81811f85f661

Single

Eligibility

NCT00325234

Patients wanting to participate in the primary trial, must discontinue any Antitumoral hormonal treatment, and must have a life expectancy of more than 3 months.

Entailment

{'Clinical Trial ID': 'NCT00325234', 'Intervention': ['INTERVENTION 1: ', ' Pemetrexed/Carboplatin', ' Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0. The cycle of treatment was 21 days.', 'INTERVENTION 2: ', ' Gemcitabine/Vinorelbine', ' Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m^2 will be given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.'], 'Eligibility': ['Inclusion Criteria:', ' Females with histologic or cytologic diagnosis of advanced breast cancer. Lesions should not be amenable to surgery or radiation of curative intent.', ' Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale.', ' One prior chemotherapy containing anthracyclines as (neo)adjuvant or palliative 1st-line treatment.', ' One prior chemotherapy containing taxanes as (neo) adjuvant or palliative 1st-line treatment.', ' Prior radiation therapy is allowed to less than 25% of the bone marrow. Participants must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry. Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.', ' At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Positron emission tomography [PET] scans and ultrasounds may not be used.', ' Antitumoral hormonal treatment must be discontinued prior to enrollment.', ' Estimated life expectancy of at least 3 months.', ' Participant compliance and geographic proximity that allow adequate follow-up.', ' Adequate organ function', ' Female participants of childbearing potential must test negative for pregnancy within 7 days of enrollment based on a urine and/or serum pregnancy test and agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.', ' Participants must sign an informed consent document.', ' Female participants must be at least 18 years of age.', 'Exclusion Criteria:', ' Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.', ' Have previously completed or withdrawn from this study or any other study investigating Pemetrexed, Gemcitabine, Carboplatin or Vinorelbine', ' Have received more than one line of chemotherapy in Metastatic Breast Cancer. Participants having received more than one combination of anthracycline plus taxane.', ' Are pregnant or breast-feeding.', " Have serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to complete the study.", ' Have a prior malignancy other than breast cancer, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.', ' Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam), unless the Creatinine Clearance is greater than or equal to 80 ml/min.', ' Have central nervous system (CNS) metastases.', ' Have clinically relevant (by physical exam) third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study entry.', ' Are unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.', ' Concurrent administration of any other antitumor therapy.'], 'Results': ['Outcome Measurement: ', ' Tumor Response Rate', ' Participants with best overall response determined from complete response (CR) or partial response (PR) according to Response Criteria in Solid Tumors (RECIST) criteria. For CR or PR, best response must be confirmed. A second assessment performed at 28 days. Two determinations of CR before progression required for rate to=CR. Evaluations include: CR=Disappearance of lesions. PR= 30% size decrease of lesions. Progressive Disease (PD)= 20% size increase of lesions. Stable Disease (SD)=Not enough shrinkage for PR nor enough increase for PD. Overall Response Rate=PR+CR/Qualified Participants*100.', ' Time frame: Baseline up to 30 days of follow-up after 21 cycles of treatment', 'Results 1: ', ' Arm/Group Title: Pemetrexed/Carboplatin', ' Arm/Group Description: Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0. The cycle of treatment was 21 days.', ' Overall Number of Participants Analyzed: 64', ' Measure Type: Number', ' Unit of Measure: percentage of participants Overall Response: 26.6 (16.3 to 39.1)', ' Complete Response: 0.0 (0.0 to 5.6)', ' Partial Response: 26.6 (16.3 to 39.1)', ' Stable Disease: 35.9 (24.3 to 48.9)', ' Progressive Disease: 26.6 (16.3 to 39.1)', ' Unknown: 10.9 (4.5 to 21.2)', 'Results 2: ', ' Arm/Group Title: Gemcitabine/Vinorelbine', ' Arm/Group Description: Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m^2 will be given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.', ' Overall Number of Participants Analyzed: 61', ' Measure Type: Number', ' Unit of Measure: percentage of participants Overall Response: 29.5 (18.5 to 42.6)', ' Complete Response: 3.3 (0.4 to 11.3)', ' Partial Response: 26.2 (15.8 to 39.1)', ' Stable Disease: 34.4 (22.7 to 47.7)', ' Progressive Disease: 27.9 (17.1 to 40.8)', ' Unknown: 8.2 (2.7 to 18.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/65 (27.69%)', ' Anaemia 5/65 (7.69%)', ' Febrile neutropenia 1/65 (1.54%)', ' Leukocytosis 0/65 (0.00%)', ' Neutropenia 4/65 (6.15%)', ' Thrombocytopenia 6/65 (9.23%)', ' Cardiac failure congestive 0/65 (0.00%)', ' Epigastric discomfort 0/65 (0.00%)', ' Nausea 1/65 (1.54%)', ' Vomiting 3/65 (4.62%)', ' Condition aggravated 0/65 (0.00%)', ' Medical device complication 0/65 (0.00%)', 'Adverse Events 2:', ' Total: 22/66 (33.33%)', ' Anaemia 1/66 (1.52%)', ' Febrile neutropenia 2/66 (3.03%)', ' Leukocytosis 1/66 (1.52%)', ' Neutropenia 2/66 (3.03%)', ' Thrombocytopenia 0/66 (0.00%)', ' Cardiac failure congestive 1/66 (1.52%)', ' Epigastric discomfort 1/66 (1.52%)', ' Nausea 0/66 (0.00%)', ' Vomiting 1/66 (1.52%)', ' Condition aggravated 1/66 (1.52%)', ' Medical device complication 1/66 (1.52%)']}

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

161c852e-a42c-47c2-ab6a-2b7bd6a4b934

Single

Adverse Events

NCT01120184

At least 1 patient in cohort 1 of the primary trial suffered from a Hemophilia, a rare coagulation disorder.

Contradiction

{'Clinical Trial ID': 'NCT01120184', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + Taxane', " Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.", 'INTERVENTION 2: ', ' Trastuzumab Emtansine + Placebo', ' Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.'], 'Eligibility': ['Inclusion Criteria:', ' Adult participants >/=18 years of age', ' HER2-positive breast cancer', ' Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Participants with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.', ' Participants must have measurable and/or non-measurable disease which must be evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1', ' Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1', ' Adequate organ function as determined by laboratory results', 'Exclusion Criteria:', ' History of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease', ' An interval of <6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis', ' Hormone therapy <7 days prior to randomization', ' Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) <21 days prior to randomization', ' Prior trastuzumab emtansine or pertuzumab therapy'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment', ' Tumor assessments were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a greater than or equal to ( ) 20 percent (%) and 5-millimeter (mm) increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.', ' Time frame: Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)', 'Results 1: ', ' Arm/Group Title: Trastuzumab + Taxane', " Arm/Group Description: Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.", ' Overall Number of Participants Analyzed: 365', ' Measure Type: Number', ' Unit of Measure: percentage of participants 63.3', 'Results 2: ', ' Arm/Group Title: Trastuzumab Emtansine + Placebo', ' Arm/Group Description: Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.', ' Overall Number of Participants Analyzed: 367', ' Measure Type: Number', ' Unit of Measure: percentage of participants 64.3'], 'Adverse Events': ['Adverse Events 1:', ' Total: 81/353 (22.95%)', ' Febrile neutropenia * 13/353 (3.68%)', ' Anaemia * 21/353 (0.28%)', ' Neutropenia * 25/353 (1.42%)', ' Thrombocytopenia * 20/353 (0.00%)', ' Hypercoagulation * 21/353 (0.28%)', ' Leukopenia * 21/353 (0.28%)', ' Atrial fibrillation * 1/353 (0.28%)', ' Cardiac failure * 0/353 (0.00%)', ' Cardiac failure congestive * 0/353 (0.00%)', ' Myocardial infarction * 1/353 (0.28%)', 'Adverse Events 2:', ' Total: 86/361 (23.82%)', ' Febrile neutropenia * 0/361 (0.00%)', ' Anaemia * 25/361 (1.39%)', ' Neutropenia * 20/361 (0.00%)', ' Thrombocytopenia * 22/361 (0.55%)', ' Hypercoagulation * 20/361 (0.00%)', ' Leukopenia * 20/361 (0.00%)', ' Atrial fibrillation * 0/361 (0.00%)', ' Cardiac failure * 0/361 (0.00%)', ' Cardiac failure congestive * 0/361 (0.00%)', ' Myocardial infarction * 0/361 (0.00%)']}

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

eb152d1b-a0d6-428c-8d1d-eb5d862a8147

Comparison

Adverse Events

NCT00546156

NCT00398567

There are no cases of Vertigo in the primary trial or the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00546156', 'Intervention': ['INTERVENTION 1: ', ' HR+, HER2-', ' Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.', 'INTERVENTION 2: ', ' Triple Negative Breast Cancer Cohort', ' Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.'], 'Eligibility': ['Inclusion Criteria:', ' Documented primary invasive breast cancer by histologic assessment', ' Tumors must express estrogen (ER) and/or progesterone receptors (PR) by standard immunohistochemical methods. Tumors must be negative for HER2. There must be sufficient sample for further protocol-specified immunohistochemical analysis', ' Patients must have high risk ER+ or PR+ breast cancer as defined by criteria listed in protocol', ' 18 year of age or older', ' Performance status of 0 or 1 by ECOG criteria', ' Use of an effective means of contraception in subjects of childbearing potential', ' Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to starting therapy.', ' Patients taking exogenous sex-steroid hormone treatments for any reason at the time of diagnosis must discontinue all hormonal treatments at least 2 weeks prior to enrollment', ' Patients must have preoperative treatment within 60 days of initial diagnosis of breast cancer', ' No other malignancy that requires on-going treatment', ' Normal organ function as outlined in the protocol', 'Exclusion Criteria:', ' Prior cytotoxic chemotherapy or radiation for the current breast cancer', ' Patients with inflammatory breast cancer', ' HER2 positive disease defined as HER2-amplified by FISH or IHC 3+. HER2 2+ must be negative by FISH', ' Known metastatic (Stage IV) disease', ' Other investigational agents within 4 weeks prior to the start of study treatment', ' Life expectancy of less than 6 months', ' Peripheral neuropathy greater than or equal to grade 2', ' Inadequately controlled hypertension', ' Any prior history of hypertensive crisis or hypertensive encephalopathy', ' NYHA grade II or greater congestive heart failure', ' History of prior myocardial infarction', ' History of unstable angina within 12 months prior to study enrollment', ' Any history of stroke or transient ischemic attack at any time', ' Known CNS disease', ' Significant vascular disease', ' Symptomatic peripheral vascular disease', ' Evidence of significant bleeding within 6 months of study; any serious non-healing wound, skin ulcers, or bone fracture; any abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within the past 6 months; any major surgical procedure within 28 days prior to randomization or anticipation of need for major surgery during course of study.', ' Known HIV positive', ' Unwilling to undergo pretreatment biopsy and consent to acquisition of archival tissue', ' Pregnant of lactating', ' Known hypersensitivity to any component of bevacizumab'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response Rate After Preoperative Therapy in This Patient Population.', ' Pathological Complete response is defined as complete disappearance of invasive tumor in the breast at the time of surgery', ' Time frame: 3 Years', 'Results 1: ', ' Arm/Group Title: HR+, HER2-', ' Arm/Group Description: Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.', ' Overall Number of Participants Analyzed: 84', ' Measure Type: Number', ' Unit of Measure: percentage of participants 8', 'Results 2: ', ' Arm/Group Title: Triple Negative Breast Cancer Cohort', ' Arm/Group Description: Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: percentage of participants 44'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/104 (3.85%)', ' Neutropenia 1/104 (0.96%)', ' Leukopenia 2/104 (1.92%)', ' paranasal sinus reaction 1/104 (0.96%)', ' cellulitis 1/104 (0.96%)', 'Adverse Events 2:', ' ']}

{'Clinical Trial ID': 'NCT00398567', 'Intervention': ['INTERVENTION 1: ', ' Part 2 - Expanded MTD Cohort', ' All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter'], 'Eligibility': ['Inclusion Criteria:', ' Pathologic diagnosis of breast cancer with current stage IIIB, IIIC or IV not curable by available therapy', ' Progression following at least one Herceptin-containing cytotoxic chemotherapy regimen (neoadjuvant, adjuvant, or metastatic setting)', ' HER2 positive breast cancer', ' At least one measurable target lesion', ' Adequate performance status', ' Adequate cardiac, kidney, and liver function', ' Adequate blood counts', ' Willingness of all subjects who are not surgically sterile or post menopausal to use acceptable methods of birth control', 'Exclusion Criteria:', ' More than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease', ' Major surgery, chemotherapy, radiotherapy, investigational agents, Herceptin or other cancer therapy within 2 weeks of treatment day 1', ' Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2', ' Extensive visceral disease', ' Active central nervous system metastases', ' Pregnant or breast feeding women', ' Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom', ' Prior exposure to HKI-272 or other HER2 targeted agents (except Herceptin and Tykerb)', ' Significant cardiac disease or dysfunction', ' History of life-threatening hypersensitivity to Herceptin', ' Inability or unwillingness to swallow HKI-272 capsules', ' Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin'], 'Results': ['Outcome Measurement: ', ' 16-week Progression-free Survival (PFS) Rate', ' 16-week progression-free survival (PFS) rate for subjects with advanced breast cancer who receive neratinib at the maximum tolerated dose (MTD) in combination with trastuzumab, evaluable population.', ' Time frame: From first dose date to progression status (PD or death) at 16-week', 'Results 1: ', ' Arm/Group Title: Part 2 - Expanded MTD Cohort', ' Arm/Group Description: All subjects receiving HKI-272 (neratinib) in combination with trastuzumab (Herceptin) HKI-272: neratinib 240 mg daily by mouth Herceptin: Herceptin 4 mg/kg IV as a loading dose followed by Herceptin 2 mg/kg weekly thereafter', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Number', ' Unit of Measure: percentage of population 44.8 (25.9 to 62.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/4 (25.00%)', ' Vertigo 0/4 (0.00%)', ' Abdominal adhesions 0/4 (0.00%)', ' Abdominal distension 0/4 (0.00%)', ' Abdominal pain 0/4 (0.00%)', ' Diarrhoea 0/4 (0.00%)', ' Nausea 0/4 (0.00%)', ' Vomiting 0/4 (0.00%)', ' Disease progression 0/4 (0.00%)', ' Influenza 0/4 (0.00%)', ' Nasopharyngitis 0/4 (0.00%)', ' Lumbar vertebral fracture 0/4 (0.00%)', ' Hyponatraemia 0/4 (0.00%)', ' Ataxia 0/4 (0.00%)']}

0701ac32-45b3-4199-aa20-a71080ce9bf6

Comparison

Intervention

NCT03573804

NCT02781051

Participants of the primary trial must undergo at least one MRI during the intervention, in the secondary trial patients must use a fitbit.

