Datasets:

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nli4ct

like 1

Single

Adverse Events

NCT00679211

1 patient in the primary trial was diangosed with Influenza.

Contradiction

{'Clinical Trial ID': 'NCT00679211', 'Intervention': ['INTERVENTION 1: ', ' 6 Months of Follow-up', ' Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.', 'INTERVENTION 2: ', ' 9 Months of Follow-up', ' Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.'], 'Eligibility': ['Inclusion Criteria:', ' Signed study-specific Informed Consent Form(s)', ' Age 18 years', ' Histologically documented breast cancer', ' HER2-positive disease', ' Metastatic breast cancer', ' Disease progression on the last chemotherapy regimen received in the metastatic setting', ' Prior treatment with an anthracycline, trastuzumab, a taxane, lapatinib, and capecitabine in the neoadjuvant, adjuvant, locally advanced, or metastatic setting and prior treatment with at least two lines of therapy (a line of therapy can be a combination of two agents or single-agent chemotherapy) in the metastatic setting', ' At least two lines of anti-HER2 therapy must have been given in the metastatic setting as monotherapy or combined with chemotherapy or hormonal therapy. The HER2-targeted agent can include trastuzumab, lapatinib, or an investigational agent with HER2-inhibitory activity.', ' A minimum of 6 weeks of trastuzumab for the treatment of metastatic disease is required', ' Patients must have had at least 14 days of exposure in the metastatic setting to lapatinib and capecitabine (given together or separately) unless they were intolerant of lapatinib and/or capecitabine', 'Exclusion Criteria:', ' Chemotherapy 21 days before enrollment', ' Trastuzumab 21 days before enrollment', ' Hormone therapy 7 days before enrollment', ' Granulocyte-stimulating agent < 14 days before enrollment', ' Investigational therapy 28 days before enrollment', ' Previous radiotherapy for treatment of metastatic breast cancer 21 days before enrollment', ' 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 3 months of the first study treatment', ' History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins', ' History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin > 500 mg/m^2; Epirubicin > 900 mg/m^2; Mitoxantrone > 120 mg/m^2 and idarubicin > 90 mg/m^2', ' Peripheral neuropathy of Grade 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0', ' History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma', ' Current unstable angina', ' History of symptomatic congestive heart failure (CHF), or ventricular arrhythmia requiring treatment', ' History of myocardial infarction within 6 months of enrollment', ' Left ventricular ejection fraction (LVEF) < 50% within 28 days of enrollment', ' History of decreased LVEF to < 50% or symptomatic CHF with previous adjuvant trastuzumab treatment', ' Severe dyspnea at rest due to complications of advanced malignancy or requiring current continuous oxygen therapy', ' Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)', ' Major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of the need for major surgery during the course of study treatment', ' Current pregnancy or lactation', ' Current known infection with human immunodeficiency virus (HIV), active hepatitis B, and/or hepatitis C virus', ' Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With an Objective Response as Assessed Through Independent Radiologic Review', ' Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST).', ' CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions.', ' PR: disappearance of all target lesions and persistence of 1 nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing nontarget lesions.', ' The primary data cut-off date was 17 September 2009 (approximately 6 months after the last patient was enrolled). The final efficacy analysis was performed using a data cut-off date of 1 January 2010 (approximately 9 months after the last patient was enrolled).', ' Time frame: From randomization until the primary analysis data cut-off date of September 2009 (6 months after last patient enrolled) and until the final efficacy analysis cut-off date of 1 January 2010 (approximately 9 months after the last patient enrolled).', 'Results 1: ', ' Arm/Group Title: 6 Months of Follow-up', ' Arm/Group Description: Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.', ' Overall Number of Participants Analyzed: 110', ' Measure Type: Number', ' Unit of Measure: percentage of participants 32.7 (24.1 to 42.1)', 'Results 2: ', ' Arm/Group Title: 9 Months of Follow-up', ' Arm/Group Description: Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.', ' Overall Number of Participants Analyzed: 110', ' Measure Type: Number', ' Unit of Measure: percentage of participants 32.7 (24.1 to 42.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 29/110 (26.36%)', ' Atrial fibrillation 1/110 (0.91%)', ' Nausea 2/110 (1.82%)', ' Abdominal pain 1/110 (0.91%)', ' Abdominal pain upper 1/110 (0.91%)', ' Constipation 1/110 (0.91%)', ' Pancreatitis 1/110 (0.91%)', ' Vomiting 1/110 (0.91%)', ' Pyrexia 3/110 (2.73%)', ' Axillary pain 2/110 (1.82%)', ' Chest pain 1/110 (0.91%)', ' Influenza like illness 1/110 (0.91%)', 'Adverse Events 2:', ' ']}

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

7be7cecb-d265-4098-9969-a40555702573

Single

Adverse Events

NCT00767520

Both cohorts of the primary trial reported the same number of patients vomiting during the trial.

Entailment

{'Clinical Trial ID': 'NCT00767520', 'Intervention': ['INTERVENTION 1: ', ' Exemestane + Dasatinib', ' Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity', 'INTERVENTION 2: ', ' Exemestane + Placebo', ' Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity'], 'Eligibility': ['Inclusion Criteria:', ' Histologically-documented invasive estrogen receptor positive breast cancer , with tumor tissue from prior surgery available for analysis', ' Prior therapy with a non-steroidal aromatase inhibitor', ' Recurrent or progressive advanced breast cancer (locally-advanced or metastatic)', ' Documented breast cancer with tumor 28 days prior to study entry', ' Women who are NOT of childbearing potential', ' Must be able to take oral medication', ' Performance Status 0 or 1', 'Exclusion Criteria:', ' Pleural or pericardial effusion or ascites (of any etiology; Grade 1) within 6 months prior to study entry', ' Any chemotherapy, immunotherapy < 6 months before study entry. Any targeted therapy (eg. lapatinib) < 6 months before study entry, unless given in combination with an NSAI', ' Any antitumor therapy, including radiotherapy or hormonal therapy, within 15 days prior to study entry', ' Prior exposure to exemestane, any Src-family kinase inhibitor including dasatinib, to agents intended to control osteolytic disease other than bisphosphonates, or to any investigational agent for breast cancer', ' Concurrent or previous malignant disease requiring chemotherapy or radiation treatment within the prior 3 years', ' Significant bleeding disorder, or ongoing or recent clinically-significant gastrointestinal bleeding', ' Any serious cardiac condition, including congestive heart failure or myocardial infarction within 6 months, uncontrolled angina, or Class III or IV heart disease as defined by the New York Heart Association, baseline ejection fraction 40%, diagnosed congenital long QT syndrome, clinically-significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes), QTc interval > 450 msec at baseline (Fridericia correction)', ' Hematologic abnormality Grade 2', ' Hypocalcemia of Grade 1', " Any Chemistry abnormality of Grade 2 [except Grade 2 indirect bilirubin permitted if diagnosed Gilbert's disease]", ' Pregnant Women and Women of Childbearing Potential (WOCBP)', ' Extremely lactose intolerant, in the judgment of treating physician (100 mg dasatinib contains 135 mg lactose, posing a problem only if intolerance is severe)', ' Receiving any of the following concomitant medications: Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Subjects must discontinue drug use at least 7 days prior to starting dasatinib)', ' Potent inhibitors of CYP3A4 isoenzyme', ' Prisoners or subjects who are involuntarily incarcerated; or subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo', ' PFS= The time (weeks) from date of randomization to date of progressive disease(PD). PFS for each randomization arm was estimated using the Kaplan-Meier product-limit method. A point estimate and a 95% confidence interval (CI) for the median PFS was computed for each randomization arm using the Brookmeyer & Crowley method. PD=Increase ( 20%) in sum of longest diameters from smallest value during study (including baseline).', ' Time frame: Prior to study therapy, at 8 week intervals until progression occurs (maximum participant PFS of 71 weeks)', 'Results 1: ', ' Arm/Group Title: Exemestane + Dasatinib', ' Arm/Group Description: Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity', ' Overall Number of Participants Analyzed: 79', ' Median (95% Confidence Interval)', ' Unit of Measure: weeks 18.1 (15.1 to 24.3)', 'Results 2: ', ' Arm/Group Title: Exemestane + Placebo', ' Arm/Group Description: Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity', ' Overall Number of Participants Analyzed: 78', ' Median (95% Confidence Interval)', ' Unit of Measure: weeks 16.1 (12.1 to 18.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 22/79 (27.85%)', ' Anaemia 0/79 (0.00%)', ' Right ventricular dysfunction 1/79 (1.27%)', ' Diarrhoea 1/79 (1.27%)', ' Vomiting 2/79 (2.53%)', ' Abdominal pain 0/79 (0.00%)', ' Colonic obstruction 0/79 (0.00%)', ' Dysphagia 1/79 (1.27%)', ' Nausea 1/79 (1.27%)', ' Mucosal inflammation 1/79 (1.27%)', ' Performance status decreased 1/79 (1.27%)', ' Sudden death 1/79 (1.27%)', 'Adverse Events 2:', ' Total: 13/76 (17.11%)', ' Anaemia 1/76 (1.32%)', ' Right ventricular dysfunction 0/76 (0.00%)', ' Diarrhoea 0/76 (0.00%)', ' Vomiting 2/76 (2.63%)', ' Abdominal pain 1/76 (1.32%)', ' Colonic obstruction 1/76 (1.32%)', ' Dysphagia 0/76 (0.00%)', ' Nausea 1/76 (1.32%)', ' Mucosal inflammation 0/76 (0.00%)', ' Performance status decreased 0/76 (0.00%)', ' Sudden death 0/76 (0.00%)']}

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

5b0d3709-7879-4dea-96c3-29178cd9f162

Comparison

Intervention

NCT01420146

NCT00077376

the primary trial and the secondary trial both have a control arm, and several test arms.

Contradiction

{'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%)']}

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

af70a3a9-d2d0-4d65-81fe-15a1becb5e95

Comparison

Eligibility

NCT00372424

NCT00041067

Patients with HER2 positive breast tumors are eligible for the primary trial and the secondary trial.

Entailment

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

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

a378f448-eef0-465a-abc0-8b4dd1156bb5

Single

Intervention

NCT01487954

All patients in the primary trial had to drink 237 ml of water, either Alkaline Water or Distilled, depending on which cohort they are in.

Entailment

{'Clinical Trial ID': 'NCT01487954', 'Intervention': ['INTERVENTION 1: ', ' Arm I: Alkaline Water', ' Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.', ' alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.', ' external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.', 'INTERVENTION 2: ', ' Arm II: Distilled Water', ' Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy', ' distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.', ' external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed stage 0-IV breast cancer and have a treatment plan consisting of 62Gy (31 fractions) of total breast radiation therapy to be eligible; patients are eligible if they have received any number of prior chemotherapies; patients having received chemotherapy prior to radiation will be stratified among randomization groups during the second phase of this study', ' Life expectancy of greater than 3 months', ' Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' Patients receiving any investigational chemotherapeutic agents during planned radiation or any prior breast or chest wall radiation treatments are excluded', ' Patients receiving concurrent chemotherapy are excluded because of an increased relative risk of skin toxicity; patients taking daily proton-pump inhibitor or H2-blocker antacid medications are excluded because of predicted interference of alkaline water consumption and stomach pH; herceptin for the purposes of this clinical trial would be considered a chemotherapy, and as such, patients receiving herceptin chemotherapy during radiation would not be eligible for participation in this protocol', ' Patients with a history of any prior malignancy except non-melanoma skin cancer or carcinoma in-situ of the cervix not in remission for twelve months are excluded; patients with known brain metastases are excluded from this clinical trial because of their overall poor prognosis', ' Pregnancy excludes female patients from this study because radiation is potentially teratogenic and abortifacient; screening beta-hcg levels and clinically-indicated diagnostic tests will be used to determine eligibility'], 'Results': ['Outcome Measurement: ', ' Acute and Grade 2 or Higher Radiation-related Skin Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0', ' Information will include the type, severity, time of onset and resolution of its onset, and its probable association with the study regimen. Frequency tables will be constructed to summarize observed incidents by severity and type of toxicity during weekly radiation treatment and 1 month after radiation treatment. Observed toxicity differences among the treatment arms may be reported in frequency tables.', ' Time frame: at 1 month after treatment', 'Results 1: ', ' Arm/Group Title: Arm I: Alkaline Water', ' Arm/Group Description: Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.', ' alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.', ' external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.', ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: percentage of participants 38', 'Results 2: ', ' Arm/Group Title: Arm II: Distilled Water', ' Arm/Group Description: Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy', ' distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.', ' external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.', ' Overall Number of Participants Analyzed: 16', ' Measure Type: Number', ' Unit of Measure: percentage of participants 38'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/29 (3.45%)', ' Skin infection * [1]0/29 (0.00%)', ' Alanine aminotransferase increased * [2]1/29 (3.45%)', ' Aspartate aminotransferase increased * [3]1/29 (3.45%)', ' Chest wall pain * [4]1/29 (3.45%)', 'Adverse Events 2:', ' Total: 1/16 (6.25%)', ' Skin infection * [1]1/16 (6.25%)', ' Alanine aminotransferase increased * [2]0/16 (0.00%)', ' Aspartate aminotransferase increased * [3]0/16 (0.00%)', ' Chest wall pain * [4]0/16 (0.00%)']}

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

f30182a1-b82a-497c-885c-9bd2e805db62

Single

Results

NCT01106898

2% of the primary trial patients had Recurrence-free Survival < 3 years.

Entailment

{'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': ''}

ae87e5a3-fdd8-4003-ae80-4b370cade158

Single

Results

NCT00696072

Most patients treated with Dasatinib and Letrozole in the primary trial had a Disease Free Interval (DFI) Greater Than 2 Years.

Contradiction

{'Clinical Trial ID': 'NCT00696072', 'Intervention': ['INTERVENTION 1: ', ' Dasatinib Plus Letrozole', ' Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years', ' Dasatinib 100 mg + Letrozole 2.5 mg', ' Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days', 'INTERVENTION 2: ', ' Letrozole', ' Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years', ' Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days'], 'Eligibility': ['For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.', 'Inclusion Criteria:', ' Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease', ' Has measurable or evaluable-only disease', ' Is female, 18 yrs of age, post menopausal or surgically sterile', ' HER2 negative, HR+, ER+ and/or PgR+ breast cancer', ' 0-1 prior chemotherapy regimen for metastatic disease.', ' Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior', ' Prior tamoxifen therapy is allowed', ' No AI therapy for >1 year without recurrence', 'Exclusion Criteria:', ' Pregnant or breast feeding', ' Prior hormonal therapy for metastatic or locally recurrent disease', ' >1 chemotherapy regimen for metastatic disease', ' Pleural or pericardial effusion', ' Serious cardiac condition'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population', ' CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.', ' Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)', 'Results 1: ', ' Arm/Group Title: Dasatinib Plus Letrozole', ' Arm/Group Description: Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years', ' Dasatinib 100 mg + Letrozole 2.5 mg', ' Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days', ' Overall Number of Participants Analyzed: 56', ' Measure Type: Number', ' Unit of Measure: participants CBR (CR+PR+SD): 40', ' CBR, DFI <= 2 Years: 20', 'CBR, DFI > 2 Years: 20', 'Results 2: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years', ' Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days', ' Overall Number of Participants Analyzed: 61', ' Measure Type: Number', ' Unit of Measure: participants CBR (CR+PR+SD): 40', ' CBR, DFI <= 2 Years: 20', 'CBR, DFI > 2 Years: 20'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/57 (24.56%)', ' Anemia * 0/57 (0.00%)', ' CVA * 2/57 (3.51%)', ' Cardiac Insufficiency * 0/57 (0.00%)', ' Congestive Heart Failure * 0/57 (0.00%)', ' Coronary Insufficiency * 1/57 (1.75%)', ' Effusion Pericardial * 0/57 (0.00%)', ' Cholelithiasis * 1/57 (1.75%)', ' Colitis * 0/57 (0.00%)', ' Dehydration * 1/57 (1.75%)', ' Diverticulitis * 0/57 (0.00%)', ' Nausea * 2/57 (3.51%)', 'Adverse Events 2:', ' Total: 2/63 (3.17%)', ' Anemia * 1/63 (1.59%)', ' CVA * 0/63 (0.00%)', ' Cardiac Insufficiency * 1/63 (1.59%)', ' Congestive Heart Failure * 1/63 (1.59%)', ' Coronary Insufficiency * 0/63 (0.00%)', ' Effusion Pericardial * 1/63 (1.59%)', ' Cholelithiasis * 0/63 (0.00%)', ' Colitis * 1/63 (1.59%)', ' Dehydration * 1/63 (1.59%)', ' Diverticulitis * 1/63 (1.59%)', ' Nausea * 0/63 (0.00%)']}

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

9f3062db-16fb-41b8-ac10-f205f66070c8

Single

Results

NCT00022672

There were no patients in either cohort of the primary trial with a PFS exceeding 6 months.

Contradiction

{'Clinical Trial ID': 'NCT00022672', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab + Anastrozole', ' Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.', 'INTERVENTION 2: ', ' Anastrozole', ' 1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.'], 'Eligibility': ['Inclusion Criteria:', ' postmenopausal women;', ' metastatic breast cancer suitable for endocrine therapy;', ' positive hormone receptor status;', ' Human epidermal growth factor receptor 2 (HER2) overexpression.', 'Exclusion Criteria:', ' patients on hormone replacement therapy;', ' previous chemotherapy for metastatic disease;', ' uncontrolled cardiac disease and history of cardiac failure.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm^2) an increase of 1.0 cm^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.', ' Time frame: 24 Months, End of Study (Up to 5 years)', 'Results 1: ', ' Arm/Group Title: Trastuzumab + Anastrozole', ' Arm/Group Description: Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.', ' Overall Number of Participants Analyzed: 103', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 24 Months: 4.8 (3.7 to 7)', ' End of Study: 5.8 (4.6 to 8.3)', 'Results 2: ', ' Arm/Group Title: Anastrozole', ' Arm/Group Description: 1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.', ' Overall Number of Participants Analyzed: 104', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 24 Months: 2.4 (2 to 4.6)', ' End of Study: 2.9 (2.1 to 4.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 25/103 (24.27%)', ' Febrile neutropenia 1/103 (0.97%)', ' Myocardial infarction 1/103 (0.97%)', ' Myocardial ischaemia 1/103 (0.97%)', ' Middle ear inflammation 1/103 (0.97%)', ' Vomiting 3/103 (2.91%)', ' Nausea 2/103 (1.94%)', ' Abdominal pain 1/103 (0.97%)', ' Constipation 1/103 (0.97%)', ' Diarrhoea 1/103 (0.97%)', ' Gastritis 1/103 (0.97%)', ' Intestinal obstruction 1/103 (0.97%)', 'Adverse Events 2:', ' Total: 6/104 (5.77%)', ' Febrile neutropenia 1/104 (0.96%)', ' Myocardial infarction 1/104 (0.96%)', ' Myocardial ischaemia 0/104 (0.00%)', ' Middle ear inflammation 0/104 (0.00%)', ' Vomiting 0/104 (0.00%)', ' Nausea 0/104 (0.00%)', ' Abdominal pain 0/104 (0.00%)', ' Constipation 0/104 (0.00%)', ' Diarrhoea 0/104 (0.00%)', ' Gastritis 0/104 (0.00%)', ' Intestinal obstruction 0/104 (0.00%)']}

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

a1c5685a-8e6e-4733-aa8b-7040bac1a397

Single

Intervention

NCT00559507

the primary trial participants are given saracatinib PO for a maximum of 28 days.

Contradiction

{'Clinical Trial ID': 'NCT00559507', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Enzyme Inhibitor Therapy)', ' Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed carcinoma of the breast', ' Unresectable disease', ' Locally advanced or metastatic (American Joint Committee on Cancer [AJCC] stage IV) disease', ' Estrogen receptor-negative and progesterone receptor-negative breast cancer defined as < 10% expression by immunohistochemistry (IHC)', ' Measurable disease, defined (per Response Evaluation Criteria in Solid Tumors [RECIST]) as 1 unidimensionally measurable lesion 20mm by conventional techniques or 10 mm by spiral computed tomography (CT) scan', ' Measurable target lesions must not be in a previously irradiated field', ' Patients with locally advanced, unresectable disease must have progression of disease following no more than one first-line chemotherapy regimen', ' Patients with evidence of recurrent disease during or within 6 months after adjuvant chemotherapy will be considered to have failed one line of chemotherapy for metastatic disease', ' Human epidermal growth factor receptor 2 (HER2)-positive patients, defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) amplification > 2.1, must have received trastuzumab (Herceptin®) in either the adjuvant or metastatic setting and have had recurrence or progression of disease, respectively', ' No known brain metastases', ' Male and female patients eligible', ' Menopausal status not specified', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 (Karnofsky PS 60-100%)', ' Life expectancy > 3 months', ' Absolute neutrophil count 1,500/mcL', ' Platelet count 100,000/mcL', ' Hemoglobin > 9 g/dL', ' Total bilirubin normal', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) 2.5 x institutional upper limit of normal', ' Creatinine normal OR creatinine clearance 60 mL/min', ' Urine protein creatinine (UPC) ratio must be 1.0', ' Patients with a UPC ratio > 1.0 must have a 24-hour urine protein < 1,000 mg to be eligible for study', ' Not pregnant or nursing', ' Women of child-bearing potential and men must use adequate contraception (e.g., hormonal or barrier method of birth control or abstinence) prior to, during, and for 8 weeks after completion of study therapy', ' Able to understand and willing to sign a written informed consent document', ' No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530', ' No QTc interval 500 msecs', ' No condition that impairs the ability to swallow AZD0530 tablets, including the following:', ' Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation', ' Prior surgical procedures affecting absorption', ' Active peptic ulcer disease', ' No intercurrent cardiac dysfunction including, but not limited to, any of the following:', ' Symptomatic congestive heart failure', ' Unstable angina pectoris', ' Uncontrolled cardiac arrhythmia', ' History of myocardial infarction within 6 months of treatment', ' No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements', ' No severe restrictive or obstructive lung disease according to baseline pulmonary function studies including any of the following pulmonary function test (PFT) parameters:', ' Total lung capacity < 60%', ' Forced vital capacity < 50%', ' Forced expiratory volume in one second (FEV_1) < 50%', ' Diffusion capacity of carbon monoxide (DLCO) < 50%', ' Resting room air O_2 saturation < 92% or a decline in O_2 saturation > 4% with exercise', ' Patients with metastatic disease may have received no more than 1 prior chemotherapy regimen', ' No unresolved toxicity grade 3 from agents received more than 3 weeks earlier', ' No chemotherapy, radiotherapy, or investigational therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study', ' No luteinizing hormone-releasing hormone agonists within 4 weeks prior to study entry', ' More than 7 days since prior and no concurrent use of specifically prohibited cytochrome P 450 3A4 (CYP3A4) agents', ' No concurrent megestrol acetate, even when prescribed for appetite stimulation', ' No other concurrent investigational or commercial agents for the treatment of breast cancer', ' No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients', ' No concurrent megestrol acetate'], 'Results': ['Outcome Measurement: ', ' Disease Control Rate (DCR)', " DCR defined as complete response (CR), partial response (PR), stable disease (SD) > 24 weeks. Simon's two-stage optimal design was used to estimate the DCR of AZD0530 after 24 weeks of therapy since this design allowed for early termination of the study. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target 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 LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started", ' Time frame: After 24 weeks of study therapy', 'Results 1: ', ' Arm/Group Title: Treatment (Enzyme Inhibitor Therapy)', ' Arm/Group Description: Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 9', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/9 (33.33%)', ' Hypoxia 1/9 (11.11%)', ' Fatigue (asthenia, lethargy, malaise) 1/9 (11.11%)', ' Adrenal insufficiency 1/9 (11.11%)', ' Sodium, low (hyponatremia) 1/9 (11.11%)', ' Elevated liver enzymes 1/9 (11.11%)']}

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

d58683e2-d276-4184-a8e9-c9df6ffd8047

Comparison

Eligibility

NCT01904903

NCT01663727

Patients must have LVEF < 50% to be eligible for the primary trial and the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT01904903', 'Intervention': ['INTERVENTION 1: ', ' HER2 Therapies, Cardiac Medications', ' Cardiac intervention - beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses', ' Oncology intervention - patients will receive one of the three following HER2 targeted therapies at the discretion of the treating oncologist:', ' Trastuzumab: loading dose of 8 mg/kg IV, followed by a maintenance dose of 6 mg/kg every 3 weeks, or a loading dose of 4 mg/kg followed by a maintenance dose of 2 mg/kg every week.', ' Pertuzumab: loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks, administered concomitantly with trastuzumab.', ' Ado trastuzumab emtansine (TDM1): 3.6mg/kg IV every three weeks.', ' Trastuzumab: HER2 therapy', ' Pertuzumab: HER2 therapy', ' Ado Trastuzumab Emtansine: HER2 therapy'], 'Eligibility': ['Inclusion Criteria:', ' Female or male patient diagnosed with stage I-IV breast cancer', ' HER2 positive breast cancer, defined by immunohistochemical staining for HER2 protein of 3+ intensity and/or amplification of the HER2 gene on fluorescence in situ hybridization (FISH) 2.0 on breast specimen or biopsy of a metastatic site', ' LVEF < 50% and 40% documented in echocardiogram done within the last 30 days', ' HER2 therapy naïve or currently receiving non-lapatinib HER2 targeted therapy', ' Patient receiving or planning to receive trastuzumab, trastuzumab with pertuzumab or ado-trastuzumab emtansine, for at least 3 months, alone or in combination with other systemic treatment or radiation', ' Age 18 years', ' Patient is willing and able to comply with protocol required assessments and procedures', 'Exclusion Criteria:', ' Previous hospitalization due to documented heart failure in the last 12 months', ' Current signs or symptoms of heart failure or ischemia', ' History of arrhythmia requiring pharmacological or electrical treatment', ' Concomitant use of anthracyclines or use of anthracyclines in the last 50 days', ' Pregnant or lactating patients. Patients of childbearing potential must implement contraceptive measures during study treatment and for 7 months after last dose of treatment drug and must have negative urine or serum pregnancy test within 7 days prior to registration.', ' History of significant neurologic or psychiatric disorders including psychotic disorders or dementia that would prohibit the understanding and giving of informed consent.'], 'Results': ['Outcome Measurement: ', ' Percentage of Patients Who Complete Planned Oncologic Therapy Without the Development of a Cardiac Event or Asymptomatic Worsening of Cardiac Function.', ' Cardiac events are defined as any of the following:', ' Presence of symptoms attributable to heart failure as confirmed by a cardiologist', ' Cardiac arrhythmia requiring pharmacological or electrical treatment', ' Myocardial infarction', ' Sudden cardiac death or death due to myocardial infarct, arrhythmia or heart failure', ' Asymptomatic worsening of cardiac function defined as:', ' - Asymptomatic decline in LVEF > 10% points from baseline and/or EF < 35% corroborated by a confirmatory echocardiogram in 2-4 weeks', ' Planned oncologic therapy is defined as:', ' In the adjuvant setting: completion of 1 year total of HER2 targeted therapy. If a patient already received part of the planned HER2 targeted therapy prior to enrollment in this trial, planned oncologic therapy will be achieved when a total of 1 year is completed.', ' In the metastatic setting: cessation of treating regimen due to progressive disease or non-cardiac toxicity or non-cardiac death.', ' Time frame: Up to 18 months.', 'Results 1: ', ' Arm/Group Title: HER2 Therapies, Cardiac Medications', ' Arm/Group Description: Cardiac intervention - beta-blockers and ACE-inhibitors titrated to the maximum tolerated doses', ' Oncology intervention - patients will receive one of the three following HER2 targeted therapies at the discretion of the treating oncologist:', ' Trastuzumab: loading dose of 8 mg/kg IV, followed by a maintenance dose of 6 mg/kg every 3 weeks, or a loading dose of 4 mg/kg followed by a maintenance dose of 2 mg/kg every week.', ' Pertuzumab: loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks, administered concomitantly with trastuzumab.', ' Ado trastuzumab emtansine (TDM1): 3.6mg/kg IV every three weeks.', ' Trastuzumab: HER2 therapy', ' Pertuzumab: HER2 therapy', ' Ado Trastuzumab Emtansine: HER2 therapy', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 27 90.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/30 (10.00%)', ' Cardiac event 3/30 (10.00%)']}

{'Clinical Trial ID': 'NCT01663727', 'Intervention': ['INTERVENTION 1: ', ' Paclitaxel+Placebo', ' Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.', 'INTERVENTION 2: ', ' Paclitaxel+ Bevacizumab', ' Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.', ' ECOG performance status of 0 or 1', ' For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception', ' For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization', 'Exclusion Criteria:', ' Disease-Specific Exclusions:', ' HER2-positive status', ' Prior chemotherapy for locally recurrent or metastatic disease', ' Prior hormonal therapy < 2 weeks prior to randomization', ' Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization', ' Investigational therapy within 28 days of randomization', ' General Medical Exclusions:', ' Life expectancy of < 12 weeks', ' Inadequate organ function', ' Uncontrolled serious medical or psychiatric illness', ' Active infection requiring intravenous (IV) antibiotics at screening', ' Pregnancy or lactation', ' History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population', ' Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.', ' Time frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)', 'Results 1: ', ' Arm/Group Title: Paclitaxel+Placebo', ' Arm/Group Description: Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.', ' Overall Number of Participants Analyzed: 242', ' Measure Type: Number', ' Unit of Measure: percentage of participants 69.4', 'Results 2: ', ' Arm/Group Title: Paclitaxel+ Bevacizumab', ' Arm/Group Description: Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.', ' Overall Number of Participants Analyzed: 239', ' Measure Type: Number', ' Unit of Measure: percentage of participants 63.6'], 'Adverse Events': ['Adverse Events 1:', ' Total: 45/233 (19.31%)', ' Anaemia * 2/233 (0.86%)', ' Febrile neutropenia * 0/233 (0.00%)', ' Leukopenia * 1/233 (0.43%)', ' Neutropenia * 1/233 (0.43%)', ' Atrial fibrillation * 1/233 (0.43%)', ' Left ventricular dysfunction * 0/233 (0.00%)', ' ACUTE CORONARY SYNDROME * 0/233 (0.00%)', ' CARDIAC FAILURE CONGESTIVE * 1/233 (0.43%)', ' Optic nerve disorder * 1/233 (0.43%)', 'Adverse Events 2:', ' Total: 66/238 (27.73%)', ' Anaemia * 1/238 (0.42%)', ' Febrile neutropenia * 4/238 (1.68%)', ' Leukopenia * 1/238 (0.42%)', ' Neutropenia * 0/238 (0.00%)', ' Atrial fibrillation * 0/238 (0.00%)', ' Left ventricular dysfunction * 1/238 (0.42%)', ' ACUTE CORONARY SYNDROME * 1/238 (0.42%)', ' CARDIAC FAILURE CONGESTIVE * 0/238 (0.00%)', ' Optic nerve disorder * 0/238 (0.00%)']}

28d8f88a-e8cb-40c0-a12b-ef555f83ff59

Single

Eligibility

NCT02721147

Stephanie has been living with her boyfriend for 2 months, she is eligible for the primary trial.

Contradiction

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

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

0ee4c935-18bd-4807-a2af-041a3d84e125

Single

Eligibility

NCT00371254

Patients must have eceptorsestrogen receptor (ER) -, progesterone receptor (PR) - and human epidermal growth factor receptor 2 (HER2) - breast cancer, aswell as not having Dysphagia.

Entailment

{'Clinical Trial ID': 'NCT00371254', 'Intervention': ['INTERVENTION 1: ', ' Dasatinib 100 mg BID', ' Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.', 'INTERVENTION 2: ', ' Dasatinib 70 mg BID', ' Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.'], 'Eligibility': ['Inclusion Criteria:', ' females, 18 or older', " recurrent or progressive locally advanced, or 'triple negative' metastatic breast cancer", ' paraffin-embedded tissue block must be available', ' measurable disease', ' prior chemotherapy with an anthracycline, a taxane, or both (neoadjuvant, adjuvant, or metastatic setting)', ' 0, 1 or 2 chemotherapies in the metastatic setting', ' adequate organ function', 'Exclusion Criteria:', ' Metastatic disease confined to bone only', ' Symptomatic CNS metastasis', ' Concurrent medical condition which may increase the risk of toxicity', ' Unable to take oral medication'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Complete Response (CR) or Partial Response (PR)', ' Tumor response was defined as the number of participants whose best response was CR or PR, per the Response Evaluation Criteria in Solid Tumor (RECIST): CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.', ' Time frame: Baseline to end of study drug therapy (up to 65 weeks).', 'Results 1: ', ' Arm/Group Title: Dasatinib 100 mg BID', ' Arm/Group Description: Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.', ' Overall Number of Participants Analyzed: 23', ' Measure Type: Number', ' Unit of Measure: participants 2', 'Results 2: ', ' Arm/Group Title: Dasatinib 70 mg BID', ' Arm/Group Description: Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.', ' Overall Number of Participants Analyzed: 20', ' Measure Type: Number', ' Unit of Measure: participants 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/44 (31.82%)', ' MYOPERICARDITIS 1/44 (2.27%)', ' PERICARDIAL EFFUSION 2/44 (4.55%)', ' NAUSEA 1/44 (2.27%)', ' ASCITES 1/44 (2.27%)', ' VOMITING 2/44 (4.55%)', ' DYSPHAGIA 1/44 (2.27%)', ' CONSTIPATION 1/44 (2.27%)', ' ABDOMINAL PAIN 1/44 (2.27%)', ' PYREXIA 2/44 (4.55%)', ' GENERALISED OEDEMA 1/44 (2.27%)', ' GENERAL PHYSICAL HEALTH DETERIORATION 1/44 (2.27%)', ' INFECTION 1/44 (2.27%)', 'Adverse Events 2:', ' ']}

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

355fb813-cbe0-44f5-b04a-87813e060d54

Comparison

Adverse Events

NCT00796978

NCT01276041

More patients in cohort 1 of the secondary trial suffered from oedema in their limbs, compared to patients in cohort 2 of the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00796978', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab', ' trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.', ' laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).', ' adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.', ' quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed adenocarcinoma of the breast', ' Immunohistochemical staining for Her2 protein of 3+ intensity or Her2 gene amplification of 2.0 by FISH testing.', ' Life expectancy > 6 months', ' ECOG performance status 2', ' Node positive disease irrespective of tumor size', ' Node negative disease:', ' TNM Stage (AJCC Cancer Staging Manual 6th edition) T1b-T4, N0-3, M0, irrespective of hormonal status', ' Baseline LVEF lower limit of normal for a particular institution', ' Complete surgical removal of invasive cancer by mastectomy or lumpectomy', ' Complete staging work-up with CT of chest, abdomen, and pelvis plus bone scan or alternatively with PET scan for stage II and higher disease, or as determined by symptoms for all other stages. Additional staging work-up as per symptoms.', ' Adequate bone marrow function as indicated by the following:', ' ANC >1000/µL', ' Platelets 100,000/µL', ' Hemoglobin >10 g/dL', ' Adequate liver function, as indicated by bilirubin 1.5 x upper limit of normal (ULN) Adequate renal function, as indicated by creatinine 1.5 x ULN', ' AST or ALT <2 x ULN unless related to primary disease.', ' Signed informed consent', 'Exclusion Criteria:', ' Enrollment after more than 120 days from the last day of mastectomy or lumpectomy', ' Patients able to tolerate and willing to receive chemotherapy', ' Prior chemotherapy for current malignancy', ' Prior herceptin therapy', ' Active cardiac disease', ' Myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion)', ' Angina pectoris requiring anti-anginal treatment', ' Documented congestive heart failure (CHF)', ' Current use of any therapy specifically for CHF', ' Cardiac arrhythmia requiring medication', ' Current uncontrolled hypertension (diastolic >100 mmHg or systolic > 200 mmHg)', ' Clinically significant valvular abnormality (associated with New York Heart Association (NYHA) class II, III, or IV symptoms)', ' Clinically significant pericardial effusion (associated with New York Heart Association (NYHA) class II, III, or IV symptoms)', ' Past cardiac disease', ' Prior myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion)', ' Prior history of CHF', ' History of cardiomyopathy', ' Other diseases and conditions', ' Evidence of metastatic breast cancer (clinical or radiological evidence)', ' Active infection', ' Concomitant malignancies or previous malignancies within the last 3 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.', ' Hypersensitivity to trastuzumab'], 'Results': ['Outcome Measurement: ', ' Percent of Participants Experiencing Cardiac Events at 1 Year', ' Number of participants that experience cardiac events that include cardiac death due to congestive heart failure (CHF), Myocardial infarction (MI) or documented arrhythmia, death without definitive cause, or signs and symptoms of CHF as defined by New York Heart Association (NYHA) class III or IV symptoms.', ' Time frame: At 1 year', 'Results 1: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: trastuzumab: Trastuzumab (Herceptin ) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.', ' laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).', ' adjuvant therapy: Patients receive trastuzumab (Herceptin ) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.', ' quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.', ' Overall Number of Participants Analyzed: 55', ' Measure Type: Number', ' Unit of Measure: percentage of participants 3.6 (0.09 to 13.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/56 (14.29%)', ' Platelets * 1/56 (1.79%)', ' Heart failure * 1/56 (1.79%)', ' Left ventricular systolic dysfunction * 1/56 (1.79%)', ' Dehydration * 1/56 (1.79%)', ' Diarrhea * 1/56 (1.79%)', ' Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary) * 1/56 (1.79%)', ' Sodium, serum-low (hyponatremia) * 1/56 (1.79%)', ' Fracture * 2/56 (3.57%)']}

{'Clinical Trial ID': 'NCT01276041', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab in Combination With Trastuzumab and Paclitaxel', ' This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.'], 'Eligibility': ['Inclusion Criteria:', ' Age 18', ' Stage IV HER2 (+) breast cancer.', ' Histologically documented HER2 (+) breast cancer as defined as IHC 3+ or FISH amplification of 2.0 of primary or metastatic site; results from the local lab are acceptable. (Optional tumor sample collection from primary or metastatic site may be obtained for HER2 testing at MSKCC).', ' ECOG performance 0 -1 (Appendix A)', " 0-1 prior treatment in the metastatic setting (ie: hormone, chemotherapy, biologic, targeted agents). Prior anthracycline, paclitaxel, and trastuzumab in the adjuvant setting are allowed. If the patient has one trastuzumab-based treatment in the metastatic setting and is given a break (even intermittently) from the partner drug given with trastuzumab and is continued on trastuzumab alone, this would still be considered as one treatment. For example, if the patient was given paclitaxel + trastuzumab and was later continued on trastuzumab alone or then restarted on paclitaxel + trastuzumab (at the physician's discretion for any reason), the regimen paclitaxel + trastuzumab followed by trastuzumab alone (or followed by paclitaxel + trastuzumab again) may be considered as one treatment.", ' Measurable or non-measurable disease. Measurable lesions are defined as those that can be measured accurately in at least one diameter, that is 20 mm using conventional imaging techniques (including incremental CT) or 10 mm using spiral CT equipment and a lymph node 15 mm along the short axis. Non-measurable lesions are all other lesions, including small lesions (longest diameter <10mm pathological a lymph nodes with 10 to less than 15mm along the short axis, bony metastases, leptomeningeal disease, ascites, pleural/pericardial effusions, inflammatory breast cancer, lymphangitis carcinomatosis, and heavily calcified and cystic/necrotic lesions.', ' LVEF 50%', ' Hematologic parameters: white blood cell (WBC) count of 3000/ul, absolute neutrophil count (ANC) 1500/ul, platelets 100,000/ul, hemoglobin 10.0 g/dl', ' Non-hematologic parameters: bilirubin 1.5 mg/dl, AST/ALT 2.5 x upper limit of normal (ULN), alkaline phosphatase 5 x ULN.', ' Creatinine 1.5 mg/dl', ' Patients with stable and treated brain lesions of a duration of 2 months may be enrolled.', 'Exclusion Criteria:', ' History of prior cardiac morbidities within 12 months (unstable angina, myocardial infarction, CHF, uncontrolled ventricular arrhythmias)', ' Prior pertuzumab', ' History of prior G 3 hypersensitivity (HSR) or any toxicity to trastuzumab that warranted permanent cessation of this antibody', ' History of prior G 3 HSR or any toxicity to paclitaxel warranted permanent cessation of this chemotherapy', ' > G 2 peripheral neuropathy', ' Patients with a history of chronic hepatitis B or C should be excluded from the study as paclitaxel is potentially hepatotoxic', 'Pregnant patients'], 'Results': ['Outcome Measurement: ', ' Percentage of Patients Who Are Progression Free at 6 Months or Later.', ' Patients who are considered progression-free at 6 months are deemed successes. Failures are those patients who progressed before the 6 month mark. 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: 6 months', 'Results 1: ', ' Arm/Group Title: Pertuzumab in Combination With Trastuzumab and Paclitaxel', ' Arm/Group Description: This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.', ' Overall Number of Participants Analyzed: 70', ' Measure Type: Number', ' Unit of Measure: percentage of partcipants 86 (75 to 93)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 18/70 (25.71%)', ' Cardiac arrest 1/70 (1.43%)', ' Pericardial effusion 1/70 (1.43%)', ' Ear pain 1/70 (1.43%)', ' Blurred vision 1/70 (1.43%)', ' Eye disorders - Other, specify 2/70 (2.86%)', ' Abdominal Pain 5/70 (7.14%)', ' Colitis 1/70 (1.43%)', ' Diarrhea 2/70 (2.86%)', ' Nausea 2/70 (2.86%)', ' Death NOS 1/70 (1.43%)', ' Edema limbs 1/70 (1.43%)', ' Fatigue 3/70 (4.29%)']}

274d9d2b-9227-4496-a525-d5477b0003ce

Single

Intervention

NCT00290745

in the primary trial participants from different ethnicities receive different interventions.