Entailment

{'Clinical Trial ID': 'NCT03573804', 'Intervention': ['INTERVENTION 1: ', ' Prone to Supine MRI Evaluated by Radiologist A', ' Radiologist A, number of participants successfully segmented', 'INTERVENTION 2: ', ' Prone to Supine MRI Evaluated by Radiologist B', ' Radiologist B, number of participants successfully segmented'], 'Eligibility': ['Inclusion Criteria:', ' Age > 18 years.', ' Female gender.', ' Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ', ' Tumor size at least 1 cm in diameter as visualized on mammogram or US.', ' A diagnostic breast MRI is considered to be clinically indicated.', ' Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.', 'Exclusion Criteria:', ' Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.', ' Severe claustrophobia.', ' Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (eGFR < 30 ml/min/1.73m2).', ' History of median sternotomy.', ' Pregnancy. Patient attestation that they are not pregnant will be acceptable.', ' Patients who have received neoadjuvant chemotherapy.'], 'Results': ['Outcome Measurement: ', ' Number of Successful Segmentation of Supine MRI Images', ' Determine what number of cases that can be successfully segmented both from using post-contrast prone MRI images and also from using post contrast supine MRI images.', ' Time frame: 30 minutes', 'Results 1: ', ' Arm/Group Title: Prone to Supine MRI Evaluated by Radiologist A', ' Arm/Group Description: Radiologist A, number of participants successfully segmented', ' Overall Number of Participants Analyzed: 62', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 54 87.1%', 'Results 2: ', ' Arm/Group Title: Prone to Supine MRI Evaluated by Radiologist B', ' Arm/Group Description: Radiologist B, number of participants successfully segmented', ' Overall Number of Participants Analyzed: 62', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 61 98.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/62 (0.00%)', 'Adverse Events 2:', ' ']}

{'Clinical Trial ID': 'NCT02781051', 'Intervention': ['INTERVENTION 1: ', ' Physical Activity Intervention', ' Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.', ' Print-based education: Subjects were given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.', ' Fitbit: Subjects were provided with a Fitbit and instructed to wear the device daily.', ' Active Living counseling: The Active Living counseling program consists of 12 weekly group educational sessions. These sessions involved discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.', ' Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).'], 'Eligibility': ['Inclusion Criteria:', ' Positive depression screen (PHQ-9) or current antidepressant treatment', ' Report <150 minutes of weekly moderate-to-vigorous physical activity (MVPA) on the GPAQ', ' Physically able to engage in physical activity', ' Written and verbal fluency in English', 'Exclusion Criteria:', ' Medical condition contraindicating physical activity participation', ' Recurrence of breast cancer', ' Ductal carcinoma in situ (DCIS) diagnosis', ' Cognitively unable to give informed consent', ' Non-English speaking'], 'Results': ['Outcome Measurement: ', ' Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer', ' Assess changes in physical activity at 6 months following physical activity intervention.', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Physical Activity Intervention', ' Arm/Group Description: Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.', ' Print-based education: Subjects were given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.', ' Fitbit: Subjects were provided with a Fitbit and instructed to wear the device daily.', ' Active Living counseling: The Active Living counseling program consists of 12 weekly group educational sessions. These sessions involved discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.', ' Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).', ' Overall Number of Participants Analyzed: 12', ' Mean (Standard Deviation)', ' Unit of Measure: minutes per week 56.2 (23.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/16 (0.00%)']}

866876f5-68de-44bd-b58a-e4b590aa4b39

Single

Results

NCT00370552

There 55 more Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) in cohort 2 of the primary trial than in cohort 1.

Contradiction

{'Clinical Trial ID': 'NCT00370552', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg', ' Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg', ' Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion criteria:', ' Locally recurrent or metastatic breast cancer, previously untreated with chemotherapy for advanced disease.', ' At least 1 target lesion per RECIST criteria. Locally recurrent disease must not be amenable to resection with curative intent.', ' No previous cytotoxic chemotherapy for locally recurrent/metastatic disease.', ' Relapse 12 months or more after completing prior adjuvant or neoadjuvant taxane therapy.', ' No previous breast cancer known to overexpress or amplify the human epidermal growth factor receptor 2 gene.', ' Prior hormonal therapy in adjuvant, recurrent, or metastatic setting allowed but must have been discontinued at least 2 weeks before randomization.', ' Karnofsky performance status of 80 to 100 or Eastern Cooperative Oncology Group performance status of 0 to 1.', ' Estimated life expectancy of at least 12 weeks.', ' Recovery from recent therapy (except for alopecia), including chemotherapy, immunotherapy, biologic therapy, or investigational product. Any such therapy must have been completed at least 3 weeks before randomization and at least 6 weeks from use of nitrosourea, or mitomycin.', ' Recovery from recent surgery and radiation therapy. At least 1 week since minor surgery and/or focal/palliative radiation therapy; at least 3 weeks from radiation; at least 4 weeks from major surgery; and at least 8 weeks from liver resection, thoracotomy, or neurosurgery.', ' Absolute neutrophil count 1500/mm^3.', ' Hemoglobin 9 g/dL.', ' Platelets 100,000/mm^3.', ' Total bilirubin 1.5 times the upper limit of normal (ULN).', ' Aspartate aminotransferase or alanine aminotransferase 2.5*ULN.', ' Normal partial thromboplastin time and either international normalized ratio or prothrombin time <1.5*ULN.', ' Serum creatinine 1.5*ULN or 24-hour creatinine clearance >60 mL/min.', ' Urine dipstick for proteinuria <2+ (negative, trace, or +1). Participants with 2+ proteinuria at baseline were to undergo 24-hour urine collection and demonstrate 1g of protein in 24 hours to be eligible.', 'Exclusion criteria:', ' Women of child-bearing potential (WOCBP) unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 6 months after treatment with bevacizumab.', ' Women who were pregnant or breastfeeding.', ' Women with a positive pregnancy test on enrollment or prior to study drug administration.', ' Sexually active fertile men, whose partners were WOCBP, not using an adequate method of birth control.', ' Evidence of baseline sensory or motor neuropathy.', ' Serious infection or nonmalignant medical illnesses uncontrolled or the control of which could be jeopardized by this therapy.', ' History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, serious gastric ulcer, or bone fracture within 6 months of study entry.', ' History of hypertensive crisis or hypertensive encephalopathy.', ' Significant vascular disease.', ' Clinically significant cardiovascular disease.', ' Baseline left ventricular ejection fraction by multiple-gated acquisition scan or echocardiogram for subjects with prior exposure to anthracyclines not within institutional normal limits.', ' Symptomatic peripheral vascular disease.', ' History of high dose chemotherapy with bone marrow transplant or peripheral blood stem cell transplant within the previous 2 years.', ' Evidence of bleeding diathesis or coagulopathy.', ' Prior treatment with an epothilone or any antiangiogenic agent.', ' Concurrent nonhealing wound, ulcer, or fracture.', ' Any current or history of brain and/or leptomeningeal metastases. Psychiatric disorders or other conditions rendering the participant incapable of complying with the requirements of the protocol.', ' Any concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix.', ' Known allergy to any of the study drugs or their excipients.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study', ' CR=Disappearance of all clinical and radiologic evidence of target lesions; PR=At least 30% reduction in the sum of the longest diameter of all target lesions.', ' Time frame: Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression', 'Results 1: ', ' Arm/Group Title: Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg', ' Arm/Group Description: Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 46', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 47.8 (32.9 to 63.1)', 'Results 2: ', ' Arm/Group Title: Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg', ' Arm/Group Description: Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 45', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 71.1 (55.7 to 83.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/45 (33.33%)', ' Anemia 1/45 (2.22%)', ' Leukopenia 0/45 (0.00%)', ' Neutropenia 0/45 (0.00%)', ' Thrombocytopenia 1/45 (2.22%)', ' Febrile neutropenia 0/45 (0.00%)', ' Angina pectoris 0/45 (0.00%)', ' Atrial fibrillation 0/45 (0.00%)', ' Vomiting 1/45 (2.22%)', ' Diarrhea 1/45 (2.22%)', ' Abdominal pain 1/45 (2.22%)', ' Diverticular perforation 0/45 (0.00%)', 'Adverse Events 2:', ' Total: 16/45 (35.56%)', ' Anemia 0/45 (0.00%)', ' Leukopenia 2/45 (4.44%)', ' Neutropenia 3/45 (6.67%)', ' Thrombocytopenia 0/45 (0.00%)', ' Febrile neutropenia 1/45 (2.22%)', ' Angina pectoris 0/45 (0.00%)', ' Atrial fibrillation 1/45 (2.22%)', ' Vomiting 0/45 (0.00%)', ' Diarrhea 0/45 (0.00%)', ' Abdominal pain 0/45 (0.00%)', ' Diverticular perforation 1/45 (2.22%)']}

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

b4304362-1cb4-4606-9de4-03935ad509f1

Comparison

Eligibility

NCT03097653

NCT00662129

Females aged between 18-25 with stable angina cannot be included in either the secondary trial or the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT03097653', 'Intervention': ['INTERVENTION 1: ', ' Decision-aid', " Decision-aid: Web platform with a multilevel information and an aid for the decision to be taken. The content is splitted in 16-20 screens; each screen contains the answer to a common question (i.e. What is mammography screening? What are its benefits and harms? What results can be expected from the participation to mammography screening? What is breast cancer?). The information covers also controversial topics as overdiagnosis, overtreatment and the disagreement among scientists about harms and benefits' quantification.", 'INTERVENTION 2: ', ' Standard Information', " Standard information: Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures."], 'Eligibility': ['Inclusion Criteria:', ' Women aged 45-69, according to the target age of the screening centres involved;', ' New invited women in mammography screening programme.', 'Exclusion Criteria:', 'None'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adequate Knowledge', ' Knowledge will be measured using a questionnaire structured in 13 questions with multiple choice answers, with 2 to 4 options. Ten questions will be qualitative and 3 will be numerical. A score of 8 out of 13 (about 60%) or higher would be considered "adequate knowledge".', ' Time frame: 7-10 days', 'Results 1: ', ' Arm/Group Title: Decision-aid', " Arm/Group Description: Decision-aid: Web platform with a multilevel information and an aid for the decision to be taken. The content is splitted in 16-20 screens; each screen contains the answer to a common question (i.e. What is mammography screening? What are its benefits and harms? What results can be expected from the participation to mammography screening? What is breast cancer?). The information covers also controversial topics as overdiagnosis, overtreatment and the disagreement among scientists about harms and benefits' quantification.", ' Overall Number of Participants Analyzed: 472', ' Measure Type: Number', ' Unit of Measure: participants 236', 'Results 2: ', ' Arm/Group Title: Standard Information', " Arm/Group Description: Standard information: Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.", ' Overall Number of Participants Analyzed: 529', ' Measure Type: Number', ' Unit of Measure: participants 218'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}

{'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%)']}

9cddd86a-4340-4918-b000-7e6e593a3f7f

Comparison

Adverse Events

NCT00528567

NCT01196052

The total number of patients affected by adverse events in cohort 2 the primary trial is more than 1000.

Contradiction

{'Clinical Trial ID': 'NCT00528567', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab and Chemotherapy', ' Participants randomized to receive bevacizumab and chemotherapy', 'INTERVENTION 2: ', ' Chemotherapy', ' Participants randomized to receive chemotherapy alone'], 'Eligibility': ['Inclusion Criteria:', ' adult patients, >=18 years of age;', ' operable primary invasive breast cancer;', ' completed definitive loco-regional surgery;', ' primary tumor centrally confirmed as triple negative.', 'Exclusion Criteria:', ' locally advanced breast cancers;', ' previous breast cancer history;', ' clinically significant cardiovascular disease.'], 'Results': ['Outcome Measurement: ', ' Time to Invasive Disease-free Survival (IDFS) Event', ' IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer.', ' Time frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)', 'Results 1: ', ' Arm/Group Title: Bevacizumab and Chemotherapy', ' Arm/Group Description: Participants randomized to receive bevacizumab and chemotherapy', ' Overall Number of Participants Analyzed: 1301', ' Median (95% Confidence Interval)', ' Unit of Measure: Months NA [1] (NA to NA)', 'Results 2: ', ' Arm/Group Title: Chemotherapy', ' Arm/Group Description: Participants randomized to receive chemotherapy alone', ' Overall Number of Participants Analyzed: 1290', ' Median (95% Confidence Interval)', ' Unit of Measure: Months NA [1] (NA to NA)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 379/1288 (29.43%)', ' Febrile neutropenia 84/1288 (6.52%)', ' Neutropenia 69/1288 (5.36%)', ' Leukopenia 8/1288 (0.62%)', ' Anaemia 1/1288 (0.08%)', ' Thrombocytopenia 4/1288 (0.31%)', ' Pancytopenia 1/1288 (0.08%)', ' Febrile bone marrow aplasia 1/1288 (0.08%)', ' Atrial fibrillation 4/1288 (0.31%)', ' Cardiac failure congestive 6/1288 (0.47%)', 'Adverse Events 2:', ' Total: 250/1271 (19.67%)', ' Febrile neutropenia 59/1271 (4.64%)', ' Neutropenia 38/1271 (2.99%)', ' Leukopenia 1/1271 (0.08%)', ' Anaemia 3/1271 (0.24%)', ' Thrombocytopenia 0/1271 (0.00%)', ' Pancytopenia 1/1271 (0.08%)', ' Febrile bone marrow aplasia 0/1271 (0.00%)', ' Atrial fibrillation 2/1271 (0.16%)', ' Cardiac failure congestive 0/1271 (0.00%)']}

{'Clinical Trial ID': 'NCT01196052', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab Emtansine', ' Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Adult patients 18 years of age.', ' Locally advanced, inflammatory, or early stage, unilateral, and histologically confirmed invasive breast cancer documented at a local laboratory (patients with inflammatory breast cancer must be able to have a core needle biopsy).', ' Herceptin (HER)2-positive tumor, confirmed by central testing using immunohistochemistry (IHC) and in situ hybridization (ISH) methods.', ' Willingness to receive anthracycline-based chemotherapy or have received doxorubicin/cyclophosphamide (AC) OR 5-fluorouracil (FU)/epirubicin/ cyclophosphamide (FEC) in a similar dose and schedule as described in the protocol as part of neoadjuvant or adjuvant treatment.', ' For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients should use condoms for the duration of the study. Specific country requirements will be followed.', ' Negative results of serum pregnancy test for premenopausal women of reproductive capacity and for women < 12 months after menopause.', ' Patients may enroll before or after AC/FEC chemotherapy has completed.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.', ' Adequate hematologic, biochemistry, and cardiac assessments.', 'Exclusion Criteria:', ' Stage IV breast cancer or bilateral breast cancer.', ' Pregnant or breastfeeding women.', ' History of other malignancy within the previous 5 years, except contralateral breast cancer and ductal carcinoma in situ (DCIS)/lobular carcinoma in situ (LCIS), appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with outcome similar to those mentioned above.', ' Radiation therapy, immunotherapy, or biotherapy within 5 years before study enrollment; non-cardiotoxic chemotherapy for malignancy treated > 5 years before study enrollment is allowed. Patients receiving AC/FEC in a similar fashion to the study treatment prescribed for adjuvant or neoadjuvant treatment of breast cancer will be allowed to enroll in the study after the completion of their AC/FEC. No other prior history of cardiotoxic chemotherapy is allowed.', ' Active cardiac history.', ' Current chronic daily treatment with oral corticosteroids or equivalent.', ' Patients with severe dyspnea at rest or requiring supplementary oxygen therapy.', ' Active, unresolved infections at screening.', ' Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.', ' Major surgery within 4 weeks before enrollment that is unrelated to the breast cancer.', ' Patients for whom concomitant radiotherapy + T-DM1 may be contraindicated yet radiation therapy is planned.', ' Known hypersensitivity to any of the study drugs or derivatives, including murine proteins.', ' Grade 2 peripheral neuropathy at Baseline.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment', ' A cardiac event was defined as death from a cardiac cause or severe congestive failure (New York Heart Association [NYHA] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of 10% from Baseline to an LVEF of < 50%.', ' Time frame: Baseline to 12 weeks after the start of trastuzumab emtansine treatment', 'Results 1: ', ' Arm/Group Title: Trastuzumab Emtansine', ' Arm/Group Description: Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.', ' Overall Number of Participants Analyzed: 143', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 0 (0.00 to 2.45)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/148 (10.14%)', ' Febrile neutropenia 1/148 (0.68%)', ' Atrial fibrillation 2/148 (1.35%)', ' Abdominal pain 1/148 (0.68%)', ' Diarrhoea 1/148 (0.68%)', ' Pyrexia 2/148 (1.35%)', ' Cellulitis 1/148 (0.68%)', ' Device related infection 2/148 (1.35%)', ' Gastroenteritis viral 1/148 (0.68%)', ' Gastrointestinal infection 1/148 (0.68%)', ' Upper respiratory tract infection 1/148 (0.68%)']}

c3f01101-2259-4677-add1-1b1f48a0202b

Single

Results

NCT00143390

In the primary trial There was less than 3 days difference between the maximum recorded TTP of the Exemestane group and the Anastrozole group.