Contradiction

{'Clinical Trial ID': 'NCT00290745', 'Intervention': ['INTERVENTION 1: ', ' Tamoxifen or Letrozole', ' tamoxifen or letrozole work in treating women with ductal carcinoma in situ', ' letrozole', ' tamoxifen citrate', ' conventional surgery', ' neoadjuvant therapy'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Diagnosis of ductal carcinoma in situ (DCIS) on core biopsy', ' No evidence of contralateral breast disease or palpable masses on breast examination', ' No presence or suspicion of invasive cancer, including contralateral invasive cancer, on core biopsy and MRI', ' No documented ipsilateral axillary adenopathy', ' Planning to undergo lumpectomy or mastectomy', ' Estrogen receptor (ER)-positive tumor by immunohistochemistry', ' PATIENT CHARACTERISTICS:', ' Female patient', ' Premenopausal or postmenopausal', ' Postmenopausal is defined by any of the following:', ' No spontaneous menses for >= 1 year', ' Bilateral oophorectomy', ' Radiation castration and amenorrheic for >= 3 months', ' Follicle-stimulating hormone (FSH) > 20 IU/L AND off all hormonal therapy (e.g., hormone replacement therapy or birth control pills) for >= 1 month', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception', ' No co-morbidities contraindicating the use of tamoxifen, including any of the following:', ' Prior history of thrombotic events', ' History of hypercoagulable state', ' History of endometrial hyperplasia', ' Abnormal vaginal bleeding', ' No history of contrast dye-related allergies/reactions', ' No history of metal-containing prostheses or implants', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics'], 'Results': ['Outcome Measurement: ', ' Median Change in 6-month Tumor Volume Compared to Baseline Using Mammography', ' Change in size of Ductal Carcinoma in situ (DCIS) for participants on hormonal therapy, as determined by mammography are determined by (1) largest diameter of tumor, as visualized on mammography (2) extent of disease on mammography (3) quantification of mammographically-detected change from baseline to 6-month and used to generate the change in tumor volume of mammographic extent of disease from baseline. Since values were not normally distributed, the median change was calculated, and Wilcoxon sign rank tests were used to evaluate the significance of these changes', ' Time frame: Baseline and 6 months', 'Results 1: ', ' Arm/Group Title: Tamoxifen or Letrozole', ' Arm/Group Description: tamoxifen or letrozole work in treating women with ductal carcinoma in situ', ' letrozole', ' tamoxifen citrate', ' conventional surgery', ' neoadjuvant therapy', ' Overall Number of Participants Analyzed: 54', ' Median (Inter-Quartile Range)', ' Unit of Measure: change in tumor volume (mm) -5.0 (-10.4 to 0.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0']}

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

3ab9c66c-06fc-4bc5-b504-d9193efa8701

Single

Eligibility

NCT01252277

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

Contradiction

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

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

d39078d9-9bc3-4b91-a012-e95f14813c9a

Comparison

Eligibility

NCT00041067

NCT01273896

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

Entailment

{'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%)']}

02538194-97ac-4749-9301-83f108927478

Comparison

Intervention

NCT01572038

NCT00826267

Each patient in the primary trial receives 3 different drugs, whereas in the secondary trial patients receive 1 of 2 possible drugs.

Entailment

{'Clinical Trial ID': 'NCT01572038', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab + Trastuzumab + Taxane', " Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice."], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection', ' HER2-positive breast cancer', ' Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2', ' LVEF of at least 50 percent (%)', 'Exclusion Criteria:', ' Previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease', ' Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence less than or equal to (</=) 6 months', ' Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting', ' Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting', ' History of persistent Grade 2 or higher (National Cancer Institute Common Toxicity Criteria [NCI-CTC], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy', ' Central nervous system (CNS) metastases', ' Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0)', ' History of other malignancy within the last 5 years prior to first study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma', ' Inadequate bone marrow, liver or renal function', ' Uncontrolled hypertension', ' Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection'], 'Results': ['Outcome Measurement: ', ' Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)', ' Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade 3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. TEAEs of special interest included LVEF decreased, liver enzymes increased, and suspected transmission of infectious agent by the study drug.', ' Time frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.', 'Results 1: ', ' Arm/Group Title: Pertuzumab + Trastuzumab + Taxane', " Arm/Group Description: Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice.", ' Overall Number of Participants Analyzed: 1436', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Any TEAE - Any Grade: 1419 98.8%', ' Any TEAE - Grade 3 or Higher ( 3): 879 61.2%', ' Any Serious TEAE: 535 37.3%', ' Any TEAE Leading to Death: 31 2.2%', ' Any TEAE Related to Pertuzumab - Any Grade: 1037 72.2%', ' Any TEAE Related to Trastuzumab - Any Grade: 946 65.9%', ' Any TEAE Related to Taxane - Any Grade: 1342 93.5%', ' Any TEAE Related to Pertuzumab - Grade 3: 286 19.9%', ' Any TEAE Related to Trastuzumab - Grade 3: 245 17.1%', ' Any TEAE Related to Taxane - Grade 3: 514 35.8%', ' Any TEAE Leading to Interruption of Pertuzumab: 334 23.3%', ' Any TEAE Leading to Interruption of Trastuzumab: 386 26.9%', ' Any TEAE Leading to Interruption of Taxane: 354 24.7%', ' Any TEAE Leading to Discontinuation of Pertuzumab: 140 9.7%', ' Any TEAE Leading to Discontinuation of Trastuzumab: 133 9.3%', ' Any TEAE Leading to Discontinuation of Taxane: 286 19.9%', ' Any TEAE to Monitor - Any Grade: 1320 91.9%', ' Any TEAE to Monitor - Grade 3: 535 37.3%', ' Any TEAE of Special Interest: 91 6.3%', ' Any TEAE Within 28 Days of Treatmt Discontinuation: 975 67.9%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 535/1436 (37.26%)', ' Febrile neutropenia 71/1436 (4.94%)', ' Neutropenia 47/1436 (3.27%)', ' Anaemia 8/1436 (0.56%)', ' Leukopenia 2/1436 (0.14%)', ' Bone marrow failure 1/1436 (0.07%)', ' Febrile bone marrow aplasia 1/1436 (0.07%)', ' Thrombocytopenia 1/1436 (0.07%)', ' Cardiac failure 12/1436 (0.84%)', ' Atrial fibrillation 8/1436 (0.56%)', ' Atrial thrombosis 2/1436 (0.14%)']}

{'Clinical Trial ID': 'NCT00826267', 'Intervention': ['INTERVENTION 1: ', ' Afatinib 50 mg', ' Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.', 'INTERVENTION 2: ', ' Lapatinib 1500 mg', ' Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.'], 'Eligibility': ['Inclusion criteria:', ' Female, age 18 years or older.', ' Histologically proven breast cancer who have not received any prior therapy.', ' Locally advanced disease Stage IIIa with no evidence of distant metastatic disease other than anatomical site lymph nodes.', ' HER2-positive.', 'Exclusion criteria:', ' Absolute neutrophil count (ANC) less than 1500/mm3.', ' Platelet count less than 100 000/ mm3.', ' Hemoglobin level less than 9.0 g/dl.', ' Bilirubin greater than 1.5 mg/dI.', ' Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than twice the upper limit of normal.', ' Serum creatinine greater than 1.5 times of the upper normal limit.', ' Significant or recent acute gastrointestinal disorders with diarrhea', ' Pregnancy or breast-feeding.', ' Organ system dysfunction including cardiac (LVEF < 50%).', ' Prior chemotherapy, radiotherapy or hormone therapy. Previous treatment with trastuzumab, EGFR, or EGFR/HER2-inhibitors.', ' Other malignancies diagnosed within the past five years.', ' Serious active infection. HIV, active hepatitis B or C.'], 'Results': ['Outcome Measurement: ', ' Objective Response (OR)', ' Objective response (complete or partial) was assessed according to RECIST 1.0 criteria.', ' Time frame: Tumour assessments were performed at screening, day 22 and day 43.', 'Results 1: ', ' Arm/Group Title: Afatinib 50 mg', ' Arm/Group Description: Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 80.0 (44.4 to 97.5)', 'Results 2: ', ' Arm/Group Title: Lapatinib 1500 mg', ' Arm/Group Description: Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.', ' Overall Number of Participants Analyzed: 8', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 75.0 (34.9 to 96.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)', 'Adverse Events 2:', ' Total: 0/8 (0.00%)']}

6d9113b4-9d18-4a1b-bc78-cc3ac1150876

Single

Intervention

NCT00558103

All participants in the primary trial are administered with Lapatinib 1500 mg PO QD.

Entailment

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

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

99599b71-85d7-4c15-8d23-4294732f87cf

Single

Eligibility

NCT00768222

Rachel is 19 years old and has skin ulcerations and allergic reactions to triclosan, she cannot take part in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00768222', 'Intervention': ['INTERVENTION 1: ', ' Chinese Silk Suture', ' Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern', 'INTERVENTION 2: ', ' VICRYL* Plus Suture', ' Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique'], 'Eligibility': ['Inclusion Criteria:', ' 18 years of age or older with written informed consent', ' Scheduled for a modified radical mastectomy', ' Surgical wound classified Class I/Clean using the CDC SSI Surgical Wound Classification', 'Exclusion Criteria:', ' Unable to give consent and unlikely to comply with study requirements and complete the 90-day follow up visit', ' Undergoing surgery for modified radical mastectomy with immediate breast reconstruction, cosmetic breast operations, reduction, expansion, insertion of prothesis, duct ectasia or infective breast disease or implant', ' Surgical wounds classified as Class II, III or IV using CDC SSI Surgical Wound Classification', ' Has inflammatory cancers or skin ulceration', ' Has known allergy or intolerance to triclosan', ' Has compromised wound healing or chronic immune deficiency, for example diabetes, prolonged steroid use, AIDS or substance abuse', ' Has serious heart and/or lung disease', ' Has skin scar history or family history', ' Has direct relationship to or involvement in this or other studies under the direction of the investigator or center', ' Received an experimental drug or device within 30 days prior to the planned start of treatment'], 'Results': ['Outcome Measurement: ', ' Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)', ' Post-operative cosmetic outcome assessed on surgical site photographs by an independent blinded central assessor using a validated 100 mm visual analog scale, with 0 representing the worst possible scar and 100 representing the best possible scar', ' Time frame: 30 days (+/- 5) post-operative', 'Results 1: ', ' Arm/Group Title: Chinese Silk Suture', ' Arm/Group Description: Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern', ' Overall Number of Participants Analyzed: 50', ' Mean (Standard Deviation)', ' Unit of Measure: score on scale 45.4 (12.0)', 'Results 2: ', ' Arm/Group Title: VICRYL* Plus Suture', ' Arm/Group Description: Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique', ' Overall Number of Participants Analyzed: 51', ' Mean (Standard Deviation)', ' Unit of Measure: score on scale 67.2 (18.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/50 (6.00%)', ' Skin lymphangitis 1/50 (2.00%)', ' Bone marrow suppression 0/50 (0.00%)', ' Allergic shock 1/50 (2.00%)', ' Deep incisional SSI 1/50 (2.00%)', 'Adverse Events 2:', ' Total: 1/51 (1.96%)', ' Skin lymphangitis 0/51 (0.00%)', ' Bone marrow suppression 1/51 (1.96%)', ' Allergic shock 0/51 (0.00%)', ' Deep incisional SSI 0/51 (0.00%)']}

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

adbc193f-ffd6-49ce-9acd-7b1675adf0c0

Single

Eligibility

NCT01617668

Patients must have healthy kidneys, liver and ovaries to participate in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01617668', 'Intervention': ['INTERVENTION 1: ', ' LCL161 + Paclitaxel (Gene Expression Signature Positive)', ' Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.', 'INTERVENTION 2: ', ' Paclitaxel Only (Gene Expression Signature Positive)', ' Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed diagnosis of invasive triple negative breast cancer', ' Known status for the LCL161 predictive gene expression signature as determined during molecular pre-screening', ' Candidates for mastectomy or breast-conserving surgery', ' Primary tumor of greater than 20 mm and less than or equal to 50 mm diameter measured by imaging (previous Amendment #3 was tumor size greater than 10 mm)', ' Regional nodes N0-N2', ' Absence of distant metastatic disease', ' ECOG performance status 0-1', ' Adequate bone marrow function', ' Adequate liver function and serum transaminases', ' Adequate renal function', 'Exclusion Criteria:', ' Bilateral or inflammatory breast cancer (bilateral mammography is required during Screening/baseline); locally recurrent breast cancer', ' Patients currently receiving systemic therapy for any other malignancy, or having received systemic therapy for a malignancy in the preceding 3 months', ' Uncontrolled cardiac disease', ' Patients who are currently receiving chronic treatment (>3 months) with corticosteroids at a dose 10 mg of prednisone (or its glucocorticoid equivalent) per day (inhaled and topical steroids are allowed), or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug', ' Impaired GI function that may affect the absorption of LCL161', ' Pregnant or breast feeding (lactating) women', ' Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 180 days after study treatment', ' Other protocol-defined inclusion/exclusion criteria may apply'], 'Results': ['Outcome Measurement: ', ' Pathological Complete Response (pCR) Rate in Breast After 12 Weeks of Therapy', ' pCR rate was defined as histopathologically confirmed absence of invasive disease in the breast. To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer. Analyses were performed separately in the gene expression signature negative and positive groups. This analysis was based on Bayesian design using a binomial distribution for the data with a beta prior. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). Median values are posterior medians of pCR rate for each group.', ' Time frame: 12 weeks', 'Results 1: ', ' Arm/Group Title: LCL161 + Paclitaxel (Gene Expression Signature Positive)', ' Arm/Group Description: Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.', ' Overall Number of Participants Analyzed: 51', ' Median (95% Confidence Interval)', ' Unit of Measure: Percentage of Participants 24.9 (14.5 to 37.8)', 'Results 2: ', ' Arm/Group Title: Paclitaxel Only (Gene Expression Signature Positive)', ' Arm/Group Description: Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.', ' Overall Number of Participants Analyzed: 50', ' Median (95% Confidence Interval)', ' Unit of Measure: Percentage of Participants 23.4 (13.3 to 36.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 45/106 (42.45%)', ' Anaemia 1/106 (0.94%)', ' Disseminated intravascular coagulation 1/106 (0.94%)', ' Febrile neutropenia 1/106 (0.94%)', ' Lymph node pain 1/106 (0.94%)', ' Neutropenia 2/106 (1.89%)', ' Sinus tachycardia 1/106 (0.94%)', ' Abdominal pain upper 0/106 (0.00%)', ' Diarrhoea 2/106 (1.89%)', ' Nausea 1/106 (0.94%)', ' Chills 2/106 (1.89%)', ' Feeling cold 1/106 (0.94%)', 'Adverse Events 2:', ' Total: 7/103 (6.80%)', ' Anaemia 1/103 (0.97%)', ' Disseminated intravascular coagulation 0/103 (0.00%)', ' Febrile neutropenia 1/103 (0.97%)', ' Lymph node pain 0/103 (0.00%)', ' Neutropenia 0/103 (0.00%)', ' Sinus tachycardia 0/103 (0.00%)', ' Abdominal pain upper 1/103 (0.97%)', ' Diarrhoea 0/103 (0.00%)', ' Nausea 0/103 (0.00%)', ' Chills 0/103 (0.00%)', ' Feeling cold 0/103 (0.00%)']}

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

c476f92a-a450-4e5c-9688-6557ff3d822b

Single

Intervention

NCT00900627

The two groups in the primary trial receive the same drug treatment, but group 2 gets double the dose.

Contradiction

{'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': ''}

39d685a4-b179-4687-a273-2a44e675f2c6

Single

Adverse Events

NCT00965523

The most common adverse events in the primary trial where Infection and Stomatitis, affecting a total of 14 patients.

Contradiction

{'Clinical Trial ID': 'NCT00965523', 'Intervention': ['INTERVENTION 1: ', ' Eribulin Mesylate', ' Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.'], 'Eligibility': ['Inclusion criteria:', ' Female patients with histologically or cytologically confirmed breast cancer.', ' Patients who have received prior chemotherapy including anthracycline and taxane.', ' Patients aged 20 - 74 years when giving informed consent and who have given written voluntary consent for participating in this study before the completion of Study 221.', ' Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.', ' Patients with a measurable lesion.', ' Patients with an expected survival of 3 months from the start of study drug therapy.', ' Female patients in whom continued administration of E7389 following Study 221 will be useful.', ' Patients who have met the criteria for starting the next cycle in Study 221.', ' Namely, patients who meet all of the following criteria:', ' Neutrophil count >= 1,500 /µL', ' Platelet count >= 100,000 /µL', ' Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 times the upper limit of normal (ULN) in the facility or <= 5 times ULN in patients with hepatic metastasis)', ' Total bilirubin <= 1.5 times ULN', ' Serum creatinine <= 1.5 times ULN', ' Non-hematological toxicity <= Grade 2 (excluding disease-associated events and laboratory abnormalities without clinical symptoms)', 'Exclusion criteria:', ' Patients with systemic infection with a fever ( 38.0°C).', ' Patients with pleural effusion, ascites or pericardial fluid requiring drainage.', ' Patients with brain metastasis presenting clinical symptoms.', ' Pregnant women, nursing mothers, or premenopausal women of childbearing potential. Premenopausal women of childbearing potential are defined as women who are <12 months after the latest menstruation and are positive in pregnancy test performed for enrollment or who have not taken the test and do not consent to take an appropriate contraceptive measure. Post-menopausal women must be amenorrheic for at least 12 months to make sure that they have no potential for becoming pregnant.', ' Patients with serious complications:', ' Patients with uncontrollable cardiac disease such as ischemic heart disease and arrhythmia at a level of severity that needs to be treated (excluding left ventricular hypertrophy, mild left ventricular volume overload and mild right leg block that accompany hypertension)', ' Patients with myocardial infarction within 6 months prior to study entry', ' Patients with a complication of hepatic cirrhosis', ' Patients with interstitial pneumonia and pulmonary fibrosis', ' Patients with a bleeding tendency', ' Patients with an active double cancer.', ' Pregnant women or nursing mothers.', ' Patients who have received extensive radiotherapy ( 30% of bone marrow).', ' Patients who refuse to receive the supportive therapy of blood transfusion for myelosuppression.', ' Patients who are participating in other clinical studies.', ' Patients who are judged by the principal investigator or the other investigators to be inappropriate as patients in this clinical study.'], 'Results': ['Outcome Measurement: ', ' Number of Subjects With Adverse Events.', ' [Not Specified]', ' Time frame: Every week during treatment and up to 30 days after last dose of study treatment', 'Results 1: ', ' Arm/Group Title: Eribulin Mesylate', ' Arm/Group Description: Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.', ' Overall Number of Participants Analyzed: 81', ' Measure Type: Number', ' Unit of Measure: Participants 81'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/81 (17.28%)', ' Neutropenia1/81 (1.23%)', ' Cataract1/81 (1.23%)', ' Ascites1/81 (1.23%)', ' Gastritis Hemorrhagic1/81 (1.23%)', ' Nausea1/81 (1.23%)', ' Stomatitis2/81 (2.47%)', ' Malaise1/81 (1.23%)', ' Oedema1/81 (1.23%)', ' Pain1/81 (1.23%)', ' Pyrexia1/81 (1.23%)', ' Infection2/81 (2.47%)', ' Upper Limb Fracture1/81 (1.23%)', ' Dehydration1/81 (1.23%)', ' Hypercalcemia1/81 (1.23%)']}

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

c66963b9-19e0-4c0f-bb65-2fec15e60b8f

Comparison

Adverse Events

NCT00559845

NCT00426556

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

Contradiction

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

{'Clinical Trial ID': 'NCT00426556', 'Intervention': ['INTERVENTION 1: ', ' Phase I - RAD001 5mg + PT, Daily', ' Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab', 'INTERVENTION 2: ', ' Phase I - RAD001 10mg + PT, Daily', ' Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab'], 'Eligibility': ['Inclusion Criteria:', ' Female or male patients 18 years old with WHO performance status 1', ' HER-2 over-expressing metastatic breast cancer cells confirmed by histology', ' Progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy (phase l)', ' Patient resistance to trastuzumab and taxanes (Phase ll)', ' Measurable disease according to RECIST (Phase ll)', ' Patients neurologically stable with adequate bone marrow, liver and renal function', 'Exclusion Criteria:', ' Patients receiving endocrine therapy for breast cancer 2 weeks prior to study treatment start', ' Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these 4 weeks prior to study treatment start or patients who have received lapatinib 2 weeks prior to study treatment start', ' Patients who have previously received mTOR inhibitors', ' Other protocol-defined inclusion/exclusion criteria may apply'], 'Results': ['Outcome Measurement: ', ' Phase II: Overall Response Rate', ' The primary objective of this phase II study was to evaluate the efficacy of the dose level/regimen of everolimus recommended from the Phase I with trastuzumab and paclitaxel (PT) therapy in patients with HER2-overexpressing metastatic breast cancer whose disease progressed on/after trastuzumab mono-and/or combination therapy based on the evaluation of objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Objective response rate (ORR) was defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR). Only patients with measurable disease (the presence of at least one measurable lesion) at baseline were included in the study. CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.', ' Time frame: every 8 - 9 weeks until disease progression or a new lesion is identified', 'Results 1: ', ' Arm/Group Title: Phase I - RAD001 5mg + PT, Daily', ' Arm/Group Description: Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants ', 'Results 2: ', ' Arm/Group Title: Phase I - RAD001 10mg + PT, Daily', ' Arm/Group Description: Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants '], 'Adverse Events': ['Adverse Events 1:', ' Total: 3/6 (50.00%)', ' Febrile neutropenia 0/6 (0.00%)', ' Leukopenia 0/6 (0.00%)', ' Neutropenia 0/6 (0.00%)', ' Thrombocytopenia 0/6 (0.00%)', ' Cardio-respiratory arrest 0/6 (0.00%)', ' Cardiopulmonary failure 0/6 (0.00%)', ' Vertigo 0/6 (0.00%)', ' Visual impairment 0/6 (0.00%)', ' Abdominal pain 0/6 (0.00%)', ' Diarrhoea 0/6 (0.00%)', ' Dysphagia 0/6 (0.00%)', ' Gastric ulcer 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 6/17 (35.29%)', ' Febrile neutropenia 0/17 (0.00%)', ' Leukopenia 0/17 (0.00%)', ' Neutropenia 0/17 (0.00%)', ' Thrombocytopenia 0/17 (0.00%)', ' Cardio-respiratory arrest 1/17 (5.88%)', ' Cardiopulmonary failure 0/17 (0.00%)', ' Vertigo 0/17 (0.00%)', ' Visual impairment 0/17 (0.00%)', ' Abdominal pain 0/17 (0.00%)', ' Diarrhoea 1/17 (5.88%)', ' Dysphagia 0/17 (0.00%)', ' Gastric ulcer 1/17 (5.88%)']}

f541ce25-c43e-496b-98e6-8470fe23f840

Single

Results

NCT01224678

Intervention 2 of the primary trial resulted in a lower percentage in Mammographic Density than intervention 1.

Entailment

{'Clinical Trial ID': 'NCT01224678', 'Intervention': ['INTERVENTION 1: ', ' Placebo', ' Patients receive oral placebo once daily for 12 months.', 'INTERVENTION 2: ', ' Vitamin D', ' Patients receive oral vitamin D (2000 IU) once daily for 12 months.'], 'Eligibility': ['Premenopausal women 55 years of age or younger with regular menstrual cycles (at least four cycles in the last six months). Women with fewer than 4 menses in the last 6 months or who have had a hysterectomy with ovaries intact will be considered premenopausal if FSH level < 20.', ' Women with breast density 25% (scattered fibroglandular densities or greater) are eligible.', ' Prior Treatment', ' Patients who are currently receiving hormone replacement therapy (estrogen or progesterone); or are taking tamoxifen or raloxifene are not eligible. Women who have taken these medications must have stopped for at least 4 months prior to study entry.', ' Topical estrogen (eg, transdermal patches and vaginal estrogens) is allowed.', ' Patients who are currently using hormonal contraception, should be taking it for at least 4 months prior to study entry.', ' Vitamin D Use', ' Patients who are taking regular vitamin D supplementation (above 400 IUs daily) and refuse or are unable to stop use are not eligible. Women who agree to stop will need to do so for at least 6 months prior to registration.', ' Patients may not start vitamin D supplementation after registration (regardless of results of vitamin D testing) but they may continue vitamin D if they are already taking 400 IUs daily or less and have been taking vitamin D for at least 6 months prior to baseline mammogram.', ' Patients with a history of breast cancer (including DCIS) or ovarian cancer are not eligible.', ' Patients with a history of breast implants or breast reduction are not eligible.', ' Patients with two or more bone fractures in the past five years are not eligible.', ' Patients with a diagnosis of osteoporosis with physician recommendation for treatment of low bone mass are not eligible.', ' Patients known to have hyperparathyroid disease or other serious disturbances of calcium metabolism requiring intervention in the past 5 years are not eligible.', ' Patients with a history of kidney stones (unless documented not to have been a calcium stone) are not eligible.', ' Patients participating in a concurrent breast cancer chemoprevention trial are not eligible.', ' Required initial laboratory values - Calcium < 10.5 mg/dL'], 'Results': ['Outcome Measurement: ', ' Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms', ' To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women. The percent change in breast density will be reported here.', ' Time frame: 12 months', 'Results 1: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Patients receive oral placebo once daily for 12 months.', ' Overall Number of Participants Analyzed: 46', ' Mean (Standard Deviation)', ' Unit of Measure: percent change -3.4 (7.1)', 'Results 2: ', ' Arm/Group Title: Vitamin D', ' Arm/Group Description: Patients receive oral vitamin D (2000 IU) once daily for 12 months.', ' Overall Number of Participants Analyzed: 40', ' Mean (Standard Deviation)', ' Unit of Measure: percent change -1.4 (11.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/150 (0.00%)', 'Adverse Events 2:', ' Total: ']}

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

dafe9dce-420e-46dc-a8ed-ac2f4c84b49b

Comparison

Intervention

NCT00291135

NCT00291694

The duration of treatment in the primary trial is half as long as in the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00291135', 'Intervention': ['INTERVENTION 1: ', ' Letrozole', ' Letrozole, 2.5 mg daily for six months'], 'Eligibility': ['Inclusion Criteria:', ' evidence of hyperplasia with/without atypia upon random periareolar fine needle aspiration of breast', ' on hormone replacement therapy', ' postmenopausal', ' increased risk of developing breast cancer based on personal or family history', ' never have taken aromatase inhibitors or selective estrogen receptor modulators in last six months', ' women who have a high risk of breast cancer', ' older than 18 years', 'Exclusion Criteria:', ' anticoagulants', ' marked breast tenderness', ' pregnant or within twelve months of breast feeding/childbirth'], 'Results': ['Outcome Measurement: ', ' Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration.', ' Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.', ' Time frame: Baseline, 6 months', 'Results 1: ', ' Arm/Group Title: Letrozole', ' Arm/Group Description: Letrozole, 2.5 mg daily for six months', ' Overall Number of Participants Analyzed: 42', ' Median (Full Range)', ' Unit of Measure: Change in % of cells positive for Ki-67 -2.3 (-21.0 to 7.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/42 (0.00%)']}

{'Clinical Trial ID': 'NCT00291694', 'Intervention': ['INTERVENTION 1: ', ' Celecoxib', ' Randomized to receive celecoxib daily for 12 months', 'INTERVENTION 2: ', ' Placebo', ' Randomized to receive placebo daily for 12 months'], 'Eligibility': ['Inclusion Criteria:', ' women who have a high risk of breast cancer', ' older than 18 years', 'Exclusion Criteria:', ' anticoagulants', ' marked breast tenderness', ' pregnant or within twelve months of breast feeding/childbirth'], 'Results': ['Outcome Measurement: ', ' Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67', ' Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.', ' Time frame: Baseline and 12 months', 'Results 1: ', ' Arm/Group Title: Celecoxib', ' Arm/Group Description: Randomized to receive celecoxib daily for 12 months', ' Overall Number of Participants Analyzed: 43', ' Median (Full Range)', ' Unit of Measure: percentage of cells staining positive -1.2 (-18 to 14.8)', 'Results 2: ', ' Arm/Group Title: Placebo', ' Arm/Group Description: Randomized to receive placebo daily for 12 months', ' Overall Number of Participants Analyzed: 21', ' Median (Full Range)', ' Unit of Measure: percentage of cells staining positive -2.0 (-8.8 to 12.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/43 (0.00%)', 'Adverse Events 2:', ' Total: ']}

24d81b18-ce9c-4927-9386-9ebef969a159

Single

Eligibility

NCT02756364

In order to meet the inclusion criteria for the primary trial patients must have had aromatase inhibitor (AI) therapy before study entry, resulting in complete tumor response.

Contradiction

{'Clinical Trial ID': 'NCT02756364', 'Intervention': ['INTERVENTION 1: ', ' Arm A: Fulvestrant 500 mg', ' Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).', 'INTERVENTION 2: ', ' Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD', ' Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).'], 'Eligibility': ['Inclusion Criteria:', ' Female participants aged 18 years or older who are postmenopausal.', ' Histologically proven diagnosis of breast cancer with evidence of metastatic disease or locoregional recurrence.', ' Histological confirmation and documentation of estrogen receptor (ER)-positive status ( 1% positive stained cells).', ' Histological or cytological confirmation and documentation of human epidermal growth factor receptor-2 (HER2)-negative status by local laboratory testing using criteria in the American Society of Oncology (ASCO)/College of American Pathologists (CAP) Clinical Practice Guideline update.', ' Measurable disease defined as either of the following:', ' At least 1 extra-osseous lesion that could be accurately measured in at least 1 dimension.', ' The lesion must have measured 20 mm with conventional imaging techniques or 10 mm with spiral CT or MRI. Lymph nodes must be 1.5 cm in the short axis to be considered measurable.', ' Bone lesions (lytic or mixed [lytic plus sclerotic]) in the absence of measurable disease as defined above. Note: Participants with sclerotic/osteoblastic bone lesions only, in the absence of measurable disease, were not eligible.', ' Progressive Disease (PD) during prior aromatase inhibitor (AI) therapy.', ' Have a history of brain metastasis provided that all of the following criteria are met:', ' Brain metastases have been treated.', ' No evidence of PD for 3 months before the first dose of study drug.', ' No hemorrhage after treatment.', ' Off dexamethasone treatment for 4 weeks before the first dose of study drug.', ' No ongoing requirement for dexamethasone or anti-epileptic drugs.', ' Eastern cooperative oncology group (ECOG) performance status of 0 or 1.', ' Clinical laboratory values as specified below within 4 weeks before the first dose of study drug:', ' Bone marrow reserve consistent with absolute neutrophil count (ANC) 1.5*10^9/L; platelet count 100*10^9/L; hemoglobin (Hgb) 9 g/dL.', ' Total bilirubin 1.5*the upper limit of the normal range (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5*ULN ( 5*ULN if liver metastases are present).', ' Creatinine clearance 40 mL/min based on Cockcroft-Gault estimate or based on a 12- or 24-hour urine collection.', ' Fasting serum glucose 130 mg/dL and fasting triglycerides 300 mg/dL.', 'Exclusion Criteria:', ' Prior therapy with mechanistic target of rapamycin (mTOR), phosphoinositide-3-kinase (PI3K), or dual PI3K-mTOR inhibitors, serine/threonine-specific protein kinase (AKT) inhibitors, or fulvestrant.', ' Prior treatment with >1 line of chemotherapy for metastatic breast cancer or for locoregional recurrence that was not amenable to resection or radiation therapy with curative intent.', ' Experienced PD on >2 endocrine therapies for metastatic breast cancer or for locoregional recurrence that was not amenable to resection or radiation therapy with curative intent.', ' Life-threatening metastatic visceral disease (defined as extensive hepatic involvement or symptomatic pulmonary lymphangitic spread).', ' Poorly controlled diabetes mellitus defined as hemoglobin A1c (glycosylated hemoglobin; HbA1c) >7%; participants with a history of transient glucose intolerance due to corticosteroid administration may be eligible if all other inclusion/exclusion criteria are met.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, PD was defined as at least a 20% increase in the sum of the 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.', ' Time frame: Up to 40 months', 'Results 1: ', ' Arm/Group Title: Arm A: Fulvestrant 500 mg', ' Arm/Group Description: Fulvestrant 500 mg, intramuscularly (IM), once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 16.0 weeks).', ' Overall Number of Participants Analyzed: 46', ' Median (95% Confidence Interval)', ' Unit of Measure: months 3.5 (1.9 to 5.6)', 'Results 2: ', ' Arm/Group Title: Arm B: Fulvestrant 500 mg + Sapanisertib 4 mg QD', ' Arm/Group Description: Fulvestrant 500 mg, IM, once on Days 1 and 15 in Cycle 1, and then on Day 1 of each subsequent 28-day cycle along with the sapanisertib 4 mg, capsules, orally, once daily in each 28-day treatment cycle until progressive disease, unacceptable toxicity, or withdrawal of consent (Median duration of treatment was 20.1 and 20.3 weeks for fulvestrant and sapanisertib respectively).', ' Overall Number of Participants Analyzed: 47', ' Median (95% Confidence Interval)', ' Unit of Measure: months 7.2 (3.9 to 10.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/46 (17.39%)', ' Angina pectoris 0/46 (0.00%)', ' Hypercalcaemia of malignancy 0/46 (0.00%)', ' Vomiting 0/46 (0.00%)', ' Diarrhoea 0/46 (0.00%)', ' Nausea 0/46 (0.00%)', ' Stomatitis 0/46 (0.00%)', ' Pyrexia 0/46 (0.00%)', ' Cholelithiasis 0/46 (0.00%)', ' Hepatic failure 1/46 (2.17%)', ' Pyelonephritis acute 0/46 (0.00%)', ' Appendicitis 0/46 (0.00%)', ' Cellulitis 0/46 (0.00%)', 'Adverse Events 2:', ' Total: 13/47 (27.66%)', ' Angina pectoris 0/47 (0.00%)', ' Hypercalcaemia of malignancy 0/47 (0.00%)', ' Vomiting 2/47 (4.26%)', ' Diarrhoea 2/47 (4.26%)', ' Nausea 0/47 (0.00%)', ' Stomatitis 1/47 (2.13%)', ' Pyrexia 2/47 (4.26%)', ' Cholelithiasis 0/47 (0.00%)', ' Hepatic failure 0/47 (0.00%)', ' Pyelonephritis acute 0/47 (0.00%)', ' Appendicitis 0/47 (0.00%)', ' Cellulitis 0/47 (0.00%)']}

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

0046e113-8ac5-4725-a285-e78b8c26f825

Comparison

Eligibility

NCT00499083

NCT03045653

In order to be eligible for both the secondary trial and the primary trial, patients must be female, over the age of 18, ECOG <2 and have Histologically confirmed HER2 + breast cancer.

Contradiction

{'Clinical Trial ID': 'NCT00499083', 'Intervention': ['INTERVENTION 1: ', ' Vaccine', ' Patients with HER-2/neu negative tumors received therapeutic autologous dendritic cells: injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments.', ' Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor.', ' Patients received 4 cycles of paclitaxel: 175 mg/m2 (IV), followed by 4 cycles of cyclophosphamide: 600 mg/m2 IV and doxorubicin hydrochloride: 60 mg/m2 IV in a bi-weekly dose dense fashion', ' All patients had pre-treatment biopsy and second tumor biopsy after 4 cycles of paclitaxel to evaluate responses to the dendritic cell injections.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed invasive breast cancer meeting the following criteria:', ' Primary tumor 3 cm by mammography, ultrasound, or palpation AND/OR palpable axillary lymph nodes > 1 cm', ' Survivin- and/or carcinoembryonic antigen-positive by IHC', ' Tumor must be localized by exam or ultrasound to allow tumor injection', ' No stage IV or metastatic disease', ' HER2/neu-negative tumor by IHC', ' If 2+ or in the indeterminate range, further testing of HER2/neu overexpression by fluorescent in situ hybridization (FISH) is required', ' Hormone receptor status known', ' PATIENT CHARACTERISTICS:', ' Female', ' Pre-, peri-, or postmenopausal', ' ECOG performance status 0-1', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for up to 6 months following completion of study therapy', ' ANC 1,500/mm³', ' Platelet count 100,000/mm³', ' Alkaline phosphatase 1.5 times upper limit of normal (ULN)', ' Total bilirubin 1.5 times ULN', ' AST and ALT 1.5 times ULN', ' Creatinine < 1.5 times ULN', ' No active serious infections', ' No prior malignancy except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinoma, or other cancer from which the patient has been disease free for 5 years', ' No comorbidity or condition that would interfere with study assessments and procedures or preclude study participation', ' PRIOR CONCURRENT THERAPY:', ' No prior chemotherapy or radiotherapy'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Pathological Complete Response', ' Assessed by the institutional pathologist.', ' Grade 1: disappearance of all tumor on microscopic assessment in the breast and LNs', ' Grade 2: presence of in situ carcinoma only in the breast, no invasive tumor, and no tumor found in the LNs', ' Grade 3: presence of invasive carcinoma with stromal alteration, such as sclerosis or fibrosis', ' Grade 4: no or few modifications of the tumor appearance', ' Time frame: At definitive surgery.', 'Results 1: ', ' Arm/Group Title: Vaccine', ' Arm/Group Description: Patients with HER-2/neu negative tumors received therapeutic autologous dendritic cells: injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments.', ' Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor.', ' Patients received 4 cycles of paclitaxel: 175 mg/m2 (IV), followed by 4 cycles of cyclophosphamide: 600 mg/m2 IV and doxorubicin hydrochloride: 60 mg/m2 IV in a bi-weekly dose dense fashion', ' All patients had pre-treatment biopsy and second tumor biopsy after 4 cycles of paclitaxel to evaluate responses to the dendritic cell injections.', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Number', ' Unit of Measure: participants 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/3 (33.33%)', ' Febrile neutropenia 1/3 (33.33%)']}

{'Clinical Trial ID': 'NCT03045653', 'Intervention': ['INTERVENTION 1: ', ' Treatment Arm', ' receiving a treatment of tamoxifen 100 mg/d'], 'Eligibility': ['Inclusion Criteria:', ' - Female 18 years, 70 years. ECOG 0-1 with no deterioration over previous 2 weeks Minimum life expectancy 3 months Histological confirmation of hormone receptor-high expressed breast cancer(IHC:ER 60% and PR 60%) on primary tumour at diagnosis/on biopsy of metastasis Histological confirmation of HER2 negative breast cancer on primary tumour at diagnosis/on biopsy of a metastasis The disease-free time of relapsed patients is more than 12 months Once received standard hormone treatment and progressed Clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection At least one evaluative focus according to RECIST creterion or non-measurable disease but only bone metastasis Adequate bone marrow and organ function Progressive disease whilst receiving endocrine therapy for locally advanced or metastatic BC or relapsed with metastatic disease whilst receiving endocrine therapy Radiological or objective clinical evidence of recurrence or progression on or after last systemic therapy prior to enrolment', ' 4 prior lines of endocrine therapy for ABC', ' 3 line of cytotoxic chemotherapy for ABC Suitable for further endocrine therapy Availability of archival tumour sample or fresh biopsy Informed consent Normal organ function', 'Exclusion Criteria:', ' Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour embolisation <21 days prior to study treatment Last dose of palliative radiotherapy <7 days prior to study treatment Rapidly progressive visceral disease not suitable for further endocrine therapy Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and stable and not requiring steroids for 4 weeks study treatment Creatinine clearance <30 ml/min. Patients with creatinine clearance <50 mL/min will start at a permanently reduced vandetanib dose of 200 mg.', ' Major surgery (excluding placement of vascular access) within 4 weeks before study treatment Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment Elevated ALP in absence of bone metastasis Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent Participation in another study with investigational product during last 30 days Inability or unwillingness to comply with study procedures, including inability to take regular oral medication'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS)', ' [Not Specified]', ' Time frame: 36months', 'Results 1: ', ' Arm/Group Title: Treatment Arm', ' Arm/Group Description: receiving a treatment of tamoxifen 100 mg/d', ' Overall Number of Participants Analyzed: 30', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5 (2.6 to 7.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/30 (0.00%)']}

e90f7748-f4b4-4822-8768-586c3f2f9980

Comparison

Eligibility

NCT00429572

NCT02455453

post-menopausal patients are excluded from the secondary trial, but eligible for the primary trial.