Entailment

{'Clinical Trial ID': 'NCT00143390', 'Intervention': ['INTERVENTION 1: ', ' Exemestane', ' One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.', 'INTERVENTION 2: ', ' Anastrozole', ' One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.'], 'Eligibility': ['Inclusion Criteria:', ' Have histologically or cytologically confirmed breast cancer at original diagnosis. At study entry, the patient must have metastatic progressive or locally recurrent inoperable breast cancer.', 'Exclusion Criteria:', ' Having received any hormonal therapy (e.g., Tamoxifen, LHRH-agonists) ovariectomy or any chemotherapy for advanced/recurrent breast cancer'], 'Results': ['Outcome Measurement: ', ' Time to Progression (TTP) - Expert Evaluation Committee Assessment', ' Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).', ' Time frame: Up to 2008 days of the treatment', 'Results 1: ', ' Arm/Group Title: Exemestane', ' Arm/Group Description: One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.', ' Overall Number of Participants Analyzed: 147', ' Median (95% Confidence Interval)', ' Unit of Measure: months 13.8 (10.8 to 16.5)', 'Results 2: ', ' Arm/Group Title: Anastrozole', ' Arm/Group Description: One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.', ' Overall Number of Participants Analyzed: 145', ' Median (95% Confidence Interval)', ' Unit of Measure: months 11.1 (10.8 to 16.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/149 (12.75%)', ' Anaemia 0/149 (0.00%)', ' Acute myocardial infarction 1/149 (0.67%)', ' Pericardial effusion 1/149 (0.67%)', ' Prinzmetal angina 1/149 (0.67%)', " Meniere's disease 0/149 (0.00%)", ' Vertigo 0/149 (0.00%)', ' Cataract 2/149 (1.34%)', ' Colitis ischaemic 1/149 (0.67%)', ' Nausea 0/149 (0.00%)', ' Vomiting 0/149 (0.00%)', ' Chest pain 1/149 (0.67%)', 'Adverse Events 2:', ' Total: 19/149 (12.75%)', ' Anaemia 1/149 (0.67%)', ' Acute myocardial infarction 0/149 (0.00%)', ' Pericardial effusion 0/149 (0.00%)', ' Prinzmetal angina 0/149 (0.00%)', " Meniere's disease 1/149 (0.67%)", ' Vertigo 2/149 (1.34%)', ' Cataract 1/149 (0.67%)', ' Colitis ischaemic 0/149 (0.00%)', ' Nausea 1/149 (0.67%)', ' Vomiting 3/149 (2.01%)', ' Chest pain 0/149 (0.00%)']}

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

33b827a0-ada5-4204-abb8-d5239ea16f0b

Single

Results

NCT00259090

the primary trial studies the impact of Fulvestrant, Anastrozole on Oestrogen Receptor H-score.

Entailment

{'Clinical Trial ID': 'NCT00259090', 'Intervention': ['INTERVENTION 1: ', ' Fulvestrant', ' Fulvestrant 500 mg once monthly injection', 'INTERVENTION 2: ', ' Fulvestrant + Anastrozole', ' Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women.', ' Biopsy confirmation of primary breast cancer.', ' Oestrogen receptor positive tumour.', ' Fit for surgery within one month.', ' Written informed consent to participate in the study', 'Exclusion Criteria:', ' Previous treatment with any anti-hormonal therapy for breast cancer.', ' Previous radiotherapy to the primary tumour.', ' Previous chemotherapy for the primary tumour.'], 'Results': ['Outcome Measurement: ', ' Percentage Change From Baseline to Time of Surgery in Oestrogen Receptor (ER) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the ER H-score.', ' For each sample, the ER H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent +/-) + (1 x percent +) + (2 x percent ++) + (3 x percent +++)]. Range 0-300. The greater the change from baseline (randomization) in ER H-score, the greater the blockage of ER expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100', ' Time frame: Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)', 'Results 1: ', ' Arm/Group Title: Fulvestrant', ' Arm/Group Description: Fulvestrant 500 mg once monthly injection', ' Overall Number of Participants Analyzed: 35', ' Mean (Standard Error)', ' Unit of Measure: Percentage change from baseline -37 (4)', 'Results 2: ', ' Arm/Group Title: Fulvestrant + Anastrozole', ' Arm/Group Description: Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet', ' Overall Number of Participants Analyzed: 31', ' Mean (Standard Error)', ' Unit of Measure: Percentage change from baseline -38 (5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/40 (0.00%)', ' Pancytopenia 0/40 (0.00%)', ' Atrial Fibrillation 0/40 (0.00%)', ' Unevaluable Event 0/40 (0.00%)', ' Subcutaneous Abscess 0/40 (0.00%)', ' Procedural Complication 0/40 (0.00%)', 'Adverse Events 2:', ' Total: 3/40 (7.50%)', ' Pancytopenia 0/40 (0.00%)', ' Atrial Fibrillation 1/40 (2.50%)', ' Unevaluable Event 1/40 (2.50%)', ' Subcutaneous Abscess 0/40 (0.00%)', ' Procedural Complication 1/40 (2.50%)']}

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

40f1d3ce-2ff8-4177-9b11-0bf10b7f6591

Comparison

Results

NCT00802945

NCT01231659

Group 1 of the secondary trial has a higher ORR than both the NKTR-102 14 Day cohort of the primary trial and the NKTR-102 21 Days cohort.

Entailment

{'Clinical Trial ID': 'NCT00802945', 'Intervention': ['INTERVENTION 1: ', ' NKTR-102 14 Day', ' NKTR-102: NKTR-102 given on a q14 day schedule', 'INTERVENTION 2: ', ' NKTR-102 21 Days', ' NKTR-102: NKTR-102 given on a q21 day schedule'], 'Eligibility': ['Inclusion Criteria:', ' Inoperable metastatic or locally advanced breast cancer', ' No more than 2 prior chemotherapy regimens given in a metastatic or locally advanced setting and prior treatment in the metastatic setting must have included a taxane', 'Exclusion Criteria:', ' Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Day 1 of Cycle 1', ' Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle or minor surgery within 2 weeks prior to Day 1 of Cycle 1'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', ' Time frame: Up to 2 years.', 'Results 1: ', ' Arm/Group Title: NKTR-102 14 Day', ' Arm/Group Description: NKTR-102: NKTR-102 given on a q14 day schedule', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Number', ' Unit of Measure: percentage of subjects 28.6 (14.6 to 46.3)', 'Results 2: ', ' Arm/Group Title: NKTR-102 21 Days', ' Arm/Group Description: NKTR-102: NKTR-102 given on a q21 day schedule', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Number', ' Unit of Measure: percentage of subjects 35 (14.6 to 46.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/35 (51.43%)', ' Anaemia * 0/35 (0.00%)', ' Febrile Neutropenia * 0/35 (0.00%)', ' Neutropenia * 1/35 (2.86%)', ' Vision Blurred * 1/35 (2.86%)', ' Abdominal Pain * 1/35 (2.86%)', ' Abdominal Pain Lower * 1/35 (2.86%)', ' Constipation * 0/35 (0.00%)', ' Diarrhoea * 6/35 (17.14%)', ' Ileitis * 0/35 (0.00%)', ' Nausea * 2/35 (5.71%)', ' Small Intestinal Obstruction * 0/35 (0.00%)', 'Adverse Events 2:', ' Total: 15/35 (42.86%)', ' Anaemia * 1/35 (2.86%)', ' Febrile Neutropenia * 1/35 (2.86%)', ' Neutropenia * 0/35 (0.00%)', ' Vision Blurred * 0/35 (0.00%)', ' Abdominal Pain * 0/35 (0.00%)', ' Abdominal Pain Lower * 0/35 (0.00%)', ' Constipation * 1/35 (2.86%)', ' Diarrhoea * 4/35 (11.43%)', ' Ileitis * 1/35 (2.86%)', ' Nausea * 0/35 (0.00%)', ' Small Intestinal Obstruction * 1/35 (2.86%)']}

{'Clinical Trial ID': 'NCT01231659', 'Intervention': ['INTERVENTION 1: ', ' Everolimus + Letrozole', ' All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer after documented recurrence or progression on Tamoxifen, Anastrozole or Examestane.', ' Refractory disease to hormonal therapy is defined as:', ' Recurrence while on, or within 12 month of end of, adjuvant treatment with Tamoxifen , Anastrozole, or Exemestane.', ' Recurrence while on, or within 24 month of end of, adjuvant treatment with Letrozole.', ' Progression while on Tamoxifen, Anastrozole or Exemestane treatment for locally advanced or metastatic breast cancer.', 'Exclusion Criteria:', ' Prior use of chemotherapy and letrozole for Advanced Breast Cancer and mTOR inhibitors as the last anticancer treatment prior to study entry.', ' Patients must have radiological evidence of recurrence or progression on last therapy prior to study entry.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Overall Response Rate (ORR)', ' Overall Response Rate (ORR) was defined as the proportion of patients whose best overall response was either complete response (CR) or partial response (PR) according to RECIST 1.0 for target lesions and assessed by CT: Complete Response (CR), disappearance of all target lesions for a period of at least one month; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (ORR) = CR + PR. Only descriptive statistics.', ' Time frame: From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 15 months', 'Results 1: ', ' Arm/Group Title: Everolimus + Letrozole', ' Arm/Group Description: All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.', ' Overall Number of Participants Analyzed: 43', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 37.2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 26/72 (36.11%)', ' Anaemia 5/72 (6.94%)', ' Cardiac arrest 1/72 (1.39%)', ' Cardiac failure congestive 1/72 (1.39%)', ' Hypercalcaemia 1/72 (1.39%)', ' Nausea 1/72 (1.39%)', ' Vomiting 3/72 (4.17%)', ' Death 1/72 (1.39%)', ' Disease progression 2/72 (2.78%)', ' Infusion related reaction 1/72 (1.39%)', ' Pyrexia 3/72 (4.17%)', ' Cholecystitis 1/72 (1.39%)', ' Cellulitis 2/72 (2.78%)']}

22bff413-a1bd-419b-b19b-2157dedc9948

Single

Intervention

NCT00880022

Only patients in cohort 2 of the primary trial undergo Trunk compression.

Entailment

{'Clinical Trial ID': 'NCT00880022', 'Intervention': ['INTERVENTION 1: ', ' Arm Compression Only', '[Not Specified]', 'INTERVENTION 2: ', ' Arm, Trunck and Chest Compression', '[Not Specified]'], 'Eligibility': ['Inclusion Criteria:', ' Individuals at least six months post- surgery and/or radiation treatment for breast cancer', ' At least 21 years of age', ' Lymphedema in one arm subsequent to breast cancer treatment with coexisting truncal swelling ** (Part One) and *lymphedema in one arm subsequent to breast cancer treatment without coexisting truncal swelling (Part Two)', ' Willing and able to drive to the study site as needed', ' Currently not using a compression pump or undergoing manual lymphatic drainage by a therapist', 'Exclusion Criteria:', ' Actively undergoing or less than six months post intravenous chemotherapy or radiation therapy', ' Individuals with congestive heart failure, chronic/acute renal disease, cor pulmonal, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, thrombophlebitis, deep vein thrombosis, infection of any kind and inflammation (redness) in the trunk or arms', ' History of bilateral breast cancer', ' Metastatic cancer', ' Inability to stand upright', ' Metal implants that would interfere with bioimpedance measurement equipment', ' Pregnancy', ' Pacemaker and internally implanted defibrillators'], 'Results': ['Outcome Measurement: ', ' Arm Volume at End of Study', ' measured by tape and then volume was calculated.', ' Time frame: end of scheduled treatments-day 30 of treatment', 'Results 1: ', ' Arm/Group Title: Arm Compression Only', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 21', ' Median (Inter-Quartile Range)', ' Unit of Measure: ml 2376.52 (1934.68 to 2622.99)', 'Results 2: ', ' Arm/Group Title: Arm, Trunck and Chest Compression', ' Arm/Group Description: [Not Specified]', ' Overall Number of Participants Analyzed: 21', ' Median (Inter-Quartile Range)', ' Unit of Measure: ml 2539.93 (2168.28 to 3295.97)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/21 (0.00%)', 'Adverse Events 2:', ' Total: 0/21 (0.00%)']}

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

b64d6e41-7ec7-4e62-beda-c28559a6cee7

Single

Adverse Events

NCT01875367

More than 3 patients in the primary trial had a common cold.

Contradiction

{'Clinical Trial ID': 'NCT01875367', 'Intervention': ['INTERVENTION 1: ', ' Arm A: T-IV + T-SC Vial + T-SC Device', ' Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.', 'INTERVENTION 2: ', ' Arm B: T-IV + T-SC Device + T-SC Vial', ' Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.'], 'Eligibility': ['Inclusion Criteria:', ' Woman, 18 years old or upper.', ' Patient with advanced breast cancer with human epidermal growth factor receptor 2 (HER 2) positive histologically confirmed. The criteria for positivity HER 2 are:', ' immuno-histochemistry (IHC) 3+ (>10% of tumor cells with complete and intense membrane staining)', ' IHC 2+ with fluorescent in situ hybridization (FISH) / Chromogenic in situ hybridization (CISH) / silver-enhanced in situ hybridization (SISH) + for HER 2 amplification (*)', ' FISH / CISH / SISH + for HER 2 amplification (*) (*) Defined as the ratio of copies of HER 2/neu and copies of centromere of chromosome 17 (CEP17)> 2.2, or a number of copies of HER 2/neu> 6, as per local laboratory criteria.', ' Patient receiving trastuzumab with or without chemotherapy or hormonal therapy for at least 4 months.', ' No evidence of disease progression (clinical and / or radiological) for at least 4 months before inclusion in the study and with a life expectancy of at least 3 months.', ' Adequate performance status: Eastern Cooperative Oncology Group (ECOG) <2.', ' Adequate bone marrow function, liver and kidney', ' Proper cardiac function (LVEF within normal limits the center, measured by echocardiography or MUGA).', ' The patient must have been informed of the study and must sign and date informed consent document for entry into the trial.', ' The patient must be willing and able to comply with study procedures and be available to answer the study questionnaires.', 'Exclusion Criteria:', ' Patients with no advanced breast cancer.', ' Breast cancer patients with tumors HER 2-negative.', ' The patient has another active malignancy other than breast adenocarcinoma; are excluded the non-melanoma skin cancer or any other properly treated in situ neoplasia. Patients with a history of malignancy, if they bear> 5 years without evidence of disease could be included.', ' The patient has uncontrolled brain metastases.', ' Concomitant administration, or in the 4 weeks prior to study entry, of other experimental treatment.', ' Known hypersensitivity to trastuzumab or to any of its components.', ' Patients with severe dyspnea at rest or requiring supplemental oxygen.', ' Heart disease or serious medical pathological prevent trastuzumab administration: documented history of congestive cardiac insufficiency (CCI), high-risk arrhythmias uncontrolled angina requiring medication, clinically significant valvular disease, history of myocardial infarction or evidence of transmural infarction on ECG or hypertension poorly controlled.', ' Presence of any concomitant serious systemic disease that is incompatible with the study (at the discretion of the investigator).', ' The patient is pregnant or lactating. Women of childbearing potential should undergo pregnancy testing blood or urine within 14 days prior to inclusion as institutional rules and use a non-hormonal contraceptive suitable: intrauterine device, barrier method (condom or diaphragm) also used in conjunction with spermicidal cream, total abstinence or surgical sterilization, during treatment with the study drugs and for 6 months following the end of treatment.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Subcutaneous vs. Intravenous Treatment Preference', ' The percentage of patients who indicate a preference for the use of the intravenous vs subcutaneous administration of trastuzumab was analyzed with the answer to the questionnaire C2, question number 39 (All things considered, what method of administration do you prefer? Subcutaneous; Intravenous; No preference) of experiences and preferences of the patient.', ' Time frame: Up to 12 weeks', 'Results 1: ', ' Arm/Group Title: Arm A: T-IV + T-SC Vial + T-SC Device', ' Arm/Group Description: Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.', ' Overall Number of Participants Analyzed: 76', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Subcutaneous: 66 86.8%', ' Intravenous: 6 7.9%', ' No preference: 4 5.3%', 'Results 2: ', ' Arm/Group Title: Arm B: T-IV + T-SC Device + T-SC Vial', ' Arm/Group Description: Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.', ' Overall Number of Participants Analyzed: 83', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Subcutaneous: 71 85.5%', ' Intravenous: 5 6.0%', ' No preference: 7 8.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/81 (2.47%)', ' Heart failure 0/81 (0.00%)', ' Fever 1/81 (1.23%)', ' Cold 0/81 (0.00%)', ' Catheter related infection (Bacteriemia) 0/81 (0.00%)', ' Lack of strength in left leg 0/81 (0.00%)', ' Ostenecrosis produced by biphosphonates 0/81 (0.00%)', ' Gastric cancer 0/81 (0.00%)', ' Stroke 0/81 (0.00%)', ' Hematuria 1/81 (1.23%)', ' Nodule in left breast 0/81 (0.00%)', 'Adverse Events 2:', ' Total: 10/85 (11.76%)', ' Heart failure 1/85 (1.18%)', ' Fever 0/85 (0.00%)', ' Cold 1/85 (1.18%)', ' Catheter related infection (Bacteriemia) 1/85 (1.18%)', ' Lack of strength in left leg 1/85 (1.18%)', ' Ostenecrosis produced by biphosphonates 1/85 (1.18%)', ' Gastric cancer 1/85 (1.18%)', ' Stroke 1/85 (1.18%)', ' Hematuria 0/85 (0.00%)', ' Nodule in left breast 1/85 (1.18%)']}