Contradiction

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

{'Clinical Trial ID': 'NCT02455453', 'Intervention': ['INTERVENTION 1: ', ' Diagnostic FFNP-PET/CT Scan', ' (2) 18F-FFNP-PET/CT scans', ' First one prior to estradiol challenge test', ' Second one immediately following one day of estradiol challenge test', ' (1) FDG-PET/CT scan at screening', ' The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study.'], 'Eligibility': ['Inclusion Criteria:', ' Patient must be postmenopausal defined as meeting one or more of the following:', ' Age 60 years', ' Amenorrheic for at least 12 months', ' Surgically sterile- having undergone bilateral oophorectomy,', ' FSH level in postmenopausal range according to institutional standards (note follicle-stimulating hormone (FSH) laboratory testing must be ordered as standard of care to determine optimal treatment and should not be ordered simply to confirm eligibility to this study)', ' OR Pre-menopausal for whom standard estradiol treatment (ET) is planned with ovarian suppression (imaging on study should be completed prior to start of ovarian suppression)', ' Patient must have histological or cytological confirmed breast cancer and fall into one of the following categories:', ' New diagnosis with plans for at least 6 months of neoadjuvant ET or any amount of neoadjuvant ET if surgery is planned as this will be used for response assessment .', ' Patients with newly diagnosed metastatic breast cancer or patient with known metastatic disease who has progressed while on therapy (no washout period is needed if the patient was treated with AIs or chemotherapy, but 2 months washout period is needed if the patient was treated with tamoxifen) who are going to be treated with ET.', ' Patient must have any one of the following types of breast cancer (primary or metastatic): ER+/PgR+/HER2- or ER+/PgR-/HER2-.', ' ER+ is defined as Allred score of at least 4 and greater.', ' PgR+ is defined as Allred score of at least 4 and greater.', ' Immunohistochemistry (IHC) is the primary assay methodology for HER2. HER2- refers to HER2 of 0, 1+ by IHC or negative by fluorescence in situ hybridization (FISH)', ' Patient must have at least one measurable lesion according to RECIST 1.1 by radiological evaluation (ultrasound, mammography, MRI, CT, PET) or physical examination.', ' Patients with evaluable osseous metastasis that are lytic or mixed lytic-sclerotic are eligible.', ' Patients with hepatic lesions may be eligible provided the location of the lesion is peripheral or not too close to hepatic ducts. Decision on hepatic lesion eligibility will be made by the principal investigator or sub-investigator after careful review of all available imaging to ensure evaluation of the lesion will not be obscured by normal hepatobiliary excretion of 18F-FFNP.', ' Patient must be able to understand and willing to sign a written informed consent document.', ' Prior chemotherapy or endocrine therapy is allowed', ' The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or, based on the judgment of the treating medical oncologist, can tolerate imaging and at least 6 months of ET', ' The patient should have a life expectancy of > 6 months.', 'Exclusion Criteria:', ' Patient with other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in-situ, who had (or have) any evidence of the other cancer present within the last 5 years', ' Unable to tolerate up to 60 min of PET imaging per imaging session.', ' Patients with non-measurable non-evaluable lesions such as pleural effusion are not eligible to participate.', ' Patients with vertebral lesions that, in the opinion of the Principal Investigator and the treating medical oncologist, pose an imminent risk for cord compression.'], 'Results': ['Outcome Measurement: ', ' Change in Primary Tumor FFNP Uptake Before and After Estradiol Challenge as Measured by Percent Change in Standardized Uptake Value (SUV)', ' [Not Specified]', ' Time frame: Completion of second FFNP-PET/CT scan (up to 4 weeks)', 'Results 1: ', ' Arm/Group Title: Diagnostic FFNP-PET/CT Scan', ' Arm/Group Description: (2) 18F-FFNP-PET/CT scans', ' First one prior to estradiol challenge test', ' Second one immediately following one day of estradiol challenge test', ' (1) FDG-PET/CT scan at screening', ' The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study.', ' Overall Number of Participants Analyzed: 45', ' Median (Full Range)', ' Unit of Measure: percent change in SUV 11.0 (-46.0 to 306.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/47 (0.00%)']}

fb8f09d6-c393-4943-bc67-fa0f0a6bdd86

Single

Eligibility

NCT00932373

Patients with Grade I peripheral neuropathy or above are eliminated from participation in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00932373', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks', ' Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks', 'INTERVENTION 2: ', ' Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks', ' Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks'], 'Eligibility': ['Inclusion Criteria:', ' Histologically documented, incurable, locally advanced or metastatic breast cancer', ' Evaluable or measurable HER2-positive disease', ' History of progression during or within 60 days after treatment with any prior trastuzumab-containing chemotherapy regimen for HER2-positive breast cancer', ' Previous treatment with chemotherapy for MBC', ' Granulocyte count 1,500/μL, platelet count 100,000/μL, and hemoglobin 9 g/dL', ' Serum bilirubin 1.5 mg/dL; AST, ALT, and alkaline phosphatase 2.5 × upper limit of normal (ULN) except for: Patients with hepatic metastases: ALT and AST 5 × ULN Patients with hepatic and/or bone metastases: alkaline phosphatase 5 × ULN', ' Serum creatinine 1.5 mg/dL or creatinine clearance of 60 mL/min based on a 24-hour urine collection', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2', ' Women of childbearing potential and men must agree to use an effective method of birth control (e.g., hormonal, barrier) while receiving study treatment', 'Exclusion Criteria:', ' History of significant cardiac disease, unstable angina, CHF, myocardial infarction, or ventricular arrhythmia requiring medication', ' History of Grade 3 hypersensitivity reaction to trastuzumab', ' History of any toxicity to trastuzumab that resulted in trastuzumab being permanently discontinued', ' Symptomatic brain metastases or any radiation or surgery for brain metastases within 3 months of first study treatment', ' Require supplemental oxygen for daily activities', ' Grade 2 peripheral neuropathy', ' Bisphosphonate therapy for symptomatic hypercalcemia', ' Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 4 weeks of first study treatment', ' Any experimental therapy within 4 weeks of first study treatment', ' Any major surgical procedure within 4 weeks of first study treatment', ' History of clinically symptomatic liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis', ' Pregnancy or lactation', ' Cardiac troponin I 0.2 ng/mL', ' Ejection fraction < 50% or below the lower limit of normal determined by echocardiogram or MUGA scan', ' Prior cumulative doxorubicin dose of > 360 mg/m2 or equivalent'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Adverse Events (AE), Serious Adverse Events (SAE), AEs With Grade >=3, and AEs Related To Treatment', ' The time frame for AEs is study treatment initiation until 30 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.', ' The time frame for SAEs is study treatment initiation until 90 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.', ' Time frame: Study treatment initiation until 30 or 90 days after last administration of study treatment', 'Results 1: ', ' Arm/Group Title: Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks', ' Arm/Group Description: Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks', ' Overall Number of Participants Analyzed: 3', ' Measure Type: Number', ' Unit of Measure: percentage of participants At least 1 AE: 100', 'AEs with Grade >=3: 33.3', ' At least 1 SAE: 33.3', ' AEs related to treatment: 66.7', 'Results 2: ', ' Arm/Group Title: Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks', ' Arm/Group Description: Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks', ' Overall Number of Participants Analyzed: 1', ' Measure Type: Number', ' Unit of Measure: percentage of participants At least 1 AE: 100', 'AEs with Grade >=3: 100', ' At least 1 SAE: 100', ' AEs related to treatment: 100'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/3 (33.33%)', ' Pain 0/3 (0.00%)', ' Cellulitis 0/3 (0.00%)', ' Influenza 0/3 (0.00%)', ' Osteomyelitis 0/3 (0.00%)', ' Pneumonia 0/3 (0.00%)', ' Humerus Fracture 0/3 (0.00%)', ' Brain Oedema 0/3 (0.00%)', ' Cerebral Haemorrhage 0/3 (0.00%)', ' Convulsion 0/3 (0.00%)', ' Dysarthria 0/3 (0.00%)', ' Hepatic Encephalopathy 0/3 (0.00%)', ' Confusional State 0/3 (0.00%)', ' Dyspnoea 1/3 (33.33%)', 'Adverse Events 2:', ' Total: 1/1 (100.00%)', ' Pain 0/1 (0.00%)', ' Cellulitis 0/1 (0.00%)', ' Influenza 0/1 (0.00%)', ' Osteomyelitis 0/1 (0.00%)', ' Pneumonia 0/1 (0.00%)', ' Humerus Fracture 0/1 (0.00%)', ' Brain Oedema 0/1 (0.00%)', ' Cerebral Haemorrhage 0/1 (0.00%)', ' Convulsion 0/1 (0.00%)', ' Dysarthria 0/1 (0.00%)', ' Hepatic Encephalopathy 0/1 (0.00%)', ' Confusional State 0/1 (0.00%)', ' Dyspnoea 0/1 (0.00%)']}

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

3c3fb5e3-1994-455a-bae4-6d267c5c89d7

Comparison

Intervention

NCT03573804

NCT02781051

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

Contradiction

{'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%)']}

2ecd62df-f5ea-417d-8783-2174a6d77087

Single

Intervention

NCT01781299

all subjects in the primary trial must commit to a regular exercise schedule.

Contradiction

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

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

b43c02bf-c4b0-495f-b7ba-879f409cb685

Comparison

Eligibility

NCT03136367

NCT00129935

Only patients which have been assigned as female at birth are eligible for the secondary trial and the primary trial.

Entailment

{'Clinical Trial ID': 'NCT03136367', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: Option Grid', ' Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.', ' Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.', 'INTERVENTION 2: ', ' Arm 2: Picture Option Grid', ' Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.', ' Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.'], 'Eligibility': ['Inclusion Criteria:', ' Assigned female at birth;', ' 18 years and older;', ' Confirmed diagnosis (via biopsy) of early stage breast cancer (stages I-IIIA);', " Eligible for both breast-conserving surgery and mastectomy based on medical records and clinician's opinion before surgery;", ' Spoken English, Spanish, or Mandarin Chinese.', 'Exclusion Criteria:', ' Transgender men and women;', ' Women who have undergone prophylactic mastectomy;', ' Women with visual impairment;', ' Women with a diagnosis of severe mental illness or severe dementia;', ' Women with inflammatory breast carcinoma.'], 'Results': ['Outcome Measurement: ', ' Change in Decision Quality: Knowledge Subscale', ' Change in decision quality, measured using the validated 16-item Decision Quality Worksheet for Breast Cancer Surgery. Decision quality is measured through three constructs: knowledge, decision process, and concordance. Knowledge is five questions that results in a score from 0 to 5 with higher numbers indicating higher knowledge. Decision process is a measure how much shared decision making process occurred, based on patient-report. It is a seven-item scale with higher numbers indicating higher shared decision process. For the concordance score, patients rated their goals and concerns on an 11-point importance scale from 0 (not important at all) to 10 (extremely important). They also indicated which surgery they intended to have at T2. A concordance summary score (0-100%) indicated the percentage of patients who received a treatment that matched their stated preference.', ' Time frame: Immediately before the index surgical consultation visit, immediately after the index surgical consultation visit and at one week post-surgery', 'Results 1: ', ' Arm/Group Title: Arm 1: Option Grid', ' Arm/Group Description: Patients in this arm will receive the Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.', ' Option Grid: The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.', ' Overall Number of Participants Analyzed: 66', ' Mean (Standard Deviation)', ' Unit of Measure: score on a scale Immediately before the index surgical consultation visit: 2.83 (1.29)', ' Immediately after the index surgical consultation visit: 2.82 (1.13)', ' One week post-surgery: 3.00 (1.11)', 'Results 2: ', ' Arm/Group Title: Arm 2: Picture Option Grid', ' Arm/Group Description: Patients in this arm will receive the Picture Option Grid for breast cancer surgery, an encounter decision aid, when they first meet with the breast surgeon to discuss their surgical options for breast cancer treatment.', ' Picture Option Grid: The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.', ' Overall Number of Participants Analyzed: 248', ' Mean (Standard Deviation)', ' Unit of Measure: score on a scale Immediately before the index surgical consultation visit: 2.95 (1.22)', ' Immediately after the index surgical consultation visit: 2.90 (1.07)', ' One week post-surgery: 2.88 (1.05)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/66 (0.00%)', 'Adverse Events 2:', ' Total: 0/248 (0.00%)']}

{'Clinical Trial ID': 'NCT00129935', 'Intervention': ['INTERVENTION 1: ', ' Arm A: EC-T', ' Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.', ' Docetaxel', ' Epirubicin', 'Cyclophosphamide', 'INTERVENTION 2: ', ' Arm B: ET-X', ' Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.', ' Docetaxel', ' Capecitabine', 'Epirubicin'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent.', ' Histological diagnosis of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 negative. Time window between surgery and study randomization must be less than 60 days.', ' Surgery must consist of mastectomy or conservative surgery with axillary lymph node dissection. Margins free of disease and ductal carcinomas in situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.', ' Positive axillary lymph nodes defined as at least 1 out of 10 nodes with presence of disease. If sentinel node technique is used, sentinel node can be the only node affected. Patients belonging to the following classifications are eligible: TNM pathologic stage N1a, TNM pathologic stage N2a, TNM pathologic stage N3a.', ' Status of hormone receptors in primary tumour. Results must be available before the end of adjuvant chemotherapy.', ' Patients must not present evidence of metastatic disease. Status of HER2 in primary tumour, known before randomization. Patients with immune histochemistry (IHC) 0 or +1 are eligible. For patients with IHC 2+, fluorescence in situ hybridization (FISH) is mandatory and result must be negative.', ' Age >= 18 and <= 70 years old.', ' Performance status (Karnofsky index) >= 80.', ' Normal electrocardiogram (EKG) in the 12 weeks prior to randomization. If needed, normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF).', ' Laboratory results (within 14 days prior to randomization):', ' Hematology: neutrophils >= 1.5 x 10^9/l; platelets >= 100 x 10^9/l; hemoglobin >= 10 mg/dl;', ' Hepatic function: total bilirubin <= 1 upper normal limit (UNL); serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) <= 2.5 UNL; alkaline phosphatase <= 2.5 UNL. If values of SGOT and SGPT > 1.5 UNL are associated to alkaline phosphatase > 2.5 UNL, patient is not eligible;', ' Renal function: creatinine <= 175 mmol/l (2 mg/dl); creatinine clearance >= 60 ml/min;', ' Pharmacogenetics: one blood sample is needed for single nucleotide polymorphism (SNP) assessment.', ' Complete stage workup during the 12 weeks prior to randomization (mammograms are allowed within a 20 week window). All patients must have a bilateral mammogram, thorax x-ray, abdominal echography and/or computed tomography (CT)-scan. If bone pain, and/or alkaline phosphatase elevation, a bone scintigraphy is mandatory. This test is recommended for all patients. Other tests: as clinically indicated.', ' Patients able to comply with treatment and study follow-up.', ' Negative pregnancy test done in the 14 prior days to randomization.', 'Exclusion Criteria:', ' Prior systemic therapy for breast cancer.', ' Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.', ' Prior radiotherapy for breast cancer.', ' Bilateral invasive breast cancer.', ' Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments.', ' Any T4 or M1 tumour.', ' Axillary lymph nodes: patients belonging to the following classifications are excluded: TNM pathologic stage N1b, TNM pathologic stage N1c, TNM pathologic stage N2b, TNM pathologic stage N3b, TNM pathologic stage N3c.', ' HER2 positive breast cancer (IHC 3+ or positive FISH result).', ' Pre-existing grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria version 2.0 [NCICTC v-2.0]).', ' Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled hypertension or high risk arrhythmias.', ' History of neurological or psychiatric disorders, which could preclude the patients from free informed consent.', ' Active uncontrolled infection.', ' Active peptic ulcer; unstable diabetes mellitus.', ' Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumour curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.', ' Chronic treatment with corticosteroids.', ' Contraindications for corticosteroid administration.', ' Concomitant treatment with raloxifene, tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis treatment or for prevention. These treatments must stop before randomisation.', ' Concomitant treatment with other investigational products; participation in other clinical trials with a non-marketed drug in the 20 previous days before randomization.', ' Concomitant treatment with another therapy for cancer.', 'Males.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Disease-free Survival (DFS) Event', ' A participant was considered to have had a DFS event if there was evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.', ' Time frame: 5 years', 'Results 1: ', ' Arm/Group Title: Arm A: EC-T', ' Arm/Group Description: Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.', ' Docetaxel', ' Epirubicin', ' Cyclophosphamide', ' Overall Number of Participants Analyzed: 669', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 127 19.0%', 'Results 2: ', ' Arm/Group Title: Arm B: ET-X', ' Arm/Group Description: Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.', ' Docetaxel', ' Capecitabine', ' Epirubicin', ' Overall Number of Participants Analyzed: 715', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 170 23.8%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 111/669 (16.59%)', ' Leukocytes * [1]1/669 (0.15%)', ' Hemoglobin * [1]1/669 (0.15%)', ' Hemoglobin * [2]0/669 (0.00%)', ' CNS cerebrovascular ischemia * [1]0/669 (0.00%)', ' CNS cerebrovascular ischemia * [3]0/669 (0.00%)', ' Heart Failure * [1]3/669 (0.45%)', ' Thrombosis/embolism * [1]1/669 (0.15%)', ' Thrombosis/embolism * [3]0/669 (0.00%)', 'Adverse Events 2:', ' Total: 138/715 (19.30%)', ' Leukocytes * [1]0/715 (0.00%)', ' Hemoglobin * [1]0/715 (0.00%)', ' Hemoglobin * [2]1/715 (0.14%)', ' CNS cerebrovascular ischemia * [1]1/715 (0.14%)', ' CNS cerebrovascular ischemia * [3]1/715 (0.14%)', ' Heart Failure * [1]1/715 (0.14%)', ' Thrombosis/embolism * [1]3/715 (0.42%)', ' Thrombosis/embolism * [3]2/715 (0.28%)']}

fdff0cf1-a0a2-4516-bdf7-109ac7adb266

Single

Adverse Events

NCT00398567

80% of patients in the primary trial did not suffer any adverse events.

Contradiction

{'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': ''}

6babfc60-5043-4f2b-9605-3e44744265e9

Single

Adverse Events

NCT00274469

No more than 1% of either cohorts of the primary trial felt nauseous.

Entailment

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

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

5ca02204-6120-4b02-bf3b-fba94d6fac4f

Single

Eligibility

NCT00836186

Patients cannot be excluded from the primary trial on the basis of gender or ethnicity.

Contradiction

{'Clinical Trial ID': 'NCT00836186', 'Intervention': ['INTERVENTION 1: ', ' Radiation Therapy', ' Women with any non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan.', ' Radiation therapy: Patients will receive whole breast radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed (Boost) is at the discretion of the treating physician. The total dose to the tumor bed cannot exceed 6600 cGy.'], 'Eligibility': ['INCLUSION CRITERIA:', ' Patient must be 18 years of age or older', ' Patients must have histologically confirmed (by routine H&E staining) adenocarcinoma of the breast any T, any N, M0 disease', ' Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy. Surgical margins at time of local surgery must be negative greater or equal to 2mm for both invasive carcinoma and for non-invasive ductal carcinoma Patients who have post-operative margins which are negative but less than 2mm will be considered eligible if the surgeon states that the margin in question cannot be improved.', ' Patients must be registered such that radiation therapy begins within 10 weeks of last surgery', ' Patients must have a performance status 0 or 1 by Eastern Cooperative Oncology Group (ECOG) criteria or a 80-100 Karnofsky Performance Scale at time of consult', ' Women of all races and ethnic groups are eligible for this trial', 'EXCLUSION CRITERIA:', ' Patients must not have received prior radiation therapy to the breast at any time for any reason', ' Patients with squamous carcinomas or sarcomas of the breast cancer are not eligible', ' Patients treated with a mastectomy are NOT eligible', ' Any patient with active local-regional disease prior to registration is not eligible', ' No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for at least 5 years', ' Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing potential must use effective non hormonal contraception while undergoing radiation therapy', ' Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment'], 'Results': ['Outcome Measurement: ', ' Number of Proteins Expressed Differently in Response to Receiving Radiation Therapy', ' Number of proteins that are expressed differently in response to receiving radiation therapy for breast cancer. The data reflect the total number of proteins pooled across all participants.', ' Time frame: 2 - 4 weeks post radiation therapy', 'Results 1: ', ' Arm/Group Title: Radiation Therapy', ' Arm/Group Description: Women with any non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan.', ' Radiation therapy: Patients will receive whole breast radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed (Boost) is at the discretion of the treating physician. The total dose to the tumor bed cannot exceed 6600 cGy.', ' Overall Number of Participants Analyzed: 65', ' Measure Type: Number', ' Unit of Measure: Proteins 31'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0']}

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

625c2690-ec9e-4ecc-85c0-9b5ca8467848

Single

Adverse Events

NCT00290758

There was one GU and three GI adverse events recorded in the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00290758', 'Intervention': ['INTERVENTION 1: ', ' Arm A (Genistein)', ' Patients receive oral genistein once daily for up to 6 months.', 'INTERVENTION 2: ', ' Arm B (Placebo)', ' Patients receive oral placebo once daily for up to 6 months.'], 'Eligibility': ['Inclusion Criteria:', ' No known soy intolerance', ' At increased risk of developing breast cancer in >= 1 previously unaffected breast, as defined by any of the following:', ' Estimated 5-year risk of developing breast cancer using the Gail model, as defined by 1 of the following:', ' Gail score >= 1.66%', ' Gail score >= 0.1% for women age 20-29 years', ' Gail score >= 1.0% for women age 30-39 years', ' Estimated 5-year risk of developing breast cancer using the Claus model:', ' Claus score >= 1.66%', ' Claus score >= 0.1% for women age 20-29 years', ' Claus score >= 1.0% for women age 30-39 years', ' Prior diagnosis of unilateral in situ or invasive breast cancer OR history of atypical hyperplasia, BRCA 1 and/or BRCA 2 positivity', ' History of lobular carcinoma in situ', ' No evidence of breast cancer, as determined by a negative mammogram within the past 6 months and a history and physical', ' No previously diagnosed breast cancer unless all systemic therapy (including endocrine therapy) was completed at least 1 year ago', ' Pre- or postmenopausal', ' ECOG performance status 0-1', ' Hemoglobin > 10.0 g/dL', ' Platelet count > 100,000/mm^3', ' Absolute neutrophil count > 1,000/mm^3', ' Creatinine < 2.0 mg/dL', ' SGPT < 82 U/L', ' SGOT < 68 U/L', ' Bilirubin < 3 mg/dL* [Note: * Patients with a higher level of bilirubin due to a familial metabolism may be eligible at the discretion of the investigator]', ' Life expectancy > 2 years', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective barrier contraception', ' Must be willing to keep a dietary diary', ' No venous thrombosis within the past year', ' No unrecognized or poorly controlled thyroid disease', ' No other cancer within the past 5 years except nonmelanomatous skin cancer or noninvasive cervical cancer', ' No other medical condition that, in the opinion of the investigator, would jeopardize either the patient or the integrity of the data obtained', ' None of the following for >= 2 weeks before the first random fine needle aspiration and during study participation:', ' Oral contraceptives', ' Soy supplements', ' High soy-containing foods', ' Fish oil supplements', ' Multivitamins', ' Vitamins C and E', ' Daily aspirin or nonsteroidal', ' Anti-inflammatory drugs', ' No other concurrent investigational agents', ' No concurrent warfarin or other blood thinners', ' Female patient', 'Exclusion Criteria:', ' Women previously diagnosed with breast cancer will not be eligible unless all systemic therapy (including endocrine therapy) was completed at least one year previously', ' Currently pregnant, or planning to become pregnant during the study period', ' History of venous thrombosis within past year', ' Medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained', ' History of other cancer within the past five years, excluding non-melanomatous skin cancer, and non-invasive cervical cancer', ' Known soy intolerance', " Unrecognized or uncontrolled thyroid disease, subjects may be on synthroid, but thyroid function must be in normal range or the patient's physician must document that the patient's thyroid is controlled.", ' Currently receiving any other investigational agents', ' Currently on coumadin, or other blood thinners', ' History of breast augmentation implants.', ' Rusults from patients who have <4000 epithelial cells in either the first or the second random Fine-needle aspiration (rFNA) will not be included in the study.'], 'Results': ['Outcome Measurement: ', ' Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling', ' Breast epithelial tissue samples are used to measure the expression of the cell proliferation marker Ki-67, by counting the percentage of positive MIB-1 immunostained cells, denoted the Ki-67 labeling index. Mean change in the Ki-67 labeling index is assessed from baseline to 6 month follow up.', ' Time frame: 6 months - baseline', 'Results 1: ', ' Arm/Group Title: Arm A (Genistein)', ' Arm/Group Description: Patients receive oral genistein once daily for up to 6 months.', ' Overall Number of Participants Analyzed: 49', ' Mean (Standard Deviation)', ' Unit of Measure: Ki-67 labeling index Postmenopausal with ER- Cancer: 4 participants', ' .325 (.343)', ' Postmenopausal with ER+ Cancer: 2 participants', ' -.418 (.191)', ' Postmenopausal Without Cancer: 14 participants', ' -.092 (.525)', ' Premonopausal with ER- Cancer: 2 participants', ' -.335 (.930)', ' Premenopausal with ER+ Cancer: 4 participants', ' -.387 (.806)', ' Premenopausal without cancer: 23 participants', ' 1.171 (2.922)', 'Results 2: ', ' Arm/Group Title: Arm B (Placebo)', ' Arm/Group Description: Patients receive oral placebo once daily for up to 6 months.', ' Overall Number of Participants Analyzed: 49', ' Mean (Standard Deviation)', ' Unit of Measure: Ki-67 labeling index Postmenopausal with ER- Cancer: 2 participants', ' .289 (.541)', ' Postmenopausal with ER+ Cancer: 5 participants', ' -.461 (.458)', ' Postmenopausal Without Cancer: 15 participants', ' -.122 (.735)', ' Premonopausal with ER- Cancer: 2 participants', ' .873 (.786)', ' Premenopausal with ER+ Cancer: 4 participants', ' -.204 (1.329)', ' Premenopausal without cancer: 21 participants', ' 0.557 (1.546)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/62 (9.68%)', ' Musculoskeletal * 1/62 (1.61%)', ' Mood Alteration: Depression * 1/62 (1.61%)', ' renal - Other * 1/62 (1.61%)', ' Obstruction, GU: Uterus * 1/62 (1.61%)', ' Sexual * 0/62 (0.00%)', ' Pulmonary/Upper Respiratory: Dyspnea * 1/62 (1.61%)', ' Ulceration * 1/62 (1.61%)', 'Adverse Events 2:', ' Total: 1/64 (1.56%)', ' Musculoskeletal * 0/64 (0.00%)', ' Mood Alteration: Depression * 0/64 (0.00%)', ' renal - Other * 0/64 (0.00%)', ' Obstruction, GU: Uterus * 0/64 (0.00%)', ' Sexual * 1/64 (1.56%)', ' Pulmonary/Upper Respiratory: Dyspnea * 0/64 (0.00%)', ' Ulceration * 0/64 (0.00%)']}

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

c28ad685-4c91-492a-85ab-180f37d9cef5

Single

Eligibility

NCT00829166

Female patients with Peripheral neuropathy >0 are excluded from the primary trial.

Contradiction

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

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

52e8d676-1744-4fdb-bab4-a553874329bd

Comparison

Intervention

NCT00068601

NCT01684215

the primary trial and the secondary trial both use subcutaneous injections as the route of administration for their interventions.

Contradiction

{'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%)']}

{'Clinical Trial ID': 'NCT01684215', 'Intervention': ['INTERVENTION 1: ', ' PD-0332991 100 mg: Dose Escalation Cohort', ' In Phase 1-Part 1, participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.', 'INTERVENTION 2: ', ' PD-0332991 125 mg: Dose Escalation Cohort', ' In Phase 1-Part 1, participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.'], 'Eligibility': ['Inclusion Criteria:', ' Phase 1', ' In Part 1, advanced solid tumor (except SCLC or retinoblastoma) proven histologically or cytologically at original diagnosis, that is refractory to standard therapy or for whom no standard of care therapy is available.', ' In Part 2 and Phase 2, post menopausal women with proven diagnosis of ER-positive, HER2-negative adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease (including bone only disease) not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.', ' Adequate blood cell counts, kidney function and liver function and and Eastern Cooperative Oncology Group [ECOG] score of 0 or 1.', ' Resolved acute effects of any prior therapy to baseline severity or Grade 1', ' Phase 2', ' Adult women ( 20 years of age) with proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.', ' Documentation of histologically or cytologically confirmed diagnosis of ER(+) breast cancer based on local laboratory results.', ' Adequate blood cell counts, kidney function and liver function and and Eastern Cooperative Oncology Group [ECOG] score of 0 to 2.', 'Exclusion Criteria:', ' Phase 1', ' Active uncontrolled or symptomatic CNS metastases.', ' Uncontrolled infection, unstable or sever intercurrent medical condition, or current drug or alcohol abuse', ' Active or unstable cardiac disease or history of heart attack within 6 months', ' Phase 2', ' HER2 positive tumor based on local laboratory results utilizing one of the sponsor approved assays.', ' Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.', ' Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicities (DLT): Part 1 Phase 1', ' DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 as any of the events occurring during 28 days of Cycle 1,attributed to study drug:grade 4 neutropenia(for a duration of greater than [>]7 days); febrile neutropenia (grade greater than or equal to [>=]3 neutropenia,body temperature >=38.5 degree Celsius);grade >=3 thrombocytopenia with bleeding episode;grade 4 thrombocytopenia;grade >=3 non-hematologic toxicity except grade 3 or more nausea, vomiting,electrolyte abnormality(if controllable by therapy);grade 3 QTc prolongation(>500 millisecond [msec])persist after correction of reversible cause such as electrolyte abnormalities or hypoxia. Lack of hematologic recovery (platelets less than [<]50,000/microliter [mcL],absolute neutrophil count <1,000/mcL,hemoglobin <8.0 gram/deciliter [g/dL]) or prolonged non hematologic toxicities that delays initiation of next dose by >7 days;receipt of <75 percent of planned dose in first cycle due to toxicity.', ' Time frame: Lead-in period (Day -7) up to Day 28 (Cycle 1)', 'Results 1: ', ' Arm/Group Title: PD-0332991 100 mg: Dose Escalation Cohort', ' Arm/Group Description: In Phase 1-Part 1, participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%', 'Results 2: ', ' Arm/Group Title: PD-0332991 125 mg: Dose Escalation Cohort', ' Arm/Group Description: In Phase 1-Part 1, participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/6 (0.00%)', ' Febrile Neutropenia * [1]0/6 (0.00%)', ' Supraventricular tachycardia * [1]0/6 (0.00%)', ' Gastrointestinal perforation * [1]0/6 (0.00%)', ' Vomiting * [1]0/6 (0.00%)', ' Malaise * [1]0/6 (0.00%)', ' Osteoarthritis * [1]0/6 (0.00%)', ' Cerebral Haemorrhage * [1]0/6 (0.00%)', ' Dizziness * [1]0/6 (0.00%)', ' Subarachnoid Haemorrhage * [1]0/6 (0.00%)', 'Adverse Events 2:', ' Total: 0/6 (0.00%)', ' Febrile Neutropenia * [1]0/6 (0.00%)', ' Supraventricular tachycardia * [1]0/6 (0.00%)', ' Gastrointestinal perforation * [1]0/6 (0.00%)', ' Vomiting * [1]0/6 (0.00%)', ' Malaise * [1]0/6 (0.00%)', ' Osteoarthritis * [1]0/6 (0.00%)', ' Cerebral Haemorrhage * [1]0/6 (0.00%)', ' Dizziness * [1]0/6 (0.00%)', ' Subarachnoid Haemorrhage * [1]0/6 (0.00%)']}

beff8878-9405-412d-af3a-0f2720275bf3

Single

Results

NCT00089661

On average cohort 1 participants in the primary trial had an increased Lumbar Spine Bone Mineral Density, whereas those in cohort 2 lost mineral density.

Entailment

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

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

96f41881-6ba5-4688-8471-9462fc727919

Single

Adverse Events

NCT02370238

There were no cases of Intracranial hemorrhage in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT02370238', 'Intervention': ['INTERVENTION 1: ', ' Paclitaxel+Reparixin (Group 1) - ITT Population', ' paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + reparixin oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.', ' Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.', 'INTERVENTION 2: ', ' Paclitaxel+Placebo (Group 2)', ' paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + placebo oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.', ' Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.'], 'Eligibility': ['Inclusion Criteria:', ' Female aged 18 years.', ' Patients with pathologically documented metastatic triple negative breast cancer (TNBC), eligible for treatment with paclitaxel. Paraffin-embedded tissue must be available from metastatic sites, if reasonably accessible, or from the primary tumor, to confirm the diagnosis of TNBC and for correlative studies (only on metastatic tissue). Fifteen slides can be obtained if the full block is not available to be sent or released.', ' TNBC will be defined as breast cancer with <1% ER+ and <1% PgR+ cells, and HER2 immunohistochemistry score of 0 or 1+ and/or in situ hybridization (ISH) with HER2 gene copy number <4 or a ratio of less than 2 between HER2 gene copy number and centromere of chromosome 17. Patients whose metastatic disease is TNBC are eligible even when their primary tumor expressed hormone receptors and/or HER2.', ' Patients must be newly diagnosed metastatic or must have relapsed following a prior (neo)adjuvant chemotherapy regimen. If a taxane (i.e., paclitaxel or docetaxel) was administered as part of the (neo)adjuvant regimen, PD must have occurred > 12 months from the end of previous (neo)adjuvant treatment. For non-taxane (neo)adjuvant regimen, PD must have occurred > 6 months from the end of previous (neo)adjuvant treatment', ' Patients with at least one baseline measurable lesion according to RECIST criteria version 1.1.', ' Zubrod (Eastern Co-operative Oncology Group [ECOG]) Performance Status (PS) of 0-1.', ' Life expectancy of at least three months.', ' Patients must be able to swallow and retain oral medication (intact tablet).', ' Able to undergo all screening assessments outlined in the protocol.', ' Adequate organ function (defined by the following parameters):', ' Serum creatinine < 140 μmol/L (< 1.6 mg/dL) or creatinine clearance > 60 mL/min.', ' Serum hemoglobin 9 g/dL; absolute neutrophil count 1.5 x 109/L; platelets 100 x 109/L.', " Serum bilirubin 1.5 x upper normal limit (UNL) except patients with Gilbert's syndrome", ' Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) 2.5 x UNL but 5.0 x UNL in case of liver metastases; alkaline phosphatase (ALP) UNL but i) 2.5 x UNL in case of liver metastases and ii) 5 UNL in case of bone metastases; albumin 2.5 g/dl.', ' No history or evidence by CT scan or MRI, of brain metastases or leptomeningeal disease.', ' No known hepatitis B virus (not due to immunization), hepatitis C virus, human immunodeficiency virus-I and -II positive status.', ' Dated and signed IEC/IRB-approved informed consent.', 'Exclusion Criteria:', ' Prior therapy for metastatic TNBC (chemotherapy, hormone therapy or biological therapy), Patients may receive bisphosphonates and other therapies to treat bone metastases, however if used, bone lesions will not be considered as measurable disease.', ' Less than four weeks since last radiotherapy (excluding palliative radiotherapy).', ' Pregnancy or lactation or unwillingness to use adequate method of birth control.', ' Neurological or psychiatric disorders which may influence understanding of study and informed consent procedures.', ' Active or uncontrolled infection.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function.', ' G>1 pre-existing peripheral neuropathy', ' Any other invasive malignancy from which the patient has been disease-free for less than 5 years with the exception of curatively treated basal or squamous cell skin cancer', ' Hypersensitivity to:', ' paclitaxel', ' ibuprofen or to more than one non-steroidal anti-inflammatory drug.', ' medications belonging to the class of sulfonamides, with the exception of sulfanilamides (e.g., sulfamethoxazole).'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' PFS was defined as the number of days between the date of randomization and the date of clinical disease progression, according to RECIST criteria version 1.1, as assessed by Independent Radiology Review, or to death due to any cause, whichever occurred first.', ' Patients must have completed at least one course of treatment and performed at least one disease assessment to be considered evaluable for response.', ' Time frame: Baseline up to every 8 weeks until disease progression or death, whichever occurs first, up to 721 days', 'Results 1: ', ' Arm/Group Title: Paclitaxel+Reparixin (Group 1) - ITT Population', ' Arm/Group Description: paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + reparixin oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.', ' Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.', ' Overall Number of Participants Analyzed: 62', ' Median (Inter-Quartile Range)', ' Unit of Measure: Days 166 (62 to 292)', 'Results 2: ', ' Arm/Group Title: Paclitaxel+Placebo (Group 2)', ' Arm/Group Description: paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + placebo oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle.', ' Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.', ' Overall Number of Participants Analyzed: 61', ' Median (Inter-Quartile Range)', ' Unit of Measure: Days 171 (105 to 393)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/61 (21.31%)', ' Anaemia 1/61 (1.64%)', ' Febrile neutropenia 1/61 (1.64%)', ' Cardiac failure congestive 0/61 (0.00%)', ' Pericardial effusion 0/61 (0.00%)', ' Constipation 1/61 (1.64%)', ' Intestinal perforation 1/61 (1.64%)', ' Stomatitis 0/61 (0.00%)', ' Non-cardiac chest pain 2/61 (3.28%)', ' Condition aggravated 1/61 (1.64%)', ' General physical health deterioration 1/61 (1.64%)', 'Adverse Events 2:', ' Total: 12/60 (20.00%)', ' Anaemia 1/60 (1.67%)', ' Febrile neutropenia 0/60 (0.00%)', ' Cardiac failure congestive 1/60 (1.67%)', ' Pericardial effusion 1/60 (1.67%)', ' Constipation 0/60 (0.00%)', ' Intestinal perforation 0/60 (0.00%)', ' Stomatitis 1/60 (1.67%)', ' Non-cardiac chest pain 0/60 (0.00%)', ' Condition aggravated 0/60 (0.00%)', ' General physical health deterioration 1/60 (1.67%)']}

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

9dbf55d5-6af3-4250-b5cb-97799cdf778a

Single

Intervention

NCT00338728

Participants of the primary trial higher doses of Imatinib mesylate than Letrozole, but are administered Letrozole twice as often.

Contradiction

{'Clinical Trial ID': 'NCT00338728', 'Intervention': ['INTERVENTION 1: ', ' Letrozole and Imatinib Mesylate', ' Imatinib mesylate 400 mg by mouth twice a day daily for 28 days and Letrozole 2.5 mg once a day daily for 28 days cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women able to comply with the protocol requirements with metastatic breast cancer, whose tumors are estrogen (ER) and/or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with greater than 10% positive malignant epithelial cells', ' Patients must have documented expression of either PDGFR or CD117 (c-kit) by immunohistochemistry', ' Patients may have received tamoxifen in the adjuvant/neoadjuvant or setting. Patients may have previously received chemotherapy in the adjuvant/ neoadjuvant setting, though this is not required. Prior chemotherapy for metastatic breast cancer is allowed. Concomitant bisphosphonates are allowed for patients with bone metastases and who have another site of measurable disease', ' Post menopausal status defined by one of the following: no spontaneous menses for at least 1 year, in women greater than or equal to 55 years spontaneous menses within the past 1 year in women greater than or equal to 55 years with postmenopausal gonadotrophin levels (luteinizing hormone [LH] and follicle stimulating hormone [FSH] levels greater than 40 IU/L ) or postmenopausal estradiol levels (less than 5 mg/dl) or according to the definition of "postmenopausal range" for the laboratory involved bilateral oophorectomy', ' Performance status, Eastern Cooperative Oncology Group (ECOG) greater than or equal to 2', ' Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 10 mm with conventional techniques. Bone disease only will not be accepted as measurable disease. Pleural or peritoneal effusions will not be accepted as measurable disease', ' Absolute neutrophil count (ANC) = 1.5 x 10 to the 9th power/L', ' Platelets greater than or equal to 100.0 x 10 to the 9th power/L', ' Hemoglobin greater than 10.0 g/dL', ' Creatinine less than 1.5 mg/dl', ' Total (T.) bilirubin less than 1.5 x normal', ' Aspartate aminotransferase (AST) less than 2.5 x normal', ' A life expectancy of at least 6 months', ' Localized radiotherapy, which does not influence the signal of evaluable lesion, is allowed prior to the initiation of imatinib mesylate. Patients must have recovered from the myelosuppressive effects of previous radiotherapy (at least 2-4 weeks)', ' Ability to understand and the willingness to sign a written informed consent', 'Exclusion Criteria:', ' Prior treatment with Femara or Gleevec', " Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing's syndrome, Addison's disease (treated or untreated)", " Patients with unstable angina, or uncontrolled cardiac disease (e.g. class III or IV New York Heart Association's functional classification)", " Other concurrent malignant disease with the exception of cone-biopsied in situ carcinoma of the cervix uteri, or adequately treated basal or squamous cell carcinoma of the skin, or other curable cancers e.g. Hodgkin's disease or non-Hodgkin lymphoma (NHL), provided 5 years have elapsed from completion of therapy, and there has been no recurrence", ' Concomitant treatment with steroids, e.g. glucocorticoids for indications other than cancer, except aerosol for obstructive airways diseases and steroid injection to the joints for treatment of inflammation', ' Other investigational drugs within the past 3 weeks and the concomitant use of investigational drugs', ' History of non-compliance to medical regimens and patients who are considered potentially unreliable', ' Patients with known brain metastasis', ' Patients with known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis)', ' Patients with known diagnosis of human immunodeficiency virus (HIV) infection', ' Patients who received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to study entry, unless the disease is rapidly progressing', ' Patients who previously received radiotherapy to greater than or equal to 25% of the bone marrow', ' Patients who had a major surgery within 2 weeks prior to study entry'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' Among participants with CR or PR as the best overall response, duration of response (DOR) was defined as the time from which measurement criteria were met for CR or PR until the date of progression. Progression-free survival (PFS) was defined as the time from study enrollment to disease progression or death from any cause, whichever occurred first. PFS data were censored at the time of removal from study. Overall survival (OS) was defined as the time from study registration to death from any cause. Information on vital status was collected following study completion through July 23, 2018 and was used in the determination of OS. Among patients with SD as the best overall response, duration of SD was defined as the time from study enrollment to disease progression or removal from study.', ' Time frame: From the registration until disease progression, death, unacceptable toxicity, or withdraw of study consent, whichever occurred first assessed up to 182 months', 'Results 1: ', ' Arm/Group Title: Letrozole and Imatinib Mesylate', ' Arm/Group Description: Imatinib mesylate 400 mg by mouth twice a day daily for 28 days and Letrozole 2.5 mg once a day daily for 28 days cycle.', ' Overall Number of Participants Analyzed: 45', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Complete Response (CR): 0 0.0%', ' Partial Response (PR): 5 11.1%', ' SD (including non-CR/Non-PD)>/=24 weeks: 16 35.6%', ' SD (including non-CR/Non-PD)</=24 weeks: 8 17.8%', ' Progressive Disease: 11 24.4%', ' Non-Evaluable: 5 11.1%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/45 (31.11%)', ' Neutropenia 22/45 (4.44%)', ' Diarrhea 7/45 (15.56%)', ' Fatigue 23/45 (6.67%)', ' Elevated bilirubin 21/45 (2.22%)', ' Myalgia 21/45 (2.22%)']}

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

e8ce8686-8d5f-4d31-b442-0cb52b7b2bec

Single

Results

NCT01118624

The majority of the primary trial participants achieved CR or PR.

Contradiction

{'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%)']}

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

d72709fd-e94e-4c27-bf56-3f028c0bbd3f

Single

Results

NCT00463788

Best Overall Response (BOR) was less than 10% higher in cohort 1 of the primary trial than in cohort 2.

Entailment

{'Clinical Trial ID': 'NCT00463788', 'Intervention': ['INTERVENTION 1: ', ' Cisplatin and Cetuximab', ' Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.', 'INTERVENTION 2: ', ' Cisplatin', ' Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed diagnosis of metastatic breast cancer (Stage IV)', ' Estrogen Receptor [ER] negative, PgR negative and HER2 less than 3+ expression by immunohistochemistry (IHC)', ' No more than 1 prior chemotherapy received for treating this metastatic breast cancer', ' No more than 1 prior anthracycline and/or taxane regimen (either adjuvant or metastatic setting)', ' Other protocol-defined inclusion criteria may apply', 'Exclusion Criteria:', ' Prior platinum agent', ' Prior mitomycin', ' Known history of brain metastases', ' Other protocol-defined exclusion criteria may apply'], 'Results': ['Outcome Measurement: ', ' Best Overall Response (BOR)', ' Percentage of participants with best overall (objective) response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).', ' Time frame: Evaluations were performed every 6 weeks until progression reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009', 'Results 1: ', ' Arm/Group Title: Cisplatin and Cetuximab', ' Arm/Group Description: Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.', ' Overall Number of Participants Analyzed: 115', ' Measure Type: Number', ' Unit of Measure: percentage of participants 20.0 (13.1 to 28.5)', 'Results 2: ', ' Arm/Group Title: Cisplatin', ' Arm/Group Description: Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.', ' Overall Number of Participants Analyzed: 58', ' Measure Type: Number', ' Unit of Measure: percentage of participants 10.3 (3.9 to 21.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 41/114 (35.96%)', ' Anaemia * 3/114 (2.63%)', ' Leukopenia * 1/114 (0.88%)', ' Thrombocytopenia * 1/114 (0.88%)', ' Tachycardia * 0/114 (0.00%)', ' Abdominal Distention * 1/114 (0.88%)', ' Abdomial Pain * 1/114 (0.88%)', ' Diarrhoea * 3/114 (2.63%)', ' Intestinal Obstruction * 0/114 (0.00%)', ' Melaena * 1/114 (0.88%)', ' Nausea * 2/114 (1.75%)', ' Vomiting * 1/114 (0.88%)', ' Asthenia * 2/114 (1.75%)', 'Adverse Events 2:', ' Total: 13/57 (22.81%)', ' Anaemia * 0/57 (0.00%)', ' Leukopenia * 0/57 (0.00%)', ' Thrombocytopenia * 0/57 (0.00%)', ' Tachycardia * 1/57 (1.75%)', ' Abdominal Distention * 0/57 (0.00%)', ' Abdomial Pain * 0/57 (0.00%)', ' Diarrhoea * 0/57 (0.00%)', ' Intestinal Obstruction * 1/57 (1.75%)', ' Melaena * 0/57 (0.00%)', ' Nausea * 0/57 (0.00%)', ' Vomiting * 1/57 (1.75%)', ' Asthenia * 0/57 (0.00%)']}

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

bdf078ad-37b0-4f8f-80a3-35fa8e59fd2b

Single

Intervention

NCT00425854

Intervention of Cohort B is described as Afatinib 50 mg, taken orally, for every day of the study.

Entailment

{'Clinical Trial ID': 'NCT00425854', 'Intervention': ['INTERVENTION 1: ', ' Cohort B', ' Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd'], 'Eligibility': ['Inclusion criteria:', 'Inclusion Criteria:', ' Female patients age 18 years or older', ' Histologically proven breast cancer after failure or relapse of no more than three lines of chemotherapy including adjuvant, irrespective of prior hormone therapy metastatic disease (stage IV);', ' HER2-negative patients (HER2 1+ or negative, or HER2 2+ and FISH negative)', ' At least one measurable tumour lesion (RECIST);', ' Availability of tumour samples', ' Written informed consent that is consistent with ICH-GCP guidelines and local law', ' Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 - 2.', 'Exclusion criteria:', 'Exclusion Criteria:', ' Active infectious disease', ' Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea', ' Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol', ' Active/symptomatic brain metastases', ' Cardiac left ventricular function with resting ejection fraction < 50% (below upper limit of normal)', ' ANC less than 1500/mm3 platelet count less than 100 000/mm3', ' Bilirubin greater than 1.5 mg /dl (>26 and#61549 mol /L, SI unit equivalent)', ' AST and ALT greater than 2.5 times the upper limit of normal or greater 5 times the upper limit of normal in case of known liver metastases', ' Serum creatinine greater than 1.5 mg/dl (>132 and#61549 mol/L, SI unit equivalent)', ' Patients who are sexually active and unwilling to use a medically acceptable method of contraception', ' Pregnancy or breast-feeding', ' Concomitant treatment with other investigational drugs or other anti-cancer-therapy during this study and/or during the past two/four weeks, prior to the first treatment with the trial drug. Concurrent treatment with biphosphonates is allowed', ' Previous treatment with trastuzumab, EGFR-, or EGFR/HER2-inhibitors patients unable to comply with the protocol', ' Active alcohol or drug abuse', ' Other malignancy within the past 5 years'], 'Results': ['Outcome Measurement: ', ' Objective Response (OR)', ' OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.', ' Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.', 'Results 1: ', ' Arm/Group Title: Cohort B', ' Arm/Group Description: Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: Participants with OR 0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 13/29 (44.83%)', ' Anaemia 1/29 (3.45%)', ' Febrile neutropenia 1/29 (3.45%)', " Meniere's disease 1/29 (3.45%)", ' Eyelid ptosis 1/29 (3.45%)', ' Miosis 1/29 (3.45%)', ' Abdominal pain 0/29 (0.00%)', ' Diarrhoea 3/29 (10.34%)', ' Dysphagia 0/29 (0.00%)', ' Nausea 0/29 (0.00%)', ' Oesophageal stenosis 0/29 (0.00%)', ' Vomiting 2/29 (6.90%)', ' Fatigue 0/29 (0.00%)']}

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

49f44497-2382-4658-b716-38e66c5c52b7

Single

Adverse Events

NCT00312208

Cases of Cardiomyopathy and Coagulation disorders were only observed in cohort 1 of the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00312208', 'Intervention': ['INTERVENTION 1: ', ' Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)', ' AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.', 'INTERVENTION 2: ', ' Docetaxel + Doxorubicin and Cyclophosphamide (TAC)', ' TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.'], 'Eligibility': ['Inclusion Criteria :', ' Histologically proven breast cancer. Interval between definitive surgery that includes axillary lymph node dissection and registration is less than or equal to 60 days. A central pathology review may be performed post randomization for confirmation of diagnosis and molecular studies.', ' Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection for operable breast cancer (T1-3, Clinical N0-1, M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and Ductal Carcinoma In Situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin.', ' Histologic examination of the tumor: Invasive adenocarcinoma with at least one axillary lymph node (pN1) showing evidence of tumor among a minimum of six resected lymph nodes.', ' Tumor must show negative HER2 neu proto-oncogene overexpression by FISH (Fluorescence In Situ Hybridization). Confirmation of non overexpression will be centrally assessed by authorized BCIRG (Breast Cancer International Research Group) laboratories prior to randomization.', ' Estrogen and/or progesterone receptor analysis performed on the primary tumor prior to randomization. Results must be known at the time of randomization.(Note: Patients whose tumor is estrogen receptor negative with progesterone receptor status unknown or undetermined, must have the progesterone receptor assayed in order to determine hormonal receptor status. Patients whose tumor is progesterone receptor negative with estrogen receptor status unknown or undetermined, must have the estrogen receptor assayed in order to determine hormonal receptor status).', ' Karnofsky Performance status index > 80%.', ' Normal cardiac function must be confirmed by LVEF (Lef Ventricular Ejection Fraction) i.e. MUGA (Multi Gated Acquisition) scan or echocardiography and ECG within 3 months prior to registration. LVEF result must be above or equal to the lower limit of normal for the institution. The ECG results must be within normal limits or show no significant abnormalities.', ' Laboratory requirements: (within 14 days prior to registration)', ' Hematology:', ' Neutrophils > or = 2.0 x 10^9/L', ' Platelets > or = 100 x 10^9/L', ' Hemoglobin > or = 10 g/dL', ' Hepatic function:', ' Total bilirubin < or = 1 UNL (Upper Normal Limit)', ' ASAT (Aspartate Amino Transferase) and ALAT (Alanine Amino Transferase) < or = 2.5 UNL', ' Alkaline phosphatase < or = 5 UNL', ' Patients with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.', ' Renal function:', ' Creatinine < or = 175 µmol/L (2 mg/dL);', ' If limit reached, the calculated creatinine clearance should be > or = 60mL/min.', ' Complete staging work-up within 3 months prior to registration. All patients will have contralateral mammography, chest X-ray (Posteroanterior and lateral) and/or CT scan and/or MRI (Magnetic Resonance Imaging), abdominal ultrasound and/or CT scan (computerized tomography) and/or MRI, and bone scan. In case of positive bone scan, bone X-ray is mandatory to rule out the possibility of non-metastatic hot spots. Other tests may be performed as clinically indicated.', ' Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.', ' Exclusion Criteria :', ' Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, genetherapy , chemotherapy).', ' Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.', ' Prior radiation therapy for breast cancer.', ' Bilateral invasive breast cancer.', ' Pregnant, or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment (chemotherapy and tamoxifen therapy) and must have negative urine or serum pregnancy test within 7 days prior to registration.', ' Any T4 or N2 or known N3 or M1 breast cancer.', ' Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by NCI-CTC (National Cancer Institute - Common Toxicity Criteria), version 2.0.', ' Other serious illness or medical condition:', ' congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias', ' history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent', ' active uncontrolled infection', ' active peptic ulcer, unstable diabetes mellitus', ' Past or current history of neoplasm other than breast carcinoma, except for:', ' curatively treated non-melanoma skin cancer', ' carcinoma in situ of the cervix', ' other cancer curatively treated and with no evidence of disease for at least 10 years', ' ipsilateral ductal carcinoma in-situ (DCIS) of the breast', ' lobular carcinoma in-situ (LCIS) of the breast', ' Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (< 20 mg methylprednisolone or equivalent).', ' Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry.', ' Definite contraindications for the use of corticosteroids.', ' Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.', ' Concurrent treatment with any other anti-cancer therapy.', ' Current therapy with any hormonal agent such as raloxifene, tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention. Patients must have discontinued these agents prior to randomization.', " The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."], 'Results': ['Outcome Measurement: ', ' Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival)', ' The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.', ' Time frame: Median follow-up 65 months', 'Results 1: ', ' Arm/Group Title: Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)', ' Arm/Group Description: AC x 4: Doxorubicin 60 mg/m as an IV bolus in combination with cyclophosphamide 600 mg/m as IV followed by docetaxel 100 mg/m as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.', ' Overall Number of Participants Analyzed: 1649', ' Measure Type: Number', ' Unit of Measure: Participants 356', 'Results 2: ', ' Arm/Group Title: Docetaxel + Doxorubicin and Cyclophosphamide (TAC)', ' Arm/Group Description: TAC x 6 : Docetaxel 75 mg/m as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.', ' Overall Number of Participants Analyzed: 1649', ' Measure Type: Number', ' Unit of Measure: Participants 352'], 'Adverse Events': ['Adverse Events 1:', ' Total: 331/1634 (20.26%)', ' Anemia 3/1634 (0.18%)', ' Coagulation disorders 1/1634 (0.06%)', ' Hemorrhage Vaginal 1/1634 (0.06%)', ' Leukopenia 18/1634 (1.10%)', ' Lymphadenopathy 0/1634 (0.00%)', ' Lymphedema 0/1634 (0.00%)', ' Pancytopenia 0/1634 (0.00%)', ' Thrombocytopenia 0/1634 (0.00%)', ' Arrhythmia 3/1634 (0.18%)', ' Arrhythmia Ventricular 0/1634 (0.00%)', ' Cardiomyopathy 1/1634 (0.06%)', 'Adverse Events 2:', ' Total: 520/1635 (31.80%)', ' Anemia 5/1635 (0.31%)', ' Coagulation disorders 0/1635 (0.00%)', ' Hemorrhage Vaginal 0/1635 (0.00%)', ' Leukopenia 56/1635 (3.43%)', ' Lymphadenopathy 1/1635 (0.06%)', ' Lymphedema 2/1635 (0.12%)', ' Pancytopenia 1/1635 (0.06%)', ' Thrombocytopenia 1/1635 (0.06%)', ' Arrhythmia 3/1635 (0.18%)', ' Arrhythmia Ventricular 1/1635 (0.06%)', ' Cardiomyopathy 0/1635 (0.00%)']}

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

4a6dc84a-3afd-4060-b8c5-981895f31099

Single

Adverse Events

NCT02574455

More than a quarter of patients in cohort 1 of the primary trial experienced an adverse event.

Entailment

{'Clinical Trial ID': 'NCT02574455', 'Intervention': ['INTERVENTION 1: ', ' Sacituzumab Govitecan', ' Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.', 'INTERVENTION 2: ', " Treatment of Physician's Choice (TPC)", ' Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.', ' Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).', ' Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.', ' Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.', ' Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.'], 'Eligibility': ['Key Inclusion Criteria:', ' Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. Triple negative is defined as <1% expression for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) by in-situ hybridization.', ' Refractory to or relapsed after at least two prior standard therapeutic regimens for advanced/metastatic TNBC.', ' Prior exposure to a taxane in localized or advanced/metastatic setting.', ' Eligible for one of the chemotherapy options listed as TPC (eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment.', ' Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.', ' Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Bone-only disease is not permitted.', ' At least 2 weeks beyond prior anti-cancer treatment (chemotherapy, endocrine therapy, radiotherapy, and/or major surgery), and recovered from all acute toxicities to Grade 1 or less (except alopecia and peripheral neuropathy).', ' At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks).', ' Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, absolute neutrophil count (ANC) > 1,500 per mm^3, platelets > 100,000 per mm^3).', ' Adequate renal and hepatic function (creatinine clearance [CrCL] > 60 mL/min, bilirubin 1.5 institutional upper limit of normal [IULN], aspartate aminotransferase [AST] and alanine aminotransferase [ALT] 2.5 x IULN or 5 x IULN if known liver metastases and serum albumin 3 g/dL).', ' Recovered from all toxicities to Grade 1 or less by National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) v4.03 (except alopecia or peripheral neuropathy that may be Grade 2 or less) at the time of randomization. Participants with Grade 2 neuropathy are eligible but may not receive vinorelbine as TPC.', ' Participants with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial.', ' Key Exclusion Criteria:', ' Women who are pregnant or lactating.', ' Women of childbearing potential or fertile men unwilling to use effective contraception during study and up to three months after treatment discontinuation in women of child-bearing potential and six months in males post last study drug.', " Participants with Gilbert's disease.", ' Participants with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while participants with other prior malignancies must have had at least a 3-year disease-free interval.', ' Participants known to be human immunodeficiency (HIV) positive, hepatitis B positive, or hepatitis C positive.', ' Infection requiring antibiotic use within one week of randomization.', " Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.", ' Note: Other protocol defined Inclusion/Exclusion criteria may apply.'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population', ' PFS was defined as the time from randomization until objective tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (greater than or equal to [ ] 20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.', ' Time frame: From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)', 'Results 1: ', ' Arm/Group Title: Sacituzumab Govitecan', ' Arm/Group Description: Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.', ' Overall Number of Participants Analyzed: 235', ' Median (95% Confidence Interval)', ' Unit of Measure: months 5.6 (4.3 to 6.3)', 'Results 2: ', " Arm/Group Title: Treatment of Physician's Choice (TPC)", ' Arm/Group Description: Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.', ' Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).', ' Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.', ' Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.', ' Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.', ' Overall Number of Participants Analyzed: 233', ' Median (95% Confidence Interval)', ' Unit of Measure: months 1.7 (1.5 to 2.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 69/258 (26.74%)', ' Anaemia 3/258 (1.16%)', ' Febrile neutropenia 13/258 (5.04%)', ' Neutropenia 5/258 (1.94%)', ' Thrombocytopenia 1/258 (0.39%)', ' Atrial fibrillation 0/258 (0.00%)', ' Mitral valve incompetence 1/258 (0.39%)', ' Pericardial effusion 0/258 (0.00%)', ' Sinus tachycardia 0/258 (0.00%)', ' Abdominal pain 3/258 (1.16%)', ' Abdominal pain upper 1/258 (0.39%)', ' Colitis 1/258 (0.39%)', 'Adverse Events 2:', ' Total: 64/224 (28.57%)', ' Anaemia 2/224 (0.89%)', ' Febrile neutropenia 4/224 (1.79%)', ' Neutropenia 1/224 (0.45%)', ' Thrombocytopenia 0/224 (0.00%)', ' Atrial fibrillation 1/224 (0.45%)', ' Mitral valve incompetence 0/224 (0.00%)', ' Pericardial effusion 2/224 (0.89%)', ' Sinus tachycardia 1/224 (0.45%)', ' Abdominal pain 3/224 (1.34%)', ' Abdominal pain upper 0/224 (0.00%)', ' Colitis 0/224 (0.00%)']}

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

11e84dc4-6573-4ad7-b2d9-cfc66b626e1c

Single

Adverse Events

NCT00193063

In the primary trial patient cohort, 3 different types of infections are observed.

Entailment

{'Clinical Trial ID': 'NCT00193063', 'Intervention': ['INTERVENTION 1: ', ' Gemcitabine/Trastuzumab', ' All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.'], 'Eligibility': ['Inclusion Criteria:', ' To be included in this study, you must meet the following criteria:', ' Her-2 positive metastatic breast cancer confirmed by biopsy', ' Measurable disease', ' Able to perform activities of daily living without considerable', ' No previous chemotherapy with gemcitabine', ' No more than one prior chemotherapy regimen for metastatic breast cancer', ' Adequate bone marrow, liver and renal function', ' Normal heart function', ' Give written informed consent prior to entering this study.', 'Exclusion Criteria:', ' You cannot participate in this study if any of the following apply to you:', ' Received previous treatment with gemcitabine', ' History of brain metastases', ' Serious underlying medical conditions', ' Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.'], 'Results': ['Outcome Measurement: ', ' Overall Response Rate (ORR)', ' The Percentage of Patients Who Experience an Objective Benefit From Treatment. 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: Gemcitabine/Trastuzumab', ' Arm/Group Description: All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Number', ' Unit of Measure: percentage of participants 30 (17 to 46)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/41 (34.15%)', ' Cardiac ischemia/infarction 2/41 (4.88%)', ' Duodenal ulcer 1/41 (2.44%)', ' Vomiting 2/41 (4.88%)', ' Fever 2/41 (4.88%)', ' Death NOS 1/41 (2.44%)', ' Liver failure 1/41 (2.44%)', ' Infection - pneumonia 2/41 (4.88%)', ' Infection - port site 2/41 (4.88%)', ' Infection - urinary tract 1/41 (2.44%)', ' Disease progression 3/41 (7.32%)', ' Confusion 1/41 (2.44%)']}

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

f1f2e066-a016-422f-8627-d0e477933352

Single

Eligibility

NCT00295867

Patients with a Karnofsky status of 94% are eligible for the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00295867', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid', ' Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months.'], 'Eligibility': ['Inclusion Criteria', ' Women > 18 years of age with histologically or cytologically confirmed stage I, II or III breast cancer.', ' If adjuvant chemotherapy is recommended, it must be completed before study start.', ' Bone marrow aspirate positive by IC/FC assay', ' a. Definition of positive: > 4 MM/ml b. Timing of bone marrow aspiration to determine study eligibility: i. If patient is to receive either no adjuvant therapy or hormonal therapy alone, the aspiration may be performed at diagnosis as part of the large MM study at University of California, San Francisco, or following diagnosis if the patient received initial surgery elsewhere. This is also true for patients who have surgery following neoadjuvant therapy for breast cancer.', ' ii. If the patient is to receive adjuvant chemotherapy, the aspiration will be performed at least three weeks after chemotherapy has been completed.', ' Adequate renal function as defined by:', ' a. Creatinine must be < upper limit of normal', ' Normal liver function tests including total bilirubin, alkaline phosphatase, and aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT)', ' Ability to understand and sign informed consent.', ' Concomitant hormonal therapy is allowed', ' Concomitant radiation therapy is allowed', ' Patients who have had surgery following neoadjuvant chemotherapy or hormonal therapy are eligible to participate in this trial', ' Exclusion Criteria', ' History of allergy to bisphosphonates. Acute phase reactions occur in up to 24% of patients and disappear with subsequent dosing. An acute phase reaction does not qualify as an allergic reaction.', ' History of renal insufficiency. Renal insufficiency is defined by a serum creatinine greater than the upper limit of normal or a creatinine clearance < 50 mL/min due to any underlying cause.', ' Karnofsky Performance status < 90%.', ' Any significant medical condition that might interfere with treatment.', ' Women participating in this study are not allowed to receive other bisphosphonate therapy during the study period, either oral or intravenous.', ' Patients who are pregnant'], 'Results': ['Outcome Measurement: ', ' Response of Bone Marrow Micrometastases', ' Median change in disseminated tumor cells (DTCs)/mL from baseline after 24 months', ' Time frame: up to 2 years', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid', ' Arm/Group Description: Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months.', ' Overall Number of Participants Analyzed: 34', ' Median (Full Range)', ' Unit of Measure: DTCs/mL -4.5 (-5.9 to 43.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/45 (2.22%)', ' appendicitis 1/45 (2.22%)']}

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

efbd87d7-f8ac-42c6-ac9a-e3a35d354885

Single

Results

NCT00558272

The biggest change in Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4 observed in the primary trial was a patient in the AZD0530 175 mg group, with a -75.9 % change from baseline.

Entailment

{'Clinical Trial ID': 'NCT00558272', 'Intervention': ['INTERVENTION 1: ', ' AZD0530 175 mg', ' AZD0530 (saracatinib) 175 mg once daily', 'INTERVENTION 2: ', ' Zoledronic Acid 4 mg', ' Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period'], 'Eligibility': ['Inclusion Criteria:', ' Subjects 18 years or older with Prostate Cancer or Breast Cancer with Metastatic Bone Disease Have evidence of recurrence or disease progression', ' At least one radiographically confirmed metastatic bone lesion', ' No change of cancer therapy for at least 8 weeks before randomization', 'Exclusion Criteria:', ' Have had any prior exposure to bisphosphonate', ' Have had hip fractures or bilateral hip prothesis fracture of any kind or surgery to bone within the past 12 months', ' Inadequate renal function or low haemoglobin', ' Inadequate liver function as demonstrated by serum bilirubin 2 times the upper limits of reference range (ULRR) or by alanine aminotransferase (ALT), aspartate aminotransferase(AST) or ALP 2.5 times the ULRR ( 5 times the ULRR in the presence of liver metastases). If bone metastases are present and liver function is otherwise considered adequate by the investigator then elevated ALP will not exclude the patient.'], 'Results': ['Outcome Measurement: ', ' Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4', ' Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.', ' Time frame: Baseline to Week 4', 'Results 1: ', ' Arm/Group Title: AZD0530 175 mg', ' Arm/Group Description: AZD0530 (saracatinib) 175 mg once daily', ' Overall Number of Participants Analyzed: 46', ' Geometric Mean (95% Confidence Interval)', ' Unit of Measure: Percentage change in betaCTX -71.1 (-75.9 to -65.4)', 'Results 2: ', ' Arm/Group Title: Zoledronic Acid 4 mg', ' Arm/Group Description: Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period', ' Overall Number of Participants Analyzed: 65', ' Geometric Mean (95% Confidence Interval)', ' Unit of Measure: Percentage change in betaCTX -68.4 (-73.0 to -63.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/68 (16.18%)', ' Anaemia 1/68 (1.47%)', ' Cardiac Arrest 1/68 (1.47%)', ' Myocardial Infarction 1/68 (1.47%)', ' Vomiting 1/68 (1.47%)', ' General Physical Health Deterioration 0/68 (0.00%)', ' Pyrexia 1/68 (1.47%)', ' Pneumonia 2/68 (2.94%)', ' Viral Infection 1/68 (1.47%)', ' Blood Creatinine Increased 0/68 (0.00%)', ' Dehydration 0/68 (0.00%)', ' Bone Pain 0/68 (0.00%)', 'Adverse Events 2:', ' Total: 4/69 (5.80%)', ' Anaemia 0/69 (0.00%)', ' Cardiac Arrest 0/69 (0.00%)', ' Myocardial Infarction 0/69 (0.00%)', ' Vomiting 0/69 (0.00%)', ' General Physical Health Deterioration 1/69 (1.45%)', ' Pyrexia 0/69 (0.00%)', ' Pneumonia 0/69 (0.00%)', ' Viral Infection 0/69 (0.00%)', ' Blood Creatinine Increased 1/69 (1.45%)', ' Dehydration 1/69 (1.45%)', ' Bone Pain 1/69 (1.45%)']}

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

a604244f-789f-4c12-8c5a-96c86d1b976e

Single

Adverse Events

NCT01565083

Two different types of tachycardia occurred to patients in cohort 2 of the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01565083', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion', ' Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).', 'INTERVENTION 2: ', ' Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion', ' Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection', ' HER2-positive as assessed by local laboratory on primary or metastatic tumor', ' At least one measurable lesion and/or non-measurable disease evaluable according to RECIST v1.1 criteria', ' Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1', ' Left ventricular ejection fraction (LVEF) of at least 55%', ' Life expectancy of at least 12 weeks', 'Exclusion Criteria:', ' Previous systemic non-hormonal anti-cancer therapy in the metastatic or locally advanced breast cancer setting', ' Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting', ' Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting', ' Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrent disease of less than 6 months', ' History of persistent Grade 2 or higher (National Cancer Institute Common Terminology Criteria [NCI-CTC], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy', ' Radiographic evidence of central nervous system metastases that are not well controlled with local therapy (irradiation or surgery)', ' Current peripheral neuropathy of NCI-CTC, version 4.0 Grade 3 or greater', ' History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, or cancers with a similar curative outcome as those mentioned above', ' Serious uncontrolled concomitant disease that would contraindicate the use of any of the investigational drugs used in this study or would put the participants at high risk for treatment-related complications', ' Inadequate hematologic, liver, or renal function', ' Uncontrolled hypertension or clinically significant cardiovascular disease', ' Hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection', ' Current chronic daily treatment with corticosteroids (>/= 10 mg/day methylprednisolone or equivalent), excluding inhaled steroids'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)', ' Tumor response was assessed by investigator according to RECIST v1.1. BOR was defined as percentage of participants with a confirmed complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total or pathological nodes (with short axis [SA] of at least (>/=) 15 millimeter [mm]) were identified as target lesions (TLs) and measured and recorded at baseline. A sum of diameters (longest for non-nodal lesions, SA for nodal lesions) for all TLs was calculated and reported as baseline sum of diameters (SD). All other lesions (or sites of disease) were identified as non-TLs. CR: disappearance of all TLs and SA reduction to less than (<) 10 mm for nodal TLs/ non-TLs. PR: >/=30 percent (%) decrease in SD of TLs, taking as reference baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. The 95% confidence interval (CI) was computed using Clopper-Pearson approach.', ' Time frame: Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)', 'Results 1: ', ' Arm/Group Title: Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion', ' Arm/Group Description: Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).', ' Overall Number of Participants Analyzed: 89', ' Measure Type: Number', ' Unit of Measure: percentage of participants 74.2 (63.8 to 82.9)', 'Results 2: ', ' Arm/Group Title: Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion', ' Arm/Group Description: Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).', ' Overall Number of Participants Analyzed: 91', ' Measure Type: Number', ' Unit of Measure: percentage of participants 63.7 (53.0 to 73.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 32/106 (30.19%)', ' Febrile neutropenia * 6/106 (5.66%)', ' Leukopenia * 1/106 (0.94%)', ' Neutropenia * 1/106 (0.94%)', ' Arrhythmia * 1/106 (0.94%)', ' Atrial fibrillation * 0/106 (0.00%)', ' Cardiac failure * 0/106 (0.00%)', ' Left ventricular dysfunction * 1/106 (0.94%)', ' Myocardial infarction * 1/106 (0.94%)', ' Supraventricular tachycardia * 0/106 (0.00%)', ' Tachycardia * 0/106 (0.00%)', 'Adverse Events 2:', ' Total: 44/107 (41.12%)', ' Febrile neutropenia * 3/107 (2.80%)', ' Leukopenia * 0/107 (0.00%)', ' Neutropenia * 3/107 (2.80%)', ' Arrhythmia * 0/107 (0.00%)', ' Atrial fibrillation * 1/107 (0.93%)', ' Cardiac failure * 1/107 (0.93%)', ' Left ventricular dysfunction * 0/107 (0.00%)', ' Myocardial infarction * 0/107 (0.00%)', ' Supraventricular tachycardia * 1/107 (0.93%)', ' Tachycardia * 1/107 (0.93%)']}

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

2b543cc7-e295-4dc6-ad04-a2e43e9b3d97

Single

Results

NCT01684215

In the primary trial there was no recorded difference in the Number/percentage of Participants With Dose Limiting Toxicities taking 100 mg vs 125 mg of oral PD-0332991.

Entailment

{'Clinical Trial ID': 'NCT01684215', 'Intervention': ['INTERVENTION 1: ', ' PD-0332991 100 mg: Dose Escalation Cohort', ' In Phase 1-Part 1, participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.', 'INTERVENTION 2: ', ' PD-0332991 125 mg: Dose Escalation Cohort', ' In Phase 1-Part 1, participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.'], 'Eligibility': ['Inclusion Criteria:', ' Phase 1', ' In Part 1, advanced solid tumor (except SCLC or retinoblastoma) proven histologically or cytologically at original diagnosis, that is refractory to standard therapy or for whom no standard of care therapy is available.', ' In Part 2 and Phase 2, post menopausal women with proven diagnosis of ER-positive, HER2-negative adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease (including bone only disease) not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.', ' Adequate blood cell counts, kidney function and liver function and and Eastern Cooperative Oncology Group [ECOG] score of 0 or 1.', ' Resolved acute effects of any prior therapy to baseline severity or Grade 1', ' Phase 2', ' Adult women ( 20 years of age) with proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.', ' Documentation of histologically or cytologically confirmed diagnosis of ER(+) breast cancer based on local laboratory results.', ' Adequate blood cell counts, kidney function and liver function and and Eastern Cooperative Oncology Group [ECOG] score of 0 to 2.', 'Exclusion Criteria:', ' Phase 1', ' Active uncontrolled or symptomatic CNS metastases.', ' Uncontrolled infection, unstable or sever intercurrent medical condition, or current drug or alcohol abuse', ' Active or unstable cardiac disease or history of heart attack within 6 months', ' Phase 2', ' HER2 positive tumor based on local laboratory results utilizing one of the sponsor approved assays.', ' Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.', ' Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Dose Limiting Toxicities (DLT): Part 1 Phase 1', ' DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 as any of the events occurring during 28 days of Cycle 1,attributed to study drug:grade 4 neutropenia(for a duration of greater than [>]7 days); febrile neutropenia (grade greater than or equal to [>=]3 neutropenia,body temperature >=38.5 degree Celsius);grade >=3 thrombocytopenia with bleeding episode;grade 4 thrombocytopenia;grade >=3 non-hematologic toxicity except grade 3 or more nausea, vomiting,electrolyte abnormality(if controllable by therapy);grade 3 QTc prolongation(>500 millisecond [msec])persist after correction of reversible cause such as electrolyte abnormalities or hypoxia. Lack of hematologic recovery (platelets less than [<]50,000/microliter [mcL],absolute neutrophil count <1,000/mcL,hemoglobin <8.0 gram/deciliter [g/dL]) or prolonged non hematologic toxicities that delays initiation of next dose by >7 days;receipt of <75 percent of planned dose in first cycle due to toxicity.', ' Time frame: Lead-in period (Day -7) up to Day 28 (Cycle 1)', 'Results 1: ', ' Arm/Group Title: PD-0332991 100 mg: Dose Escalation Cohort', ' Arm/Group Description: In Phase 1-Part 1, participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%', 'Results 2: ', ' Arm/Group Title: PD-0332991 125 mg: Dose Escalation Cohort', ' Arm/Group Description: In Phase 1-Part 1, participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/6 (0.00%)', ' Febrile Neutropenia * [1]0/6 (0.00%)', ' Supraventricular tachycardia * [1]0/6 (0.00%)', ' Gastrointestinal perforation * [1]0/6 (0.00%)', ' Vomiting * [1]0/6 (0.00%)', ' Malaise * [1]0/6 (0.00%)', ' Osteoarthritis * [1]0/6 (0.00%)', ' Cerebral Haemorrhage * [1]0/6 (0.00%)', ' Dizziness * [1]0/6 (0.00%)', ' Subarachnoid Haemorrhage * [1]0/6 (0.00%)', 'Adverse Events 2:', ' Total: 0/6 (0.00%)', ' Febrile Neutropenia * [1]0/6 (0.00%)', ' Supraventricular tachycardia * [1]0/6 (0.00%)', ' Gastrointestinal perforation * [1]0/6 (0.00%)', ' Vomiting * [1]0/6 (0.00%)', ' Malaise * [1]0/6 (0.00%)', ' Osteoarthritis * [1]0/6 (0.00%)', ' Cerebral Haemorrhage * [1]0/6 (0.00%)', ' Dizziness * [1]0/6 (0.00%)', ' Subarachnoid Haemorrhage * [1]0/6 (0.00%)']}

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

987b1da5-0276-417d-a659-8e298529ccac

Comparison

Eligibility

NCT01176916

NCT00186121

postmenopausal women with T1-4N1-3M1 Early invasive breast cancer are eligible for the primary trial, and Premenopausal women with T4-4N1-3M1 Early invasive breast cancerare eligible for the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT01176916', 'Intervention': ['INTERVENTION 1: ', ' Exemestane', ' Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.'], 'Eligibility': ['Inclusion Criteria:', ' Early invasive breast cancer (T1-4N1-3M0) confirmed by histology or cytology.', ' ER positive.', ' The patient must be postmenopausal woman.', ' The patient has received adjuvant Tamoxifen therapy for up to 2-3 years and will switch to receive Aromasin® treatment (The decision to prescribe Aromasin® will necessarily precede and will be independent of the decision to enroll patients in the study).', 'Exclusion Criteria:', ' Following the adjuvant Tamoxifen therapy for 2-3 years and prior to receiving Aromasin® treatment, there is evidence of a local relapse or distant metastasis of breast cancer, or a second primary cancer.', ' Following the adjuvant Tamoxifen therapy for 2-3 years and received other aromatase inhibitors (not Aromasin®).'], 'Results': ['Outcome Measurement: ', ' Time-to-Event', ' An event was defined as the earliest occurrence of any of the following: 1) Loco-regional/distant recurrence of the primary breast cancer (BC) (Loco-regional recurrence was defined as any recurrence in the ipsilateral breast, chest wall or axillary lymph nodes.); 2) Appearance of a second primary or contralateral breast cancer; 3) Death due to any cause.', ' Time frame: 2-3 years (time for previously taking tamoxifen [prior to this study] and time for taking Aromasin [in this study] add up to 5 years)', 'Results 1: ', ' Arm/Group Title: Exemestane', ' Arm/Group Description: Participants received exemestane (Aromasin) tablet 25 mg once daily in this study. They had previously taken tamoxifen for 2 to 3 years and switched to Aromisin in this study for completion of 5 consecutive years of adjuvant hormonal therapy.', ' Overall Number of Participants Analyzed: 558', ' Median (95% Confidence Interval)', ' Unit of Measure: months NA [1] (NA to NA)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 38/558 (6.81%)', ' Angina unstable * 1/558 (0.18%)', ' Coronary artery disease * 1/558 (0.18%)', ' Autoimmune thyroiditis * 1/558 (0.18%)', ' Goitre * 1/558 (0.18%)', ' Hypothyroidism * 1/558 (0.18%)', ' Glaucoma * 1/558 (0.18%)', ' Chronic gastritis * 1/558 (0.18%)', ' Gastric polyps * 2/558 (0.36%)', ' Haemorrhoids * 1/558 (0.18%)', ' Tongue haemorrhage * 1/558 (0.18%)']}

{'Clinical Trial ID': 'NCT00186121', 'Intervention': ['INTERVENTION 1: ', ' Anastrozole + Goserelin', ' Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily.'], 'Eligibility': ['INCLUSION CRITERIA', ' Histologically-confirmed, bi-dimensionally measurable, recurrent or metastatic carcinoma of the breast that is progressive', ' Premenopausal, defined as any of:', ' Last menstrual period within 3 months, or', ' Post-hysterectomy without bilateral oophorectomy and with follicle-stimulating hormone (FSH) in the premenopausal range, or,', ' If tamoxifen administered within the past 3 months, plasma estradiol must be in the premenopausal range', ' Either positive estrogen and/or progesterone receptor determination by Immunohistochemistry (IHC) or competitive binding assay on metastatic disease, or if not performed on their metastatic disease a positive result on their primary breast cancer specimen.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2', ' Granulocytes > 1500/mm^3', ' Platelets > 100,000/mm^3', ' Serum glutamic oxaloacetic transaminase (SGOT) < 2.5 x upper limit of normal', ' Total bilirubin < 1.5 mg/dL', ' May have received irradiation to bony sites of disease for pain control or for prevention of fracture. The irradiated site(s) will NOT be evaluable for disease response.', ' Must be using effective contraception or not be of childbearing potential', ' Signed written informed consent', ' INCLUSION CRITERIA', ' Active, unresolved infection', ' Active malignancy other than breast cancer, in situ carcinoma of the cervix, or non-melanomatous skin cancers in the past 5 years', ' Prior treatment with an aromatase inhibitor or inactivator', ' Prior treatment with an luteinizing hormone-releasing hormone (LH/RH) agonist/antagonist', ' Adjuvant chemotherapy within 6 months of study entry.', ' Received chemotherapy or hormonal therapy in the 3 weeks prior to enrollment', ' Central nervous system metastasis', ' Lymphangitic pulmonary metastasis', ' Pregnant or lactating'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' ORR was determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rates.', ' CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks.', ' PR = 50% decrease in tumor size for at least 4 weeks, without any new lesion or any 25% increase in size of any lesion.', ' All measurements by ruler or calipers.', ' Time frame: 3 months', 'Results 1: ', ' Arm/Group Title: Anastrozole + Goserelin', ' Arm/Group Description: Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily.', ' Overall Number of Participants Analyzed: 32', ' Measure Type: Number', ' Unit of Measure: percentage of participants 37.5 (21 to 56)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/32 (0.00%)']}

b9e8a0b3-574f-4079-9191-214af99e97a8

Comparison

Intervention

NCT01697345

NCT00513292

Fluorouracil, testosterone, and cyclophosphamide (FEC) are used in both cohorts of the secondary trial, but not in cohort 1 of the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01697345', 'Intervention': ['INTERVENTION 1: ', ' FSFI Total Score (Pretest)', ' Administered to participants prior to starting vaginal testosterone therapy.', 'INTERVENTION 2: ', ' FSFI Total Score (Postteset)', ' Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).'], 'Eligibility': ['Inclusion Criteria:', ' Women with breast cancer', ' Currently taking an aromatase inhibitor (AI)', ' Age > 50 years of age', ' Postmenopausal, or two years since last menstrual cycle', ' Urogenital/vulvovaginal symptoms such as vaginal dryness and pain with intercourse', ' Changes in sexual health quality of life/sexual functioning since starting AI therapy', 'Exclusion Criteria:', ' The use of other treatments for breast cancer such as chemotherapy or radiation within the past 12 months', ' A known sensitivity to medications containing testosterone', ' The use of exogenous hormone replacement therapy (HRT) in the past three months, including systemic and local estrogen or testosterone therapy'], 'Results': ['Outcome Measurement: ', ' Total Female Sexual Function Index (FSFI) Score', ' The Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI score < 26.5 suggests female sexual dysfunction.', ' Time frame: Baseline, 4 weeks', 'Results 1: ', ' Arm/Group Title: FSFI Total Score (Pretest)', ' Arm/Group Description: Administered to participants prior to starting vaginal testosterone therapy.', ' Overall Number of Participants Analyzed: 12', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 8.691 (3.803)', 'Results 2: ', ' Arm/Group Title: FSFI Total Score (Postteset)', ' Arm/Group Description: Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).', ' Overall Number of Participants Analyzed: 12', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale 18.783 (7.050)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/13 (0.00%)', 'Adverse Events 2:', ' ']}

{'Clinical Trial ID': 'NCT00513292', 'Intervention': ['INTERVENTION 1: ', ' FEC-75 Then Paclitaxel/Trastuzumab', ' Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies', 'INTERVENTION 2: ', ' Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', ' Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Diagnosis of invasive adenocarcinoma by core needle biopsy', ' Fine needle aspiration allowed provided primary tumor size < 2 cm and lymph node metastases are present', ' Excisional biopsy of the primary tumor allowed provided biopsy-positive lymph nodes are present', ' Primary tumor 2 cm and/or 1 biopsy-positive lymph node', ' HER2-positive disease', ' Confirmation by fluorescent in situ hybridization (FISH) requires gene amplification', ' Confirmation by immunohistochemistry (IHC) requires a strongly positive (3+) staining intensity score', ' Ductal carcinoma in situ (DCIS) or synchronous DCIS of the contralateral breast regardless of prior therapy allowed', ' Synchronous invasive breast cancer not allowed', ' Ipsilateral DCIS treated by local excision with or without hormonal therapy allowed', ' Those treated with radiation therapy are not allowed', ' No definitive clinical or radiologic evidence of metastatic disease', ' No history of invasive breast cancer', ' Hormone receptor status known', ' Menopausal status not specified', ' ECOG performance status of 0 -1', ' Absolute neutrophil count 1,200/mm³', ' Platelet count 100,000/mm³', ' Total bilirubin normal unless the patient has a grade 1 bilirubin elevation (normal to 1.5 times upper limit of normal [ULN]) resulting from Gilbert disease or similar syndrome due to slow conjugation of bilirubin', ' Alkaline phosphatase 2.5 times ULN', ' AST 1.5 times ULN', ' Creatinine normal', ' Left ventricular ejection fraction (LVEF) 55 by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) within the past 3 months', ' Patients with either skeletal pain or alkaline phosphatase that is > ULN but 2.5 times ULN allowed if bone scans fail to demonstrate metastatic disease', ' Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy', ' Prior non-breast malignancies allowed if disease-free for 5 years since completion of initial treatment regimen and deemed by their physician to be at low risk for recurrence', ' Patients who had the following cancers are eligible if diagnosed and treated within the past 5 years:', ' Carcinoma in situ of the cervix', ' Colon carcinoma in situ', ' Melanoma in situ', ' Basal cell and squamous cell carcinoma of the skin', ' No cardiac disease that would preclude the use of epirubicin hydrochloride or trastuzumab (Herceptin®) including any of the following:', ' Active cardiac disease', ' Angina pectoris that requires the use of antianginal medication', ' Cardiac arrhythmia requiring medication', ' Severe conduction abnormality', ' Clinically significant valvular disease', ' Cardiomegaly on chest x-ray', ' Ventricular hypertrophy on EKG', " Patient's with poorly controlled hypertension ( i.e., diastolic greater than 100 mm/Hg)", ' Patients with hypertension that is well controlled on medication are eligible', ' History of cardiac disease', ' Myocardial infarction documented as a clinical diagnosis or by EKG or any other tests', ' Documented congestive heart failure', ' Documented cardiomyopathy', " No sensory or motor neuropathy grade 2, as defined by the NCI's CTCAE v3.0", ' Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy', ' Women of child bearing potential must have a negative urine or serum pregnancy test within 2 weeks of registration', ' Not pregnant or nursing', ' No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements', ' No non-malignant systemic disease (e.g., cardiovascular, renal, hepatic) that would preclude treatment with either of the treatment regimens', ' No prior surgical axillary staging procedure', ' Prior non-excisional biopsy of an axillary node allowed', ' No prior treatment for this breast cancer', ' Hormonal therapy allowed if had been given for up to a total of 28 days anytime after diagnosis and before study entry', ' Hormonal therapy must stop at or before study entry and be re-started, if indicated, following surgery', ' No prior therapy with anthracyclines or taxanes for any malignancy', ' No other investigational agents within the past 30 days', ' No concurrent sex hormonal therapy (e.g., birth control pills, ovarian hormonal replacement therapy)', ' No concurrent therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention'], 'Results': ['Outcome Measurement: ', ' pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy', ' Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.', ' Time frame: Up to 5 years', 'Results 1: ', ' Arm/Group Title: FEC-75 Then Paclitaxel/Trastuzumab', ' Arm/Group Description: Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 138', ' Measure Type: Number', ' Unit of Measure: percentage of participants 56.5 (47.8 to 64.9)', 'Results 2: ', ' Arm/Group Title: Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75', ' Arm/Group Description: Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies', ' Overall Number of Participants Analyzed: 142', ' Measure Type: Number', ' Unit of Measure: percentage of participants 54.2 (45.7 to 62.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/138 (13.77%)', ' Blood disorder 1/138 (0.72%)', ' Febrile neutropenia 1/138 (0.72%)', ' Hemoglobin decreased 8/138 (5.80%)', ' Hemolysis 0/138 (0.00%)', ' Atrial fibrillation 0/138 (0.00%)', ' Left ventricular failure 3/138 (2.17%)', ' Myocardial ischemia 0/138 (0.00%)', ' Sinus tachycardia 1/138 (0.72%)', ' Supraventricular tachycardia 0/138 (0.00%)', ' Extraocular muscle paresis 0/138 (0.00%)', 'Adverse Events 2:', ' Total: 26/142 (18.31%)', ' Blood disorder 1/142 (0.70%)', ' Febrile neutropenia 3/142 (2.11%)', ' Hemoglobin decreased 11/142 (7.75%)', ' Hemolysis 1/142 (0.70%)', ' Atrial fibrillation 1/142 (0.70%)', ' Left ventricular failure 5/142 (3.52%)', ' Myocardial ischemia 1/142 (0.70%)', ' Sinus tachycardia 1/142 (0.70%)', ' Supraventricular tachycardia 1/142 (0.70%)', ' Extraocular muscle paresis 1/142 (0.70%)']}