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

2ea80a50-0db3-4ff2-8ca0-71eb048649f7

Comparison

Eligibility

NCT00880464

NCT00458237

Patients with AIDS are eligible for both the secondary trial and the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00880464', 'Intervention': ['INTERVENTION 1: ', ' Vaccine', 'Biological/Vaccine: Autologous, Lethally Irradiated Breast Cancer Cells Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out', ' Autologous, Lethally Irradiated Breast Cancer Cells: Vaccination with autologous tumor cells engineered by adenoviral mediated gene transfer to secrete GM-CS'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast cancer, pre-operative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging', ' Cohort 1: At least 2cm of residual disease in sum of diameters by clinical or radiographic findings following their preoperative chemotherapy', ' Cohort 2: Patients who have not received preoperative chemotherapy must have at least 4cm of disease in the largest diameter by clinical or radiographic findings', ' Prior therapy for Cohort 1 only: Must have completed preoperative (neoadjuvant) chemotherapy with either a standard regimen (containing an anthracycline and/or a taxane) or on a clinical trial', ' HER2 positive tumors must have received at least one prior trastuzumab-based therapy, and may not receive concurrent trastuzumab therapy and vaccination', ' Must initiate hormonal therapy (if indicated), including ovarian suppression, at least 4 weeks prior to initiation of vaccinations', ' Must have completed definitive resection of primary tumor with adequated excision of gross disease. Surgery should have occured more than 28 days but within 12 weeks prior to enrollment', ' May receive concurrent hormonal therapy, such as tamoxifen, ovarian suppression, and aromatase inhibitors', ' Must have had prior banked tumor of sufficient cellular yield for vaccination', ' ECOG Performance Status 0 or 1', ' 18 years of age or older', ' Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy', ' Adequate recovery from recent surgery and radiation therapy', 'Exclusion Criteria:', ' Uncontrolled active infection or illness', ' Other medical or psychiatric illness or social situation that would limit study compliance', ' Pregnancy or nursing mothers', ' Evidence of HIV infection', ' Previous participation in an adenovirus-based trial', ' Concurrent invasive malignancies'], 'Results': ['Outcome Measurement: ', ' Minimum Number of Vaccine Doses Created Using Participant Tumor Sample', ' Tumor samples were obtained via malignant effusion or a surgically accessible tumor nodule of 2 cm in greatest diameter. Tumor cells were processed to single cell suspension and transduced with adenoviral vector encoding human Granulocyte-macrophage colony-stimulating factor (GM-CSF). Then, the cells washed extensively and irradiated with 10,000 cGy. Over the next 14 days, sterility cultures were tested for endotoxin and mycoplasma contamination. Individual vaccine cell dose and number varied depending on the final cell yield from vaccine production. For stage II-III patients, the minimal dose was 1 x 10^5 cells and the maximal dose was 4 x 10^6 cells. For metastatic patients, the minimal dose was 1 x 10^5 cells and the maximal dose was 1 x 10^7 cells.', ' Time frame: 40 Months', 'Results 1: ', ' Arm/Group Title: Vaccine', ' Arm/Group Description: Biological/Vaccine: Autologous, Lethally Irradiated Breast Cancer Cells Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out', ' Autologous, Lethally Irradiated Breast Cancer Cells: Vaccination with autologous tumor cells engineered by adenoviral mediated gene transfer to secrete GM-CS', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: doses 6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/7 (14.29%)', ' Fatigue 1/7 (14.29%)']}

{'Clinical Trial ID': 'NCT00458237', 'Intervention': ['INTERVENTION 1: ', ' Phase I: Everolimus (Dose Level 1) and Trastuzumab', ' Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Phase I: Everolimus (Dose Level 2) and Trastuzumab', ' Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast cancer, with stage IV disease', ' Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as greater than or equal to 20mm with conventional techniques or as greater than or equal to 10mm with spiral CT scan.', ' Primary tumor or metastasis must overexpress HER2', ' Patient must have received 1-2 prior chemotherapeutic regiments for metastatic breast cancer and must have been off treatment for at least three weeks.', ' Patient must have received and progressed on at least 1 prior trastuzumab-containing regimen, but not more than 2, in the metastatic setting.', ' Patients may have received prior radiation therapy', ' Patients may have received hormonal therapy in the adjuvant or metastatic setting', ' 18 years of age or older', ' Life expectancy of greater than 6 months', ' Normal organ and marrow function as defined in the protocol', ' Left ventricular ejection fraction (LVEF) greater than or equal to the institutional lower limit of normal', 'Exclusion Criteria:', ' Treatment with any investigational drug within 4 weeks', ' Long-term treatment, over 3 months, with a systemic steroid or another immunosuppressive agent', ' Other malignancies within the past 3 years, except for adequately treated carcinoma of teh cervix or basal-or squamous-cell carcinoma of the skin', ' Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001', ' An active, bleeding diathesis or an oral anti-vitamin K medication', ' Prior treatment with an mTOR inhibitor', ' History of non-compliance with medical regimens', ' Unwillingness or inability to comply with the protocol', ' Major surgery within 2 weeks before study entry', ' Patients with active brain metastases or leptomeningeal carcinomatosis', ' Patients who have experienced grade 1 or grade 2 hypersensitivity reactions to prior trastuzumab therapy are eligible ONLY IF these reactions did not prevent further administration', ' Severe and/or uncontrolled intercurrent medical condition, psychiatric illness or a social situation that could limit their ability to comply with the study requirements.', ' Pregnant or breast-feeding women', ' HIV positive patients', ' Known hypersensitivity to RAD001 (everolimus) or other rapamycins'], 'Results': ['Outcome Measurement: ', ' Maximum Tolerated Dose (MTD)', ' The MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached. Dose Limiting Toxicities (DLTs) were defined as follows (CTCAE v4.0):', ' Any grade 4 hematologic toxicity, excluding anemia.', ' Any grade 3 or 4 nonhematologic toxicity, except for nausea, vomiting, diarrhea, or hyperlipidemia that responds promptly (within 24 hours for nausea, vomiting, and diarrhea and within 1 week for hyperlipidemia) to appropriate treatment, and except for cardiac toxicity which will be assessed after 12 weeks of treatment.', ' Need to hold >1 dose of trastuzumab or > 7 doses of RAD001 within the first 3 weeks because of the presence of toxicity.', ' Time frame: Cycle One (first 21 days of treatment)', 'Results 1: ', ' Arm/Group Title: Phase I: Everolimus (Dose Level 1) and Trastuzumab', ' Arm/Group Description: Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants with DLT 0', 'Results 2: ', ' Arm/Group Title: Phase I: Everolimus (Dose Level 2) and Trastuzumab', ' Arm/Group Description: Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: participants with DLT 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/3 (0.00%)', ' Muco/stomatitis (symptom) oral cavity 0/3 (0.00%)', ' Fatigue 0/3 (0.00%)', ' Vascular access-Thrombosis/embolism [1]0/3 (0.00%)', ' Leukocytes 0/3 (0.00%)', ' Lymphopenia 0/3 (0.00%)', ' Neutrophils 0/3 (0.00%)', ' Platelets 0/3 (0.00%)', ' Hypokalemia 0/3 (0.00%)', ' Thrombosis/thrombus/embolism [2]0/3 (0.00%)', 'Adverse Events 2:', ' Total: 1/3 (33.33%)', ' Muco/stomatitis (symptom) oral cavity 0/3 (0.00%)', ' Fatigue 0/3 (0.00%)', ' Vascular access-Thrombosis/embolism [1]0/3 (0.00%)', ' Leukocytes 0/3 (0.00%)', ' Lymphopenia 1/3 (33.33%)', ' Neutrophils 0/3 (0.00%)', ' Platelets 0/3 (0.00%)', ' Hypokalemia 0/3 (0.00%)', ' Thrombosis/thrombus/embolism [2]0/3 (0.00%)']}

20545360-b2a1-4be9-997a-97040866b239

Comparison

Results

NCT02425891

NCT00593827

the secondary trial and the primary trial both measure PFS of their patient cohorts and use the same time frame.

Contradiction

{'Clinical Trial ID': 'NCT02425891', 'Intervention': ['INTERVENTION 1: ', ' Placebo Plus Nab-Paclitaxel', ' Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Atezolizumab Plus Nab-Paclitaxel', ' Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression', ' No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC', ' Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)', ' A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 20 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at baseline, and not fewer than 12 unstained slides will be eligible upon discussion with Medical Monitor', ' Eastern Cooperative Oncology Group performance status of 0 or 1', ' Measurable disease as defined by RECIST v1.1', ' Adequate hematologic and end-organ function', 'Exclusion Criteria:', ' Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases', ' Leptomeningeal disease', ' Pregnancy or lactation', ' History of autoimmune disease', ' Prior allogeneic stem cell or solid organ transplantation', ' Positive test for human immunodeficiency virus', ' Active hepatitis B or hepatitis C', ' Receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during treatment, or within 5 months following the last dose of atezolizumab/placebo'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants', ' PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.', ' Time frame: Baseline up to approximately 34 months', 'Results 1: ', ' Arm/Group Title: Placebo Plus Nab-Paclitaxel', ' Arm/Group Description: Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 451', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 5.49 (5.32 to 5.59)', 'Results 2: ', ' Arm/Group Title: Atezolizumab Plus Nab-Paclitaxel', ' Arm/Group Description: Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 451', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 7.16 (5.59 to 7.46)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 110/460 (23.91%)', ' ANAEMIA 1/460 (0.22%)', ' FEBRILE NEUTROPENIA 5/460 (1.09%)', ' HAEMOLYSIS 0/460 (0.00%)', ' LEUKOCYTOSIS 0/460 (0.00%)', ' NEUTROPENIA 1/460 (0.22%)', ' PANCYTOPENIA 1/460 (0.22%)', ' ACUTE MYOCARDIAL INFARCTION 0/460 (0.00%)', ' ANGINA UNSTABLE 1/460 (0.22%)', ' ARRHYTHMIA 1/460 (0.22%)', ' ATRIAL FIBRILLATION 1/460 (0.22%)', ' CARDIAC FAILURE 0/460 (0.00%)', 'Adverse Events 2:', ' Total: 80/430 (18.60%)', ' ANAEMIA 1/430 (0.23%)', ' FEBRILE NEUTROPENIA 1/430 (0.23%)', ' HAEMOLYSIS 1/430 (0.23%)', ' LEUKOCYTOSIS 1/430 (0.23%)', ' NEUTROPENIA 0/430 (0.00%)', ' PANCYTOPENIA 0/430 (0.00%)', ' ACUTE MYOCARDIAL INFARCTION 1/430 (0.23%)', ' ANGINA UNSTABLE 0/430 (0.00%)', ' ARRHYTHMIA 1/430 (0.23%)', ' ATRIAL FIBRILLATION 2/430 (0.47%)', ' CARDIAC FAILURE 2/430 (0.47%)']}

{'Clinical Trial ID': 'NCT00593827', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone 16 mg/m^2', ' ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest', 'INTERVENTION 2: ', ' Ixabepilone 40 mg/m^2', ' ixabepilone 40 mg/m^2 every 3 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) 50', ' Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer', ' Prior chemotherapy is permitted with no limit on the number of prior regimens', ' Two weeks or more have elapsed since last chemotherapy or radiation treatment', ' Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2', ' Is female, 18 yrs of age', ' Protocol defined appropriate laboratory values', ' Negative pregnancy test within 7 calendar days prior to registration', ' Has signed a patient informed consent', 'Exclusion Criteria:', ' Had prior treatment with ixabepilone or other epothilones', ' Has HER2+ disease', ' Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events [NCI CTCAE] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)', ' Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy', ' Is receiving concurrent investigational therapy or has received such therapy within the past 30 days', ' Has peripheral neuropathy > Grade 1', ' Has evidence of central nervous system (CNS) involvement requiring radiation or steroid treatment. Participants with stable brain metastases who are off steroids at least 2 weeks are eligible', ' Is pregnant or breast feeding'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months', ' PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.', ' Time frame: From the date of randomization to 6-months on study', 'Results 1: ', ' Arm/Group Title: Ixabepilone 16 mg/m^2', ' Arm/Group Description: ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest', ' Overall Number of Participants Analyzed: 85', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 28.6 (18.9 to 38.9)', 'Results 2: ', ' Arm/Group Title: Ixabepilone 40 mg/m^2', ' Arm/Group Description: ixabepilone 40 mg/m^2 every 3 weeks', ' Overall Number of Participants Analyzed: 91', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants 42.7 (31.5 to 53.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 25/82 (30.49%)', ' neutropenia 1/82 (1.22%)', ' anemia 1/82 (1.22%)', ' thrombocytopenia 1/82 (1.22%)', ' febrile neutropenia 0/82 (0.00%)', ' tachycardia 3/82 (3.66%)', ' fibrillation atrial 0/82 (0.00%)', ' supraventricular tachycardia 1/82 (1.22%)', ' ventricular tachycardia 1/82 (1.22%)', ' angina attack 0/82 (0.00%)', ' congestive heart failure 0/82 (0.00%)', ' flutter atrial 0/82 (0.00%)', 'Adverse Events 2:', ' Total: 30/89 (33.71%)', ' neutropenia 5/89 (5.62%)', ' anemia 1/89 (1.12%)', ' thrombocytopenia 1/89 (1.12%)', ' febrile neutropenia 2/89 (2.25%)', ' tachycardia 1/89 (1.12%)', ' fibrillation atrial 1/89 (1.12%)', ' supraventricular tachycardia 0/89 (0.00%)', ' ventricular tachycardia 0/89 (0.00%)', ' angina attack 1/89 (1.12%)', ' congestive heart failure 1/89 (1.12%)', ' flutter atrial 1/89 (1.12%)']}

3b1bdc19-62cd-4ff1-9e30-424e124342f3

Comparison

Adverse Events

NCT01466972

NCT01446159

the primary trial recorded one patient with congestive heart failure, the secondary trial did not record any.

Entailment

{'Clinical Trial ID': 'NCT01466972', 'Intervention': ['INTERVENTION 1: ', ' Pazopanib in Combination With a NSAI', ' Non-randomized, open label', ' Pazopanib: Oral, 800mg tablet daily per cycle'], 'Eligibility': ['Inclusion Criteria:', ' Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up.', ' - Procedures conducted as a part of routine clinical management of the subject (e.g., blood count, imaging study) and obtained prior to signed informed consent may be utilized for Screening or Baseline purposes provided these tests are obtained as specified in the protocol).', ' Subjects must have measurable or evaluable disease. Disease sites that are evaluable for progression but not measurable per RECIST guidelines include:', ' Bone lesions', ' Previously irradiated lesions', ' Cutaneous manifestations (non-discreet lesions only)', ' Age 18 years.', ' Postmenopausal women defined by one of the criteria:', ' No spontaneous menses for at least 12 months if the subject is 50 years old;', ' Amenorrheic for at least 12 months if the subject is < 50 years old, with serum estradiol within the institutional postmenopausal range;', ' Bilateral oophorectomy;', ' If prior hysterectomy but intact ovaries, must be 55 years old, or have serum estradiol within the postmenopausal range;', ' If premenopausal, must be on a GnRH agonist (leuprolide or goserelin) with serum estradiol levels within the institutional postmenopausal range.', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2.', ' Histologically or cytologically confirmed estrogen receptor (ER) and/or progesterone receptor (PgR) positive carcinoma of the breast with unresectable, locally advanced and/or metastatic (AJCC Stage IV) disease.', ' Subjects must have received prior hormonal therapy for the treatment of breast cancer as follows:', ' Progression must be documented while taking a nonsteroidal aromatase inhibitor including anastrozole or letrozole.', ' No more than 2 prior hormonal therapies for metastatic disease.', ' If hormonal therapy was administered in the adjuvant setting, subjects must have received therapy for at least 6 months prior to developing metastatic disease.', ' Note: A regimen of sequential tamoxifen/AI in the adjuvant setting is considered to be one therapy', ' - If hormonal therapy was administered in the metastatic setting, subjects must have received therapy for at least 3 months prior to progression', ' Subjects whose tumors overexpress ErbB2 are eligible provided that they have progressed following therapy which included trastuzumab and/or lapatinib.', ' Note for prior lapatinib: Subjects must have completed therapy with lapatinib at least 7 days prior to the first dose of study drug.', ' Note for prior trastuzumab: Subjects who received Q3 weekly, Q2 weekly or Q1 weekly must have completed therapy with trastuzumab at least 3 weeks, 2 weeks or 1 week, respectively, prior to the first dose of study drug.', ' Adequate hematologic and hepatic function as defined in Protocol Table 1', ' Subjects must have discontinued hormone replacement therapy (HRT) (e.g., conjugated estrogens tablets, USP or premarin), at least 28 days prior to receiving the first dose of randomized therapy.', ' Radiotherapy prior to initiation of therapy is allowed to a limited area (e.g., palliative treatment for painful bone metastases), if it is not the sole site of disease. Subjects must have completed treatment at least one week prior to starting study drugs, and must have recovered from all treatment-related toxicities.', ' Bisphosphonate or RANK ligand inhibitor therapy for bone metastases is allowed. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, is not permitted;', ' Ability to swallow and retain oral medication.', 'Exclusion Criteria:', ' Prior use of pazopanib', ' Premenopausal levels of estradiol, or ongoing menses (see definitions of menopause above).', ' Known central nervous system (CNS) metastases or leptomeningeal carcinomatosis. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if the subject has clinical findings suggestive of CNS metastasis.', ' History of another active malignancy. Note: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.', ' Clinically significant gastrointestinal abnormalities which might interfere with oral dosing, including, but not limited to:', ' Malabsorption syndrome', ' Major resection of the stomach or small bowel that could affect the absorption of study drug', ' Inflammatory bowel disease', ' Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation', ' History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment', ' Presence of uncontrolled infection.', ' Prolongation of corrected QT interval (QTc) >480msecs.', ' History of any one or more of the following cardiovascular conditions within the past 6 months:', ' Angioplasty or stenting', ' Myocardial infarction', ' Unstable angina', ' Coronary artery by-pass graft surgery', ' Symptomatic peripheral vascular disease', ' Class II, III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).', ' Use of an investigational agent, including an investigational anti-cancer agent, within 14 days prior to the first dose of study drug.', ' Prior use of an investigational drug that targets VEGF or VEGF receptors.', ' Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity.', ' Poorly controlled hypertension (defined as systolic blood pressure (SBP) of 140mmHg or diastolic blood pressure (DBP) of 90mmHg).', ' Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure must be re-assessed prior to start of study therapy. The mean SBP/DBP values must be <140/90mmHg (OR 150/90mmHg, if this criterion is approved by Safety Review Team) in order for a subject to be eligible for the study.', ' History of cerebrovascular accident (CVA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.', ' Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulant agents for at least 6 weeks are eligible.', ' Major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer not related to cancer (procedures such as catheter placement not considered to be major).', ' Evidence of active bleeding or bleeding diathesis.', " Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures"], 'Results': ['Outcome Measurement: ', ' Number of Participants With Clinical Benefit (CB)', ' For the purpose of this study, participants who obtained a complete response (CR), partial response (PR), or stable disease (SD) at 12 weeks per Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 were defined as having a clinical benefit from the treatment. An overall response rate of 20% was considered to be clinically meaningful. All participants who take at least two weeks of study drug and the non-steroidal aromatase inhibitor were evaluated for toxicity and efficacy', ' Time frame: 12 weeks', 'Results 1: ', ' Arm/Group Title: Pazopanib in Combination With a NSAI', ' Arm/Group Description: Non-randomized, open label', ' Pazopanib: Oral, 800mg tablet daily per cycle', ' Overall Number of Participants Analyzed: 28', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 13 46.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/30 (26.67%)', ' Heart Failure 1/30 (3.33%)', ' Vertigo 1/30 (3.33%)', ' Small intestinal obstruction 1/30 (3.33%)', ' Fever 1/30 (3.33%)', ' Aspartate aminotransferase increased 1/30 (3.33%)', ' Alanine aminotransferase increased 1/30 (3.33%)', ' Back Pain 1/30 (3.33%)', ' Pleural effusion 1/30 (3.33%)', ' Rash maculo-papular 1/30 (3.33%)', ' Hypotension 1/30 (3.33%)']}

{'Clinical Trial ID': 'NCT01446159', 'Intervention': ['INTERVENTION 1: ', ' MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', " Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.", 'INTERVENTION 2: ', ' MEDI-573 30 mg/kg + AI', ' Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically-confirmed MBC not deemed amenable to curative surgery or curative radiation therapy', ' Tumors are positive for ER, PgR, or both', ' Tumors must be negative for HER2 (by FISH, CISH or IHC)', ' Female gender and age 18 years at time of study entry', ' Postmenopausal', ' Karnofsky Performance Status 70', ' Life expectancy of 6 months', 'Exclusion Criteria:', ' Subjects who received prior chemotherapy, hormonal therapy, immunotherapy or biologic therapy for advanced or metastatic disease with the following exceptions:', ' Prior adjuvant therapy with an AI and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of MEDI-573', ' Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed', ' Extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or disease that is considered by the investigator to be rapidly progressing or life threatening (eg, subjects who are intended for chemotherapy)', ' Active brain metastases with the exception of subject has been treated and are asymptomatic and there has been no evidence of CNS progression for at least 4 weeks of first dose of MEDI-573', ' Evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis', ' Unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to Grade 1 at the time of starting study treatment', ' Previous treatment with agents that target the IGF receptor', ' History of allergy or reaction attributed to compounds of chemical or biologic composition similar to those of MEDI-573 or AI', ' History of another invasive malignancy within 5 years except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the cervix', ' Poorly controlled diabetes mellitus'], 'Results': ['Outcome Measurement: ', ' Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', ' An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).', ' Time frame: From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)', 'Results 1: ', ' Arm/Group Title: MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)', " Arm/Group Description: Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.", ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Any TEAEs: 3 100.0%', ' Any TESAEs: 2 66.7%', 'Results 2: ', ' Arm/Group Title: MEDI-573 30 mg/kg + AI', ' Arm/Group Description: Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Any TEAEs: 3 100.0%', ' Any TESAEs: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/3 (66.67%)', ' Febrile neutropenia 1/3 (33.33%)', ' Atrial flutter 0/3 (0.00%)', ' Atrial fibrillation 0/3 (0.00%)', ' Cardiac failure 0/3 (0.00%)', ' Sinus bradycardia 1/3 (33.33%)', ' Supraventricular tachycardia 0/3 (0.00%)', ' Abdominal pain upper 0/3 (0.00%)', ' Dysphagia 0/3 (0.00%)', ' Intestinal mass 0/3 (0.00%)', ' Pancreatitis acute 0/3 (0.00%)', ' Small intestinal obstruction 0/3 (0.00%)', 'Adverse Events 2:', ' Total: 0/3 (0.00%)', ' Febrile neutropenia 0/3 (0.00%)', ' Atrial flutter 0/3 (0.00%)', ' Atrial fibrillation 0/3 (0.00%)', ' Cardiac failure 0/3 (0.00%)', ' Sinus bradycardia 0/3 (0.00%)', ' Supraventricular tachycardia 0/3 (0.00%)', ' Abdominal pain upper 0/3 (0.00%)', ' Dysphagia 0/3 (0.00%)', ' Intestinal mass 0/3 (0.00%)', ' Pancreatitis acute 0/3 (0.00%)', ' Small intestinal obstruction 0/3 (0.00%)']}

a44cd0d1-92b3-4add-badf-b8dd5a324138

Comparison

Intervention

NCT01738438

NCT00331552

Cyclophosphamide, Cabozantinib and Trastuzumab were used in the secondary trial intervention, but not in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01738438', 'Intervention': ['INTERVENTION 1: ', ' Cabozantinib', ' Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast cancer with stage IV disease', ' Primary tumor and/or metastasis must be ER-negative, PR-negative and HER2-negative', ' May have received 0-3 prior chemotherapeutic regimens for metastatic breast cancer. Must be off treatment for at least 21 days prior to enrollment', ' Must have discontinued all biologic therapy at least 14 days before enrollment', ' May have received prior radiation therapy in the early stage or metastatic setting, but must have completed treatment at least 14 days prior to enrollment', ' Must agree to use medically acceptable methods of contraception', ' Confirmed availability of formalin-fixed, paraffin-embedded tumor tissue', ' Able to swallow tablets', 'Exclusion Criteria:', ' Pregnant or breastfeeding', ' Received another investigational agent within 14 days prior to enrollment', ' Received prior c-Met inhibitor', ' Known brain metastases that are untreated, symptomatic or require therapy to control symptoms', ' Psychiatric illness or social situation that could limit ability to comply with study requirements', ' Require concomitant treatment in therapeutic doses with anticoagulants or antiplatelet agents', ' Diagnosis of another malignancy requiring systemic treatment within the last two years (except non-melanoma skin cancer or in-situ carcinoma of the cervix)', ' Known to be positive for HIV', ' Active infection requiring IV antibiotics at Day 1 of cycle 1', ' Uncontrolled, significant intercurrent illness', ' Requires chronic concomitant treatment of a strong CYP3A4 inducer', ' tumor in contact with, invading or encasing major blood vessels', ' Have experienced clinically significant gastrointestinal bleeding within 6 months, hemoptysis of more than 0.5 teaspoon of red blood within 3 months or other signs indicative of pulmonary hemorrhage within 3 months of enrollment'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate', ' The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) on treatment based on RECIST1.1 criteria. For target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Confirmatory scans were required 3 weeks following initial documentation.', ' Time frame: Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).', 'Results 1: ', ' Arm/Group Title: Cabozantinib', ' Arm/Group Description: Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Number', ' Unit of Measure: proportion of participants 0.09 (0.02 to 0.26)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/35 (40.00%)', ' Infections and infestations - Other 1/35 (2.86%)', ' Wound dehiscence 1/35 (2.86%)', ' Activated partial thromboplastin time prolonged 1/35 (2.86%)', ' Alanine aminotransferase increased 1/35 (2.86%)', ' Aspartate aminotransferase increased 2/35 (5.71%)', ' Lipase increased 3/35 (8.57%)', ' Hypophosphatemia 1/35 (2.86%)', ' Bone pain 2/35 (5.71%)']}

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

291bb67e-f02f-49d4-b967-29cc9f5098c4

Comparison

Eligibility

NCT00274768

NCT00654836

Patients with stage 4 cancer are eligible for the secondary trial and the primary trial.

Entailment

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

{'Clinical Trial ID': 'NCT00654836', 'Intervention': ['INTERVENTION 1: ', ' Carboplatin, ABI-007 and Bevacizumab', " Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15."], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically or cytologically confirmed primary adenocarcinoma of the breast', ' Locally recurrent or metastatic disease', ' Must have HER-2-negative breast cancer or, if HER-2-positive, must be unable to receive trastuzumab (Herceptin®) or have previously received trastuzumab in the past', ' Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm by conventional techniques or as > 10 mm by spiral CT scan.', ' No known CNS disease', ' Hormone receptor status not specified', ' PATIENT CHARACTERISTICS:', 'Inclusion criteria:', ' Postmenopausal status not specified', ' ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%', ' Life expectancy > 12 weeks', ' WBC 3,000/mcL', ' Absolute neutrophil count 1,500/mcL', ' Platelet count 100,000/mcL', ' Total bilirubin normal', ' AST and ALT 2.5 times upper limit of normal (ULN)', ' Alkaline phosphatase 2.5 times ULN (unless bone metastasis is present in the absence of liver metastasis)', ' Creatinine 1.5 mg/dL', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No other concurrent malignancies within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix', 'Exclusion criteria:', ' Pre-existing neuropathy grade 1', ' Uncontrolled intercurrent illness including, but not limited to, any of the following:', ' Ongoing or active infection', ' Symptomatic congestive heart failure', ' Unstable angina pectoris', ' Cardiac arrhythmia', ' Serious, non-healing wound, ulcer, or bone fracture', ' Psychiatric illness/social situations that would limit compliance with study requirements', ' Inadequately controlled hypertension (defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications)', ' History of hypertensive crisis or hypertensive encephalopathy', ' New York Heart Association class II-IV congestive heart failure', ' History of myocardial infarction or unstable angina within the past 6 months', ' History of stroke or transient ischemic attack within the past 6 months', ' Significant vascular disease (e.g., aortic aneurysm, aortic dissection)', ' Symptomatic peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Significant traumatic injury within the past 28 days', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months', ' Proteinuria, as demonstrated by either urine protein:creatinine ratio 1.0 OR urine dipstick for proteinuria 2+', ' Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline must demonstrate 24-hour urine protein 1g', ' History of allergy or hypersensitivity to paclitaxel albumin-stabilized nanoparticle formulation, paclitaxel, bevacizumab, carboplatin, albumin, drug product excipients, or chemically similar agents', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' Recovered from all prior therapy', ' No prior chemotherapy for locally recurrent or metastatic disease', ' Prior neoadjuvant or adjuvant chemotherapy allowed', ' More than 1 week since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device', ' More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy', ' More than 4 weeks since prior radiotherapy', ' More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)', ' At least 1 year since prior taxane regimen', ' No other concurrent investigational agents', ' Concurrent anticoagulation allowed, provided the following criteria are met:', ' Stable dose of warfarin or low molecular weight heparin', ' INR within desired range (2-3)', ' No evidence of active bleeding or coagulopathy', ' No concurrent combination antiretroviral therapy for HIV-positive patients', ' No other concurrent radiotherapy, chemotherapy, immunotherapy, or antitumor hormonal therapy'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' Progression-free survival was measured from treatment initiation to 30 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', ' Time frame: 30 Months', 'Results 1: ', ' Arm/Group Title: Carboplatin, ABI-007 and Bevacizumab', " Arm/Group Description: Participants received combination carboplatin, ABI-007 (i.e., a nanoparticle albumin-bound paclitaxel also called Abraxane), and bevacizumab (Avastin). Bevacizumab was administered as 15 mg/kg on days 1, 22, and 43 for patients without hematologic toxicity. For those with hematologic toxicity, bevacizumab was administered as 10mg/kg on day 1 and 15. Similarly, for patients without hematologic toxicity, a standard carboplatin dose according to the participant's area under the plasma drug concentration-time curve (AUC-6) was administered on days 1, 22, and 43. For patients with a hematologic toxicity, carboplatin was only given on day 1. Finally, for those without hematologic toxicity, ABI-007 (Abraxane) 100mg/m2 was administered on days 1,8, 15, 22, 29, 36,43,and 50. Conversely, for patients with hematologic toxicity, Abraxane was administered as 100mg/m2 only on days 1, 8, and 15.", ' Overall Number of Participants Analyzed: 32', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 16 (9.80 to 22.20)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 24/32 (75.00%)', ' Disease Progression * [1]24/32 (75.00%)']}