0151d1fa-05c8-45a0-b21e-f08478ea5110

Comparison

Adverse Events

NCT01075100

NCT00290758

several different mental health issues were observed in the primary trial and the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT01075100', 'Intervention': ['INTERVENTION 1: ', ' Triple Negative', ' ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.', 'INTERVENTION 2: ', ' HR Positive', ' ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Male or female patients will be eligible for inclusion in this study if they meet all of the following criteria:', ' Has measurable metastatic and or locally unresectable breast cancer with documented HER2 negative (-) disease', ' Has at least 1 measurable lesion per RECIST criteria (lesions that can be accurately measured in at least 1 dimension (longest diameter (LD) to be recorded) as 20 mm with conventional techniques (CT, MRI, X-ray) or as 10 mm with spiral CT scan). Irradiated lesions cannot be used to assess response but can be used to assess progression.', ' Has received up to 2 (0 to 2) prior chemotherapy regimens for metastatic disease with the following conditions:', 'Has had no prior treatment with ixabepilone or platinum agents', ' Has had no adjuvant chemotherapy within the 6 months prior to study, but may have received prior anthracyclines and/or taxanes as adjuvant chemotherapy', ' 3 weeks or more have elapsed since last chemotherapy treatment and any related toxicities have resolved to <Grade 1; at least 30 days must have passed since any investigational product has been administered and associated toxicities must have resolved to <Grade 1 (if applicable).', ' Has an ECOG Performance Status (PS) 0-2', ' Is 18 years of age', ' Has a life expectancy of at least 12 weeks', ' Has laboratory values of:', ' White blood cell (WBC) count 3000 x 106/L Absolute neutrophil count (ANC) 1500 x 106/L Hemoglobin 9 g/dL Total bilirubin 1x upper limit of normal (ULN) AST and ALT 2.5 x ULN Alkaline phosphatase 2.5 x ULN; up to 5xULN if elevation is due to bone disease Serum creatinine 1.5 mg/dL Calculated creatinine clearance >50 mL/min (based on Cockroft and Gault method [Appendix III]) Platelet count 100,000 x 106/L', ' If patient has had radiation therapy, it has been completed >3 weeks prior to the start of study treatment. NOTE: Previously irradiated lesions will not be evaluable. However, these patients will still be eligible.', ' 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 (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 3 months thereafter', ' Has signed the most recent Patient Informed Consent Form', ' Has signed a Patient Authorization Form Note: Having tissue available is not an inclusion criterion in this study; however, available tissue will be collected (see Section 8) if possible.', 'Exclusion Criteria:', ' A patient will be excluded from this study if he or she meets any of the following criteria:', ' Had prior treatment with ixabepilone or other epothilones', ' Had prior radiation to 30% of major bone marrow containing areas (pelvis, lumbar spine)', ' Has ER+ and/or PR+ disease that has not progressed on hormone therapy, unless the patient has life-threatening or rapidly progressing visceral disease', ' Has HER2+ disease (IHC staining of 3+ [uniform, intense membrane staining of >30% of invasive tumor cells]), a FISH result of more than 6 HER2 gene copies per nucleus or a FISH ratio (HER2 gene signals to chromosome 17 signals of >2.2)', ' Has only lytic bone disease or nonmeasurable disease only', ' Has a known, prior, severe (NCI CTCAE Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor®EL (polyoxyethylated castor oil) or has history of severe allergic reactions to cisplatin or other platinum-containing compounds', ' Has been treated previously with a platinum-containing agent', ' Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Washout periods for these prior therapies are specified in Section 5.', ' Is receiving concurrent investigational therapy or has received such therapy within the 30 days prior to dosing Day 1', ' Has neuropathy (motor or sensory) >Grade 1', ' Has evidence of CNS involvement requiring radiation or steroid treatment. Patients with stable brain metastases who are off steroids at least 2 weeks are eligible.', ' Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection', ' Has clinically relevant coagulopathy either secondary to hepatic dysfunction or an underlying condition requiring therapeutic anticoagulation (specifically, A-fib, history of DVT). A daily aspirin or Plavix for CAD are permitted.', ' 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 a pregnant or breast feeding woman', ' Is unable to comply with the requirements of the study'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' Evaluate the objective response rate calculated as CR+ PR in the population evaluable for response, as well as the 2 subgroups (hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]) and ER-/PR-HER2-, separately).', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', ' Time frame: 24 months', 'Results 1: ', ' Arm/Group Title: Triple Negative', ' Arm/Group Description: ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 46', ' Measure Type: Number', ' Unit of Measure: percentage of participants 30.4 (17.7 to 45.8)', 'Results 2: ', ' Arm/Group Title: HR Positive', ' Arm/Group Description: ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 53', ' Measure Type: Number', ' Unit of Measure: percentage of participants 34 (21.5 to 48.3)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 10/48 (20.83%)', ' NEUTROPENIA 1/48 (2.08%)', ' THROMBOCYTOPENIA 0/48 (0.00%)', ' VOLUME BLOOD DECREASED 1/48 (2.08%)', ' FIBRILLATION ATRIAL 1/48 (2.08%)', ' HYPOTENSION 1/48 (2.08%)', ' ABDOMINAL PAIN 1/48 (2.08%)', ' APPETITE DECREASED 0/48 (0.00%)', ' DEHYDRATION 4/48 (8.33%)', ' DIARRHEA 4/48 (8.33%)', ' NAUSEA 3/48 (6.25%)', ' VOMITING 2/48 (4.17%)', ' FEVER 1/48 (2.08%)', ' RIGORS 0/48 (0.00%)', 'Adverse Events 2:', ' Total: 5/53 (9.43%)', ' NEUTROPENIA 1/53 (1.89%)', ' THROMBOCYTOPENIA 1/53 (1.89%)', ' VOLUME BLOOD DECREASED 0/53 (0.00%)', ' FIBRILLATION ATRIAL 0/53 (0.00%)', ' HYPOTENSION 0/53 (0.00%)', ' ABDOMINAL PAIN 0/53 (0.00%)', ' APPETITE DECREASED 1/53 (1.89%)', ' DEHYDRATION 0/53 (0.00%)', ' DIARRHEA 0/53 (0.00%)', ' NAUSEA 1/53 (1.89%)', ' VOMITING 1/53 (1.89%)', ' FEVER 1/53 (1.89%)', ' RIGORS 1/53 (1.89%)']}

{'Clinical Trial ID': 'NCT00290758', 'Intervention': ['INTERVENTION 1: ', ' Arm A (Genistein)', ' Patients receive oral genistein once daily for up to 6 months.', 'INTERVENTION 2: ', ' Arm B (Placebo)', ' Patients receive oral placebo once daily for up to 6 months.'], 'Eligibility': ['Inclusion Criteria:', ' No known soy intolerance', ' At increased risk of developing breast cancer in >= 1 previously unaffected breast, as defined by any of the following:', ' Estimated 5-year risk of developing breast cancer using the Gail model, as defined by 1 of the following:', ' Gail score >= 1.66%', ' Gail score >= 0.1% for women age 20-29 years', ' Gail score >= 1.0% for women age 30-39 years', ' Estimated 5-year risk of developing breast cancer using the Claus model:', ' Claus score >= 1.66%', ' Claus score >= 0.1% for women age 20-29 years', ' Claus score >= 1.0% for women age 30-39 years', ' Prior diagnosis of unilateral in situ or invasive breast cancer OR history of atypical hyperplasia, BRCA 1 and/or BRCA 2 positivity', ' History of lobular carcinoma in situ', ' No evidence of breast cancer, as determined by a negative mammogram within the past 6 months and a history and physical', ' No previously diagnosed breast cancer unless all systemic therapy (including endocrine therapy) was completed at least 1 year ago', ' Pre- or postmenopausal', ' ECOG performance status 0-1', ' Hemoglobin > 10.0 g/dL', ' Platelet count > 100,000/mm^3', ' Absolute neutrophil count > 1,000/mm^3', ' Creatinine < 2.0 mg/dL', ' SGPT < 82 U/L', ' SGOT < 68 U/L', ' Bilirubin < 3 mg/dL* [Note: * Patients with a higher level of bilirubin due to a familial metabolism may be eligible at the discretion of the investigator]', ' Life expectancy > 2 years', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective barrier contraception', ' Must be willing to keep a dietary diary', ' No venous thrombosis within the past year', ' No unrecognized or poorly controlled thyroid disease', ' No other cancer within the past 5 years except nonmelanomatous skin cancer or noninvasive cervical cancer', ' No other medical condition that, in the opinion of the investigator, would jeopardize either the patient or the integrity of the data obtained', ' None of the following for >= 2 weeks before the first random fine needle aspiration and during study participation:', ' Oral contraceptives', ' Soy supplements', ' High soy-containing foods', ' Fish oil supplements', ' Multivitamins', ' Vitamins C and E', ' Daily aspirin or nonsteroidal', ' Anti-inflammatory drugs', ' No other concurrent investigational agents', ' No concurrent warfarin or other blood thinners', ' Female patient', 'Exclusion Criteria:', ' Women previously diagnosed with breast cancer will not be eligible unless all systemic therapy (including endocrine therapy) was completed at least one year previously', ' Currently pregnant, or planning to become pregnant during the study period', ' History of venous thrombosis within past year', ' Medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained', ' History of other cancer within the past five years, excluding non-melanomatous skin cancer, and non-invasive cervical cancer', ' Known soy intolerance', " Unrecognized or uncontrolled thyroid disease, subjects may be on synthroid, but thyroid function must be in normal range or the patient's physician must document that the patient's thyroid is controlled.", ' Currently receiving any other investigational agents', ' Currently on coumadin, or other blood thinners', ' History of breast augmentation implants.', ' Rusults from patients who have <4000 epithelial cells in either the first or the second random Fine-needle aspiration (rFNA) will not be included in the study.'], 'Results': ['Outcome Measurement: ', ' Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling', ' Breast epithelial tissue samples are used to measure the expression of the cell proliferation marker Ki-67, by counting the percentage of positive MIB-1 immunostained cells, denoted the Ki-67 labeling index. Mean change in the Ki-67 labeling index is assessed from baseline to 6 month follow up.', ' Time frame: 6 months - baseline', 'Results 1: ', ' Arm/Group Title: Arm A (Genistein)', ' Arm/Group Description: Patients receive oral genistein once daily for up to 6 months.', ' Overall Number of Participants Analyzed: 49', ' Mean (Standard Deviation)', ' Unit of Measure: Ki-67 labeling index Postmenopausal with ER- Cancer: 4 participants', ' .325 (.343)', ' Postmenopausal with ER+ Cancer: 2 participants', ' -.418 (.191)', ' Postmenopausal Without Cancer: 14 participants', ' -.092 (.525)', ' Premonopausal with ER- Cancer: 2 participants', ' -.335 (.930)', ' Premenopausal with ER+ Cancer: 4 participants', ' -.387 (.806)', ' Premenopausal without cancer: 23 participants', ' 1.171 (2.922)', 'Results 2: ', ' Arm/Group Title: Arm B (Placebo)', ' Arm/Group Description: Patients receive oral placebo once daily for up to 6 months.', ' Overall Number of Participants Analyzed: 49', ' Mean (Standard Deviation)', ' Unit of Measure: Ki-67 labeling index Postmenopausal with ER- Cancer: 2 participants', ' .289 (.541)', ' Postmenopausal with ER+ Cancer: 5 participants', ' -.461 (.458)', ' Postmenopausal Without Cancer: 15 participants', ' -.122 (.735)', ' Premonopausal with ER- Cancer: 2 participants', ' .873 (.786)', ' Premenopausal with ER+ Cancer: 4 participants', ' -.204 (1.329)', ' Premenopausal without cancer: 21 participants', ' 0.557 (1.546)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/62 (9.68%)', ' Musculoskeletal * 1/62 (1.61%)', ' Mood Alteration: Depression * 1/62 (1.61%)', ' renal - Other * 1/62 (1.61%)', ' Obstruction, GU: Uterus * 1/62 (1.61%)', ' Sexual * 0/62 (0.00%)', ' Pulmonary/Upper Respiratory: Dyspnea * 1/62 (1.61%)', ' Ulceration * 1/62 (1.61%)', 'Adverse Events 2:', ' Total: 1/64 (1.56%)', ' Musculoskeletal * 0/64 (0.00%)', ' Mood Alteration: Depression * 0/64 (0.00%)', ' renal - Other * 0/64 (0.00%)', ' Obstruction, GU: Uterus * 0/64 (0.00%)', ' Sexual * 1/64 (1.56%)', ' Pulmonary/Upper Respiratory: Dyspnea * 0/64 (0.00%)', ' Ulceration * 0/64 (0.00%)']}

b4b3ebdf-0e46-48fd-a57d-7d2a6c8a48de

Single

Eligibility

NCT02027376

A patient was treated with Pertuzumab for 6 months, and this treatment was discontinued less than 1 month prior to study entry and the patient has not fully recovered from the entailing side effects, hence this patient is eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT02027376', 'Intervention': ['INTERVENTION 1: ', ' LDE225 (Sonidegib) 400mg in Combination With Docetaxel', ' Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.', 'INTERVENTION 2: ', ' LDE225 (Sonidegib) 600mg in Combination With Docetaxel', ' Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.'], 'Eligibility': ['Inclusion Criteria:', ' The patient is capable to understand and comply with the protocol and has signed the informed consent document.', ' Females with histologically confirmed advanced breast cancer.', ' TN breast cancer by local laboratory determination. Hormonal Receptor (HR) negative defined as < 1% positive cells by Immunohistochemistry (IHC) for both Estrogen Receptor (ER) and Progesterone Receptor (PgR), and HER2 negative defined as in situ hybridization (ISH) negative or IHC 0 or 1+ in the absence of ISH (Note: patients with IHC 2+ must have an ISH determination in order to confirm the HER2 negativity.', ' Measurable or non-measurable disease according to RECIST 1.1 criteria.', ' Patient is at least 18 years of age.', ' World Health Organization (WHO) Performance Status 1.', ' Life expectancy 12 weeks.', ' Common laboratory values within normal range (…)', ' A negative serum pregnancy test 72 hours before starting study treatment for pre-menopausal women and for women < 1 year from the last menstruation date.', 'Exclusion Criteria:', ' Have received more than 3 prior chemotherapy regimens for ABC.', ' Patients with untreated brain metastases. However, a patient with Central Nervous System (CNS) metastases may participate in this trial if > 4 weeks from therapy completion (incl. radiation and/or surgery), is clinically stable with respect to the tumor at the time of study entry and is not receiving corticosteroid therapy.', ' Patients with acute or chronic liver or renal disease or pancreatitis.', ' Patients with a second primary malignancy that is clinically detectable at the time of consideration for study enrollment.', ' Patients unable to swallow tablets.', ' History of a positive HIV test (HIV testing is not mandatory).', ' History of a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result (Hepatitis B or C testing is not mandatory).', ' Impairment of gastrointestinal (GI) function or GI disease (e.g. ulcerative disease, uncontrolled nausea, vomiting, grade 2 diarrhea, malabsorption syndrome or small bowel resection).', ' Peripheral vascular disease requiring active therapy or having had surgery < 12 months prior to starting study drug.', ' Impaired cardiac function or clinically significant heart disease (…)', ' A past medical history of clinically significant ECG abnormalities or a family history of prolonged QT-interval syndrome', ' Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)', ' Patients who are receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A4/5 (listed in Protocol Attachment 3) or drugs metabolized by CYP2B6 or CYP2C9 (listed in Protocol Attachment 3) that cannot be discontinued prior to study entry and for the duration of the study. Medications that are strong CYP3A4/5 inhibitors should be discontinued for at least 2 days, and strong CYP3A4/5 inducers for at least 1 week prior to initiating LDE225 dosing.', ' Patients who have received chemotherapy within a period of time that is < the cycle length used for that treatment (e.g. < 3 weeks for fluorouracil, doxorubicine, epirubicin) prior to starting study drug or who have not recovered from the side effects of such therapy.', ' Patients who have received biologic therapy (e.g. antibodies) 4 weeks prior to starting study drug or who have not recovered from the side effects of such therapy.', ' Patients who have been treated with a small molecule therapeutic 5 t1/2 or 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy.', ' Patients who have received any other investigational agents 5 t1/2 or 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy.', ' Patients who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) 4 weeks or limited field radiation for palliation 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.', ' Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin) who cannot discontinue this treatment at least 5 days prior to starting study drug.', ' Patients who are currently receiving immunosuppressive treatment and in whom the treatment cannot be discontinued prior to starting study drug, except in the case of patients with basal cell carcinoma (BCC). Immunosuppressive treatment should be discontinued for at least 1 week prior to initiating LDE225 dosing.', '…'], 'Results': ['Outcome Measurement: ', ' Incidence Rate of DLT Within the First Two Cycles of LDE225 (Sonidegib) in Combination With Docetaxel', ' DLT was defined as the occurrence of any of the following adverse events or abnormal laboratory values (graded according to the NCI-CTCAE version 4.0) assessed as possibly, probably or definitively related to study drugs, occurring within the first two cycles of treatment: Neutropenia grade 4 lasting more than one week, febrile neutropenia, thrombocytopenia grade 3 with bleeding more than grade 2, thrombocytopenia grade 4, Increased plasma creatinine phosphokinase (CK) grade 3-4, any non-hematologic grade 4 toxicity, or grade 3 toxicity except nausea and vomiting, Grade 2 GI toxicity (except nausea and vomiting) lasting more than 2 weeks, Inability to resume dosing for cycles 2 or 3 at the current dose level within 14 days, due to treatment-related toxicity. Dose reductions in cycles 1 and 2 will be considered a DLT', ' Time frame: Up to cycle 2', 'Results 1: ', ' Arm/Group Title: LDE225 (Sonidegib) 400mg in Combination With Docetaxel', ' Arm/Group Description: Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%', 'Results 2: ', ' Arm/Group Title: LDE225 (Sonidegib) 600mg in Combination With Docetaxel', ' Arm/Group Description: Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.', ' Overall Number of Participants Analyzed: 4', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/5 (0.00%)', ' Overdose * [1]0/5 (0.00%)', 'Adverse Events 2:', ' Total: 1/4 (25.00%)', ' Overdose * [1]1/4 (25.00%)']}

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

b838a265-99e4-42f0-bd72-b4f72d7eb16e

Comparison

Eligibility

NCT00676793

NCT01931163

Patients suffering from vomiting are still eligible for both the secondary trial and the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00676793', 'Intervention': ['INTERVENTION 1: ', ' ECGC and Breast Cancer', ' Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.'], 'Eligibility': ['Inclusion Criteria:', ' Definitive biopsy demonstrating primary breast cancer', ' Residual breast cancer requiring additional surgical resection', ' Stage I, II or III disease', ' Patient has ability to give signed informed consent', ' Normal hepatic and renal function (creatinine<1.5, transaminases <1.5 times upper limit of normal).', ' ECOG Performance status of 0 or 1.', ' Age 21 years and less than 75', 'Exclusion Criteria:', ' Prior hormonal or surgical therapy for breast cancer', ' Abnormal liver function test', ' Liver or kidney problems that would interfere with metabolism of study drug', ' Any condition that would hamper informed consent or ability to comply with study protocol', ' Participation in another research study in the last three months', ' Known malignancy at any site other than breast', ' Recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)', ' Allergy or intolerance to any component of green tea', ' Inability or refusal to comply with definitive surgical therapy'], 'Results': ['Outcome Measurement: ', ' Change in Serum VEGF in Breast Cancer', ' Change in serum VEGF from baseline to post treatment with polyphenon E.', ' Time frame: Baseline and 4 to 6 weeks', 'Results 1: ', ' Arm/Group Title: ECGC and Breast Cancer', ' Arm/Group Description: Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.', ' Overall Number of Participants Analyzed: 19', ' Median (Inter-Quartile Range)', ' Unit of Measure: pg/ml 270 (-142.5 to 581.25)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/32 (0.00%)']}

{'Clinical Trial ID': 'NCT01931163', 'Intervention': ['INTERVENTION 1: ', ' Everolimus Plus Cisplatin', ' Everolimus 10mg by mouth daily for 12 weeks; Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles'], 'Eligibility': ['Inclusion Criteria:', ' Female patients 18 years of age.', ' Clinical/pathological documentation of residual disease after neo-adjuvant therapy.', ' Patients with synchronous bilateral cancers are eligible only if:', ' Index cancer is triple-negative, defined as ER-, PR-, and HER2-.', ' HER2 negative tumors. HER2 negativity must be confirmed by one of the following:', ' FISH-negative (FISH ratio <2.2), or', ' IHC 0-1+, or', ' IHC 2-3+ AND FISH-negative (FISH ratio <2.2).', ' Estrogen receptor negative and progesterone receptor negative (<10% staining by IHC for estrogen receptor and progesterone receptor).', ' Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.', ' Adequate hematologic function, defined by:', ' Absolute neutrophil count 2 >1000/mm3', ' Platelet count 100,000/mm3', ' Hemoglobin >9 g/dL', ' Adequate liver function, defined by:', ' AST and ALT 2.5 x the upper limit of normal (ULN)', " Total bilirubin 1.5 x ULN (unless the patient has grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin).", ' Adequate renal function, defined by:', ' Serum creatinine 1.5 x ULN', ' Complete staging work-up 24 weeks prior to initiation of study treatment with computed tomography (CT) scans of the chest and abdomen/pelvis (abdomen/pelvis preferred; abdomen accepted), a CT scan of the head or MRI of the brain (if symptomatic), and either a positron emission tomography (PET) scan or a bone scan.', ' Adequate cardiac function, defined by a left ventricular ejection fraction (LVEF) value of >50% (or normal per institutional guidelines) by MUGA scan or echocardiogram (ECHO).', ' Patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.', ' Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.', ' Patient must be accessible for treatment and follow-up.', ' Women of childbearing potential must agree to use an acceptable method of birth control to avoid pregnancy for the duration of study treatment, and for 3 months thereafter.', ' Able to swallow and retain oral medication.', ' Patient must be willing to undergo breast biopsies as required by the study protocol.', ' All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.', 'Exclusion Criteria:', ' Women who are pregnant or breastfeeding.', ' History of previously treated ductal carcinoma in situ (DCIS) is acceptable.', ' Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.', ' Known intolerance or hypersensitivity to Everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus);', ' Previous cancer (with the exception of non-melanoma skin cancer or cervical carcinoma in situ) in the past 5 years.', ' Patients who have any severe and/or uncontrolled medical conditions such as:', ' unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction 6 months prior to start of Everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease', ' Symptomatic congestive heart failure of New York heart Association Class III or IV', ' active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA),', ' known severely impaired lung function (spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air),', ' active, bleeding diathesis;', ' Patients may not receive any other investigational or anti-cancer treatments while participating in this study.', ' Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.', ' Inability to comply with study and/or follow-up procedures.', ' Patients who have received live attenuated vaccines within 1 week of start of Everolimus and during the study. Patient should also avoid close contact with others who have received live attenuated vaccines.', ' Examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines;', ' Known history of HIV seropositivity;', ' Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment. Highly effective contraception methods include combination of any two of the following (a+b or a+c or b+c):', ' Use of oral, injected or implanted hormonal methods of contraception or;', ' Placement of an intrauterine device (IUD) or intrauterine system (IUS);', ' Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;', ' Total abstinence or;', ' Male/female sterilization. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential.', ' Chronic treatment with corticosteroids or other immunosuppressive agents. Topical or inhaled corticosteroids are allowed;'], 'Results': ['Outcome Measurement: ', ' Tumor Response', ' Evaluate tumor response using RECIST criteria after 12 weeks of treatment at definitive surgery.', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.', ' Time frame: tumor response at 12 weeks after treatment', 'Results 1: ', ' Arm/Group Title: Everolimus Plus Cisplatin', ' Arm/Group Description: Everolimus 10mg by mouth daily for 12 weeks; Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles', ' Overall Number of Participants Analyzed: 22', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 22 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/22 (27.27%)', ' Thrombocytopenia 1/22 (4.55%)', ' leucocytopenia 1/22 (4.55%)', ' neutropenia 1/22 (4.55%)', ' papilledema 1/22 (4.55%)', ' Nausea 1/22 (4.55%)', ' hyperglycemia 1/22 (4.55%)']}

240e9cb0-3e40-4478-9d2c-fb4ff22e1e21

Comparison

Eligibility

NCT00428922

NCT00499083

Patients with prior chemotherapy for the treatment of stage 4 cancer are not eligible for either the primary trial or the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00428922', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab, Bevacizumab, and Docetaxel', ' Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed breast cancer with evidence of metastatic disease', ' HER2 3+ or FISH (fluorescent in situ hybridization)+', ' Age 18 years', ' No prior trastuzumab, except as given in the adjuvant or neoadjuvant setting.', ' No prior chemotherapy in the metastatic setting.', 'Exclusion Criteria:', ' CNS (central nervous system) metastases', ' Prior radiation therapy within the last 4 weeks', ' Pregnant (positive pregnancy test) or lactating women', ' Major surgical procedure, open biopsy, non-healing wounds, or significant traumatic injury within 28 days prior to starting study or anticipation of need for major surgical procedure during the study', ' Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to start of study.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) and to Evaluate Safety of the Trastuzumab, Bevacizumab and Docetaxel Regimen.', ' The trial was designed as a single-stage phase II rather then usual two-stage design because of the progression free survival (PFS) primary endpoint, as it is impractical to wait to assess PFS for patients in the first stage. We will consider a PFS of 50% at twelve months (median PFS of 12 months) or less uninteresting and a PFS of 70% at twelve months (median PFS of twenty months) worthy of pursuing the regimen in a future trials. The single-stage design is as follows: p0=0.50, p1=0.70, α=0.10, β= 0.10. This leads to a total sample size of 39 patients, 24 or higher of who are progression-free at 12 months.', ' Time frame: up to 3 years', 'Results 1: ', ' Arm/Group Title: Trastuzumab, Bevacizumab, and Docetaxel', ' Arm/Group Description: Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M ]', ' Overall Number of Participants Analyzed: 26', ' Median (95% Confidence Interval)', ' Unit of Measure: months 14.3 (9.3 to 35)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/26 (0.00%)']}

{'Clinical Trial ID': 'NCT00499083', 'Intervention': ['INTERVENTION 1: ', ' Vaccine', ' Patients with HER-2/neu negative tumors received therapeutic autologous dendritic cells: injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments.', ' Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor.', ' Patients received 4 cycles of paclitaxel: 175 mg/m2 (IV), followed by 4 cycles of cyclophosphamide: 600 mg/m2 IV and doxorubicin hydrochloride: 60 mg/m2 IV in a bi-weekly dose dense fashion', ' All patients had pre-treatment biopsy and second tumor biopsy after 4 cycles of paclitaxel to evaluate responses to the dendritic cell injections.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed invasive breast cancer meeting the following criteria:', ' Primary tumor 3 cm by mammography, ultrasound, or palpation AND/OR palpable axillary lymph nodes > 1 cm', ' Survivin- and/or carcinoembryonic antigen-positive by IHC', ' Tumor must be localized by exam or ultrasound to allow tumor injection', ' No stage IV or metastatic disease', ' HER2/neu-negative tumor by IHC', ' If 2+ or in the indeterminate range, further testing of HER2/neu overexpression by fluorescent in situ hybridization (FISH) is required', ' Hormone receptor status known', ' PATIENT CHARACTERISTICS:', ' Female', ' Pre-, peri-, or postmenopausal', ' ECOG performance status 0-1', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective contraception during and for up to 6 months following completion of study therapy', ' ANC 1,500/mm³', ' Platelet count 100,000/mm³', ' Alkaline phosphatase 1.5 times upper limit of normal (ULN)', ' Total bilirubin 1.5 times ULN', ' AST and ALT 1.5 times ULN', ' Creatinine < 1.5 times ULN', ' No active serious infections', ' No prior malignancy except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinoma, or other cancer from which the patient has been disease free for 5 years', ' No comorbidity or condition that would interfere with study assessments and procedures or preclude study participation', ' PRIOR CONCURRENT THERAPY:', ' No prior chemotherapy or radiotherapy'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Pathological Complete Response', ' Assessed by the institutional pathologist.', ' Grade 1: disappearance of all tumor on microscopic assessment in the breast and LNs', ' Grade 2: presence of in situ carcinoma only in the breast, no invasive tumor, and no tumor found in the LNs', ' Grade 3: presence of invasive carcinoma with stromal alteration, such as sclerosis or fibrosis', ' Grade 4: no or few modifications of the tumor appearance', ' Time frame: At definitive surgery.', 'Results 1: ', ' Arm/Group Title: Vaccine', ' Arm/Group Description: Patients with HER-2/neu negative tumors received therapeutic autologous dendritic cells: injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments.', ' Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor.', ' Patients received 4 cycles of paclitaxel: 175 mg/m2 (IV), followed by 4 cycles of cyclophosphamide: 600 mg/m2 IV and doxorubicin hydrochloride: 60 mg/m2 IV in a bi-weekly dose dense fashion', ' All patients had pre-treatment biopsy and second tumor biopsy after 4 cycles of paclitaxel to evaluate responses to the dendritic cell injections.', ' Overall Number of Participants Analyzed: 14', ' Measure Type: Number', ' Unit of Measure: participants 2'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/3 (33.33%)', ' Febrile neutropenia 1/3 (33.33%)']}

a1644573-fba8-4598-8353-a40d3ef1968c

Single

Adverse Events

NCT01298193

More than 15 patients in cohort 1 of the primary trial experienced adverse events.

Entailment

{'Clinical Trial ID': 'NCT01298193', 'Intervention': ['INTERVENTION 1: ', ' Observational Phase (First Cycle):', ' Observational phase (first cycle):', ' Day 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 [5-HT3] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg).', ' Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).'], 'Eligibility': ['Inclusion Criteria:', ' Female patient 18 years of age.', ' Patient has a histological confirmed early-stage (I to III) breast cancer.', ' Patient is able to understand study procedures and agrees to participate in the study by giving written informed consent.', ' Patient is naive to moderate or highly emetogenic chemotherapy per "Hesketh" criteria.', ' Patient is scheduled to receive of chemotherapy with Docetaxel-Cyclophosphamide (Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2) administered every 21 days.', ' Patient has a predicted life expectancy 4 months.', ' Functional State 0-1 Eastern Cooperative Oncology Group (ECOG) Scale (see Appendix 12.2).', ' Patient has an adequate organ function including the following:', ' Bone marrow reserve: Absolute Neutrophil Count >1500/mm3 and white blood cell (WBC) count >3000/mm3; Platelet Count >100.000/mm3', ' Hepatic: aspartate aminotransferase (AST) <2.5 x upper limit of normal; alanine aminotransferase (ALT) <2.5 x upper limit of normal; Bilirubin within the normal limit.', ' Renal: Creatinine <1.5 x upper limit of normal.', ' Premenopausal female patients must demonstrate a negative serum and/or urine pregnancy test within 3 days of study drug administration, and agree to use a double-barrier form of contraception for at least 14 days prior to, throughout and for at least 14 days following the last dose of study medication. Women taking oral contraceptive agents must agree to add a barrier form of contraception. Abstinence is also considered an acceptable form of contraception. (Note: A female patient who is not of reproductive potential is eligible without requiring the use of contraception. A female patient who is not of reproductive potential is defined as one who has either: 1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels in the postmenopausal range as determined by the laboratory, or 12 months of spontaneous amenorrhea); 2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy; or 3) bilateral tubal ligation.)', ' Patient is able to read, understand and complete study questionnaires.', 'Exclusion Criteria:', ' Patient is scheduled to receive any chemotherapy treatment different to the Docetaxel-Cyclophosphamide chemotherapy.', ' Patient has received or will receive radiation therapy to the abdomen, chest or pelvis in the month prior to the study enter.', ' Patient has vomited in the 24 hours prior to Treatment Day 1.', ' Patient has a history of treatment with emetogenic chemotherapy of moderate or high level per "Hesketh" (classification of emetogenic chemotherapy agents).', ' Patient has an active infection (e.g., pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy which, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.', ' Patient currently uses any illicit drugs, including marijuana, or has current evidence of alcohol abuse as determined by the investigator.', ' Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.', ' Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.', ' Patient has a history of hypersensitivity to aprepitant, 5-HT3 antagonists, or dexamethasone.', ' Patient is pregnant or breast feeding.', ' Patient has participated in a study with aprepitant or has taken a non approved (investigational) drug within the last 4 weeks.', ' Patient is taking systemic corticosteroid therapy at any dose; topical and inhaled corticosteroids are permitted.', ' Patient is taking, or will be taking within 28 days of Day 1 of cycle 2 (cycle in which patients will start taking aprepitant) the following CYP3A4 inducers:', ' phenytoin or carbamazepine', ' barbiturates', ' rifampicin or rifabutin', " St. John's Wort", ' Patient is taking, or will be taking within 7 days of Day 1 of cycle 2 the following CYP3A4 substrates:', ' terfenadine', ' cisapride', ' astemizole', ' pimozide', ' Patient is taking, or will be taking within the 7 days of Day 1 of cycle 2 the following CYP3A4 inhibitors:', ' clarithromycin', ' ketoconazole, itraconazole', ' Patient will be taking an antiemetic within 48 hours of Day 1 of cycle 2. Prohibited antiemetics include:', ' 5-HT3 antagonists (ondansetron, granisetron, dolasetron, tropisetron or palonosetron)', ' phenothiazines (e.g., prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine)', ' butyrophenones (e.g., haloperidol or droperidol)', ' benzamides (e.g., metoclopramide or alizapride)', ' domperidone', ' cannabinoids', ' herbal therapies with potential antiemetic properties', ' scopolamine', ' cyclizine', ' Patient has used benzodiazepines or opiates, except for single daily doses of triazolam, temazepam or midazolam in the 48 hours prior to Day 1 of cycle 2. Continuation of chronic benzodiazepines or opiate therapy is permitted provided it was initiated at least 48 hours before enrollment.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Complete Response (CR)', ' Complete response is defined as no vomiting and no use of rescue treatment within the first cycle of Docetaxel-Cyclophosphamide for the treatment of early-stage breast cancer patients. A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are, by definition, separated by the absence of emesis and retching for at least 1 minute. The timing (date and time) of each vomiting episode will be recorded by the patient in each cycle diary at the time of occurrence. Assessments of efficacy will begin at the initiation of chemotherapy infusion (0 hours) until the morning of Day 6 (approximately 120 hours) after chemotherapy during 1-2 cycles.', ' Time frame: Up to 21 days after cycle 1 of chemotherapy treatment', 'Results 1: ', ' Arm/Group Title: Observational Phase (First Cycle):', ' Arm/Group Description: Observational phase (first cycle):', ' Day 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 [5-HT3] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg).', ' Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).', ' Overall Number of Participants Analyzed: 185', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 161 87.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 31/185 (16.76%)', ' Anemic Shock [1]1/185 (0.54%)', ' Febrile Neutropenia [2]13/185 (7.03%)', ' Febrile Neutropenia 2/185 (1.08%)', ' Febrile neutropenia [3]3/185 (1.62%)', ' Neutrophil Count Decreased [2]2/185 (1.08%)', ' Neutrophil Count Decreased [3]2/185 (1.08%)', ' Neutrophil Count Decreased [4]2/185 (1.08%)', ' Colon Diverticulitis 1/185 (0.54%)', ' Vomiting [2]1/185 (0.54%)']}

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

ba533122-db9d-49e1-a2d1-936c8fdfdd00

Single

Adverse Events

NCT00274456

There are a total of 7 cases of Gastritis in the primary trial across both cohorts.

Contradiction

{'Clinical Trial ID': 'NCT00274456', 'Intervention': ['INTERVENTION 1: ', ' ABI-007 300 mg/m^2 q3w', ' ABI-007 300 mg/m^2 administered once every third week (q3w).', 'INTERVENTION 2: ', ' ABI-007 100 mg/m^2 Weekly', ' ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest'], 'Eligibility': ['Inclusion Criteria:', ' Patients had to meet the following criteria to be eligible for the study:', ' Pathologically confirmed adenocarcinoma of the breast.', ' No prior chemotherapy for metastatic breast cancer.', ' Stage IV disease.', ' Measurable disease (must have been 2.0 cm, except for pulmonary lesions that were well documented on CT scan that were 1.0 cm).', ' At least 3 weeks since prior cytotoxic chemotherapy (patients should have recovered from all acute effects of such therapy.', ' At least 4 weeks since radiotherapy, with full recovery. The measurable disease was completely outside the radiation portal or there was radiologic or clinical exam proof of progressive disease within the radiation portal.', ' At least 4 weeks since major surgery, with full recovery.', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-2.', ' Age 18 years.', ' Patient had the following blood counts at Baseline:', ' Absolute neutrophil count (ANC) 1.5*10^9 cells/L', ' Platelets 100*10^9 cells/L', ' Hemoglobin (Hgb) 9 g/dL.', ' Patient had the following baseline blood chemistry levels:', ' Aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]) 2.5x upper limit of normal (ULN) range', ' Total bilirubin normal', ' Alkaline phosphatase 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis)', ' Creatinine 1.5 mg/dL.', ' Peripheral neuropathy Grade 0 or 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).', ' If female of childbearing potential, pregnancy test was negative (within 72 hours of the first dose of study drug).', ' If fertile, the patient agreed to use an effective method to avoid pregnancy for the duration of the study.', ' Informed consent had been obtained.', 'Exclusion Criteria:', ' Patients who met any of the following criteria were excluded from the study:', ' Prior neo-adjuvant or adjuvant chemotherapy was allowed. No prior chemotherapy for metastatic disease was allowed. If a taxane was part of the adjuvant regimen, at least one year should have transpired since completion of taxane regimen.', ' Cumulative life-time dose of doxorubicin >360 mg/m^2. Doxorubicin was allowed as prior neo-adjuvant or adjuvant therapy but not for metastatic disease.', ' Concurrent immunotherapy or hormonal therapy for breast cancer.', ' Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment.', ' Serious intercurrent medical or psychiatric illness, including serious active infection.', ' History of class II-IV congestive heart failure.', ' History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.', ' Patients who had received an investigational drug within the previous 3 weeks.', ' Patient was enrolled in a different clinical study in which investigational procedures were performed or investigational therapies were administered. Also, a patient was not permitted enroll in such clinical trials while participating in this study.', ' Pregnant or nursing women', ' Patients with prior hypersensitivity to either Taxol or Taxotere.'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator', ' Percentage of participants who achieve an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms. A partial response (PR) is >= 30% decrease in the sum of the longest diameters of target lesion. PR was also recorded when all measurable disease has completely disappeared, but a non-measurable component (ie, ascites) is still present but not progressing. Overall response (ORR) = CR+PR.', ' Time frame: Day 1 up to 95 weeks', 'Results 1: ', ' Arm/Group Title: ABI-007 300 mg/m^2 q3w', ' Arm/Group Description: ABI-007 300 mg/m^2 administered once every third week (q3w).', ' Overall Number of Participants Analyzed: 76', ' Measure Type: Number', ' Unit of Measure: percentage of participants Independent reader assessed ORR: 37 (26.0 to 47.7)', ' Investigator assessed ORR: 46 (34.8 to 57.3)', 'Results 2: ', ' Arm/Group Title: ABI-007 100 mg/m^2 Weekly', ' Arm/Group Description: ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest', ' Overall Number of Participants Analyzed: 76', ' Measure Type: Number', ' Unit of Measure: percentage of participants Independent reader assessed ORR: 45 (33.6 to 55.9)', ' Investigator assessed ORR: 63 (52.3 to 74.0)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/76 (18.42%)', ' Neutropenia 10/76 (13.16%)', ' Febrile neutropenia 1/76 (1.32%)', ' Anaemia 0/76 (0.00%)', ' Thrombocytopenia 0/76 (0.00%)', ' Cardiopulmonary failure 0/76 (0.00%)', ' Optic ischaemic neuropathy 0/76 (0.00%)', ' Bowel peristalsis increased 1/76 (1.32%)', ' Colitis 0/76 (0.00%)', ' Diarrhoea 0/76 (0.00%)', ' Gastritis 0/76 (0.00%)', ' Nausea 0/76 (0.00%)', 'Adverse Events 2:', ' Total: 12/76 (15.79%)', ' Neutropenia 2/76 (2.63%)', ' Febrile neutropenia 1/76 (1.32%)', ' Anaemia 0/76 (0.00%)', ' Thrombocytopenia 0/76 (0.00%)', ' Cardiopulmonary failure 1/76 (1.32%)', ' Optic ischaemic neuropathy 1/76 (1.32%)', ' Bowel peristalsis increased 0/76 (0.00%)', ' Colitis 1/76 (1.32%)', ' Diarrhoea 0/76 (0.00%)', ' Gastritis 0/76 (0.00%)', ' Nausea 1/76 (1.32%)']}

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

f20cd859-7159-457a-a1cb-56bdb01d521b

Single

Adverse Events

NCT00003782

Neither of the cohorts in the primary trial had more than 5% of patients experiencing side effects.