55704a1f-eab2-44ea-a6de-8df508a28066

Comparison

Eligibility

NCT01593020

NCT00834678

Patients with aspartate aminotransferase more than 3 times the upper limit of normal are excluded from both the secondary trial and the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01593020', 'Intervention': ['INTERVENTION 1: ', ' Paclitaxel Weekly for 12 Doses Followed by FAC/FEC', ' Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.', 'INTERVENTION 2: ', ' Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC', ' Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.'], 'Eligibility': ['Inclusion Criteria:', ' Signed written informed consent', ' Histologically confirmed primary invasive adenocarcinoma of the breast.', ' Clinical stage breast cancer T2-3, N0-3, M0', ' Negative HER-2/neu expression as determined by local hospital laboratory using Fluorescence In Situ Hybridization (FISH), or is less or equal to 1+ using Immunohistochemistry (IHC).', ' No prior treatment for primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy or surgery. Subjects receiving hormone replacement treatment (HRT) are eligible if this therapy is discontinued at least 2 weeks before starting study treatment. Treatment for DCIS is allowed, such as surgery, hormonal therapy and radiotherapy.', ' Karnofsky performance status (KPS) of 80 - 100', ' The ability and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.', ' Baseline MUGA or echocardiogram scans with LVEF of > 50%.', ' Normal PTT and either INR or PT < 1.5 x ULN.', ' Men or women 18 years of age or older.', ' Women of childbearing potential (WOCBP) must agree to use a medically acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drugs.', ' Willingness to have core biopsies and/or FNA performed before the start of study treatment and at the end of 12 week on treatment.', 'Exclusion Criteria:', ' Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast-feeding.', ' Disease free of prior malignancy for < 5 years with the exception of DCIS, curatively treated basal carcinoma of the skin, local skin squamous cell carcinoma, or carcinoma in situ of the cervix.', ' Absolute neutrophils count (ANC) < 1500/mm^3', ' Total bilirubin > 1.5 times the upper limit of normal (ULN)', ' AST or ALT > 2.5 times the upper limit of normal (ULN)', ' Platelets < 100,000/mm^3.', ' Serum creatinine > 1.5 x ULN or creatinine clearance < 60 mL/min (measured or calculated by Cockcroft-Galt method)', ' Evidence of metastatic breast cancer following a standard tumor staging work-up', ' Evidence of inflammatory breast cancer.', ' Evidence of any grade 2 sensory or motor neuropathy.', ' Known human immunodeficiency viral (HIV) infection', ' Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy.', ' Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocols.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response (pCR)', ' Pathologic complete response (pCR) defined as complete absence of any viable invasive cancer cells in the resected breast and lymph nodes. Participants undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. Tumors removed by either lumpectomy with axillary dissection (i.e. breast conservation surgery) or modified radical mastectomy (i.e. mastectomy with axillary clearance). Surgical specimens (breast and axillary lymph node tissue) evaluated for pathological complete response.', ' Time frame: 4 -6 weeks from last dose of FAC/FEC-regimen.', 'Results 1: ', ' Arm/Group Title: Paclitaxel Weekly for 12 Doses Followed by FAC/FEC', ' Arm/Group Description: Patients will receive Paclitaxel 80 mg/m2 IVPB over 1 hour weekly for 12 doses followed by FAC/FEC.', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 7 26.9%', 'Results 2: ', ' Arm/Group Title: Eribulin on Days 1 and 8 Every 3 Weeks for 4 Cycles (21 Day Cycle) Followed by FAC/FEC', ' Arm/Group Description: Patients will receive eribulin 1.4 mg/m2 IV infusion or per institutional guidelines over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle) followed by FAC/FEC.', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 4.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/28 (10.71%)', ' Neutrophil count decreased 3/28 (10.71%)', ' White blood cell decreased 0/28 (0.00%)', ' Left ventricular systolic dysfunction 1/28 (3.57%)', ' Nausea 1/28 (3.57%)', ' Vomiting 0/28 (0.00%)', ' Fatigue 2/28 (7.14%)', ' Alanine aminotransferase increased 0/28 (0.00%)', ' Aspartate aminotransferase increased 0/28 (0.00%)', ' Myalgia 0/28 (0.00%)', ' Paresthesia 1/28 (3.57%)', 'Adverse Events 2:', ' Total: 9/23 (39.13%)', ' Neutrophil count decreased 9/23 (39.13%)', ' White blood cell decreased 1/23 (4.35%)', ' Left ventricular systolic dysfunction 0/23 (0.00%)', ' Nausea 0/23 (0.00%)', ' Vomiting 1/23 (4.35%)', ' Fatigue 1/23 (4.35%)', ' Alanine aminotransferase increased 1/23 (4.35%)', ' Aspartate aminotransferase increased 1/23 (4.35%)', ' Myalgia 1/23 (4.35%)', ' Paresthesia 0/23 (0.00%)']}

{'Clinical Trial ID': 'NCT00834678', 'Intervention': ['INTERVENTION 1: ', ' Bendamustine and Erlotinib', ' Participants in dose level I were administered 100 mg/m^2 IV of Bendamustine on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.', ' Participants in dose level II were administered 120 mg/m^2 IV of Bendamustine on days 1 and 2 and 150 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast cancer meeting 1 of the following criteria:', ' Unresectable stage IIIB or IIIC disease', ' Stage IV disease', ' Must be negative for all of the following:', ' Estrogen receptor (< 10%)', ' Progesterone receptor (<10%)', ' HER-2 (negative FISH, IHC 0 - 1+, or IHC +2 with negative FISH)', ' Measurable or evaluable disease', ' No symptomatic or progressive CNS (central nervous system) metastases', ' Previously treated CNS metastases allowed provided all of the following criteria are met:', ' At least 8 weeks since prior radiation to brain or CNS metastases', ' No concurrent steroids', ' No leptomeningeal disease', ' PATIENT CHARACTERISTICS:', ' Menopausal status not specified', ' ECOG (Eastern Cooperative Oncology Group) performance status 0-2', ' Life expectancy 6 months', ' WBC > 1,500/mm³', ' Platelet count > 100,000/mm³', ' Creatinine clearance > 40 mL/min', ' Normal electrolytes (i.e., Na, K, and Ca normal; minor deviations are allowed if they do not impact on patient safety in the clinical judgment of the treating physician)', ' Bilirubin 1.5 times upper limit of normal (ULN)', ' ALT and AST 2.5 times ULN ( 5 times ULN in the presence of documented liver metastases)', ' Alkaline phosphatase 2.5 times ULN ( 5 times ULN in the presence of liver or bone metastases)', ' Not pregnant or nursing', ' Fertile patients must use effective barrier contraception', ' No uncontrolled intercurrent illness', ' No active infection requiring systemic therapy', ' Able to swallow oral medications and with no medical problems or prior surgeries that may interfere with the absorption of oral medications including the following:', ' Uncontrolled nausea, vomiting, or diarrhea', ' Lack of the physical integrity of the upper gastrointestinal tract', ' Malabsorption syndrome', ' No known hypersensitivity to bendamustine hydrochloride, mannitol, or erlotinib hydrochloride', ' No prior malignancy in the past 5 years except for adequately treated basal cell or squamous cell skin carcinoma, or adequately treated stage I-II cancer for which the patient is in complete remission', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' Prior adjuvant or neoadjuvant chemotherapy and 1 prior chemotherapy regimen in the metastatic setting allowed provided recovered from all acute toxicities', ' No prior bendamustine hydrochloride or EGFR-directed therapy', ' No other concurrent antineoplastic treatments, including radiotherapy, chemotherapy, biological therapy, hormonal therapy, immunotherapy, gene therapy, and surgery', ' Intravenous bisphosphonates allowed', ' No concurrent antiretroviral therapy for HIV-positive patients', ' No other concurrent investigational agents'], 'Results': ['Outcome Measurement: ', ' Maximum-tolerated Dose of Bendamustine Hydrochloride (Phase I)', ' 28 day cycle included intravenous bendamustine on days 1 and 2.', ' Time frame: Up to two years', 'Results 1: ', ' Arm/Group Title: Bendamustine and Erlotinib', ' Arm/Group Description: Participants in dose level I were administered 100 mg/m^2 IV of Bendamustine on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.', ' Participants in dose level II were administered 120 mg/m^2 IV of Bendamustine on days 1 and 2 and 150 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.', ' Overall Number of Participants Analyzed: 11', ' Measure Type: Number', ' Unit of Measure: mg/m^2 120'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/11 (27.27%)', ' Infection 3/11 (27.27%)']}

6e1955b8-e6fa-42b2-a498-7ada9e733304

Single

Eligibility

NCT00821886

Patients prescribed with bisoprolol or labetalol to treat CHF are eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00821886', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone/Trastuzumab/Carboplatin', ' Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate', ' Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)', ' Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52', ' Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)'], 'Eligibility': ['Inclusion Criteria:', ' Female and male patients 18 years of age.', ' Histologically confirmed adenocarcinoma of the breast.', ' Primary palpable disease confined to a breast and axilla on physical examination. For patients without clinically suspicious axillary adenopathy, the primary tumor must be larger than 2 cm in diameter (clinical T2-T3, N0-N1, M0). For patients with clinically suspicious axillary adenopathy, the primary breast tumor can be any size (clinical T1-T3, N1-N2, M0). (T1N0M0 lesions are excluded.)', ' Patients who have no clearly defined palpable breast mass or axillary lymph nodes but are radiographically measurable are eligible. Accepted procedures for measuring breast disease are mammography, MRI, and breast ultrasound. In these patients, radiographic tumor measurements need to be repeated after 3 cycles and prior to surgery.', ' Positive HER2 status (overexpression and/or amplification of HER2 in the primary tumor) as defined by: IHC 3+ or fluorescence in situ hybridization (FISH) positive (ratio >2.2) testing. Documentation of the HER2 results must be available at the time of study enrollment.', ' An ECOG (Eastern Cooperative Oncology Group) performance score of 2', ' Normal bone marrow function as defined by:', ' absolute neutrophil count (ANC) >1,500/µL;', ' platelets >100,000/µL;', ' hemoglobin >10 g/dL.', ' Normal hepatic and renal function.', ' Left ventricular ejection fraction (LVEF) within the institutional limits of normal, whichever is lower, as measured by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO).', ' Life expectancy > 12 weeks.', ' Estrogen and progesterone (or estrogen alone) receptor status in the primary tumor known or pending at the time of study enrollment.', ' For women of childbearing potential, negative serum pregnancy test within 7 days prior to starting treatment.', ' For women of childbearing potential, agreement to use a method of contraception that is acceptable to their physician from time of first signing the informed consent until at least 3 months after the last dose of study drug. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately. Patient agreement to discontinue breast-feeding, if applicable, during study treatment. Men enrolled in the study must also agree to use a method of contraception that is acceptable to their physician during their study participation.', ' For patients with previous invasive cancers (including breast cancer) treated with curative intent, completion of chemotherapy or radiation therapy more than 5 years prior to enrollment for this study and no evidence of recurrent disease. Patients may be receiving anti-estrogen hormonal therapy prescribed for previous invasive breast cancer as long as the diagnosis of invasive cancer was made more than 5 years prior to study enrollment. Patients may be using anti-estrogen hormonal therapy at the time of current diagnosis but must discontinue this therapy before beginning study treatment.', ' For patients who had, or will have sentinel lymph node and/or axillary dissection prior to initiation of study treatment, completion at least 4 weeks prior to starting study treatment and well-healed wound.', ' Ability to understand and willingness to sign a written informed consent document.', 'Exclusion Criteria:', ' Previous treatment for this breast cancer.', ' Evidence of metastatic disease.', ' Prior radiation that included 30% of major bone marrow-containing areas.', ' Women who are pregnant or breastfeeding.', ' Neuropathy (motor or sensory) grade 1 at study entry.', ' History of significant cardiac disease or cardiac risk factors or the following:', ' uncontrolled arrhythmias', ' poorly controlled hypertension (e.g., systolic blood pressure [BP]> 150 mmHg or diastolic BP >100 mmHg) in spite of optimal medical management', ' angina pectoris requiring antianginal medication or unstable angina within the previous 6 months', ' history of documented congestive heart failure (CHF)', ' any documented myocardial infarction within the previous 6 months', ' clinically significant valvular heart disease', ' current use of medications (e.g., digitalis, beta-blockers, calcium channel-blockers) that alter cardiac conduction, if these medications are administered for the management of cardiac arrhythmia, angina, or CHF. If these medications are administered for other reasons (e.g., hypertension), the patient may be eligible.', ' patients with cardiomegaly on chest x-ray or ventricular hypertrophy on ECG unless ECHO or MUGA scan within the last 3 months demonstrates that the LVEF is institutional lower limit of normal.', ' Symptomatic intrinsic lung disease.', ' Active malignancy, other than superficial basal cell carcinoma, superficial squamous (skin) cell carcinoma, carcinoma in situ, or non-invasive breast cancer, within the past 5 years.', ' Uncontrolled intercurrent illness including (but not limited to) ongoing or active infection >grade 2.', ' Mental condition or psychiatric disorder rendering the subject unable to understand the nature, scope, and possible consequences of the study or that would limit compliance with study requirements.', ' Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving a reasonable suspicion of a disease or condition that contraindicates the use of a study agent or that may affect the interpretation of the results or renders the subjects at high risk from treatment complications.', ' Chronic use of CYP3A4 inhibitors and use of the following strong CYP3A4 inhibitors: ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine, and voriconazole. Use of these agents must be discontinued at least 72 hours prior to initiation of study treatment.', ' Received chemotherapy for any indication within the 5 years preceding study enrollment.', ' Prior treatment with trastuzumab or any other anti-HER2 agent for any indication.', ' Concurrent treatment with any other anti-cancer therapy.', ' Concurrent radiation therapy during neoadjuvant study treatment.', ' Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment must be stopped prior to study enrollment.', ' Current therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention of breast cancer. These agents must be discontinued prior to study enrollment.', ' Participation within the previous 30 days in a study with an experimental drug.', ' Known or suspected allergy to Cremophor EL (polyoxyethylated castor oil), a drug formulated in Cremophor EL such as paclitaxel, or any other agent given in the course of this trial.', ' Inability or unwillingness to comply with study procedures including those for follow-up.'], 'Results': ['Outcome Measurement: ', ' Pathologic Complete Response (pCR)', ' Proportion of patients who do not exhibit residual invasive breast cancer in breast or axillary lymph nodes at time of surgery', ' Time frame: average18 months', 'Results 1: ', ' Arm/Group Title: Ixabepilone/Trastuzumab/Carboplatin', ' Arm/Group Description: Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate', ' Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)', ' Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52', ' Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: participants 27'], 'Adverse Events': ['Adverse Events 1:', ' Total: 17/58 (29.31%)', ' Febrile Neutropenia 4/58 (6.90%)', ' Constipation 1/58 (1.72%)', ' Diarrhea 1/58 (1.72%)', ' Duodenal ulcer 1/58 (1.72%)', ' Fever 1/58 (1.72%)', ' Non-cardiac chest pain 1/58 (1.72%)', ' Cholecystitis 1/58 (1.72%)', ' Infections and infestations - Other, MRSA 2/58 (3.45%)', ' Bronchial infection 1/58 (1.72%)', ' Infections and infestations - Other, pneumonia 1/58 (1.72%)']}

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

52337e14-7f51-40c1-b965-fb6aba8ae4e7

Single

Eligibility

NCT00004092

Patients with Cancer that has spread from a breast tumor to their CNS are able to take part in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00004092', 'Intervention': ['INTERVENTION 1: ', ' Arm I (ACT)', ' Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.', ' filgrastim: Given IV or subcutaneously', ' cyclophosphamide: Given IV', ' doxorubicin hydrochloride: Given IV', ' paclitaxel: Given IV', ' peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells', 'INTERVENTION 2: ', ' Arm II (STAMP V)', ' Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.', ' filgrastim: Given IV or subcutaneously', ' carboplatin: Given IV', ' cyclophosphamide: Given IV', ' thiotepa: Given IV', ' peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically proven high-risk primary breast cancer with less than 60% chance of progression-free survival of 3 years from diagnosis', ' Stage II with at least 10 positive axillary nodes OR', ' Stage IIIA or IIIB', ' No histologically proven bone marrow metastasis', ' No CNS metastasis', ' Hormone receptor status:', ' Hormone receptor status known', ' PATIENT CHARACTERISTICS:', ' Age:', ' Physiological age 60 or under', ' Menopausal status:', ' Not specified', 'Performance status:', ' Karnofsky 80-100%', ' Life expectancy:', ' See Disease Characteristics', ' Hematopoietic:', ' Neutrophil count at least 1,500/mm^3', ' Platelet count at least 100,000/mm^3', ' Hepatic:', ' Bilirubin no greater than 1.5 mg/dL', ' SGOT or SGPT no greater than 2 times upper limit of normal', ' Hepatitis B antigen negative', ' Renal:', ' Creatinine no greater than 1.2 mg/dL', ' Creatinine clearance at least 70 mL/min', ' No prior hemorrhagic cystitis', ' Cardiovascular:', ' Ejection fraction at least 55% by MUGA', ' No prior significant valvular heart disease or arrhythmia', ' Pulmonary:', ' FEV_1 at least 60% of predicted', ' pO_2 at least 85 mm Hg on room air', ' pCO_2 at least 43 mm Hg on room air', ' DLCO at least 60% lower limit of predicted', ' Other:', ' No other prior malignancy except squamous cell or basal cell skin cancer or stage I or carcinoma in situ of the cervix', ' No CNS dysfunction that would preclude compliance', ' HIV negative', ' No sensitivity to E. coli-derived products', ' Not pregnant', ' Fertile patients must use effective contraception', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy:', ' Not specified', ' Chemotherapy:', ' At least 4 weeks since prior chemotherapy', ' No prior doxorubicin of total dose exceeding 240 mg/m^2', ' No prior paclitaxel of total dose of at least 750 mg/m^2', ' No more than 12 months since prior conventional-dose adjuvant chemotherapy', ' Endocrine therapy:', ' At least 4 weeks since prior hormonal therapy', ' Radiotherapy:', ' At least 4 weeks since prior radiotherapy', ' No prior radiation to the left chest wall', ' Surgery:', 'Not specified'], 'Results': ['Outcome Measurement: ', ' Five-Year Relapse-free Survival', ' RFS events included death or disease recurrence. Patients who did not experience disease recurrence or death were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.', ' Time frame: Five years', 'Results 1: ', ' Arm/Group Title: Arm I (ACT)', ' Arm/Group Description: Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.', ' filgrastim: Given IV or subcutaneously', ' cyclophosphamide: Given IV', ' doxorubicin hydrochloride: Given IV', ' paclitaxel: Given IV', ' peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: percentage of participants 47 (24 to 67)', 'Results 2: ', ' Arm/Group Title: Arm II (STAMP V)', ' Arm/Group Description: Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.', ' filgrastim: Given IV or subcutaneously', ' carboplatin: Given IV', ' cyclophosphamide: Given IV', ' thiotepa: Given IV', ' peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells', ' Overall Number of Participants Analyzed: 51', ' Measure Type: Number', ' Unit of Measure: percentage of participants 55 (41 to 68)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/21 (0.00%)', 'Adverse Events 2:', ' Total: ']}

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

8a6397e9-84cd-4a2e-ac6a-b56ee355d862

Comparison

Intervention

NCT01401959

NCT00852930

the primary trial designates specific interventions to its patients depending on their hormone status, Cohort A is TNBC patients and cohort B is ER/PR +HER2- BC Patients, in contrast the secondary trial assigns interventions randomly.

Entailment

{'Clinical Trial ID': 'NCT01401959', 'Intervention': ['INTERVENTION 1: ', ' Cohort A: Triple-negative Breast Cancer Patients', ' Patients with triple-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.', 'INTERVENTION 2: ', ' Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients', ' Patients with hormone receptor positive (ER and/or PR positive), HER negative breast cancer breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.'], 'Eligibility': ['Inclusion Criteria:', ' Female patients >=18 years-of-age.', ' Histologically confirmed breast cancer prior to surgery with the following staging criteria: T1-T3, T4a, T4b, N0-N2, N3a and M0 (T1N0M0 patients are excluded). Inflammatory disease is excluded.', ' Previous treatment with a minimum of 4 cycles of neoadjuvant anthracycline and/or taxane containing chemotherapy (+trastuzumab in HER2-positive patients).', ' Patients must be 21 days and 84 days from breast surgery and fully recovered. Patients may have had mastectomy or breast conservation surgery with axillary node dissection.', ' Pathologic CR (pCR) not achieved following neoadjuvant treatment (i.e., residual invasive breast cancer (>5 mm) in the breast or presence of nodal disease at surgery [ypT0/T1a, N1-N3a, M0 or ypT1b-T4, N0-N3a, M0].', ' Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.', ' Recovery from any toxic effects of prior therapy to <=Grade 1 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.0) except fatigue or alopecia.', ' Peripheral neuropathy Grade <=2 per NCI CTCAE v4.0 at trial entry.', ' Normal left ventricular ejection fraction (LVEF), within the institutional limits of normal, as measured by echocardiography (ECHO) or multi-gated (MUGA) scan in patients to receive trastuzumab with eribulin (HER2-positive).', ' Adequate hematologic, hepatic, and renal function', ' Complete staging work-up to confirm localized disease should include computed tomography (CT) scans of the chest and abdomen/pelvis (abdomen/pelvis preferred; abdomen accepted), a CT scan of the head or MRI of the brain (if symptomatic), and either a positron emission tomography (PET) scan or a bone scan. (Note: a PET/CT is acceptable for baseline imaging in lieu of CT examinations or bone scan). Negative scans performed prior to the initiation of neoadjuvant therapy, or at any subsequent time, are acceptable and do not need to be repeated.', ' Female patients who are not of child-bearing potential and female patients of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum pregnancy test performed within 7 days prior to start of trial treatment.', ' Willingness and ability to comply with trial and follow-up procedures.', ' Ability to understand the investigative nature of this trial and give written informed consent.', ' Agree to delay in reconstruction in terms of implants placed in setting of expanders until chemotherapy is completed and the patient has recovered. Expansion of expanders may continue during trial treatment.', 'Exclusion Criteria:', ' Presence of other active cancers, or history of treatment for invasive cancer <3 years prior to trial entry (except thyroid, cervical cancer). Patients with Stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.', ' Radiotherapy prior to the start of study treatment.', ' History or clinical evidence of central nervous system metastases or other metastatic disease.', ' Non-healed surgical wound.', ' Known or suspected allergy/hypersensitivity to eribulin.', ' Cardiac disease, including: congestive heart failure Class II-IV per New York Heart Association classification;cardiac ventricular arrhythmias requiring anti-arrhythmic therapy; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months.', ' Chronic use of drugs that cause QTc prolongation.Patients must discontinue use of these drugs 7 days prior to the start of study treatment.', ' Women who are pregnant or lactating. All females of child-bearing potential must have negative serum pregnancy test within 48 hours prior to trial treatment.', ' Patients with known diagnosis of human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.', " Prolongation of heart rate-corrected QT interval (QTc) >480 msecs (using Bazett's formula).", ' Minor surgical procedures (with the exception of the placement of port-a-cath or other central venous access) performed less than 7 days prior to beginning protocol treatment.', ' History of cerebrovascular accident including transient ischemic attack (TIA), or untreated deep venous thrombosis (DVT)/ pulmonary embolism (PE) within the past 6 months. Note: Patients with recent DVT/PE receiving treatment with a stable dose of therapeutic anti-coagulating agents are eligible.', ' Patients may not receive any other investigational or anti-cancer treatments while participating in this trial.', ' History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the trial participation or investigational product(s) administration or may interfere with the interpretation of the results.', ' Inability or unwillingness to comply with trial and/or follow-up procedures outlined in the protocol.'], 'Results': ['Outcome Measurement: ', ' Percentage of Patients With a 2 Year Disease-Free Survival (DFS) as a Measure of Efficacy', ' The percentage of patients that are without evidence of disease recurrence at the 2 year timepoint, as measured from date of first protocol treatment date to first documented disease progression date or date of death from any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', ' Time frame: Up to 2 years', 'Results 1: ', ' Arm/Group Title: Cohort A: Triple-negative Breast Cancer Patients', ' Arm/Group Description: Patients with triple-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.', ' Overall Number of Participants Analyzed: 53', ' Measure Type: Number', ' Unit of Measure: percentage of patients 56 (42 to 69)', 'Results 2: ', ' Arm/Group Title: Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients', ' Arm/Group Description: Patients with hormone receptor positive (ER and/or PR positive), HER negative breast cancer breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.', ' Overall Number of Participants Analyzed: 42', ' Measure Type: Number', ' Unit of Measure: percentage of patients 83 (67 to 91)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/53 (15.09%)', ' Febrile neutropenia * 1/53 (1.89%)', ' Cardiac failure congestive * 1/53 (1.89%)', ' Ventricular arrhythmia * 1/53 (1.89%)', ' Cellulitis * 0/53 (0.00%)', ' Mastitis * 1/53 (1.89%)', ' Pneumonia * 1/53 (1.89%)', ' Sinusitis * 0/53 (0.00%)', ' Tracheobronchitis * 0/53 (0.00%)', ' Diabetes mellitus inadequate control * 0/53 (0.00%)', ' Hyperglycaemia * 1/53 (1.89%)', 'Adverse Events 2:', ' Total: 1/42 (2.38%)', ' Febrile neutropenia * 0/42 (0.00%)', ' Cardiac failure congestive * 0/42 (0.00%)', ' Ventricular arrhythmia * 0/42 (0.00%)', ' Cellulitis * 0/42 (0.00%)', ' Mastitis * 0/42 (0.00%)', ' Pneumonia * 0/42 (0.00%)', ' Sinusitis * 0/42 (0.00%)', ' Tracheobronchitis * 1/42 (2.38%)', ' Diabetes mellitus inadequate control * 0/42 (0.00%)', ' Hyperglycaemia * 0/42 (0.00%)']}

{'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%)']}

8b5f946c-71d9-42cd-aa9a-1d3a4845c460

Comparison

Intervention

NCT01852032

NCT01118624

the secondary trial administers placebo tablets at twice the rate of the primary trial, but less than half the dose.

Contradiction

{'Clinical Trial ID': 'NCT01852032', 'Intervention': ['INTERVENTION 1: ', ' Breast Cancer Patients', ' Tomosynthesis Breast Scanning is done and breast CT Scanning is done.'], 'Eligibility': ['Inclusion Criteria:', ' 35 years of age or older', ' While male patients will not be explicitly excluded, it is expected that all patients in this study will be women', ' Diagnostic findings from prior mammography suspicious for, or highly suggestive of, breast malignancy -BIRADS (Breast Imaging Reporting and Data System) categories 4 and 5', ' Scheduled for ultrasound or stereotactic core biopsy', ' Ability to lie still on a table top for up to 10 minutes, longer than the typical breast CT duration.', ' Ability to understand risks, procedures, and benefits involved', 'Exclusion Criteria:', ' Recent breast biopsy', ' History of breast augmentation implant', ' Pregnant or Positive urine pregnancy test (UPT) or currently breast-feeding', ' History of moderate or severe adverse reaction to iodinated contrast injection', ' Recent serum creatinine 1.5 mg/dL', ' History of Diabetes Mellitus', ' Currently taking Glucophage or Glucovance (Metformin)', ' History of chronic asthma', ' History of allergy to iodine', ' Multiple food and/or drug allergy', ' Renal disease', ' History of pulmonary disease, phobia of breath holding, or other condition that could prevent the subject from being able to perform the 16 second breath hold'], 'Results': ['Outcome Measurement: ', ' Beta of CT Coronal View', ' frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.', ' beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).', 'Time frame: Day 1', 'Results 1: ', ' Arm/Group Title: Breast Cancer Patients', ' Arm/Group Description: Tomosynthesis Breast Scanning is done and breast CT Scanning is done.', ' Overall Number of Participants Analyzed: 23', ' Mean (Standard Deviation)', ' Unit of Measure: power-law slope(B) 1.75 (0.424)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/23 (0.00%)']}

{'Clinical Trial ID': 'NCT01118624', 'Intervention': ['INTERVENTION 1: ', ' Pralatrexate', ' Study drug 190 mg/m^2 for 2 to 4 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' HER-2 negative advanced or metastatic breast cancer', ' Disease has become worse after at least 1 prior chemotherapy regimen for advanced or metastatic disease', ' Advanced or metastatic disease resistant to both a taxane and an anthracycline-containing chemotherapy regimen, or resistant to taxanes and for whom further anthracycline therapy is not indicated', ' Patients with controlled brain metastases must have finished receiving radiation therapy and if on corticosteroids, be on a stable or tapering dose of 10 mg/day of prednisone or equivalent for at least 28 days prior to study entry', ' Measurable disease', ' Female 18 years of age or older', ' Performance status less than or equal to 2', ' Life expectancy of more than 3 months', ' Blood, liver and kidney laboratory test results that meet protocol requirements', ' Patients must have a negative serum pregnancy test within 14 days before enrollment and agree to use medically acceptable and effective birth control from enrollment until at least 30 days after the last dose of pralatrexate. Patients who are postmenopausal for at least 1 year (more than 12 months since last menses) or are surgically sterilized do not require this test.', ' Willing to attend visits for repeat dosing and follow up', ' Give written informed consent', 'Exclusion Criteria:', ' Patients with only bone metastasis', ' Patients with a single metastatic site without histological proof that the lesion is metastatic breast cancer', ' Patients with inflammatory breast cancer', ' Treatment with systemic chemotherapy, hormone therapy, radiation therapy, or other investigational therapy within 3 weeks (6 weeks for nitrosoureas, mitomycin C) prior to enrollment, except for the following:', ' Bisphosphonates, if ongoing', ' Prior treatment with methotrexate', ' Prior treatment with anti-angiogenics within 6 months prior to enrollment', ' Have received more than 2 prior chemotherapy regimens (more than 3 if one of the treatments was neoadjuvant or adjuvant chemotherapy)', ' Have previously received pralatrexate', ' Have received more than the allowed maximum total dose of anthracycline', ' Prior radiation therapy on more than 30% of bone marrow reserve or prior bone marrow/stem cell transplantation', ' Congestive heart failure Class III/IV', ' Uncontrolled hypertension (high blood pressure)', ' Active infection or any serious medical condition, which would impair the ability of the patient to receive protocol treatment', ' Females who are pregnant or breastfeeding', ' Major surgery within 14 days of enrollment', ' Another active cancer in addition to advanced or metastatic breast cancer, except well treated in situ cervical cancer and basal cell skin cancer', ' Dementia or other altered mental status that would prevent the patient from understanding and giving informed consent or limit her ability to follow the study requirements', ' Patients who are human immunodeficiency virus (HIV)-positive and have a CD4 count of less than 100 mm3 or detectable viral load within past 3 months and is receiving anti-retroviral therapy', ' Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) who have a detectable viral load or immunological evidence of chronic active disease or receiving/requiring antiviral therapy'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' Tumor response evaluation was performed using RECIST 1.0 using CT/MRI. Proportion of patients achieving a CR or PR is considered in the overall response.', ' Time frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.', 'Results 1: ', ' Arm/Group Title: Pralatrexate', ' Arm/Group Description: Study drug 190 mg/m^2 for 2 to 4 weeks.', ' Overall Number of Participants Analyzed: 22', ' Measure Type: Number', ' Unit of Measure: participants 1'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/22 (27.27%)', ' THROMBOCYTOPENIA 2/22 (9.09%)', ' MUCOSAL INFLAMMATION 2/22 (9.09%)', ' PLEURAL EFFUSION 2/22 (9.09%)']}

8f0aff7f-0d9e-498b-bcb6-05e6d309724c

Comparison

Results

NCT00313170

NCT00305448

Patients in the primary trial treated with Fulvestrant 250 mg had a 33% higher Objective response rate than those treated with Fulvestrant 250 mg + Loading Dose.