Entailment

{'Clinical Trial ID': 'NCT00003782', 'Intervention': ['INTERVENTION 1: ', ' Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel', ' Doxorubicin + Cyclophosphamide, then Docetaxel', 'INTERVENTION 2: ', ' Arm 2: Doxorubicin + Docetaxel', ' Doxorubicin + Docetaxel'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed invasive adenocarcinoma of the breast', ' Confined to the breast and ipsilateral axilla on clinical exam', ' Stage I, II, or IIIA (cT1-3, N0-1, M0)', ' At least one axillary lymph node with evidence of tumor on histologic exam', ' Sentinel node biopsy allowed if followed by axillary dissection', ' No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven on biopsy to not be involved with tumor', ' No bilateral malignancy or mass in the opposite breast, unless mass is histologically proven to be benign', ' Must have undergone either a prior total mastectomy and axillary dissection (modified radical mastectomy) OR', ' Prior lumpectomy and axillary dissection', ' Patients must receive radiotherapy after randomization (not before) AND after chemotherapy', ' Margins must be clear', ' No ipsilateral lymph nodes that are fixed to one another or to other structures (N2 disease) and/or any positive nonaxillary lymph nodes (intramammary nodes are considered axillary nodes)', ' No histologically evident invasive tumor or ductal carcinoma in situ', ' No diffuse tumors by mammography that would not be surgically amenable to lumpectomy', ' No other dominant mass in the ipsilateral breast remnant unless one of the following is true:', ' Histologically benign', ' Surgically removed with clear margins if malignant', " No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude", ' Tethering or dimpling of the skin or nipple inversion allowed', ' No metastatic disease', ' Skeletal pain allowed if bone scan negative for metastases', ' Hormone receptor status:', ' Estrogen and progesterone status determined', ' PATIENT CHARACTERISTICS:', ' Age:', ' greater than or equal to 18 years', ' Sex:', ' Female', ' Menopausal status:', ' Not specified', 'Performance status:', ' Not specified', ' Life expectancy:', ' At least 10 years, excluding diagnosis of cancer', ' Hematopoietic:', ' Absolute neutrophil count at least 1,500/mm^3 (may be less, if in the opinion of the investigator, this represents an ethnic or racial variation)', ' Platelet count at least 100,000/mm^3* NOTE: *If platelet count is above the upper limit of normal (ULN), significant underlying hematologic disorders must be excluded', ' Hepatic:', ' Bilirubin no greater than ULN', ' Alkaline phosphatase less than 2.5 times ULN*', ' SGOT less than 1.5 times ULN*', ' No nonmalignant systemic hepatic disease that would preclude study participation NOTE: *Alkaline phosphatase and SGOT cannot both be greater than ULN', ' Renal:', ' Creatinine no greater than normal', ' No nonmalignant systemic renal disease that would preclude study participation', ' Cardiovascular:', ' No nonmalignant systemic cardiovascular disease that would preclude study participation', ' LVEF at least lower limit of normal (LLN) by MUGA or echocardiogram', ' No active cardiac disease that would preclude use of doxorubicin or docetaxel, including the following:', ' Any prior myocardial infarction', ' Angina pectoris requiring anti-anginal medication', ' History of congestive heart failure', ' Cardiac arrhythmia requiring medication', ' Severe conduction abnormality', ' Valvular disease with documented cardiac function compromise', ' Cardiomegaly on chest x-ray or ventricular hypertrophy on EKG, unless LVEF at least LLN', ' Poorly controlled hypertension (diastolic greater than 100 mm/Hg)', ' Hypertension well controlled by medication allowed', ' Other:', ' No grade 2 or greater peripheral neuropathy', ' No other prior malignancy within the past 5 years except:', ' Effectively treated squamous cell or basal cell skin cancer', ' Surgically treated carcinoma in situ of the cervix', ' Segmentally resected lobular carcinoma in situ of the ipsilateral or contralateral breast', ' Not pregnant or nursing', ' Negative pregnancy test', ' Fertile patients must use effective barrier contraception', ' No nonmalignant systemic disease that would preclude study participation', ' No diabetes with morning fasting blood glucose of 200 mg/dL or greater', ' No psychiatric or addictive disorders that would preclude informed consent', ' No contraindication to corticosteroids that would preclude study participation', ' PRIOR CONCURRENT THERAPY:', ' Biologic therapy:', ' No prior immunotherapy for breast cancer', ' Chemotherapy:', ' No prior chemotherapy for breast cancer', ' No prior anthracyclines or taxanes', ' No other concurrent investigational chemotherapy', ' Endocrine therapy:', ' No prior hormonal therapy for breast cancer', ' No concurrent hormonal birth control methods or other hormonal therapy', ' No concurrent raloxifene, including for osteoporosis', ' Concurrent low-dose topical estrogen in the form of conjugated estrogen ring or conjugated estrogen vaginal cream (dose no more than 0.3 mg or 1/8 of an applicator applied vaginally 3 times a week) allowed', ' Radiotherapy:', ' See Disease Characteristics', ' No prior radiotherapy for this malignancy', ' Surgery:', ' See Disease Characteristics', ' No more than 84 days since prior surgery for breast cancer (e.g., lumpectomy, mastectomy, sentinel node biopsy, axillary dissection, or re-excision of lumpectomy margins)', ' Other:', ' No prior systemic therapy for this malignancy', ' No concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers, or calcium-channel blockers) for cardiac arrhythmia, angina, or congestive heart failure (allowed if administered for other reasons [e.g., hypertension])', ' Concurrent bisphosphonates allowed'], 'Results': ['Outcome Measurement: ', ' Overall Survival', ' [Not Specified]', ' Time frame: 8 years', 'Results 1: ', ' Arm/Group Title: Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel', ' Arm/Group Description: Doxorubicin + Cyclophosphamide, then Docetaxel', ' Overall Number of Participants Analyzed: 1753', ' Measure Type: Number', ' Unit of Measure: percentage of patients alive 83', 'Results 2: ', ' Arm/Group Title: Arm 2: Doxorubicin + Docetaxel', ' Arm/Group Description: Doxorubicin + Docetaxel', ' Overall Number of Participants Analyzed: 1753', ' Measure Type: Number', ' Unit of Measure: percentage of patients alive 79'], 'Adverse Events': ['Adverse Events 1:', ' Total: 66/1748 (3.78%)', ' Febrile neutropenia 2/1748 (0.11%)', ' Cardiac disorders - Other, specify 3/1748 (0.17%)', ' Conduction disorder 0/1748 (0.00%)', ' Myocardial infarction 0/1748 (0.00%)', ' Ventricular arrhythmia 1/1748 (0.06%)', ' Left ventricular systolic dysfunction 0/1748 (0.00%)', ' Colitis 1/1748 (0.06%)', ' Diarrhea 0/1748 (0.00%)', ' Duodenal ulcer 0/1748 (0.00%)', 'Adverse Events 2:', ' Total: 43/1748 (2.46%)', ' Febrile neutropenia 1/1748 (0.06%)', ' Cardiac disorders - Other, specify 1/1748 (0.06%)', ' Conduction disorder 0/1748 (0.00%)', ' Myocardial infarction 1/1748 (0.06%)', ' Ventricular arrhythmia 0/1748 (0.00%)', ' Left ventricular systolic dysfunction 1/1748 (0.06%)', ' Colitis 1/1748 (0.06%)', ' Diarrhea 1/1748 (0.06%)', ' Duodenal ulcer 1/1748 (0.06%)']}

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

d33df923-6c12-4135-b339-5cefdd240985

Comparison

Adverse Events

NCT00333775

NCT00201864

There are several coagulative adverse events recorded in the primary trial, but not a single one in the secondary trial.

Contradiction

{'Clinical Trial ID': 'NCT00333775', 'Intervention': ['INTERVENTION 1: ', ' Docetaxel 100 mg/m^2 Plus Placebo', ' Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.', 'INTERVENTION 2: ', ' Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg', ' Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.'], 'Eligibility': ['Inclusion criteria:', ' Female patients 18 years of age.', ' Human epidermal growth factor receptor 2 (HER2)-negative cancer of the breast with locally recurrent or metastatic disease, suitable for chemotherapy.', ' No adjuvant chemotherapy within 6 months before randomization, and no taxane-based chemotherapy within 12 months before randomization.', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.', 'Exclusion criteria:', ' Previous chemotherapy for metastatic or locally recurrent breast cancer.', ' Radiotherapy for treatment of metastatic disease.', ' Other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix.', ' Spinal cord compression or brain metastases.', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization.', ' Inadequate bone marrow, liver, or renal function.', ' Uncontrolled hypertension.'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' Progression-free survival was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Progression-free survival was defined as the time from randomization to the time of the first documented disease progression or death, whichever occurred first. Disease progression was defined as 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions, or appearance of new lesion(s).', ' Time frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)', 'Results 1: ', ' Arm/Group Title: Docetaxel 100 mg/m^2 Plus Placebo', ' Arm/Group Description: Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.', ' Overall Number of Participants Analyzed: 241', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 8.0 (7.2 to 8.3)', 'Results 2: ', ' Arm/Group Title: Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg', ' Arm/Group Description: Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.', ' Overall Number of Participants Analyzed: 248', ' Median (95% Confidence Interval)', ' Unit of Measure: Months 8.7 (8.2 to 9.9)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 82/217 (37.79%)', ' Febrile neutropenia 21/217 (9.68%)', ' Neutropenia 4/217 (1.84%)', ' Leukopenia 0/217 (0.00%)', ' Anaemia 1/217 (0.46%)', ' Thrombocytopenia 0/217 (0.00%)', ' Atrial fibrillation 0/217 (0.00%)', ' Arrhythmia 1/217 (0.46%)', ' Arteriospasm coronary 0/217 (0.00%)', ' Atrioventricular block first degree 0/217 (0.00%)', ' Cardiac failure 0/217 (0.00%)', 'Adverse Events 2:', ' Total: 106/252 (42.06%)', ' Febrile neutropenia 29/252 (11.51%)', ' Neutropenia 13/252 (5.16%)', ' Leukopenia 3/252 (1.19%)', ' Anaemia 0/252 (0.00%)', ' Thrombocytopenia 1/252 (0.40%)', ' Atrial fibrillation 1/252 (0.40%)', ' Arrhythmia 0/252 (0.00%)', ' Arteriospasm coronary 1/252 (0.40%)', ' Atrioventricular block first degree 1/252 (0.40%)', ' Cardiac failure 1/252 (0.40%)']}

{'Clinical Trial ID': 'NCT00201864', 'Intervention': ['INTERVENTION 1: ', ' Exemestane and Fulvestrant', ' Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection', ' Exemestane: 25 mg orally per day', ' Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days.'], 'Eligibility': ['Inclusion Criteria:', ' Proven breast cancer', ' Metastatic or locally advanced breast cancer', ' Hormonally responsive disease defined as estrogen (ER) and/ or progesterone receptor (PR) positive (>10% staining by immunohistochemistry)', ' Postmenopausal status', ' No more than 1 prior chemotherapy for stage IV metastatic breast cancer allowed', ' ECOG (Eastern Cooperative Oncology Group) performance status 0-2', ' Adequate organ function', 'Exclusion Criteria:', ' No prior Exemestane or Fulvestrant', ' Uncontrolled intercurrent illness including but not limited to:', ' ongoing or active infection', ' symptomatic congestive heart failure', ' unstable angina pectoris', ' cardiac arrhythmia', ' myocardial infarction within the last 3 months', ' psychiatric illness/social situations that would limit compliance with study', ' Lymphangitic pulmonary disease; carcinomatous meningitis, bone marrow only metastases; and a rising tumor marker without any other site of metastatic disease.', ' Presence of bleeding diathesis or coagulopathy, patients requiring coumadin'], 'Results': ['Outcome Measurement: ', ' Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.', ' TTP is defined as the time from first treatment to objective evidence of progression on the basis of radiological evaluation and/or physical exam (if physical examination identifies a site of measurable disease). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions', ' Time frame: Every 2 cycles up to 2 years', 'Results 1: ', ' Arm/Group Title: Exemestane and Fulvestrant', ' Arm/Group Description: Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection', ' Exemestane: 25 mg orally per day', ' Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days.', ' Overall Number of Participants Analyzed: 40', ' Median (95% Confidence Interval)', ' Unit of Measure: months 6.9 (3.9 to 13.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/40 (15.00%)', ' Nausea 1/40 (2.50%)', ' Vomiting 1/40 (2.50%)', ' Chest pain 1/40 (2.50%)', ' Hypercalcemia 1/40 (2.50%)', ' Thromboembolism 2/40 (5.00%)']}

0f49a1ec-ed73-465b-be20-b70fe990b1f0

Comparison

Intervention

NCT03196635

NCT01943916

the primary trial and the secondary trial are both evaluating imaging techniques.

Entailment

{'Clinical Trial ID': 'NCT03196635', 'Intervention': ['INTERVENTION 1: ', ' All Study Participants, PA Compression Image Sets', ' All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.', 'INTERVENTION 2: ', ' All Study Participants, TC Compression Image Sets', ' All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.'], 'Eligibility': ['Inclusion Criteria:', ' Are women aged 40 years or older;', ' Are asymptomatic and scheduled for FFDM 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:', ' Have been previously included in this study or are participating in another study expected to interfere with study procedures or outcomes;', ' Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including breast biopsy, lumpectomy, or reconstruction, within five (5) years ( 5 years) of the study exam date;', ' Are currently undergoing radiotherapy or chemotherapy, or have a history of prior radiotherapy treatment on either breast;', ' Are currently lactating; or', ' Have breast implants.'], 'Results': ['Outcome Measurement: ', ' Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets', ' One PA image set and one TC image set was acquired from each completed subject. The overall clinical image quality acceptability was collected and summarized on a per subject-basis using binary responses of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets. Two readers evaluated each of the 60 image sets (30 PA and 30 TC compression image sets from 30 completed participants). In cases of disagreement between Readers 1 and 2, a third reader provided adjudication.', ' Time frame: Through study completion, on average 1 month', 'Results 1: ', ' Arm/Group Title: All Study Participants, PA Compression Image Sets', ' Arm/Group Description: All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 30 100.0%', 'Results 2: ', ' Arm/Group Title: All Study Participants, TC Compression Image Sets', ' Arm/Group Description: All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.', ' Overall Number of Participants Analyzed: 30', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 30 100.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/30 (0.00%)', 'Adverse Events 2:', ' ']}

{'Clinical Trial ID': 'NCT01943916', 'Intervention': ['INTERVENTION 1: ', ' Overall Population', ' Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.'], 'Eligibility': ['Inclusion Criteria:', ' female', ' 18 years of age or older', ' suspicious mass of breast, identified by a health care practitioner within the past 30 days with diagnostic methodology other than conventional ultrasound.', 'Exclusion Criteria:', ' presence of a condition or impediment that may interfere with imaging.', ' pregnant or lactating', ' undergoing neoadjuvant therapy'], 'Results': ['Outcome Measurement: ', ' Specificity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS)', ' Primary effectiveness endpoint was the difference in specificity for the Imagio OA/US relative to IUS, across all 7 independent readers; both imaging modalities used in 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 months +/- 30 days follow-up', 'Results 1: ', ' Arm/Group Title: Overall Population', ' Arm/Group Description: Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.', ' Overall Number of Participants Analyzed: 1739', ' Mean (99% Confidence Interval)', " Unit of Measure: % benign+TPB masses correctly Id'd 14.9 (12.9 to 16.9)"], 'Adverse Events': ['Adverse Events 1:', ' Total: 5/1972 (0.25%)', ' Atrial fibrillation [1]1/1972 (0.05%)', ' Cardiac failure congestive [2]1/1972 (0.05%)', ' Device breakage [3]1/1972 (0.05%)', ' Uterine Leiomyoma [4]1/1972 (0.05%)', ' Non-small cell lung cancer Stage I [5]1/1972 (0.05%)', ' Haemothorax [6]1/1972 (0.05%)', ' Pneumothorax [7]1/1972 (0.05%)']}

7370c10d-f6e7-4153-9649-9d2598ce1ed7

Single

Results

NCT00558272

The biggest change in Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4 observed in the primary trial was a patient in the Zoledronic Acid 4 mg group, with a -73.0 % change from baseline.

Contradiction

{'Clinical Trial ID': 'NCT00558272', 'Intervention': ['INTERVENTION 1: ', ' AZD0530 175 mg', ' AZD0530 (saracatinib) 175 mg once daily', 'INTERVENTION 2: ', ' Zoledronic Acid 4 mg', ' Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period'], 'Eligibility': ['Inclusion Criteria:', ' Subjects 18 years or older with Prostate Cancer or Breast Cancer with Metastatic Bone Disease Have evidence of recurrence or disease progression', ' At least one radiographically confirmed metastatic bone lesion', ' No change of cancer therapy for at least 8 weeks before randomization', 'Exclusion Criteria:', ' Have had any prior exposure to bisphosphonate', ' Have had hip fractures or bilateral hip prothesis fracture of any kind or surgery to bone within the past 12 months', ' Inadequate renal function or low haemoglobin', ' Inadequate liver function as demonstrated by serum bilirubin 2 times the upper limits of reference range (ULRR) or by alanine aminotransferase (ALT), aspartate aminotransferase(AST) or ALP 2.5 times the ULRR ( 5 times the ULRR in the presence of liver metastases). If bone metastases are present and liver function is otherwise considered adequate by the investigator then elevated ALP will not exclude the patient.'], 'Results': ['Outcome Measurement: ', ' Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4', ' Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.', ' Time frame: Baseline to Week 4', 'Results 1: ', ' Arm/Group Title: AZD0530 175 mg', ' Arm/Group Description: AZD0530 (saracatinib) 175 mg once daily', ' Overall Number of Participants Analyzed: 46', ' Geometric Mean (95% Confidence Interval)', ' Unit of Measure: Percentage change in betaCTX -71.1 (-75.9 to -65.4)', 'Results 2: ', ' Arm/Group Title: Zoledronic Acid 4 mg', ' Arm/Group Description: Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period', ' Overall Number of Participants Analyzed: 65', ' Geometric Mean (95% Confidence Interval)', ' Unit of Measure: Percentage change in betaCTX -68.4 (-73.0 to -63.2)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 11/68 (16.18%)', ' Anaemia 1/68 (1.47%)', ' Cardiac Arrest 1/68 (1.47%)', ' Myocardial Infarction 1/68 (1.47%)', ' Vomiting 1/68 (1.47%)', ' General Physical Health Deterioration 0/68 (0.00%)', ' Pyrexia 1/68 (1.47%)', ' Pneumonia 2/68 (2.94%)', ' Viral Infection 1/68 (1.47%)', ' Blood Creatinine Increased 0/68 (0.00%)', ' Dehydration 0/68 (0.00%)', ' Bone Pain 0/68 (0.00%)', 'Adverse Events 2:', ' Total: 4/69 (5.80%)', ' Anaemia 0/69 (0.00%)', ' Cardiac Arrest 0/69 (0.00%)', ' Myocardial Infarction 0/69 (0.00%)', ' Vomiting 0/69 (0.00%)', ' General Physical Health Deterioration 1/69 (1.45%)', ' Pyrexia 0/69 (0.00%)', ' Pneumonia 0/69 (0.00%)', ' Viral Infection 0/69 (0.00%)', ' Blood Creatinine Increased 1/69 (1.45%)', ' Dehydration 1/69 (1.45%)', ' Bone Pain 1/69 (1.45%)']}

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

3f89537a-479e-4314-b9de-4caf845850fc

Comparison

Eligibility

NCT01985971

NCT03273426

Patients will have to undergo an MRI scan of the spine for before entry for both the secondary trial and the primary trial, for the primary trial patients will also need to have a brain MR and PET imaging, after study entry.

Contradiction

{'Clinical Trial ID': 'NCT01985971', 'Intervention': ['INTERVENTION 1: ', ' EF5 PET/CT Imaging', 'PET/CT Imaging'], 'Eligibility': ['Inclusion Criteria:', ' Subjects with measurable brain metastases of at least 1 cm in any plane based on anatomic imaging.', ' Subjects with prior resection of brain metastases with progressions on brain MRI.', ' Histologic confirmation of breast cancer.', ' Age of study subject must be > 18 years.', ' ECOG Performance Status 2.', ' Ability to undergo brain MR and PET imaging', ' Study subjects must have normal organ and marrow function as defined below:', ' WBC >2,000/mmᶟ, platelets >90,000/mmᶟ, total bilirubin <2.0 mg/dl, creatinine <2.0 mg/dl.', ' The effects of EF5 on the developing human fetus are unknown. For this reason, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation (1 month). Should a woman become pregnant pr suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test the day of the F18 -EF5 PET scan prior to the F18 -EF5 injection.', ' Ability to understand, participate and provide a documented signed informed consent.', ' Subjects who are allergic to gadolinium will have MRI scans without gadolinium contrast.', 'Exclusion Criteria:', ' History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5.', ' Pregnant women are excluded because EF5 has an unknown risk for adverse events in fetuses and nursing infants secondary the administration of EF5 to the mother. Breastfeeding should be discontinued if EF5 is administered to the mother.', ' Subject has any other condition or personal circumstance that, in the judgement of the investigator, might interfere with the collection of complete good quality data.', ' Subjects who are unable to provide informed consent.', ' Patients with prior whole brain radiotherapy.', ' Patients with moderate to severe renal failure, defined as estimated GFR less than 30 ml/Lmin 1.73m²'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adverse Events', ' [Not Specified]', 'Time frame: 2 year', 'Results 1: ', ' Arm/Group Title: EF5 PET/CT Imaging', ' Arm/Group Description: PET/CT Imaging', ' Overall Number of Participants Analyzed: 2', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/2 (0.00%)']}

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

8e9f417a-dc0f-4c20-9cf7-5f8586c23df2

Single

Results

NCT03366428

3/49 the primary trial Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer had a Maximum change from baseline in QTcF of over 30 ms.

Entailment

{'Clinical Trial ID': 'NCT03366428', 'Intervention': ['INTERVENTION 1: ', ' DS-8201a', ' Participants who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks on Day 1 of each 21-day cycle.'], 'Eligibility': ['Inclusion Criteria:', ' Has a pathologically documented unresectable or metastatic breast cancer with HER2 expression (immunohistochemistry [IHC] 3+, IHC 2+, IHC 1+ and/or in situ hybridization [ISH] +) that is refractory to or intolerable with standard treatment, or for which no standard treatment is available', ' Has a left ventricular ejection fraction (LVEF) 50%', ' Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1', 'Exclusion Criteria:', ' Has a medical history of myocardial infarction within 6 months before enrollment', ' Has a medical history of ventricular arrhythmias, other than rare occasional premature ventricular contractions', ' Has uncontrolled or significant cardiovascular disease'], 'Results': ['Outcome Measurement: ', ' Changes in QTcF After Treatment With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer', ' The number of participants with notable electrocardiogram changes meeting predefined criteria is being reported.', ' Time frame: Screening (within 7 days before enrollment) up to Cycle 3 Day 15 (each cycle is 21 days)', 'Results 1: ', ' Arm/Group Title: DS-8201a', ' Arm/Group Description: Participants who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks on Day 1 of each 21-day cycle.', ' Overall Number of Participants Analyzed: 49', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Maximum change from baseline in QTcF: >30 ms: 3 6.1%', ' Maximum change from baseline in QTcF: >60 ms: 0 0.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/51 (17.65%)', ' Nausea 2/51 (3.92%)', ' Cellulitis 1/51 (1.96%)', ' Lung infection 1/51 (1.96%)', ' Femur fracture 1/51 (1.96%)', ' Post procedural complication 1/51 (1.96%)', ' Fracture 1/51 (1.96%)', ' Interstitial lung disease 1/51 (1.96%)', ' Pneumonitis 1/51 (1.96%)']}

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

8ba451be-606a-4a57-a85e-82b5e5b286fc

Comparison

Adverse Events

NCT00721630

NCT00364611

the primary trial and the secondary trial recorded the same proportion of patients experiencing nausea.

Contradiction

{'Clinical Trial ID': 'NCT00721630', 'Intervention': ['INTERVENTION 1: ', ' Capecitabine + Lapatinib', ' The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.', ' capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week).'], 'Eligibility': ['Inclusion Criteria:', ' Patients with a diagnosis of invasive adenocarcinoma of the breast confirmed by histology or cytology at MSKCC.', ' Clinical evidence of metastatic breast cancer.', ' HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or FISH ( 2.0).', ' Progressive disease following treatment with trastuzumab for metastatic breast cancer or as adjuvant therapy (either single-agent or combination therapy)', ' Prior therapy inclusion:', ' No more than two prior chemotherapy regimens allowed for advanced stage disease', ' No prior fluoropyrimidine in the metastatic setting. Adjuvant fluoropyrimidine is permitted if >6 months prior to treatment on study.', ' No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted.', ' No more than 450mg/m2 cumulative dose of prior doxorubicin', ' At least 3 weeks since prior chemotherapy or radiation therapy', ' Age or = to 18. Because no dosing or adverse event data are currently available on the use of lapatinib in patients <18 years of age, children are excluded from this study.', ' Patients must be willing to discontinue sex hormonal therapy e.g., birth control pills, ovarian hormonal replacement therapy, etc., prior to enrollment. Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.', ' Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.', ' Asymptomatic, central nervous system metastases are permitted if patients remain clinically stable after discontinuation of corticosteroids and anticonvulsants.', ' ECOG performance status < or = to 2', ' Life expectancy of greater than 12 weeks', ' Patients must have normal organ and marrow function as defined below:', ' leukocytes or = to 3,000/μL', ' absolute neutrophil count or = 1,500/μL', ' platelets or = 100,000/μL', ' total bilirubin within normal institutional limits AST (SGOT)/ALT(SGPT) or = 2.5x institutional upper limit of normal serum creatinine within normal institutional limits', ' Cardiac ejection fraction at or above the lower limit of normal of 50% as measured by multigated radionuclide angiography (MUGA) scan. If LVEF is greater than 70%, and ECHO should be performed as well. Baseline and on treatment scans should be performed using the same modality and preferably at the same institution.', ' Ability to understand and the willingness to sign a written informed. consent document.', ' Able to swallow and retain oral medication.', 'Exclusion Criteria:', ' Patients may not be receiving any concurrent anticancer therapy or investigational agents with the intention of treating breast cancer.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or capecitabine.', ' Known DPD deficiency.', ' Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months of study entry, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.', ' Pregnant women are excluded from this study because lapatinib is member of the 4- anilinoquinazoline class of kinase inhibitors with 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 lapatinib, breastfeeding should be discontinued if the mother is treated with lapatinib.', ' HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.', " Patients with 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:', ' Medications that inhibit or induce CYP3A4 are prohibited. 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.', ' Renal function as measured by creatinine clearance < 30ml/min', ' Patients are permitted to participate in other non-therapeutic clinical trials while receiving treatment on this study (ie, experimental imaging, minor procedures necessary for tissue acquisition on study)'], 'Results': ['Outcome Measurement: ', ' Estimate Efficacy of Capecitabine 7/7 in Combination With Lapatinib in Patients With HER2 Overexpressed/Amplified, Trastuzumab-refractory, Metastatic Breast Cancer as Determined by Overall Response Rate (Complete Response (CR) + Partial Response (PR))', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Capecitabine + Lapatinib', ' Arm/Group Description: The regimen consists of capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily.', ' capecitabine, lapatinib: Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week).', ' Overall Number of Participants Analyzed: 23', ' Measure Type: Count of Participants', ' Unit of Measure: Participants Partial Response: 5 21.7%', ' Stable Disease >/= 6 months: 6 26.1%', ' Stable disease <6 months: 11 47.8%', ' Progression of disease: 1 4.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 9/23 (39.13%)', ' Anemia 1/23 (4.35%)', ' Diarrhea 1/23 (4.35%)', ' Nausea 1/23 (4.35%)', ' Fracture 1/23 (4.35%)', ' ALT 1/23 (4.35%)', ' AST 1/23 (4.35%)', ' INR 1/23 (4.35%)', ' PTT 1/23 (4.35%)', ' Glucose, high 1/23 (4.35%)', ' Limb Pain 1/23 (4.35%)', ' Ataxia 2/23 (8.70%)', ' Neurology - Other 1/23 (4.35%)', ' Seizure 1/23 (4.35%)', ' Syncope 1/23 (4.35%)', ' Confusion 1/23 (4.35%)']}

{'Clinical Trial ID': 'NCT00364611', 'Intervention': ['INTERVENTION 1: ', ' Docetaxel and Bevacizumab', ' Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met', 'INTERVENTION 2: ', ' Docetaxel, Bevacizumab and Trastuzumab', ' Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met'], 'Eligibility': ['The following information on clinical trials is provided for information purposes only to allow participants and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.', 'INCLUSION CRITERIA:', ' Histologically or cytologically proven adenocarcinoma of the breast at first diagnosis', ' Stage IV disease with at least one measurable lesion according to the RECIST criteria', ' HER2/neu positive as determined by 3+ immunohistochemistry (IHC) staining or fluorescence in situ hybridization (FISH) positivity or negative tumors', ' Life expectancy of >/= 24 weeks', ' No prior chemotherapy for metastatic breast cancer. (Prior endocrine therapy is permitted).', ' Prior neoadjuvant or adjuvant chemotherapy is permitted, or at least 12 months must have elapsed since the neoadjuvant or adjuvant therapy. Subjects may have received prior adjuvant anthracyclines (maximum cumulative dose, 360 mg/m^2 doxorubicin or 750 mg/m^2 epirubicin)', ' At least 4 weeks since prior surgery, radiotherapy, endocrine therapy, or experimental drug therapy with complete recovery from the effects of these interventions', ' It is recommended that all baseline staging should be completed within 35 days prior to study entry. All subjects will have the following workup as applicable; CT scan of brain, CT scan or MRI of chest and abdomen, and bone scan or PET scan. In cases of positive bone or PET scans, bone X-ray evaluation and/or MRI is required to confirm or exclude metastatic bone disease. Subjects with metastatic disease limited to bone are ineligible unless at least one lytic lesion is measurable and can be followed by RECIST criteria. Other tests may be performed as clinically indicated', ' Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) of >/= 50% or shortening fraction (multiple-gated acquisition [MUGA] scan or echocardiography respectively). The result must be greater than the lower limit of normal (LLN) for the institution.', ' Subjects receiving bisphosphonate therapy; however, if bisphosphonates were started within <2 months prior to treatment the bone lesions will not be evaluated for response, and the subjects must have another site of metastatic disease that is either measurable or evaluable for response', 'EXCLUSION CRITERIA:', ' Prior chemotherapy for metastatic breast cancer', ' Prior treatment with bevacizumab or other anti-VEGF therapy', ' Concurrent treatment with any other non-protocol anticancer therapy with the exception of radiation therapy as long as all target lesions being followed are not in the radiation field and if HER2/neu positive, HER2/neu-directed therapy', ' Current or prior history of brain or leptomeningeal metastases', ' Presence of neuropathy >/= 2', ' Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically significant (>/= Grade 2) peripheral vascular disease', ' History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma in-situ of the cervix', ' Clinically significant cardiovascular disease', ' Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning therapy', ' History of bleeding diathesis or coagulopathy'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival (PFS) Rate: Percentage of Participants With PFS', ' PFS was the time from registration to first documentation of', ' progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors (RECIST) - criteria pre-defining changes in lesion size or appearance', ' symptomatic deterioration', ' death due to any cause (in absence of PD).', ' The Percentage of participants with PFS is reported.', ' For the analysis, participants were censored', ' on the last available tumor assessment date on study treatment if they', ' had no PFS event', ' were on anticancer therapy not related to study treatment', ' on the registration date if they', ' did not receive study drug', ' had no post baseline tumor assessment', ' Time frame: Up to 6 months and 12 months after treatment initiation', 'Results 1: ', ' Arm/Group Title: Docetaxel and Bevacizumab', ' Arm/Group Description: Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met', ' Overall Number of Participants Analyzed: 52', ' Measure Type: Number', ' Unit of Measure: percentage of participants PFS rate at 6 months: 59.6 (45.1 to 73.0)', ' PFS rate at 12 months: 30.8 (18.7 to 45.1)', 'Results 2: ', ' Arm/Group Title: Docetaxel, Bevacizumab and Trastuzumab', ' Arm/Group Description: Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: percentage of participants PFS rate at 6 months: 90.5 (69.6 to 98.8)', ' PFS rate at 12 months: 81.0 (58.1 to 94.6)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 14/52 (26.92%)', ' Febrile neutropenia * 1/52 (1.92%)', ' Tachycardia * 1/52 (1.92%)', ' Atrial fibrillation * 0/52 (0.00%)', ' Duodenal ulcer * 1/52 (1.92%)', ' Gastric ulcer * 1/52 (1.92%)', ' Nausea * 1/52 (1.92%)', ' Abdominal pain * 0/52 (0.00%)', ' Asthenia * 1/52 (1.92%)', ' Disease progression * 1/52 (1.92%)', ' Mucosal inflammation * 1/52 (1.92%)', ' Appendicitis * 1/52 (1.92%)', 'Adverse Events 2:', ' Total: 4/20 (20.00%)', ' Febrile neutropenia * 0/20 (0.00%)', ' Tachycardia * 0/20 (0.00%)', ' Atrial fibrillation * 1/20 (5.00%)', ' Duodenal ulcer * 0/20 (0.00%)', ' Gastric ulcer * 0/20 (0.00%)', ' Nausea * 0/20 (0.00%)', ' Abdominal pain * 1/20 (5.00%)', ' Asthenia * 0/20 (0.00%)', ' Disease progression * 0/20 (0.00%)', ' Mucosal inflammation * 0/20 (0.00%)', ' Appendicitis * 0/20 (0.00%)']}

46906361-5133-4db9-b9e5-b9b7f80a8666

Single

Eligibility

NCT00121992

In order to be eligible for the primary trial, patients must not have prior radiation, anthracycline or systemic anticancer therapy , and must have T1-3, N0 and M0 breast cancer.

Entailment

{'Clinical Trial ID': 'NCT00121992', 'Intervention': ['INTERVENTION 1: ', ' Arm A: FAC', ' FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv', ' 5-fluorouracil', ' Doxorubicin', 'Cyclophosphamide', 'INTERVENTION 2: ', ' Arm B: TAC', ' TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv', ' Docetaxel', ' Doxorubicin', 'Cyclophosphamide'], 'Eligibility': ['Inclusion Criteria:', ' Written informed consent', ' Operable breast cancer patients (T1-T3) with negative axillary lymph nodes (10 axillary nodes dissection) and high risk criteria according to St. Gallen consensus criteria.', ' Histologically proven breast cancer. Interval between surgery and registration is less than 60 days.', ' Definitive surgical treatment must be either mastectomy, or breast conservative surgery. Margins of resected specimen from surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ is not considered as positive margin.', ' Patients without proven metastatic disease.', ' Estrogen and progesterone receptors performed on the primary tumour prior to randomization.', ' Age between 18 years and 70 years.', ' Karnofsky performance status index > 80 %.', ' Adequate hepatic, renal and heart functions.', ' Adequate hematology levels.', ' Negative pregnancy test', 'Exclusion Criteria:', ' Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).', ' Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.', ' Prior radiation therapy for breast cancer.', ' Bilateral invasive breast cancer.', ' Pregnant, or lactating patients.', ' Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment .', ' Any T4 or N1-3 or M1 breast cancer.', ' Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI criteria.', ' Other serious illness or medical condition', ' Past or current history of neoplasm other than breast carcinoma.', ' Ipsilateral ductal carcinoma in-situ (DCIS) of the breast.', ' Lobular carcinoma in-situ (LCIS) of the breast.', ' Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose', ' Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry.', ' Definite contraindications for the use of corticosteroids.', ' Concurrent treatment with other experimental drugs.', ' Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.', ' Concurrent treatment with any other anti-cancer therapy.', 'Male patients.'], 'Results': ['Outcome Measurement: ', ' Disease-free Survival (DFS) Events', ' DFS is calculated from the date of randomization until the first date of recurrence local, regional or distant, second primary tumor or death.', ' Time frame: 10 years', 'Results 1: ', ' Arm/Group Title: Arm A: FAC', ' Arm/Group Description: FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv', ' 5-fluorouracil', ' Doxorubicin', ' Cyclophosphamide', ' Overall Number of Participants Analyzed: 521', ' Measure Type: Number', ' Unit of Measure: events 127', 'Results 2: ', ' Arm/Group Title: Arm B: TAC', ' Arm/Group Description: TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv', ' Docetaxel', ' Doxorubicin', ' Cyclophosphamide', ' Overall Number of Participants Analyzed: 539', ' Measure Type: Number', ' Unit of Measure: events 112'], 'Adverse Events': ['Adverse Events 1:', ' Total: 21/519 (4.05%)', ' Anaemia 1/519 (0.19%)', ' Blood bilirubin 0/519 (0.00%)', ' Leukopenia 0/519 (0.00%)', ' Neutropenia 1/519 (0.19%)', ' Arrhythmia 0/519 (0.00%)', ' Carotid artery thrombosis 1/519 (0.19%)', ' Ear infection 0/519 (0.00%)', ' Conjunctivitis 0/519 (0.00%)', ' Abdominal pain 1/519 (0.19%)', ' Anal fissure 0/519 (0.00%)', ' Constipation 0/519 (0.00%)', ' Diarrhoea 1/519 (0.19%)', 'Adverse Events 2:', ' Total: 119/532 (22.37%)', ' Anaemia 1/532 (0.19%)', ' Blood bilirubin 1/532 (0.19%)', ' Leukopenia 1/532 (0.19%)', ' Neutropenia 5/532 (0.94%)', ' Arrhythmia 1/532 (0.19%)', ' Carotid artery thrombosis 0/532 (0.00%)', ' Ear infection 1/532 (0.19%)', ' Conjunctivitis 1/532 (0.19%)', ' Abdominal pain 1/532 (0.19%)', ' Anal fissure 1/532 (0.19%)', ' Constipation 1/532 (0.19%)', ' Diarrhoea 6/532 (1.13%)']}

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

ab17f223-3f70-4b63-bfc5-1fca5d6ec05d

Single

Eligibility

NCT01094184

A patient who had a Joint injection in the last month would not be eligible for the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT01094184', 'Intervention': ['INTERVENTION 1: ', ' Bevacizumab 10 mg/kg Q2W', ' Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.', 'INTERVENTION 2: ', ' Bevacizumab 15 mg/kg Q3W', ' Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed triple-negative (estrogen, progesterone, and HER-2 receptor negative) adenocarcinoma of the breast in pre- or post-menopausal women with measurable or non-measurable metastatic disease', " Participant who in the Investigator's opinion requires combination therapy for their disease", ' Life expectancy of greater than or equal to (>/=)12 weeks', 'Exclusion Criteria:', ' Previous chemotherapy for metastatic breast cancer', ' Participants currently undergoing radiation therapy for the treatment of metastatic disease (apart from the relief of metastatic bone pain)', ' Major surgery or significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment'], 'Results': ['Outcome Measurement: ', ' Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2', " FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.", ' Time frame: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)', 'Results 1: ', ' Arm/Group Title: Bevacizumab 10 mg/kg Q2W', ' Arm/Group Description: Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.', ' Overall Number of Participants Analyzed: 31', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 31 participants', ' 98.3 (21.342)', ' Change at Cycle 2: 25 participants', ' 5.83 (17.027)', 'Results 2: ', ' Arm/Group Title: Bevacizumab 15 mg/kg Q3W', ' Arm/Group Description: Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.', ' Overall Number of Participants Analyzed: 12', ' Mean (Standard Deviation)', ' Unit of Measure: units on a scale Baseline: 12 participants', ' 102.21 (21.036)', ' Change at Cycle 2: 6 participants', ' -2.48 (14.697)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 15/36 (41.67%)', ' Neutropenia * 0/36 (0.00%)', ' Diarrhoea * 1/36 (2.78%)', ' Small intestinal perforation * 0/36 (0.00%)', ' Catheter site dermatitis * 0/36 (0.00%)', ' Disease progression * 1/36 (2.78%)', ' Fatigue * 1/36 (2.78%)', ' Pain * 1/36 (2.78%)', ' Pyrexia * 1/36 (2.78%)', ' Hypersensitivity * 1/36 (2.78%)', ' Device related infection * 1/36 (2.78%)', ' Gastroenteritis * 0/36 (0.00%)', 'Adverse Events 2:', ' Total: 7/13 (53.85%)', ' Neutropenia * 2/13 (15.38%)', ' Diarrhoea * 0/13 (0.00%)', ' Small intestinal perforation * 1/13 (7.69%)', ' Catheter site dermatitis * 1/13 (7.69%)', ' Disease progression * 0/13 (0.00%)', ' Fatigue * 0/13 (0.00%)', ' Pain * 0/13 (0.00%)', ' Pyrexia * 0/13 (0.00%)', ' Hypersensitivity * 0/13 (0.00%)', ' Device related infection * 0/13 (0.00%)', ' Gastroenteritis * 1/13 (7.69%)']}

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

3320983d-55cb-49f9-9265-ca4e77acf62a

Single

Adverse Events

NCT01250379

None of the patients in the primary trial had Thrombocytopenia, congestive Cardiac failure, Pancytopenia, Acute coronary syndrome or Atrial fibrillation.

Entailment

{'Clinical Trial ID': 'NCT01250379', 'Intervention': ['INTERVENTION 1: ', ' CT Arm', " Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.", 'INTERVENTION 2: ', ' CT+BV Arm', " Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study."], 'Eligibility': ['Inclusion Criteria:', ' Female patients, >/= 18 years of age', ' Histologically confirmed HER2-negative breast cancer', ' Disease progression during or following first-line treatment with Avastin and chemotherapy for locally recurrent or metastatic breast cancer', ' Avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy', ' ECOG performance status 0-2', ' At least 28 days since prior radiation therapy or surgery and recovery from treatment', 'Exclusion Criteria:', ' Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin for first-line treatment', ' Active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years', ' Inadequate renal function', ' Clinically relevant cardio-vascular disease', ' Known CNS disease except for treated brain metastases', ' Chronic daily treatment with high-dose aspirin (>325 mg/day) or clopidogrel (>75 mg/day)', ' Pregnant or lactating women'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)', ' Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.', ' Time frame: Baseline (less than or equal to [ ] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years', 'Results 1: ', ' Arm/Group Title: CT Arm', " Arm/Group Description: Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.", ' Overall Number of Participants Analyzed: 247', ' Measure Type: Number', ' Unit of Measure: percentage of participants 88.7', 'Results 2: ', ' Arm/Group Title: CT+BV Arm', " Arm/Group Description: Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.", ' Overall Number of Participants Analyzed: 247', ' Measure Type: Number', ' Unit of Measure: percentage of participants 93.9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 55/238 (23.11%)', ' Febrile neutropenia * 5/238 (2.10%)', ' Neutropenia * 6/238 (2.52%)', ' Leukopenia * 1/238 (0.42%)', ' Thrombocytopenia * 0/238 (0.00%)', ' Anaemia * 1/238 (0.42%)', ' Pancytopenia * 0/238 (0.00%)', ' Cardiac failure * 1/238 (0.42%)', ' Acute coronary syndrome * 0/238 (0.00%)', ' Atrial fibrillation * 0/238 (0.00%)', ' Cardiac failure congestive * 0/238 (0.00%)', 'Adverse Events 2:', ' Total: 89/245 (36.33%)', ' Febrile neutropenia * 12/245 (4.90%)', ' Neutropenia * 10/245 (4.08%)', ' Leukopenia * 2/245 (0.82%)', ' Thrombocytopenia * 5/245 (2.04%)', ' Anaemia * 1/245 (0.41%)', ' Pancytopenia * 1/245 (0.41%)', ' Cardiac failure * 2/245 (0.82%)', ' Acute coronary syndrome * 1/245 (0.41%)', ' Atrial fibrillation * 1/245 (0.41%)', ' Cardiac failure congestive * 2/245 (0.82%)']}

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

6c57e451-a706-4b32-ae71-254e9d0e04de

Single

Intervention

NCT00383500

the primary trial is not testing a drug based intervention, it is testing a Medical device called the Flexitouch.

Entailment

{'Clinical Trial ID': 'NCT00383500', 'Intervention': ['INTERVENTION 1: ', ' Flexitouch Device', ' Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)', 'INTERVENTION 2: ', ' Manual Lymphatic Drainage (MLD)', ' Lymphedema management via self-administered manual lymphatic drainage therapy'], 'Eligibility': ['Inclusion Criteria:', ' Unilateral breast cancer', ' Scheduled to undergo breast surgery and axillary lymph node dissection, with or without breast conserving techniques.', ' Referred to the surgeons of the Stanford University Breast Cancer Program', ' Capacity to provide informed consent.', ' All experimental protocols will be reviewed and approved by the Stanford Institutional Review Board for the Protection of Human Subjects.', 'Exclusion Criteria:', " Other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate.", ' Recurrent breast cancer or other forms of pre-existing lymphedema.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy', ' Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups', ' Time frame: 36 months', 'Results 1: ', ' Arm/Group Title: Flexitouch Device', ' Arm/Group Description: Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)', ' Overall Number of Participants Analyzed: 19', ' Measure Type: Number', ' Unit of Measure: participants 19', 'Results 2: ', ' Arm/Group Title: Manual Lymphatic Drainage (MLD)', ' Arm/Group Description: Lymphedema management via self-administered manual lymphatic drainage therapy', ' Overall Number of Participants Analyzed: 21', ' Measure Type: Number', ' Unit of Measure: participants 21'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/19 (0.00%)', 'Adverse Events 2:', ' Total: ']}

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

73a5f715-6d4c-43f3-ace4-9f1217d3d0c4

Comparison

Adverse Events

NCT00006110

NCT00464646

the secondary trial records only gastrointestinal adverse events, whereas the primary trial doesn’t record any GI adverse events.