Contradiction

{'Clinical Trial ID': 'NCT00313170', '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 (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 BC.', ' Treatment with more than one previous regimen of endocrine therapy for advanced BC.', ' An existing condition that prevents compliance.'], 'Results': ['Outcome Measurement: ', ' Objective Response (ORR)', ' Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1).', ' Time frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.', 'Results 1: ', ' Arm/Group Title: Fulvestrant 250 mg', ' Arm/Group Description: Fulvestrant 250 mg', ' Overall Number of Participants Analyzed: 47', ' Measure Type: Number', ' Unit of Measure: Percentage of patients 8.5 (2.4 to 20.4)', '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 patients 5.9 (1.2 to 16.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/47 (8.51%)', ' Anaemia 0/47 (0.00%)', ' Myocardial Infarction 0/47 (0.00%)', ' Macular Hole 1/47 (2.13%)', ' Diverticulum Intestinal Haemorrhagic 0/47 (0.00%)', ' Melaena 0/47 (0.00%)', ' Pain 0/47 (0.00%)', ' Pneumonia 0/47 (0.00%)', ' Hip Fracture 0/47 (0.00%)', ' Meniscus Lesion 1/47 (2.13%)', ' Amnesia 0/47 (0.00%)', ' Ischaemic Stroke 1/47 (2.13%)', ' Depression 0/47 (0.00%)', 'Adverse Events 2:', ' Total: 9/50 (18.00%)', ' Anaemia 1/50 (2.00%)', ' Myocardial Infarction 1/50 (2.00%)', ' Macular Hole 0/50 (0.00%)', ' Diverticulum Intestinal Haemorrhagic 1/50 (2.00%)', ' Melaena 1/50 (2.00%)', ' Pain 0/50 (0.00%)', ' Pneumonia 0/50 (0.00%)', ' Hip Fracture 0/50 (0.00%)', ' Meniscus Lesion 0/50 (0.00%)', ' Amnesia 0/50 (0.00%)', ' Ischaemic Stroke 0/50 (0.00%)', ' Depression 1/50 (2.00%)']}

{'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%)']}

b7936bbc-f0c0-444c-a199-2db323c30396

Comparison

Intervention

NCT01373671

NCT00686127

Lidoderm products are used in intervention arm 1 of the secondary trial, and a Siemens product is used in arm 1 of the primary trial

Entailment

{'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:', ' ']}

{'Clinical Trial ID': 'NCT00686127', 'Intervention': ['INTERVENTION 1: ', ' Lidocaine Patch', ' Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.', 'INTERVENTION 2: ', ' Placebo Patch', ' Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.'], 'Eligibility': ['Inclusion Criteria:', ' Adult women >18 years who develop neuropathic pain in the breast scar area and/or ipsilateral arm following breast cancer surgery', ' Has a healed incision(s)', ' Has no recurrent disease in the painful area', ' Is able to read, write and understand English', 'Exclusion Criteria:', ' Presence of another type of pain that is more severe than the neuropathic pain', ' Use of an opioid analgesic of greater than 60 mg codeine/day', ' Is actively trying to become pregnant', ' Has a medical contraindication to the use of lidocaine', ' Has an allergy to lidocaine', ' Is taking a coanalgesic for neuropathic pain.'], 'Results': ['Outcome Measurement: ', ' Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks', ' Patients scored their pain intensity in the breast and/or ipsilateral arm using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10). The change in pain intensity was calculated from two time points as the later time point (12 weeks) minus the earlier time point (Baseline).', ' Time frame: Baseline, 12 weeks', 'Results 1: ', ' Arm/Group Title: Lidocaine Patch', ' Arm/Group Description: Lidocaine patch 5% (Lidoderm , Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: units on a scale ', 'Results 2: ', ' Arm/Group Title: Placebo Patch', ' Arm/Group Description: Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.', ' Overall Number of Participants Analyzed: 1', ' Measure Type: Number', ' Unit of Measure: units on a scale 4'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/14 (0.00%)', 'Adverse Events 2:', ' Total: 0/7 (0.00%)']}

6d6625ec-26b7-4157-a38c-87c770201323

Single

Eligibility

NCT01305941

Patients must present IHC 3+ or FISH amplified results to participate in the primary trial, meaning their cancer is Histologically-confirmed as being triple-positive.

Contradiction

{'Clinical Trial ID': 'NCT01305941', 'Intervention': ['INTERVENTION 1: ', ' Everolimus +Vinorelbine + Trastuzumab', ' daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab', ' Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets', ' Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.', ' Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly'], 'Eligibility': ['Inclusion Criteria', ' Histologically-confirmed HER2-positive (IHC 3+ or fluorescence in situ hybridization (FISH) amplified; by clinical assay on either primary or metastatic tumor) adenocarcinoma of the breast with at least one progressive and/or new metastatic brain lesion (>/=5 mm on radiographic imaging) after receipt of intracranial radiation therapy (whole brain radiation therapy, stereotactic radiosurgery, gamma knife, or equivalent). Patients in whom brain metastases (BM) are asymptomatic and detected during routine brain MRI screening per institutional protocols are eligible.', ' Prior intracranial radiation therapy (whole brain radiation therapy, stereotactic radiosurgery, gamma knife or equivalent) is allowed but not required.', ' Patients with no prior treatment with intracranial Response (ICR) may be included unless ICR is emergently indicated (in consultation with a local therapist, ie neurosurgeon or radiation oncologist)', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.', ' Life expectancy >12 weeks.', ' At least 21 years of age.', ' No prior mTOR inhibitors', ' Prior navelbine allowed provided navelbine therapy discontinued >/= 12 months from Day 1 of treatment under this protocol.', ' Last anti-cancer treatment (including any investigational drug) >/= 2 weeks from initiation of protocol based therapy, provided all adverse events (AEs) (other than alopecia) have resolved to grade 1 at baseline.', ' No active serious infection or other comorbid illness which would impair ability to participate in the trial.', ' Left ventricular ejection fraction assessment (echocardiogram or multigated acquisition scan (MUGA) scan) performed within 4 weeks prior to study initiation, showing a Left ventricular ejection fraction (LVEF) value lower limit of normal (LLN).', ' If patient is on dexamethasone, must be on stable or decreasing dose of dexamethasone for 7 days. If patient is on different glucocorticoid e.g., prednisone, must be converted to dexamethasone prior to enrollment. Refer to dose modification of everolimus for patients taking dexamethasone.', ' Interval 4 weeks between open brain biopsy and initiation of protocol-based therapy.', ' international normalized ratio (INR) 2.0. Anticoagulation is allowed if target INR 2.0 on a stable dose of warfarin or if patient on a stable dose of Low-molecular-weight (LMW) heparin for >1 weeks at time of enrollment.', ' Fasting serum cholesterol 300 mg/dL OR 7.75 mmol/L AND fasting triglycerides 2.5 x ULN. Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.', ' Patients must have adequate organ function as evidenced by:', ' Absolute neutrophil count 1.5/µL', ' Platelet count 100,000/µL', ' Hg 9 g/dL', ' Bilirubin 1.5 x upper limit of normal (ULN)', ' aspartate aminotransferase (AST) or Alanine transaminase (ALT) 2.5 x ULN ( 5 x ULN if liver metastases are present)', ' Serum creatinine 1.5 x ULN', ' Archived, paraffin-embedded tissue block (primary or metastatic) available for genomic studies is required.', ' Signed, institutional review board (IRB)-approved written informed consent.', ' Exclusion Criteria', ' Patients who have received prior treatment with an mTOR inhibitor (e.g., sirolimus, temsirolimus, everolimus); patients who have received prior treatment with navelbine within prior 12 months.', ' patients with a known hypersensitivity to everolimus or other rapamycins (e.g. sirolimus, temsirolimus) or to its excipients.', ' Patients requiring treatment with any other systemic glucocorticoid. Note: This restriction regarding choice of glucocorticoid does not apply should patient need <2 week course of glucocorticoid for treatment of non-infectious pneumonitis during study (see section 4.5.2).', ' Patients with a known hypersensitivity to vinorelbine or to its excipients.', ' Prior allergic reaction to trastuzumab for the treatment of metastatic breast cancer.', ' Concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted biologic therapy.', ' Peripheral neuropathy grade 3.', ' Evidence of frank hemorrhage or impending herniation on baseline brain imaging. Note: asymptomatic micro-hemorrhage is allowed.', ' Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented Cerebrospinal fluid (CSF) cytology. Note: discrete dural metastases are permitted.', ' Active cardiac disease including any of the following:', ' Angina pectoris that requires the use of anti-anginal medication;', ' Ventricular arrhythmias except for benign premature ventricular contractions;', ' Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;', ' Conduction abnormality requiring a pacemaker;', ' Valvular disease with documented compromise in cardiac function;', ' Symptomatic pericarditis', ' History of cardiac dysfunction including any one of the following:', ' Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;', ' History of documented congestive heart failure (New York Heart Association functional classification III-IV);', ' Documented cardiomyopathy', ' Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia), or patients that may require major surgery during the course of the study.', ' Patients should not receive immunization with attenuated live vaccines within 1 week of study entry or during study period. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guérin (BCG), yellow fever, varicella, and Typhoid Vaccine Live Oral (TY21a) typhoid vaccines.', ' Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.', ' Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:', ' severely impaired lung function, defined as spirometry and diffusion lung capacity for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or 02 saturation that is 88% at rest on room air', ' uncontrolled diabetes, defined as fasting serum glucose >1.5 x ULN (Note: Optimal glycemic control should be achieved before starting trial therapy)', ' active (acute or chronic) or uncontrolled severe infections', ' liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).', ' Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. Hepatitis B Virus (HBV) DNA and hepatitis C Virus (HCV) RNA polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.', ' A known history of HIV seropositivity.', ' Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).', ' Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low-dose warfarin and aspirin or equivalent, as long as the INR 2.0).', ' Unable or unwilling to discontinue use of prohibited fruit (or its juices) and prohibited medications listed in Appendices II and III for at least 14 days or 5 half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.', ' Female patients who are pregnant or breastfeeding, or adults of reproductive potential who are not using effective birth control methods. Adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 7 days prior to everolimus initiation.', ' Male patients whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment', ' Contraindication to gadolinium-enhanced MRI imaging.', ' Inability to comply with study and/or follow-up procedures.', ' History of noncompliance to medical regimens.'], 'Results': ['Outcome Measurement: ', ' Intracranial Objective Response Rate- Modified RECIST Criteria', ' response will be evaluated via gadolinium-enhanced brain MRI using modified RECIST criteria.', ' Complete Response (CR) - Disappearance of all target and nontarget lesions', ' Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.', ' Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started.', ' Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size.', ' Time frame: 3 years', 'Results 1: ', ' Arm/Group Title: Everolimus +Vinorelbine + Trastuzumab', ' Arm/Group Description: daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab', ' Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets', ' Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.', ' Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Response: 0 0.0%', ' Partial Response: 1 3.8%', ' Stable Disease: 17 65.4%', ' Progressive Disease: 8 30.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/32 (40.63%)', ' Anemia * 1/32 (3.13%)', ' Adrenal Insufficiency * 1/32 (3.13%)', ' Vomiting * 1/32 (3.13%)', ' Fever * 2/32 (6.25%)', ' Infusion related reaction * 1/32 (3.13%)', ' Pain * 1/32 (3.13%)', ' Anaphylaxis * 1/32 (3.13%)', ' Lung Infection * 1/32 (3.13%)', ' Sepsis * 3/32 (9.38%)', ' Upper Respiratory Infection * 1/32 (3.13%)', ' Creatinine Increased * 2/32 (6.25%)']}

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

e8b8c2b7-612d-4bab-b8a6-3dbc756cc210

Single

Intervention

NCT00606931

the primary trial tests MRI scanning as a technique for guiding biopsies.

Contradiction

{'Clinical Trial ID': 'NCT00606931', 'Intervention': ['INTERVENTION 1: ', ' PET Guided Biopsy', ' No comparison group. All enrolled participants were expected to undergo PET guided biopsy.'], 'Eligibility': ['Inclusion Criteria:', ' Individuals aged 25 years or older', ' Individuals who have at least one breast imaging finding requiring biopsy, specifically:', ' Individuals who have a breast abnormality(ies) moderately suspicious for or highly suggestive of malignancy on imaging with mammography, ultrasound, or MRI (as per ACR BIRADS™ 4C or 5) and requiring biopsy confirmation OR o Individuals with known breast cancer who have additional imaging abnormality(ies) suspicious for malignancy detected on a high-resolution FDG PET scan', ' Individuals who had recent conventional imaging work-up including x-ray mammography of the breast containing the abnormality of interest.', ' Individuals with suspected tumor size measuring one cm or less on mammography and/or ultrasound and/or MRI if the lesion is visible on any of these modalities, except that each site may enroll up to three patients each where the lesion of interest as measured on mammography (or ultrasound and/or MRI if not detectable on mammography) is more than 1 cm. (Note: The study will target patient enrollment such that at least 50% of the lesions to undergo biopsy across all sites will be less than 1 cm in diameter as measured on mammography, or as measured by other modalities, such as ultrasound, CT, or MRI, if the lesion is not detectable or measurable on mammography.)', ' Individuals who have agreed to participate in the study and who have signed study-specific informed consent', 'Exclusion Criteria:', ' Women who are or may be pregnant', ' Women who are currently lactating or discontinued breastfeeding < 2 months prior to the study', ' Age less than 25 years', ' Individuals with breast implant(s) in the breast containing the lesion of interest', ' Individuals who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PET-guided biopsy', ' Patients with contraindications for core biopsy and other invasive procedures such as blood coagulation disorders, infection, or who are unwilling to discontinue use of anticoagulant medication prior to the procedure', ' Individuals with Type I or poorly controlled Type II diabetes mellitus', ' Individuals with a blood glucose level that is above 140 mg/dl at the time of PEM imaging', ' Inability to provide informed consent', ' Individuals who have had surgery on the study breast(s) within the past 12 months'], 'Results': ['Outcome Measurement: ', ' Number of Lesions That Were Successfully Biopsied Using the PET-guided Biopsy Method.', ' Success in completion of the PET guided biopsy of a suspicious lesion was determined by', ' Alteration in lesion morphology (no change in vs change in lesion morphology) after sampling AND/OR', ' Visualization of regions with high radioactive uptake within the biopsy specimen consistent with target lesion (focal uptake present vs absent).', ' Time frame: within two days of obtaining histopathology of the lesion biopsied', 'Results 1: ', ' Arm/Group Title: PET Guided Biopsy', ' Arm/Group Description: No comparison group. All enrolled participants were expected to undergo PET guided biopsy.', ' Overall Number of Participants Analyzed: 19', ' Measure Type: Number', ' Unit of Measure: Number of lesions 24'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0']}

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

7e0259a3-073b-45f5-8e08-2cfaceecef0b