Contradiction

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

{'Clinical Trial ID': 'NCT00464646', 'Intervention': ['INTERVENTION 1: ', ' Cohort A', ' Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)', 'INTERVENTION 2: ', ' Cohort B', ' Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer'], 'Eligibility': ['Inclusion Criteria:', ' Conditions for eligibility for patients with LABC (Cohort A):', ' The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.', ' Patients must have clinical Stage IIIA, IIIB, or IIIC disease with a mass in the breast or axilla that is greater than or equal to 2.0 cm measured by clinical exam, unless the patient has inflammatory breast carcinoma, in which case measurable disease is not required.', ' Conditions for eligibility for patients with resected Stage III breast cancer (Cohort B)', ' Patients must have undergone either a total mastectomy or a lumpectomy.', ' Patients must have completed one of the following procedures for evaluation of pathologic nodal status.', ' Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes, or', ' Axillary lymphadenectomy without SN isolation procedure.', ' The interval between the last surgery (for breast cancer treatment or staging) and study entry must be no more than 84 days.', ' By pathologic evaluation, ipsilateral nodes must be pN2 or pN3.', ' For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for LCIS are eligible without additional resection.)', ' For patients who undergo mastectomy, margins must be free of gross residual tumor. Patients with microscopic positive margins are eligible.', ' Conditions for patient eligibility (ALL patients)', ' The patient must have consented to participate and must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.', ' Patients must be female.', ' The patient must be greater than or equal to 18 years old.', " The patient's ECOG performance status must be 0 or 1.", ' The tumor must be invasive adenocarcinoma of the breast on histologic examination.', ' The breast cancer must be determined to be HER2-positive prior to study entry. Assays performed using FISH require gene amplification. Assays using IHC require a strongly positive (3+) staining score.', ' At the time of study entry, blood counts must meet the following criteria:', ' Absolute neutrophil count (ANC) must be greater than/equal to 1200/mm3.', ' Platelet count must be greater than/equal to 100,000/mm3.', ' Hemoglobin must be greater than/equal to 10 g/dL.', ' The following criteria for evidence of adequate hepatic function must be met:', " total bilirubin must be less than/equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and", ' alkaline phosphatase must be less than 2.5 x ULN for the lab; and', ' AST must be less than/equal to 1.5 x ULN for the lab.', ' Alkaline phosphatase and AST may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than/equal to 2.5 x ULN, then the AST must be less than/equal to the ULN. If the AST is greater than the ULN but less than/equal to 1.5 x ULN, then the alkaline phosphatase must be less than/equal to ULN.', ' Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (CT, MRI, or PET scan) does not demonstrate metastatic disease, and has adequate hepatic function.', ' Patients with either skeletal pain or alkaline phosphatase that is greater than ULN but less than/equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan or PET scan does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are confirmed as benign by x-ray, MRI, or biopsy.', ' Serum creatinine less than/equal to ULN for the lab.', ' Urine protein/creatinine (UPC) ratio must be less than 1.0.', " All patients must have their LVEF assessed by 2-D echocardiogram within 3 months prior to study entry. (MUGA scan may be substituted for 2-D echocardiogram based on institutional preferences.) The LVEF must be greater than/equal to 55% regardless of the institution's LLN.", " Note: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments to determine if trastuzumab and bevacizumab therapy can be administered, it is critical that this baseline study be an accurate assessment of the patient's LVEF. If the baseline LVEF is greater than 65%, the investigator is encouraged to have the accuracy of the initial LVEF result confirmed and to consider repeating the study if the accuracy is uncertain.", 'Exclusion Criteria:', ' Conditions for patient ineligibility (Cohort A)', ' FNA alone to diagnose the primary tumor.', ' Surgical axillary staging procedure prior to study entry. (Procedures that are permitted include: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy SN biopsy for patients with clinically negative axillary nodes.', ' Condition for patient ineligibility (Cohort B)', ' Breast reconstruction using tissue expanders or implants at the time of mastectomy.', ' Conditions for patient ineligibility (ALL patients)', ' Definitive clinical or radiologic evidence of metastatic disease.', ' Synchronous bilateral invasive breast cancer.', ' History of ipsilateral or contralateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with RT.', ' History of non-breast malignancies within the 5 years prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the previous 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.', ' Prior therapy with anthracyclines, taxanes, trastuzumab, or bevacizumab for any malignancy.', ' Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.', ' Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other SERM. (Patients are eligible if these medications are discontinued prior to study entry.)', ' Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. These patients are eligible if this therapy is discontinued prior to study entry. (Women of reproductive potential must agree to use an effective non-hormonal method of contraception during study therapy and for at least 6 months after completion of targeted therapy.)', ' Cardiac disease that would preclude the use of the drugs included in the FB-5 treatment regimen. This includes but is not confined to:', ' Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions controlled by medication; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; and clinically significant valvular disease.', ' History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; documented CHF; or documented cardiomyopathy.', ' Uncontrolled hypertension defined as systolic BP greater than 150 mmHg or diastolic BP greater han 90 mmHg, with or without anti-hypertensive medication. Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.', ' History of hypertensive crisis or hypertensive encephalopathy.', ' History of TIA or CVA.', ' History of other arterial thrombotic event within 12 months before study entry.', ' Symptomatic peripheral vascular disease.', ' Any significant bleeding within 6 months before study entry, exclusive of menorrhagia in premenopausal women.', ' Serious or non-healing wound, skin ulcers, or bone fracture.', ' Gastroduodenal ulcer(s) determined by endoscopy to be active.', ' History of GI perforation, abdominal fistulae, or intra-abdominal abscess.', ' Anticipation of need for major surgical procedures (other than the breast surgery required for patients in Cohort A) during study therapy and for at least 3 months following completion of bevacizumab.', ' Known bleeding diathesis, coagulopathy, or requirement for therapeutic doses of coumadin.', ' Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.', " Sensory/motor neuropathy greater than/equal to grade 2, as defined by the NCI's CTCAE v3.0.", ' Conditions that would prohibit administration of corticosteroids.', ' History of hypersensitivity reaction to drugs formulated with polysorbate 80.', ' Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing should be performed according to institutional standards for women of child-bearing potential.)', ' Use of any investigational agent within 4 weeks prior to enrollment in the study.', ' Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.'], 'Results': ['Outcome Measurement: ', ' Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A)', ' The determination of pCR is performed by the local pathologist following examination of tissue (breast and nodes)removed at the time of surgery. The outcome measure is the number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or SNs identified after neoadjuvant chemotherapy.', ' Time frame: Assessed at time of surgery on average at 8 months', 'Results 1: ', ' Arm/Group Title: Cohort A', ' Arm/Group Description: Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)', ' Overall Number of Participants Analyzed: 73', ' Measure Type: Number', ' Unit of Measure: participants 34', 'Results 2: ', ' Arm/Group Title: Cohort B', ' Arm/Group Description: Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer', ' Overall Number of Participants Analyzed: 0', ' Measure Type: Number', ' Unit of Measure: participants '], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/76 (21.05%)', ' Hemoglobin 0/76 (0.00%)', ' Left ventricular systolic function 1/76 (1.32%)', ' Hypertension 0/76 (0.00%)', ' Dehydration 1/76 (1.32%)', ' Diarrhea 1/76 (1.32%)', ' Hemorrhage, GI - stomach 0/76 (0.00%)', ' Perforation, GI - colon 1/76 (1.32%)', ' Ulcer, GI - stomach 0/76 (0.00%)', ' Pain- head/headache 3/76 (3.95%)', ' Pain- back 2/76 (2.63%)', 'Adverse Events 2:', ' Total: 5/29 (17.24%)', ' Hemoglobin 1/29 (3.45%)', ' Left ventricular systolic function 0/29 (0.00%)', ' Hypertension 1/29 (3.45%)', ' Dehydration 1/29 (3.45%)', ' Diarrhea 0/29 (0.00%)', ' Hemorrhage, GI - stomach 1/29 (3.45%)', ' Perforation, GI - colon 0/29 (0.00%)', ' Ulcer, GI - stomach 1/29 (3.45%)', ' Pain- head/headache 0/29 (0.00%)', ' Pain- back 0/29 (0.00%)']}

83883edd-ea16-4b20-8a97-2a545f957add

Single

Eligibility

NCT00895414

Orange juice is banned for patients undertaking the primary trial.

Contradiction

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

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

ad0628ef-be51-4d54-a5c6-7608df258629

Single

Adverse Events

NCT00203502

Less than 30% of patients in the primary trial experienced at least 1 adverse event.

Contradiction

{'Clinical Trial ID': 'NCT00203502', 'Intervention': ['INTERVENTION 1: ', ' Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin', ' Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2', ' + Avastin 15 mg/kg', ' Q 3 weeks X 4 cycles', ' Bevacizumab/Avastin: IV 15mg/kg 21 days', ' Cyclophosphamide: 500mg per meter squared, IV every 21 days', ' Doxorubicin: 60 mg per meter squared, IV every 21 days'], 'Eligibility': ['Inclusion Criteria:', ' The diagnosis of breast cancer established by biopsy.', ' Normal kidney function', ' Normal LVEF evaluated by MUGA Scan', ' >18 years of age', ' Good performance status defined by ECOG scale of 0 or 1', ' Consent', ' Women of childbearing potential must have a negative pregnancy test.', ' Use of effective means of contraception in subjects of child-bearing potential while on treatment and for at least 3 months thereafter.', ' Peripheral Neuropathy: must be < grade 1', ' Hematologic (minimal values)', ' Absolute neutrophil count >1,500/mm3', ' Hemoglobin >8.0 g/dl', ' Platelet count >100,000/mm3', ' Hepatic', ' Total bilirubin <ULN', ' AST, ALT, Alkaline Phosphatase must be within range', 'Exclusion Criteria:', ' Patients with locally advanced breast cancer with skin ulcerations', ' Stage IV breast cancer', ' Inflammatory breast cancer', ' Allergy to any component of the treatment regimen', ' Women who are breast feeding', ' Pregnancy or refusal to use effective contraception', ' Inability to comply with study and/or follow-up procedures.', ' Current, recent, or planned participation in a experimental drug study', ' Blood pressure of >150/100 mmHg. Essential hypertension well controlled with anti hypertensives is not an exclusion criterion.', ' unstable angina', ' New York Heart Association Grade II or greater congestive heart failure', ' history of myocardial infarction within 6 months', ' history of stroke within 6 months', ' Clinical significant peripheral vascular disease', ' Evidence of bleeding diathesis or coagulopathy', ' Presence of central nervous system or brain metastasis', ' major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0', ' Minor surgical procedure such as fine needle aspirations or core biopsy within 7 days prior to day 0', ' Pregnant or lactating', ' Urine protein: creatinine ratio >1.0 at screening', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0', ' Serious, non-healing wound, ulcer, or bone fracture'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Pathological Complete Response.', ' Pathological complete response was defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the resected breast.', ' Time frame: Participants were assessed during surgery, an average of one hour', 'Results 1: ', ' Arm/Group Title: Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin', ' Arm/Group Description: Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2', ' + Avastin 15 mg/kg', ' Q 3 weeks X 4 cycles', ' Bevacizumab/Avastin: IV 15mg/kg 21 days', ' Cyclophosphamide: 500mg per meter squared, IV every 21 days', ' Doxorubicin: 60 mg per meter squared, IV every 21 days', ' Overall Number of Participants Analyzed: 39', ' Measure Type: Number', ' Unit of Measure: percentage of evaluable patients 41 (27.7 to 55.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 39/39 (100.00%)', ' Febrile Neutropenia 1/39 (2.56%)', ' Heart failure 1/39 (2.56%)', ' Diarrhea 3/39 (7.69%)', ' Nausea/vomiting 4/39 (10.26%)', ' Mucositis 3/39 (7.69%)', ' Fatigue 4/39 (10.26%)', ' infection 3/39 (7.69%)', ' Urinary tract infection 2/39 (5.13%)', ' Musculoskeletal pain 6/39 (15.38%)', ' Syncope 1/39 (2.56%)', ' Insomnia 3/39 (7.69%)', ' Anxiety 2/39 (5.13%)']}

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

619d88fd-cef5-4f1a-83dc-3cc710c1c93d

Single

Intervention

NCT00322374

Cohort 2 of the primary trial receive a higher dose of Ixabepilone than cohort 1, but the same dose of Epirubicin.

Entailment

{'Clinical Trial ID': 'NCT00322374', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2', ' Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.', 'INTERVENTION 2: ', ' Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2', ' Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.'], 'Eligibility': ['Inclusion Criteria:', ' Women 18 years', ' Histologically or cytologically confirmed diagnosis of metastatic breast cancer', ' Measurable or nonmeasurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST)', 'Exclusion Criteria:', ' Number of prior chemotherapy lines of treatment in the metastatic setting 2'], 'Results': ['Outcome Measurement: ', ' Number of Participants With a Dose Limiting Toxicity (DLT)', ' DLT: any of the following considered related to ixabepilone, epirubicin or combination occurring in Cycle 1: Absolute neutrophil count <500 cells/mm^3 for 7 consecutive days or febrile neutropenia of any duration;Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 w/bleeding requiring platelet transfusion;Any other drug-related Gr3/4 non-hematologic toxicity except Gr3 injection site reaction, fatigue, transient arthralgia/myalgia;Delayed recovery to Gr 1 or baseline (except for alopecia) from toxicity related to treatment w/ ixabepilone + epirubicin delaying initiation of next cycle 3 wks', ' Time frame: From Baseline to the end of Cycle 1 (Day 21)', 'Results 1: ', ' Arm/Group Title: Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2', ' Arm/Group Description: Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: Participants Participants with DLT:Grade 4 (severe) neutropenia: 1', ' Total Participants with DLT: 1', ' Participants without DLT: 5', 'Results 2: ', ' Arm/Group Title: Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2', ' Arm/Group Description: Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Number', ' Unit of Measure: Participants Participants with DLT:Grade 4 (severe) neutropenia: 1', ' Total Participants with DLT: 1', ' Participants without DLT: 5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 2/6 (33.33%)', ' ANAEMIA 0/6 (0.00%)', ' NEUTROPENIA 0/6 (0.00%)', ' FEBRILE NEUTROPENIA 0/6 (0.00%)', ' FEBRILE BONE MARROW APLASIA 0/6 (0.00%)', ' NAUSEA 0/6 (0.00%)', ' VOMITING 1/6 (16.67%)', ' PYREXIA 0/6 (0.00%)', ' HYPERSENSITIVITY 1/6 (16.67%)', ' PLATELET COUNT DECREASED 0/6 (0.00%)', ' BACK PAIN 0/6 (0.00%)', ' SYNCOPE 0/6 (0.00%)', ' CEREBROVASCULAR ACCIDENT 0/6 (0.00%)', 'Adverse Events 2:', ' Total: 8/30 (26.67%)', ' ANAEMIA 1/30 (3.33%)', ' NEUTROPENIA 0/30 (0.00%)', ' FEBRILE NEUTROPENIA 1/30 (3.33%)', ' FEBRILE BONE MARROW APLASIA 2/30 (6.67%)', ' NAUSEA 2/30 (6.67%)', ' VOMITING 0/30 (0.00%)', ' PYREXIA 2/30 (6.67%)', ' HYPERSENSITIVITY 0/30 (0.00%)', ' PLATELET COUNT DECREASED 0/30 (0.00%)', ' BACK PAIN 1/30 (3.33%)', ' SYNCOPE 0/30 (0.00%)', ' CEREBROVASCULAR ACCIDENT 1/30 (3.33%)']}

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

42d6a15e-fa43-4ebc-b627-70f4dd0233f8

Comparison

Intervention

NCT02203565

NCT00194779

laboratory biomarker analysis and questionnaires are used in the secondary trial and the primary trial.

Contradiction

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

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

fc60c272-ceeb-47b5-b25b-dca832a2a57e

Comparison

Adverse Events

NCT00810797

NCT00828074

Skin infections were more common in patients in cohort 2 of the secondary trial, than in cohort 1 of the primary trial.

Contradiction

{'Clinical Trial ID': 'NCT00810797', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Exemestane)', ' Patients receive 25mg oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' exemestane: Given orally', ' laboratory biomarker analysis: One year after completion of study treatment', ' quality-of-life assessment: One year after completion of study treatment', ' immunohistochemistry staining method: Correlative studies'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed metastatic carcinoma of the breast', ' Hormone receptor (estrogen receptor [ER] and/or progesterone receptor [PR]) positive disease (defined as: ER and/or PR positivity as >= 5% staining), as confirmed by immunohistochemistry (IHC) based on primary breast tissue or metastatic tissue', ' Postmenopausal, as defined by any of the following:', ' Natural menopause, with at least 1 year since last menses', ' Chemotherapy-induced menopause with at least 1 year from last menses and serum luteinizing hormone (LH)/follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal range', ' History of surgical or radiation-induced ovarian ablation', ' For women =< 56 years old and with a history of hysterectomy but at least one ovary intact, serum LH/FSH and estradiol levels must be within the postmenopausal range', ' Postmenopausal women with disease recurrence while receiving either tamoxifen or a non-steroidal aromatase inhibitor (AI) as adjuvant therapy (as long as adjuvant hormonal therapy was taken for 6 months before disease progression) or with disease recurrence following the discontinuation/completion of adjuvant hormonal therapy', ' Postmenopausal women with disease progression following either 0, 1 or 2 prior hormonal therapies for metastatic breast cancer, as long as the subject has had no prior exposure to exemestane (EXE)', ' Measurable or non-measurable (but evaluable) disease, as defined by RECIST criteria', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0-1', ' Neutrophil count >= 1.5 X 10^9 cells/L', ' Platelet count >= 100 X 10^9 cells/L', ' Serum creatinine =< 1.5 times upper limit of normal (ULN)', ' Total serum bilirubin =< 1.5 times ULN', ' Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels =< 2.5 x ULN in patients without liver metastases or =< 5 times ULN in patients with liver metastases', ' Alkaline phosphatase =< 2.5 times the ULN for patients without bone or liver metastases', ' Subjects must have an estimated life expectancy of greater than 6 months', 'Exclusion Criteria:', ' Prior exposure to EXE, whether in the adjuvant or metastatic setting', ' Prior history of any other cancer with the exception of non-melanoma skin cancer and treated in situ carcinoma of the cervix', ' Active or symptomatic central nervous system (CNS) metastasis (stable or treated brain metastasis allowed but patients must be off decadron, if given for CNS disease)', ' Hormone-receptor negative or unknown breast cancer', ' More than two prior chemotherapy regimen for treatment of metastatic disease (any prior chemotherapy given in the adjuvant setting is permitted)', ' Administration of any other anti-cancer therapy within 2 weeks of initiating study treatment; use of bisphosphonates, however, are permitted for patients with known bone metastases', ' Treatment with any other concurrent investigational agent or anti-tumor drug (chemotherapy, antibody therapy or other biologic agents), will not be permitted', ' Subjects who have had no prior exposure to endocrine therapy', ' Any uncontrolled medical co-morbidity or psychiatric disorder which interferes with the ability to provide informed consent or comply with study procedures'], 'Results': ['Outcome Measurement: ', ' Progression-free Survival', ' Estimated using the product-limit method of Kaplan and Meier. 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: Until disease progression of death from any cause, up to 3 years', 'Results 1: ', ' Arm/Group Title: Treatment (Exemestane)', ' Arm/Group Description: Patients receive 25mg oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.', ' exemestane: Given orally', ' laboratory biomarker analysis: One year after completion of study treatment', ' quality-of-life assessment: One year after completion of study treatment', ' immunohistochemistry staining method: Correlative studies', ' Overall Number of Participants Analyzed: 36', ' Median (95% Confidence Interval)', ' Unit of Measure: months 4.3 (2.0 to 6.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/36 (11.11%)', ' Rectal hemorrhage * 1/36 (2.78%)', ' Disease progression * 1/36 (2.78%)', ' Device related infection * 1/36 (2.78%)', ' Skin infection * 1/36 (2.78%)', ' Hypotension * 1/36 (2.78%)']}

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

dfe1236f-ac29-4c1c-a287-6f46abb7703d

Single

Results

NCT02513472

Cohort 1 of the primary trial produced better Objective Response Rate results than cohort 2.

Entailment

{'Clinical Trial ID': 'NCT02513472', 'Intervention': ['INTERVENTION 1: ', ' Stratum 1: Eribulin Mesylate + Pembrolizumab', ' Participants with mTNBC who were never treated with systemic anticancer therapy in the metastatic setting received eribulin mesylate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and pembrolizumab 200 mg, intravenous infusion on Day 1 in Treatment Cycle 1 (safety run-in, Phase 1b) and then continued in each 21-days Treatment Cycles in the presence of clinical benefit until confirmed disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor in Phase 2 in the Stratum 1.', 'INTERVENTION 2: ', ' Stratum 2: Eribulin Mesylate + Pembrolizumab', ' Participants with mTNBC previously treated with 1 to 2 lines of systemic anticancer therapy in the metastatic setting received eribulin mesylate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and pembrolizumab 200 mg, intravenous infusion on Day 1 in Treatment Cycle 1 (safety run-in, Phase 1b) and then continued in each 21-days Treatment Cycles in the presence of clinical benefit until confirmed disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor in Phase 2 in the Stratum 2.'], 'Eligibility': ['Inclusion Criteria:', ' Females or males, aged >=18 years at the time of signing the informed consent form (ICF).', ' mTNBC (confirmed from most recent tissue sample) meeting the following criteria:', ' Estrogen receptor (ER) and progesterone receptor negative (a tumor is ER and/or progesterone receptor positive if at least 1 percent (%) of the cells examined have estrogen and/or progesterone receptors) and human epidermal growth factor receptor 2 (HER2) negative (defined as immunohistochemistry [IHC] less than (<) 2+ or fluorescence in situ hybridization [FISH] negative).', ' Previously treated with 0 to 2 lines of systemic anticancer therapy (cytotoxic or targeted anticancer agents) in the metastatic setting. Hormonal therapy and bone metastases treatment (example, bisphosphonates, denosumab, etc) are not considered forms of systemic anticancer therapy.', ' Presence of measurable disease meeting the following criteria:', ' At least 1 lesion of >=10 millimeter (mm) in long axis diameter for nonlymph nodes or >=15 mm in short axis diameter for lymph nodes that is serially measurable according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using computerized tomography (CT) or magnetic resonance imaging (MRI) or panoramic and close-up color photography.', ' Lesions that have had radiotherapy must show subsequent radiographic evidence of increased size to be deemed a target lesion.', ' Life expectancy of >=3 months.', ' Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.', ' Adequate renal function as evidenced by serum creatinine less than or equal to (<=) 1.5 milligram per deciliter (mg/dL) or calculated creatinine clearance >=50 millimeter per minute (mL/min) according to the Cockcroft and Gault formula.', ' Adequate bone marrow function, defined as:', ' Absolute neutrophil count (ANC) >=1.5*10^9/L.', ' Hemoglobin (Hb) >=10.0 gram per deciliter (g/dL) (can be corrected by growth factor or transfusion).', ' Platelet count >=100*10^9/L.', ' Adequate liver function, defined as:', ' Total bilirubin <=1.5*upper limit of normal (ULN).', ' Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <=3*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. ALT and AST <= 5*ULN if participant has liver metastases.', ' Resolution of all chemotherapy-related or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (<= Grade 2) and alopecia.', ' Archived tissue sample or new biopsy sample.', ' Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [B-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 International units per litre (IU/L) or equivalent units of B-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.', ' All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least 1 month before dosing).', ' Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (example, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, a combination oral contraceptive (estrogen/progesterone), or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 120 days after study drug discontinuation. If currently abstinent, the participant must agree to use a double barrier method as described above if she becomes sexually active during the study period or for 120 days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 28 days before dosing and must continue to use the same contraceptive during the study and for 120 days after study drug discontinuation.', ' Males who have had a successful vasectomy (confirmed azoospermia) or they and their female partners meet the criteria above (that is, not of childbearing potential or practicing highly effective contraception throughout the study period or for 120 days after study drug discontinuation). No sperm donation is allowed during the study period or for 120 days after study drug discontinuation.', ' Willing and able to comply with all aspects of the treatment protocol.', ' Provide written informed consent.', 'Exclusion Criteria:', ' Previous treatment with eribulin mesylate or any anti-programmed death receptor-1 (anti-PD-1), programmed death receptor ligand-1 (PD-L1), or PD-L2 agent.', ' Active autoimmune disease that has required systemic treatment in the past 2 years (that is, with use of disease modifying agents, corticosteroids, or immunosuppresive drugs). Replacement therapy (example, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment.', ' Less than 6 months since prior adjuvant chemotherapy.', ' Current enrollment in another interventional clinical study or used any investigational drug or device within the past 28 days preceding informed consent.', ' Treatment with chemotherapy or biological therapy within the previous 3 weeks, radiation or small molecule targeted therapy within the previous 2 weeks.', ' Known central nervous system (CNS) disease, except for those participants with treated brain metastasis who are stable for at least 1 month, having no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.', ' Known history of human immunodeficiency virus (HIV) positive.', ' Known active hepatitis B (example, HBsAg reactive) or hepatitis C (example, hepatitis C virus ribonucleic acid (HCV RNA) detected).', ' Existing anticancer treatment-related toxicities of Grades >= 2 (except for alopecia and Grade 2 sensory neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE v4.03).', ' Any other malignancy that required treatment or has shown evidence of recurrence (except for nonmelanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ) during the 5 years prior to enrollment in this study.', ' History of significant cardiovascular disease, defined as:', ' congestive heart failure greater than New York Heart Association (NYHA) Class II according to the NYHA Functional Classification.', ' unstable angina or myocardial infarction within 6 months of enrollment.', ' serious cardiac arrhythmia.', ' Clinically significant electrocardiogram (ECG) abnormality, including a marked Baseline prolonged QT interval/corrected QT interval ([QT/QTc], example, a repeated demonstration of a QTc interval >500 millisecond [ms]).', " History of concomitant medical conditions or infectious diseases that, in the opinion of the investigator, would compromise the participant's ability to safely complete the study.", ' Hypersensitivity to the active substance or any other excipients of the eribulin mesylate drug product, or severe hypersensitivity (>=Grade 3) to pembrolizumab and/or any of its excipients.', ' Scheduled for major surgery during the study.', ' Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the sponsor.', ' Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.', ' Has a history of interstitial lung disease.', ' Has an active infection requiring systemic therapy.', ' Has received a live-virus vaccination within 30 days of planned start of study therapy. Seasonal flu vaccines that do not contain live virus are permitted.', " The investigator's belief that the participant is medically unfit to receive eribulin mesylate and pembrolizumab or unsuitable for any other reason."], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR)', ' ORR was defined as percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using independent imaging review (IIR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% confidence interval (CI) calculated by Clopper-Pearson method. As planned, data up to the primary completion date only were analyzed.', ' Time frame: From date of first dose of study drug administration to date of first documentation of disease progression or death, whichever occurred first (up to 3 years 11 months)', 'Results 1: ', ' Arm/Group Title: Stratum 1: Eribulin Mesylate + Pembrolizumab', ' Arm/Group Description: Participants with mTNBC who were never treated with systemic anticancer therapy in the metastatic setting received eribulin mesylate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and pembrolizumab 200 mg, intravenous infusion on Day 1 in Treatment Cycle 1 (safety run-in, Phase 1b) and then continued in each 21-days Treatment Cycles in the presence of clinical benefit until confirmed disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor in Phase 2 in the Stratum 1.', ' Overall Number of Participants Analyzed: 66', ' Measure Type: Number', ' Unit of Measure: percentage of participant 25.8 (15.8 to 38.0)', 'Results 2: ', ' Arm/Group Title: Stratum 2: Eribulin Mesylate + Pembrolizumab', ' Arm/Group Description: Participants with mTNBC previously treated with 1 to 2 lines of systemic anticancer therapy in the metastatic setting received eribulin mesylate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and pembrolizumab 200 mg, intravenous infusion on Day 1 in Treatment Cycle 1 (safety run-in, Phase 1b) and then continued in each 21-days Treatment Cycles in the presence of clinical benefit until confirmed disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor in Phase 2 in the Stratum 2.', ' Overall Number of Participants Analyzed: 101', ' Measure Type: Number', ' Unit of Measure: percentage of participant 21.8 (14.2 to 31.1)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 30/66 (45.45%)', ' Anaemia 1/66 (1.52%)', ' Febrile neutropenia 1/66 (1.52%)', ' Neutropenia 2/66 (3.03%)', ' Cardiac arrest 1/66 (1.52%)', ' Pericardial effusion 0/66 (0.00%)', ' Adrenal insufficiency 1/66 (1.52%)', ' Retinal detachment 0/66 (0.00%)', ' Abdominal pain upper 1/66 (1.52%)', ' Colitis 1/66 (1.52%)', ' Constipation 0/66 (0.00%)', ' Diarrhoea 1/66 (1.52%)', ' Duodenal ulcer 0/66 (0.00%)', 'Adverse Events 2:', ' Total: 57/101 (56.44%)', ' Anaemia 1/101 (0.99%)', ' Febrile neutropenia 3/101 (2.97%)', ' Neutropenia 3/101 (2.97%)', ' Cardiac arrest 0/101 (0.00%)', ' Pericardial effusion 1/101 (0.99%)', ' Adrenal insufficiency 1/101 (0.99%)', ' Retinal detachment 1/101 (0.99%)', ' Abdominal pain upper 0/101 (0.00%)', ' Colitis 1/101 (0.99%)', ' Constipation 1/101 (0.99%)', ' Diarrhoea 0/101 (0.00%)']}

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

b1060434-0f7c-4c4a-bcff-53c3124bb51e

Single

Eligibility

NCT00627978

Women with leptomeningeal metastases are unfortunately excluded from the primary trial, as this would complicate the evaluation of neurologic and other adverse events.

Entailment

{'Clinical Trial ID': 'NCT00627978', 'Intervention': ['INTERVENTION 1: ', ' Ixabepilone', ' Participants are treated with Ixabepilone.', ' ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours', 'INTERVENTION 2: ', ' Control', ' No treatment with Ixabepilone'], 'Eligibility': ['Inclusion Criteria', ' Ability to understand and the willingness to sign a written informed consent document.', ' Histologic or cytologic diagnosis of adenocarcinoma originating in the breast.', ' Evidence that the cancer is metastatic or locally advanced and not curable by local measures (i.e., surgery, radiation).', ' NOTE: There is no limit on number of prior chemotherapy regimens received.', ' Karnofsky performance status (KPS) score of 70 - 100; (Appendix 1).', ' Life expectancy of at least 12 weeks.', ' Adequate recovery of drug related toxicities from prior systemic therapy (recovery to < = Grade 1 except for Grade 2 fatigue and alopecia).', ' Adequate recovery from recent surgery and radiation therapy. At least one week must have elapsed from the time of a minor surgery and/or focal/palliative radiation therapy; at least 3 weeks for major surgery and other radiation therapy.', ' Women or Men, age > = 18 years.', ' Patients must have normal organ and marrow function as defined below:', ' Hematologic function with absolute neutrophils 1,500/mm3 and/or platelets > 125,000/mm3', ' Hepatic function with serum bilirubin less than 1.5 times the upper institutional limits of normal, ALT 2.5 times the upper institutional limits of normal ( 5 times the upper institutional limits of normal if documented hepatic metastases are present)', ' Renal function with serum creatinine 1.5 times the upper limit of normal', ' Women of childbearing potential (WOCBP) and men with partners who are of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.', ' WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea > = 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL). Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.', ' - WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.', ' Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.', ' Exclusion Criteria', ' Patients with known and active brain and/or leptomeningeal metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.', ' CTC Grade 2 or greater neuropathy (motor or sensory) at study entry.', ' Prior treatment with ixabepilone.', ' Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy, 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.', ' Known history of HIV infection.', ' Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.', ' Patients may not be receiving any other concurrent chemotherapy, hormonal therapy, immunotherapy regimens or radiation therapy, standard or investigational.', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to ixabepilone.', ' Known prior severe hypersensitivity reactions to agents containing CremophorEL.', ' Patients may not be receiving any prohibited therapies and/or medications.', ' Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.'], 'Results': ['Outcome Measurement: ', ' Axons With Abnormal Morphology', ' Digital photographs for morphometry were captured at a magnification of 8000-16,000x and the photos were uploaded onto an imaging platform of transmission electron microscope (iTEM) (Olympus, Mu¨nster, Germany). The figures were enlarged by 50%, and an individual linear array was used to measure the axonal diameter (cross-sectional area) and the number of unmyelinated axons per Remak Schwann cell was enumerated according to the established methodology.', ' Time frame: Baseline and Over 7 cycles of treatment, approximately 21 weeks', 'Results 1: ', ' Arm/Group Title: Ixabepilone', ' Arm/Group Description: Participants are treated with Ixabepilone.', ' ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours', ' Overall Number of Participants Analyzed: 10', ' Measure Type: Number', ' Unit of Measure: percentage of axons Axons grade 0 (normal) or 1 morphology baseline: 52', ' Axons grade 0 (normal) or 1 morphology Cycle 7: 2', ' Axons grade 3 or 4 morphology baseline: 24', ' Axons grade 3 or 4 morphology Cycle 7: 79', 'Results 2: ', ' Arm/Group Title: Control', ' Arm/Group Description: No treatment with Ixabepilone', ' Overall Number of Participants Analyzed: 5', ' Measure Type: Number', ' Unit of Measure: percentage of axons Axons grade 0 (normal) or 1 morphology baseline: 82', ' Axons grade 0 (normal) or 1 morphology Cycle 7: NA [1]', ' Axons grade 3 or 4 morphology baseline: 15.5', ' Axons grade 3 or 4 morphology Cycle 7: NA [1]'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/0', 'Adverse Events 2:', ' Total: 0/0']}

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

e2862bbf-562f-4c96-abf1-fc9f07655b46

Single

Results

NCT00240071

At least one participant of the primary trial died in under a 100 days.

Contradiction

{'Clinical Trial ID': 'NCT00240071', 'Intervention': ['INTERVENTION 1: ', ' Avastin (Bevacizumab) Plus Hormone', ' All patients received Avastin (Bevacizumab) 15 mg/kg IV every three weeks as well as continuing with hormonal therapy they previously were taking.'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have cytologically or histologically proven breast cancer which is estrogen receptor or progesterone receptor positive and is locally advanced and /or metastatic.', ' Give 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, without prejudice (Appendix E).', ' Be female and greater than or equal to 19 years of age (age limit required by the State of Alabama). Women of childbearing potential must have a negative pregnancy test and must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.', ' Be ambulatory (outpatient) and have an Eastern Cooperative Oncology Group (ECOG) PS <2 (Appendix B).', 'Previous treatment: Patients must have responded to first or second line hormonal therapy (Partial and complete response greater than 6 months using RECIST criteria. Patients with stable disease for more than 6 months will be eligible) and became resistant to the hormonal agent. They must remain on the current hormone therapy to which they initially responded but now are resistant.', ' Clear documentation of acquired hormonal resistance.', ' Evaluable disease will be considered eligible, but measurable disease according to RECIST criteria will be preferable (Appendix C). The target lesion(s) must not have been previously irradiated (newly arising lesions in previously irradiated areas are acceptable).', ' Patients must have adequate organ and marrow function as defined as follows: absolute neutrophil count > 1,500/mm3, hemoglobin > 8.0 g/dl, platelets > 75,000/mm3, total bilirubin < 2 mg/dl, serum creatinine < 2 mg/dl, transaminases (AST, ALT) may be up to 2.5 x institutional upper limit of normal for patients with no liver metastases and up to 5 x institutional upper normal limit for patients with documented liver metastases. In addition < 1 gr of protein in 24 hr urine collection and urine protein/creatinine ratio < 1.0', ' Prior chemotherapy does not exclude patients from study as long as the current therapy was hormonal therapy alone.', ' Patients with de novo hormone therapy resistance will not be eligible.', ' No life threatening parenchymal disease or rapidly progressing disease warranting cytotoxic chemotherapy.', ' No history of brain metastases.', ' No history of thrombosis during the previous year, including transient ischemic attack.', ' Hypertension must be controlled (< 150/100 mmHg).', ' Ejection Fraction > 50%.', 'Exclusion Criteria:', ' Patients who are "de novo" resistant to hormone therapy.', ' Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than this Genentech-sponsored bevacizumab cancer study.', ' Blood pressure of >150/100 mmHg', ' Unstable angina', ' New York Heart Association (NYHA) Grade II or greater congestive heart failure', ' History of myocardial infarction within 6 months', ' History of stroke within 6 months', ' Clinically significant peripheral vascular disease', ' History of a bleeding disorder', ' Presence of central nervous system or brain metastases', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study', ' Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0', ' Pregnant (positive pregnancy test) or lactating', ' Urine protein: creatinine ratio greater than or equal to 1.0 at screening. Patients demonstrating > 1 gr of protein in 24 hr urine collection within 4 weeks prior to study entry will not participate in the trial.', ' History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0', ' Serious, non-healing wound, ulcer, or bone fracture', ' Unwilling or unable to comply with the protocol for the duration of the study.', ' Psychiatric illness/social situations that would limit compliance with study requirements.', ' Previously radiated area(s) must not be the only site of disease.', ' History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS)', ' Progression free survival is defined as time from date of registration until the date of first documented disease progression or date of death from any cause, whichever occurs first.', ' Time frame: From date of registration until disease progression or death, whichever occurs first', 'Results 1: ', ' Arm/Group Title: Avastin (Bevacizumab) Plus Hormone', ' Arm/Group Description: All patients received Avastin (Bevacizumab) 15 mg/kg IV every three weeks as well as continuing with hormonal therapy they previously were taking.', ' Overall Number of Participants Analyzed: 30', ' Median (95% Confidence Interval)', ' Unit of Measure: days 125.5 (90 to 256)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/30 (23.33%)', ' Grade III diarrhea *1/30 (3.33%)', ' Grade III fatigue *2/30 (6.67%)', ' Grade III syncope *2/30 (6.67%)', ' Hyperkalemia *1/30 (3.33%)', ' Knee and foot pain *1/30 (3.33%)', ' Grade III neuropathy *1/30 (3.33%)', ' Grade III dyspnea on exertion *2/30 (6.67%)', ' Grade III leg ulcer 1/30 (3.33%)', ' Grade III hypertension 4/30 (13.33%)']}

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

aed75656-1594-4d99-be42-7097f7926c18

Single

Adverse Events

NCT01961544

the primary trial reported a combined total of 3 cases of Pericardial effusion, Asthenia and Gastritis in cohort 1.

Contradiction

{'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%)']}

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

6ce5a9d7-5793-43b0-92ed-980cca3be02b

Single

Eligibility

NCT00217399

To be included in the primary trial, patients must have at least 1 unidimensionally measurable lesion, there are no size boundaries for eligibility.

Contradiction

{'Clinical Trial ID': 'NCT00217399', 'Intervention': ['INTERVENTION 1: ', ' Sorafenib and Anastrozole', ' All patients receive sorafenib and anastrozole.'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed breast cancer', ' Metastatic disease', ' Measurable disease, defined as >=1 unidimensionally measurable lesion, including >= 1 of the following:', ' Lesion >= 10 mm on CT scan (5 mm sections)', ' Lesion >= 20 mm on CT scan or MRI (10 mm sections)', ' Bone disease that is >= 10 mm on MRI', ' Lytic bone lesions that are >= 10 mm on CT scan (with 5 mm sections) OR >= 20 mm on plain film or CT scan (with 10 mm sections)', ' Lesion >= 10 mm on physical exam', ' Patients must have received >= 1 prior aromatase inhibitor in either the adjuvant or metastatic setting and must have had either disease recurrence or disease progression on a prior aromatase inhibitor therapy', ' No brain metastases diagnosed within the past 6 months OR previously untreated brain metastases', ' Estrogen receptor-positive and/or progesterone receptor-positive, defined as > 1% staining by immunohistochemistry or > 10 fmol/mg of protein by radio-ligand dextran-coated steroid binding assay', ' Postmenopausal, as defined by 1 of the following:', ' Prior bilateral oophorectomy', ' No menses for >= 12 months in patients with an intact uterus', ' Follicle-stimulating hormone (FSH) in postmenopausal range in patients < 60 years of age who have had a prior hysterectomy or have been amenorrheic for >= 3 months', ' Age >= 60 years', ' Pre- or perimenopausal patients receiving monthly injections of goserelin at a dose of 3.6 mg are eligible', ' ECOG 0-2', ' More than 3 months', ' Absolute neutrophil count >= 1,500/mm3 Platelet count >= 100,000/mm3 No bleeding diathesis', ' Bilirubin =< 1.5 times upper limit of normal (ULN AST and ALT =< 2.5 times ULN', ' Systolic blood pressure (BP) < 150 mm Hg and diastolic BP < 100 mm Hg on at least one reading prior to study entry No uncontrolled hypertension', ' None of the following within the past 6 months:', ' Symptomatic congestive heart failure', ' Unstable angina pectoris', ' Myocardial infarction', ' Cardiac arrhythmia with hemodynamic compromise', ' Not pregnant or nursing', ' Able to swallow oral medication', ' No known HIV positivity', ' No ongoing or active infection', ' No psychiatric illness or social situation that would preclude study compliance', ' No other active invasive malignancy within the past 5 years except nonmelanoma skin cancer or treated carcinoma in situ of the cervix', ' No other uncontrolled illness', ' More than 4 weeks since prior chemotherapy', ' No more than 2 prior chemotherapy regimens for metastatic disease', ' At least 8 weeks since prior anastrozole therapy', ' Concurrent steroids allowed if dose is stable', ' More than 4 weeks since prior radiotherapy', ' More than 4 weeks since prior major surgery', ' Recovered from prior therapy', ' No prior sorafenib', ' No concurrent therapeutic anticoagulation', ' Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for venous or arterial access devices allowed provided PT and PTT are =< 1.5 times ULN', ' No concurrent agents that may interact with sorafenib, including any of the following:', " Hypericum perforatum (St. John's wort)", ' Rifampin', ' P450 CYP3A4 enzyme-inducing anticonvulsants (e.g., phenytoin, carbamazepine, or phenobarbital)', ' No other concurrent investigational agents', 'Exclusion Criteria:', ' estrogen receptor status unknown', ' history of myocardial infarction within 6 months', ' performance status 3', ' performance status 4', ' premenopausal', ' progesterone receptor status unknown', 'HIV positive'], 'Results': ['Outcome Measurement: ', ' Complete Response + Partial Response + Stable Disease > 24 Weeks', ' Clinical Outcome measured using Response Evaluation Criteria In Solid Tumors (RECIST,)V1.0, 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; Stable Disease (SD), a tumor that is neither growing nor shrinking.', ' A patient has clinical benefit from treatment if CR + PR + SD > 24 weeks.', ' Time frame: 24 weeks', 'Results 1: ', ' Arm/Group Title: Sorafenib and Anastrozole', ' Arm/Group Description: All patients receive sorafenib and anastrozole.', ' Overall Number of Participants Analyzed: 35', ' Measure Type: Number', ' Unit of Measure: participants 35'], 'Adverse Events': ['Adverse Events 1:', ' Total: 12/35 (34.29%)', ' hand-foot syndome * 12/35 (34.29%)']}

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

b2a4f905-c6b5-4977-95de-5aa6424a5bb6

Single

Adverse Events

NCT00591851

There were 4 different Gastrointestinal adverse events recorded in cohort 1 of the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00591851', 'Intervention': ['INTERVENTION 1: ', ' AC Followed by Paclitaxel + Trastuzumab', ' Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.'], 'Eligibility': ['Inclusion Criteria:', ' adenocarcinoma breast cancer', ' ECOG performance status of 0 or 1', ' peripheral neuropathy less than or equal to 1', ' discontinued hormonal therapy as a chemoprevention while onstudy', ' LVEF by MUGA > 55%?', ' Absolute neutrophil count (ANC)> 1000/µL)', ' platelet count > 100,000/µL)', ' SGOT OR SGPT < 92.5 units/L', 'Exclusion Criteria:', ' Stage IV breast cancer', ' any chemotherapy, radiation therapy, immunotherapy, or biotherapy for a CURRENT breast cancer', ' pregnant or lactating patients', ' active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer', ' previous allergy/hypersensitivity to Doxorubicin, Cyclophosphamide, Paclitaxel, or other drugs formulated in Cremophor EL?', ' unstable angina, congestive heart failure, current use of digitalis, beta-blockers, or calcium blockers for therapy of congestive heart failure, arrhythmia requiring medical therapy, or a history of a myocardial infarction within 12 months', ' psychiatric illness that prevents her from understanding the nature of this study and complying with protocol requirements?', ' active, unresolved infections', ' sensitivity to E. coli derived proteins', ' prior chemotherapy with an anthracycline', ' prior Herceptin therapy'], 'Results': ['Outcome Measurement: ', ' Cardiac Saftey', ' LVEF by Muga scan', ' Time frame: Baseline-18 months', 'Results 1: ', ' Arm/Group Title: AC Followed by Paclitaxel + Trastuzumab', ' Arm/Group Description: Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.', ' Overall Number of Participants Analyzed: 70', ' Median (Full Range)', ' Unit of Measure: percentage of LVEF LVEF at Baseline: 68 (55 to 81)', ' LVEF at Month 2: 67 (58 to 79)', ' LVEF at Month 6 (67/70 pts): 66 (52 to 75)', ' LVEF at Month 9 (68/70 pts): 65 (50 to 75)', ' LVEF at Month 18 (48/70 pts): 66 (57 to 75)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 19/70 (27.14%)', ' Febrile Neutropenia 24/70 (5.71%)', ' Pericarditis 21/70 (1.43%)', ' Sinus bradycardia 21/70 (1.43%)', ' Abdominal Pain 2/70 (2.86%)', ' Diarrhea 21/70 (1.43%)', ' Lower gastrointestinal hemorrhage 21/70 (1.43%)', ' Nausea 21/70 (1.43%)', ' Non Cardiac-Chest pain 22/70 (2.86%)', ' Fever 24/70 (5.71%)', ' Skin infection 41/70 (1.43%)', ' Neutrophil count decreased 31/70 (1.43%)']}

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

a611e8dd-cafc-46dd-b8ed-3fa7c5f5a7b4

Comparison

Eligibility

NCT00847171

NCT01764022

Sufferers of Systemic lupus erythematosus are excluded from the primary trial but may still be eligible for the secondary trial.

Entailment

{'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%)']}

4db02d9b-d96e-4ced-947c-71cebcccc933

Single

Adverse Events

NCT00201864

One patient in the primary trial had a WBC count far below normal.

Contradiction

{'Clinical Trial ID': 'NCT00201864', 'Intervention': ['INTERVENTION 1: ', ' Exemestane and Fulvestrant', ' Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection', ' Exemestane: 25 mg orally per day', ' Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days.'], 'Eligibility': ['Inclusion Criteria:', ' Proven breast cancer', ' Metastatic or locally advanced breast cancer', ' Hormonally responsive disease defined as estrogen (ER) and/ or progesterone receptor (PR) positive (>10% staining by immunohistochemistry)', ' Postmenopausal status', ' No more than 1 prior chemotherapy for stage IV metastatic breast cancer allowed', ' ECOG (Eastern Cooperative Oncology Group) performance status 0-2', ' Adequate organ function', 'Exclusion Criteria:', ' No prior Exemestane or Fulvestrant', ' Uncontrolled intercurrent illness including but not limited to:', ' ongoing or active infection', ' symptomatic congestive heart failure', ' unstable angina pectoris', ' cardiac arrhythmia', ' myocardial infarction within the last 3 months', ' psychiatric illness/social situations that would limit compliance with study', ' Lymphangitic pulmonary disease; carcinomatous meningitis, bone marrow only metastases; and a rising tumor marker without any other site of metastatic disease.', ' Presence of bleeding diathesis or coagulopathy, patients requiring coumadin'], 'Results': ['Outcome Measurement: ', ' Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.', ' TTP is defined as the time from first treatment to objective evidence of progression on the basis of radiological evaluation and/or physical exam (if physical examination identifies a site of measurable disease). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions', ' Time frame: Every 2 cycles up to 2 years', 'Results 1: ', ' Arm/Group Title: Exemestane and Fulvestrant', ' Arm/Group Description: Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection', ' Exemestane: 25 mg orally per day', ' Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days.', ' Overall Number of Participants Analyzed: 40', ' Median (95% Confidence Interval)', ' Unit of Measure: months 6.9 (3.9 to 13.5)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 6/40 (15.00%)', ' Nausea 1/40 (2.50%)', ' Vomiting 1/40 (2.50%)', ' Chest pain 1/40 (2.50%)', ' Hypercalcemia 1/40 (2.50%)', ' Thromboembolism 2/40 (5.00%)']}

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

cfb07772-e485-491c-8ae3-9009e3d04415

Comparison

Intervention

NCT01712009

NCT00343382

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

Entailment

{'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: ']}

a283b69c-0f36-4773-a711-9e6088a8ee63

Single

Adverse Events

NCT00915018

The only cases of cardiac problems in the primary trial occurred in cohort 1.

Contradiction

{'Clinical Trial ID': 'NCT00915018', 'Intervention': ['INTERVENTION 1: ', ' Neratinib + Paclitaxel', ' Neratinib + Paclitaxel', ' Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.', ' Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.', 'INTERVENTION 2: ', ' Trastuzumab + Paclitaxel', ' Trastuzumab + Paclitaxel', ' Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.', ' Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.'], 'Eligibility': ['Inclusion Criteria:', ' ErbB-2 positive locally recurrent or metastatic breast cancer', ' Eastern Cooperative Oncology Group (ECOG) 0-2', ' Measurable disease', ' Availability of tumor tissue for HER2 status confirmation', 'Exclusion Criteria:', ' Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease', ' Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting', ' Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy', ' History of heart disease', ' History of gastrointestinal disease'], 'Results': ['Outcome Measurement: ', ' Progression-Free Survival', ' Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy.', ' Time frame: From randomization to disease progression or death, assessed up to 5.3 years', 'Results 1: ', ' Arm/Group Title: Neratinib + Paclitaxel', ' Arm/Group Description: Neratinib + Paclitaxel', ' Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.', ' Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.', ' Overall Number of Participants Analyzed: 242', ' Median (95% Confidence Interval)', ' Unit of Measure: months 12.9 (11.1 to 14.9)', 'Results 2: ', ' Arm/Group Title: Trastuzumab + Paclitaxel', ' Arm/Group Description: Trastuzumab + Paclitaxel', ' Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.', ' Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.', ' Overall Number of Participants Analyzed: 237', ' Median (95% Confidence Interval)', ' Unit of Measure: months 12.9 (11.1 to 14.8)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 67/240 (27.92%)', ' Anaemia 0/240 (0.00%)', ' Febrile neutropenia 1/240 (0.42%)', ' Leukopenia 2/240 (0.83%)', ' Neutropenia 1/240 (0.42%)', ' Thrombocytopenia 0/240 (0.00%)', ' Atrial fibrillation 0/240 (0.00%)', ' Cardiac failure congestive 2/240 (0.83%)', ' Cardiac tamponade 1/240 (0.42%)', ' Cardio-respiratory arrest 1/240 (0.42%)', ' Left ventricular dysfunction 0/240 (0.00%)', 'Adverse Events 2:', ' Total: 56/234 (23.93%)', ' Anaemia 1/234 (0.43%)', ' Febrile neutropenia 0/234 (0.00%)', ' Leukopenia 0/234 (0.00%)', ' Neutropenia 0/234 (0.00%)', ' Thrombocytopenia 1/234 (0.43%)', ' Atrial fibrillation 1/234 (0.43%)', ' Cardiac failure congestive 0/234 (0.00%)', ' Cardiac tamponade 0/234 (0.00%)', ' Cardio-respiratory arrest 0/234 (0.00%)', ' Left ventricular dysfunction 1/234 (0.43%)']}

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

8d90d538-3b56-48dd-bd58-007d266c923c

Comparison

Intervention

NCT00904033

NCT03592121

Patients are not required to be sexually active to receive the primary trial intervention, this is however a requirement for the secondary trial.

Entailment

{'Clinical Trial ID': 'NCT00904033', 'Intervention': ['INTERVENTION 1: ', ' No Exercise', ' Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week', 'INTERVENTION 2: ', ' Exercise', ' Exercise Arm: Exercise consisting of progressive walking and resistance band training', ' Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise'], 'Eligibility': ['Inclusion Criteria:', ' Must be female.', ' Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device (IUD), or double barrier device) and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Contraceptive use needs to be continued at least 1 month after the trial has ended.', ' Must provide informed consent.', ' Must be willing to discontinue use of calcium and/or vitamin D supplements.', ' Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of < 10.2mg/dl.', ' Must have a functional capacity rating of 2 on the Eastern Cooperative Oncology Group (ECOG) performance status when assessed at baseline.', " Must have the approval of their treating physician (or physician's nurse practitioner or physician's assistant) to participate in sub-maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program and to receive the 12-week supplementation of calcitriol 45 μg. Participants assigned to either of the calcitriol treatment arms will be instructed to stop taking calcium and/or vitamin D supplements.", ' Must be less than five years from the diagnosis of breast cancer and have received chemotherapy, radiation therapy, and/or hormonal therapy. Chemotherapy and radiation therapy, if received, must have been completed prior to study enrollment. Hormonal therapy may be ongoing.', 'Exclusion Criteria:', ' Subjects with life-threatening conditions that would preclude them from breast cancer treatment including chronic cardiac failure, which is unstable despite medication use, uncontrolled hypertension, uncontrolled diabetes mellitus, or unstable coronary artery disease.', ' Patients who had a myocardial infarction within the past year.', " Patients with severe metabolic disorders, which includes phenylketonuria (PKU), homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol.", ' Patients with impaired renal function (CRCL < 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years.', ' Patients with hypercalcemia (corrected serum Ca > 10.2 mg/dl) or a history of hypercalcemia or vitamin D toxicity.', ' Patients currently taking calcium supplements or aluminum-based antacids must be willing to discontinue their use if they are to enroll in the study.', ' Patients currently taking vitamin D supplements must immediately discontinue their use if they are to enroll in the study.', ' Patients with a known sensitivity to calcitriol.', ' Women who are pregnant or lactating.', ' Previously verified diagnosed of osteoporosis.', ' Women on antiresorptive drugs (e.g. bisphosphonates) within the past year.', ' Patients not capable of participating in an exercise intervention due to severe knee arthrosis or ligament/cartilage injuries of the lower extremities.', ' Women currently using oral contraception.', ' Women with malabsorptive syndromes (i.e. cystic fibrosis, chronic pancreatitis) or taking medications that decrease the absorption of fat soluble vitamins (i.e. Orlistat, Questran).', ' Participants assigned to calcitriol who are routinely taking a multivitamin supplement may continue the supplement as long as the amount of vitamin D in the supplement is not in excess of the RDA (recommended daily allowance) of 400 IU or 10 μg. If they are not taking a multivitamin supplement, they will be asked to not start supplementation while on study.'], 'Results': ['Outcome Measurement: ', ' Bone Resorption (Exercise)', ' Bone Resorption using Serum NTx (Exercise comparison)', ' Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (NM) Bone Collagen Equivalents (BCE).', ' Time frame: Week 12', 'Results 1: ', ' Arm/Group Title: No Exercise', ' Arm/Group Description: Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week', ' Overall Number of Participants Analyzed: 20', ' Least Squares Mean (Standard Error)', ' Unit of Measure: nm BCE 13.8 (1.656)', 'Results 2: ', ' Arm/Group Title: Exercise', ' Arm/Group Description: Exercise Arm: Exercise consisting of progressive walking and resistance band training', ' Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise', ' Overall Number of Participants Analyzed: 19', ' Least Squares Mean (Standard Error)', ' Unit of Measure: nm BCE 14.7 (1.033)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/10 (0.00%)', 'Adverse Events 2:', ' Total: 0/10 (0.00%)']}

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

fa0fe1a0-2b89-4b78-8fdb-04dee84b4421

Single

Intervention

NCT00620373

the primary trial tests two different breast imaging modalities, namely X-ray and gamma imaging.

Entailment

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

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

8502cb9e-e382-41bc-b547-02d2d7beb381

Single

Eligibility

NCT01105312

Patients with non-measurable diseases are only eligible for phase I of the primary trial.

Entailment

{'Clinical Trial ID': 'NCT01105312', 'Intervention': ['INTERVENTION 1: ', ' Phase I: Dose Level One', ' Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.', 'INTERVENTION 2: ', ' Phase I: Dose Level Two', ' Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 30 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.'], 'Eligibility': ['DISEASE CHARACTERISTICS:', ' Histologically confirmed breast cancer', ' Metastatic disease amenable to biopsy', ' Unresected tumor with no intention to undergo resection during study', ' Archival tissue from the primary diagnosis or fresh biopsy from metastatic cancer site required', ' Measurable or non-measurable disease for phase I study (The Phase I portion of this study closed and the Phase II portion of the study opened as per NCCTG Addendum 6, effective January 23, 2012.)', ' Measurable disease only for phase II study', ' Available tumor estrogen (ER), progesterone (PR), and HER2 status from metastatic site tested by IHC or FISH OR results from the original tumor diagnosis', ' Any ER, PR, or HER2 level (positive or negative) acceptable (phase I)', ' Triple-negative disease only (phase II)', ' ER and PR negative defined as 1% by IHC', ' HER2 negative', ' Patients with triple-negative breast cancer allowed provided there is clinical or radiographic evidence of tumor progression in the adjuvant or metastatic setting', ' No patients whose disease can be treated with known standard therapy that is potentially curative or definitely capable of extending life expectancy', ' No known CNS metastasis', ' Hormone-receptor status:', ' ER and PR positive or negative (phase I)', ' ER and PR negative (phase II)', ' PATIENT CHARACTERISTICS:', ' ECOG performance status 0-1 (phase I) or 0-2 (phase II)', ' Postmenopausal defined by 1 of the following:', ' 60 years of age', ' 45 years of age with last menstrual period 12 months prior and estradiol and follicle-stimulating hormone levels in postmenopausal range', ' Bilateral oophorectomy', ' Life expectancy 12 weeks', ' ANC 1,500/mm^3', ' Platelet count 100,000/mm^3', ' Total bilirubin normal', ' ALT and AST 3 times upper limit of normal (ULN) ( 5 times ULN if due to liver metastasis)', ' Serum creatinine 1.5 times ULN', ' TSH normal (thyroid hormone supplements allowed for patients with hypothyroidism)', ' Not pregnant or nursing', ' Fertile patients must use effective contraception', ' Willing to return to Mayo Clinic or NCCTG institution (phase II) for follow-up', ' Willing to provide blood samples for correlative research purposes', ' No uncontrolled or intercurrent illness including, but not limited to, any of the following:', ' Ongoing or active infection', ' Symptomatic congestive heart failure', ' Unstable angina pectoris', ' Cardiac arrhythmia', ' Psychiatric illness and/or social situations that would limit compliance with study requirements', ' No NYHA class III or IV cardiovascular disease', ' No known seizure disorder', ' No co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens', ' No immunocompromised patients, including patients known to be HIV positive', ' Immunocompromised patients due to the use of corticosteroids allowed', ' No malignancy within the past 5 years except for nonmelanoma skin cancer or carcinoma in situ of the cervix', ' No history of myocardial infarction 6 months', ' No congenital long QT syndrome or QTcF>450 msec, including:', ' Complete left bundle block or use of a permanent cardiac pacemaker, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (<50 beats per minute)', ' Right bundle branch block + left anterior hemiblock (bifascicular block)', ' No congestive heart failure requiring use of maintenance therapy for life-threatening ventricular arrhythmias', ' PRIOR CONCURRENT THERAPY:', ' See Disease Characteristics', ' More than 4 weeks since prior chemotherapy or radiotherapy and fully recovered', ' No radiotherapy to > 25 % of bone marrow', ' Prior treatments allowed (phase II):', ' 0 or 1 prior chemotherapy regimens for breast cancer', ' 2 prior aromatase-inhibitor regimens (including letrozole)', ' Not currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered', ' No other concurrent investigational agent for the primary neoplasm', ' No concurrent CYP3A4 inhibitors or inducers'], 'Results': ['Outcome Measurement: ', ' Maximum-tolerated Dose (Phase I)', " MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6> new patients). If dose-limiting toxicity (DLT) is not seen in any of the 3 patients, 3 new patients will be accrued and treated at the next higher dose level. If DLT are seen in 2 or 3 of 3 patients treated at a given dose level, then the next 3 patients will be treated at the next lower dose level, if only 3 patients were enrolled and treated at this lower dose level. The number of DLT's will be reported here.", ' Time frame: Up to 2.5 months', 'Results 1: ', ' Arm/Group Title: Phase I: Dose Level One', ' Arm/Group Description: Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 20 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 1 16.7%', 'Results 2: ', ' Arm/Group Title: Phase I: Dose Level Two', ' Arm/Group Description: Each patient will receive panobinostat (LBH589) and letrozole. Patients will be administered 30 mg LBH589 PO, 3 days per week for a total of 4 weeks. Patients will also be administered letrozole 2.5 mg PO Days 1-28 every 4 weeks.', ' Overall Number of Participants Analyzed: 6', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 3 50.0%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 4/16 (25.00%)', ' Bladder infection 0/16 (0.00%)', ' Lung infection 1/16 (6.25%)', ' Fracture 1/16 (6.25%)', ' Platelet count decreased 3/16 (18.75%)', ' White blood cell decreased 1/16 (6.25%)', ' Hypokalemia 0/16 (0.00%)', ' Hyponatremia 0/16 (0.00%)', 'Adverse Events 2:', ' Total: 1/6 (16.67%)', ' Bladder infection 1/6 (16.67%)', ' Lung infection 0/6 (0.00%)', ' Fracture 0/6 (0.00%)', ' Platelet count decreased 0/6 (0.00%)', ' White blood cell decreased 0/6 (0.00%)', ' Hypokalemia 0/6 (0.00%)', ' Hyponatremia 0/6 (0.00%)']}

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

f6c64bb3-1836-4685-8541-8856f003524b

Comparison

Results

NCT00073528

NCT00191152

the secondary trial and the primary trial study the Progression Free Survival (PFS) of their participants, however they use different Units of Measure.

Entailment

{'Clinical Trial ID': 'NCT00073528', 'Intervention': ['INTERVENTION 1: ', ' Placebo + Letrozole 2.5 mg', ' Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib.', 'INTERVENTION 2: ', ' Lapatinib 1500 mg + Letrozole 2.5 mg', ' Participants received 6 tablets of Lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib.'], 'Eligibility': ['Key inclusion criteria', ' Signed informed consent;', ' Subjects with histologically confirmed invasive breast cancer with stage IV disease at primary diagnosis or at relapse after curative-intent surgery;', ' Subjects with either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST).', ' If the disease was restricted to a solitary lesion, its neoplastic nature was confirmed by cytology or histology.', ' Tumors that were ER+ and/or PgR+;', ' Post-menopausal female subjects 18 years of age.', ' ECOG Performance Status of 0 or 1;', ' Subjects who had archived tumor tissue available to compare tumor response with intra-tumoral expression of ErbB1 and ErbB2.', ' Adjuvant therapy with an aromatase inhibitor and / or trastuzumab was allowed; however, treatment was to stop more than 1 year prior (>12 months) to the first dose of randomized therapy.', ' Subjects must have ended hormonal replacement therapy (HRT) at least 1 month (30 days) prior to receiving the first dose of randomized therapy.', ' Key exclusion criteria:', ' Pre-menopausal, pregnant, or lactating;', ' Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for advanced or metastatic disease;', ' Bisphosphonate therapy for bone metastases was allowed; however, treatment was to be initiated prior to the first dose of randomized therapy. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, was not permitted;', ' Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy (lapatinib or placebo);', ' Subjects with known history of/clinical evidence of CNS metastases or leptomeningeal carcinomatosis; and / or subjects on concurrent anti-cancer therapies other than letrozole; and / or who have not recovered from toxicities related to prior adjuvant therapy (surgery, radiotherapy, chemotherapy etc.)', ' Subjects with active or uncontrolled infection and/ or with history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator', ' PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.', ' Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months', 'Results 1: ', ' Arm/Group Title: Placebo + Letrozole 2.5 mg', ' Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib.', ' Overall Number of Participants Analyzed: 108', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 89 82.4%', 'Results 2: ', ' Arm/Group Title: Lapatinib 1500 mg + Letrozole 2.5 mg', ' Arm/Group Description: Participants received 6 tablets of Lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib.', ' Overall Number of Participants Analyzed: 111', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 88 79.3%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 103/624 (16.51%)', ' Anaemia 2/624 (0.32%)', ' Febrile neutropenia 0/624 (0.00%)', ' Jaundice 0/624 (0.00%)', ' Leukocytosis 0/624 (0.00%)', ' Thrombocytopenia 0/624 (0.00%)', ' Arrhythmia 2/624 (0.32%)', ' Atrial fibrillation 2/624 (0.32%)', ' Cardiac failure 2/624 (0.32%)', ' Dyspnoea 5/624 (0.80%)', ' Left ventricular dysfunction 1/624 (0.16%)', ' Left ventricular failure 1/624 (0.16%)', 'Adverse Events 2:', ' Total: 150/654 (22.94%)', ' Anaemia 5/654 (0.76%)', ' Febrile neutropenia 3/654 (0.46%)', ' Jaundice 1/654 (0.15%)', ' Leukocytosis 1/654 (0.15%)', ' Thrombocytopenia 2/654 (0.31%)', ' Arrhythmia 0/654 (0.00%)', ' Atrial fibrillation 1/654 (0.15%)', ' Cardiac failure 1/654 (0.15%)', ' Dyspnoea 6/654 (0.92%)', ' Left ventricular dysfunction 7/654 (1.07%)', ' Left ventricular failure 0/654 (0.00%)']}

{'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%)']}

79272218-91b9-4331-ba44-6a3709a13f62

Comparison

Results

NCT01964924

NCT00524303

the primary trial and the secondary trial both report Objective Response Rate (ORR) of their patients.

Contradiction

{'Clinical Trial ID': 'NCT01964924', 'Intervention': ['INTERVENTION 1: ', ' Treatment (Trametinib, Akt Inhibitor GSK2141795)', ' PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.', ' PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', ' Akt Inhibitor GSK2141795: Given PO', ' Laboratory Biomarker Analysis: Correlative studies', ' Trametinib: Given PO'], 'Eligibility': ['Inclusion Criteria:', ' Patients must have histologically or cytologically confirmed metastatic invasive breast cancer that is negative for the estrogen receptor (ER), progesterone receptor (PR) and HER2 by institutional guidelines', ' Patients must have measurable disease (Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1])', ' Patients must have had exposure to at least 1 and no more than 3 prior chemotherapy regimens for the treatment of metastatic breast cancer', ' Patients must consent to both a pretreatment and a post-treatment mandatory research biopsy prior to enrolling on trial, and therefore, must have tissue (excluding bone or brain) that is amenable to biopsy', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1', ' Life expectancy of greater than 3 months', ' Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels', ' All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) grade =< 1 (except alopecia) at the time of enrollment', ' Absolute neutrophil count >= 1,500/mcL', ' Platelets >= 75,000/mcL', ' Total bilirubin =< 1.5 × institutional upper limit of normal', ' Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 × institutional upper limit of normal', ' Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)', ' Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min', ' Patients must have controlled blood pressure with a systolic blood pressure < 140 mmHg and diastolic < 90 mmHg; anti-hypertensive medications are permitted', ' Patients must be at least 4 weeks from last radiation dose; patients must be at least 4 weeks from last chemotherapy, targeted therapy, or biologic therapy (exception allowed for a 2 week washout for patients who were on chemotherapy at less than a standard of care dose, as long as all other eligibility criteria are met); patients must be at least 4 weeks from last surgical procedure and recovered from all post-operative complications', ' Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of trametinib monotherapy or in combination with GSK2141795 administration', ' Ability to understand and the willingness to sign a written informed consent document', 'Exclusion Criteria:', ' History of another malignancy', ' Exception: patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible', ' History of interstitial lung disease or pneumonitis', ' History of type I diabetes mellitus; if a patient has type II diabetes, they must have a hemoglobin (hemoglobin A1C) =< 8%; patients with a screening fasting glucose > 120 mg/dL will be excluded', ' Uncontrolled hypothyroidism; patients must have a normal thyroid-stimulating hormone (TSH) per institutional standards at baseline', ' Patients who are receiving any other investigational agents', ' Individuals with symptomatic or progressive brain metastases are ineligible; subjects with treated brain metastases are eligible if they have no radiographic or other signs of progression in the brain for >= 3 weeks after completion of local therapy; any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for >= 3 weeks prior to study enrollment', ' History of allergic reactions attributed to compounds of similar chemical or biologic composition to trametinib monotherapy or trametinib in combination with GSK2141795', ' Current use of a prohibited medication; the following medications or non-drug therapies are prohibited:', ' Other anti-cancer therapy while on study treatment (megestrol if used as an appetite stimulant is allowed)', " The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John's wort, kava, ephedra [ma huang], gingko biloba, yohimbe, saw palmetto, or ginseng)", ' Patients receiving strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible', ' History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, history of hyperviscosity or hypercoagulability syndromes; visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as evidence of new optic disc cupping, evidence of new visual field defects, and intraocular pressure > 21 mm Hg', ' Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements', ' Pregnant women are excluded from this study, breastfeeding should be discontinued if the mother is treated with trametinib monotherapy or trametinib in combination with GSK2141795', ' Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible'], 'Results': ['Outcome Measurement: ', ' Objective Response Rate (ORR), Defined as the Proportion of Patients Who Have Had a Partial Response (PR) or Complete Response (CR) (RECIST 1.1 Based) Within the First 6 Months After Initiation of Therapy With Trametinib', ' Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', ' Time frame: 6 months', 'Results 1: ', ' Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795)', ' Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.', ' PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', ' Akt Inhibitor GSK2141795: Given PO', ' Laboratory Biomarker Analysis: Correlative studies', ' Trametinib: Given PO', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Count of Participants', ' Unit of Measure: Participants 2 5.4%'], 'Adverse Events': ['Adverse Events 1:', ' Total: 30/37 (81.08%)', ' Anemia 1/37 (2.70%)', ' Leukocytosis 1/37 (2.70%)', ' Cardiac arrest 1/37 (2.70%)', ' Vertigo 1/37 (2.70%)', ' Diarrhea 0/37 (0.00%)', ' Dysphagia 1/37 (2.70%)', ' Enterocolitis 0/37 (0.00%)', ' Vomiting 0/37 (0.00%)', ' Death NOS 1/37 (2.70%)', ' Edema face 1/37 (2.70%)', ' Edema limbs 1/37 (2.70%)', ' Fever 1/37 (2.70%)']}

{'Clinical Trial ID': 'NCT00524303', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab', ' Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.', 'INTERVENTION 2: ', ' Lapatinib', ' Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.'], 'Eligibility': ['Inclusion Criteria:', ' Have signed an informed consent form (ICF) and a Patient Authorization Form (HIPAA).', ' Have histologically or cytologically confirmed ErbB2- (HER2/neu-) overexpressing invasive breast cancer (T2-4, N0-2).', ' ErbB2 overexpressing breast cancer, defined as one of the following definitions:', ' 3+ staining by immunohistochemistry (IHC),', ' a fluorescent in situ hybridization (FISH) result of more than six HER2 gene copies per nucleus', ' a FISH ratio of more than 2.2.', ' Have either measurable or evaluable disease.', ' Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 (Refer to Section 11.4).', ' Have LVEF within the institutional range of normal as measured by either echocardiogram (ECHO) or MUGA scans. The same modality must be used consistently throughout the study.', ' Be deemed able to tolerate 8 cycles of preoperative chemotherapy, including 4 cycles with an anthracycline (epirubicin).', ' Must be willing to undergo 2 mandatory core biopsies (4 passes each) after diagnosis to obtain tissue for biologic expression profiling. Any subject with clinically palpable residual disease may undergo an optional third biopsy to allow identification of presumed pathways of resistance to therapy. This information might be useful in providing the subject with options for other targeted therapies if definitive surgery confirms residual disease. Definitive local therapy with surgery and radiation therapy as indicated will be performed after completion of 12 weeks of paclitaxel-based chemotherapy.', ' Are able to swallow and retain oral medication (intact pill).', ' Are able to complete all screening assessments as outlined in the protocol.', ' Have adequate organ function as defined in Table 4:', ' Table 1 Baseline Laboratory Values', ' Hematologic:', ' ANC (absolute neutrophil count) >1.5 x 109/L hemoglobin >9 g/dL platelets >75 x 109/L', ' Hepatic:', ' albumin >2.5 g/dL serum bilirubin <1.25 x ULN AST / ALT <3 x ULN if no documented liver metastases AST / ALT <3 x ULN with documented liver metastases', ' Renal:', ' serum creatinine <2.0 mg/dL', ' OR - calculated creatinine clearance >40 mL/min', ' Are subjects aged >18 years with any menopausal status:', ' Non-child-bearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation or hysterectomy, or women who are postmenopausal)', ' Child-bearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility.) This category includes women with oligomenorrhea (severe), women who are perimenopausal, and young women who have begun to menstruate. These subjects must have a negative serum pregnancy test at screening and agree to one of the following:', " Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication; or Consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject; any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraceptives (either combined or progestogen only) where not contraindicated for this subject population or per local practice.; or barrier methods, including diaphragm or condom with a spermicide.", ' Please note that breast cancer subjects on this trial cannot receive injectable levonorgestrel or injectable progestogen due to the potential for an adverse effect of anti-hormonal therapies on chemotherapy administered for breast cancer [Albain, 2002]. Progestogen may also affect the proliferative rate of endocrine-responsive tumors.', 'Exclusion Criteria:', ' Have received any prior chemotherapy.', ' Had prior therapy with an ErbB1 and/or ErbB2 inhibitor.', ' Are receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, and biologic therapy) while taking study medication.', ' Have malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Women with ulcerative colitis are also excluded.', " Have a concurrent disease or condition that would make the woman inappropriate for study participation, or any serious medical disorder that would interfere with the woman's safety.", ' 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 active cardiac disease, defined as one or more of the following:', ' History of uncontrolled or symptomatic angina History of arrhythmias requiring medications, or clinically significant Myocardial infarction <6 months from study entry Uncontrolled or symptomatic congestive heart failure Ejection fraction below the institutional normal limit Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient', ' Are pregnant or breastfeeding.', ' Have received concurrent treatment with an investigational agent or participate in another clinical trial.', ' Have received concurrent treatment with prohibited medications (refer to Section 5.8.2 for details on prohibited medications).', ' Have used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication.', ' Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the agents used in this study or their excipients.', ' Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin).'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy', ' A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel.', ' Time frame: Week 26', 'Results 1: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.', ' Overall Number of Participants Analyzed: 26', ' Measure Type: Number', ' Unit of Measure: percentage of participants 54.0', 'Results 2: ', ' Arm/Group Title: Lapatinib', ' Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.', ' Overall Number of Participants Analyzed: 29', ' Measure Type: Number', ' Unit of Measure: percentage of participants 45.0'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/32 (21.88%)', ' Febrile nuetropenia 3/32 (9.38%)', ' Neutropenia 3/32 (9.38%)', ' Anaemia 1/32 (3.13%)', ' Diarrhoea 0/32 (0.00%)', ' Vomiting 0/32 (0.00%)', ' Nausea 0/32 (0.00%)', ' Stomatitis 0/32 (0.00%)', ' Pyrexia 0/32 (0.00%)', ' Chest discomfort 0/32 (0.00%)', ' Cellilitis 0/32 (0.00%)', ' Diverticulitis 0/32 (0.00%)', ' Gastroenteritis 0/32 (0.00%)', 'Adverse Events 2:', ' Total: 7/34 (20.59%)', ' Febrile nuetropenia 0/34 (0.00%)', ' Neutropenia 0/34 (0.00%)', ' Anaemia 0/34 (0.00%)', ' Diarrhoea 2/34 (5.88%)', ' Vomiting 1/34 (2.94%)', ' Nausea 0/34 (0.00%)', ' Stomatitis 0/34 (0.00%)', ' Pyrexia 3/34 (8.82%)', ' Chest discomfort 0/34 (0.00%)', ' Cellilitis 1/34 (2.94%)', ' Diverticulitis 1/34 (2.94%)', ' Gastroenteritis 0/34 (0.00%)']}

97e3b0d7-3320-4eb5-bc42-5031db87692e

Single

Results

NCT00708214

All Participants with disease progression (After 16 Weeks of Treatment) in the primary trial were in the Afatinib 50 mg With Letrozole group.

Contradiction

{'Clinical Trial ID': 'NCT00708214', 'Intervention': ['INTERVENTION 1: ', ' Afatinib 50 mg With Letrozole', ' Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.', 'INTERVENTION 2: ', ' Afatinib 40 mg With Letrozole', ' Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.'], 'Eligibility': ['Inclusion criteria:', ' Female patients with histologically proven breast adenocarcinoma', ' Presence of metastatic disease No more than 2 prior chemotherapy regimens for metastatic disease, which could include trastuzumab Patients must currently be on letrozole and developed acquired resistance as defined by disease progression on letrozole following previous response (partial response or better, stable disease superior or equal to 24 weeks)', ' Diagnosis of disease progression inferior or equal to 6 weeks prior to trial entrydefined as:', ' Increase in the number of bone lesions on bone scan or on MRI AND/OR', ' Increased pain in an area of known bony metastasis AND superior or equal to 2 serial elevations in CA 15.3 AND/OR', ' Progression according to RECIST criteria on CT scan, MRI, or x-ray Patients must have documented menopause confirmed by estradiol level inferior to 11 pg/ml', 'Exclusion criteria:', ' Premenopausal patients', ' Rapidly progressive disease in major organs (i.e. lymphangitic spread in the lung and/or bulky liver metastasis) Patient with brain metastasis Significant cardiovascular diseases Previous treatment with an EGFR and/or HER-2 inhibiting drug(patients who received trastuzumab with chemotherapy but not with letrozole can be enrolled)'], 'Results': ['Outcome Measurement: ', ' Percentage of Progression Free Participants After 16 Weeks of Treatment', ' Progression was defined according to 1 of the following criteria: New bone lesion(s) on bone scan or on magnetic resonance imaging; Progression or occurrence of new lesion(s) according to the Response Evaluation Criteria In Solid Tumours version 1.0 (RECIST); an increase in tumour marker CA 15.3 of more than 20 percent,compared with baseline, at 2 consecutive examinations; occurrence of disease-related skeletal events. If a patient did not fulfil any criteria and was withdrawn because of clinical deterioration amounting to PD according to the Investigator, they were considered as having PD.', ' Time frame: 16 weeks', 'Results 1: ', ' Arm/Group Title: Afatinib 50 mg With Letrozole', ' Arm/Group Description: Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 28.57 (3.67 to 70.96)', 'Results 2: ', ' Arm/Group Title: Afatinib 40 mg With Letrozole', ' Arm/Group Description: Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.', ' Overall Number of Participants Analyzed: 13', ' Measure Type: Number', ' Unit of Measure: Percentage of participants 0.00 (0.00 to 24.71)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 1/7 (14.29%)', ' Disseminated intravascular coagulation 0/7 (0.00%)', ' Diarrhoea 0/7 (0.00%)', ' Nausea 0/7 (0.00%)', ' Vomiting 0/7 (0.00%)', ' Asthenia 0/7 (0.00%)', ' Mucosal inflammation 0/7 (0.00%)', ' Obstruction 0/7 (0.00%)', ' Oedema peripheral 0/7 (0.00%)', ' Arthritis bacterial 0/7 (0.00%)', ' Erysipelas 1/7 (14.29%)', ' Pneumococcal sepsis 0/7 (0.00%)', ' Post precedural sepsis 0/7 (0.00%)', 'Adverse Events 2:', ' Total: 3/13 (23.08%)', ' Disseminated intravascular coagulation 1/13 (7.69%)', ' Diarrhoea 1/13 (7.69%)', ' Nausea 0/13 (0.00%)', ' Vomiting 1/13 (7.69%)', ' Asthenia 0/13 (0.00%)', ' Mucosal inflammation 1/13 (7.69%)', ' Obstruction 1/13 (7.69%)', ' Oedema peripheral 1/13 (7.69%)', ' Arthritis bacterial 1/13 (7.69%)', ' Erysipelas 0/13 (0.00%)', ' Pneumococcal sepsis 1/13 (7.69%)']}

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

83251670-803e-4fec-a5cf-50f052932752

Single

Adverse Events

NCT01610284

1 patient in the primary trial had an abrupt loss of heart function.

Entailment

{'Clinical Trial ID': 'NCT01610284', 'Intervention': ['INTERVENTION 1: ', ' BKM120 100mg + Fulvestrant', ' BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.', 'INTERVENTION 2: ', ' Placebo + Fulvestrant', ' BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.'], 'Eligibility': ['Key Inclusion Criteria:', ' Locally advanced or metastatic breast cancer', ' HER2-negative and hormone receptor-positive status (common breast cancer classification tests)', ' Postmenopausal woman', ' A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PI3K activation status)', ' Progression or recurrence of breast cancer while on or after aromatase inhibitor treatment', ' Measurable disease or non measurable disease bone lesions in the absence of measurable disease as per RECIST 1.1', ' Adequate bone marrow and organ function defined by laboratory values', ' Key Exclusion Criteria:', ' Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant', ' More than one prior chemotherapy line for metastatic disease', ' Symptomatic brain metastases', ' Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent', ' Active heart (cardiac) disease as defined in the protocol', ' Certain scores on an anxiety and depression mood questionnaires'], 'Results': ['Outcome Measurement: ', ' Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort', ' 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 progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm.', ' 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 approximately 4 years', 'Results 1: ', ' Arm/Group Title: BKM120 100mg + Fulvestrant', ' Arm/Group Description: BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.', ' Overall Number of Participants Analyzed: 576', ' Median (95% Confidence Interval)', ' Unit of Measure: Months FAS-Full population: 576 participants', ' 6.9 (6.8 to 7.8)', ' FAS-Main cohort: 427 participants', ' 6.8 (5.0 to 7.0)', ' FAS-PI3K pathway activated: 188 participants', ' 6.8 (4.9 to 7.1)', ' FAS-PI3K pathway non-activated: 239 participants', ' 6.9 (4.6 to 7.2)', ' FAS-PI3K pathway unknown: 149 participants', ' 8.7 (7.0 to 12.4)', 'Results 2: ', ' Arm/Group Title: Placebo + Fulvestrant', ' Arm/Group Description: BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.', ' Overall Number of Participants Analyzed: 571', ' Median (95% Confidence Interval)', ' Unit of Measure: Months FAS-Full population: 571 participants', ' 5.0 (4.0 to 5.2)', ' FAS-Main cohort: 424 participants', ' 4.5 (3.3 to 5.0)', ' FAS-PI3K pathway activated: 184 participants', ' 4.0 (3.1 to 5.2)', ' FAS-PI3K pathway non-activated: 240 participants', ' 4.6 (3.3 to 5.1)', ' FAS-PI3K pathway unknown: 147 participants', ' 6.8 (5.0 to 8.4)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 146/573 (25.48%)', ' Anaemia 4/573 (0.70%)', ' Disseminated intravascular coagulation 0/573 (0.00%)', ' Neutropenia 1/573 (0.17%)', ' Thrombocytopenia 0/573 (0.00%)', ' Acute coronary syndrome 1/573 (0.17%)', ' Angina pectoris 1/573 (0.17%)', ' Atrial fibrillation 2/573 (0.35%)', ' Atrial flutter 0/573 (0.00%)', ' Cardiac arrest 1/573 (0.17%)', ' Cardiac failure 0/573 (0.00%)', 'Adverse Events 2:', ' Total: 101/570 (17.72%)', ' Anaemia 3/570 (0.53%)', ' Disseminated intravascular coagulation 1/570 (0.18%)', ' Neutropenia 1/570 (0.18%)', ' Thrombocytopenia 1/570 (0.18%)', ' Acute coronary syndrome 0/570 (0.00%)', ' Angina pectoris 1/570 (0.18%)', ' Atrial fibrillation 0/570 (0.00%)', ' Atrial flutter 1/570 (0.18%)', ' Cardiac arrest 0/570 (0.00%)', ' Cardiac failure 1/570 (0.18%)']}

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

efd950a8-ae79-4d4a-9ce7-3f1d0a37e6de

Comparison

Adverse Events

NCT01256567

NCT01926886

The most common adverse event in the primary trial was Febrile neutropenia (42.86%), whereas in the secondary trial it was a decrease in Ejection fraction (4.95%).

Entailment

{'Clinical Trial ID': 'NCT01256567', 'Intervention': ['INTERVENTION 1: ', ' Ramucirumab and Docetaxel Combination', ' Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.', ' Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks.'], 'Eligibility': ['Inclusion Criteria:', ' The participant is Japanese', ' The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' The participant has a histopathologically or cytologically confirmed diagnosis of breast adenocarcinoma that is now metastatic or locally-recurrent and inoperable with curative intent', ' The participant has measurable and/or non-measurable disease', " The participants' primary and/or metastatic tumor is Human Epidermal Growth Factor Receptor 2 (HER2) negative", ' The participant received neo adjuvant or adjuvant taxane therapy 6 months prior to the study', ' The participant received neo adjuvant or adjuvant biologic therapy 6 weeks prior to the study', ' The participant completed all prior radiotherapy 3 weeks prior to the study registration date', ' The participant received prior hormonal therapy for breast cancer in the neo adjuvant, adjuvant,and/or the metastatic setting 2 weeks prior to the study registration date', " The participant's left ventricular ejection fraction (LVEF) is within normal ranges", ' The participant has adequate hematologic, hepatic, and coagulation function.', ' Eligible participants of reproductive potential agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and for 12 weeks after the last dose of study medication', 'Exclusion Criteria:', ' The participant has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non-melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. Participants with previous treatment of malignancy is eligible, provided that she has been disease free for >3 years', ' The participant has a known sensitivity to docetaxel', ' The participant has a known sensitivity to agents of similar biologic composition as ramucirumab', ' The participant has a history of chronic diarrheal disease within 6 months prior to the study registration date', ' The participant has received irradiation to a major bone marrow area within 30 days prior to the study registration date', ' The participant has received any experimental agents within 4 weeks prior to the study registration date', ' The participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders', ' The participant has Grade 3-4 bleeding within 3 months prior to the study registration date', ' The participant has an ongoing or active infection requiring antibiotic, antifungal, or antiviral therapy', ' The participant has uncontrolled hypertension, symptomatic congestive heart failure, psychiatric illness, or any other serious uncontrolled medical disorders', ' The participant has brain metastases', ' The participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness', ' The participant is pregnant or lactating', ' The participant has not fully recovered from effects of prior chemotherapy', ' The participant has undergone major surgery within 28 days prior to the study registration date'], 'Results': ['Outcome Measurement: ', ' Number of Participants With Adverse Events', ' Number participants with drug related dose-limiting toxicities (DLT) during Cycle 1; ramucirumab related: treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or higher TEAE, or TEAE leading to discontinuation or ramucirumab dose modification. DLT=G4 neutropenia >7days; G 3 neutropenia with fever 38.5°C requiring IV antibiotics or bacteriemia or sepsis; G4 thrombocytopenia; G 3 thrombocytopenia with bleeding requiring platelets; G 3 prothrombin time and/or partial thromboplastin time in absence of anticoagulants; G 2 hyperbilirubinemia 5 days; QTc >500 milliseconds (ms) or increase 100 ms or arrhythmia; G 4 or uncontrollable hypertension; G 3 nonhematologic toxicity (excluding G3: hypersensitivity, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea without loperamide therapy, nausea/vomiting without antiemetics, transient G3/4 elevation of aminotransferases); treatment delay >2 weeks due to toxicity.', ' Time frame: Baseline up to data cut off (approximately 48.3 weeks)', 'Results 1: ', ' Arm/Group Title: Ramucirumab and Docetaxel Combination', ' Arm/Group Description: Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.', ' Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks.', ' Overall Number of Participants Analyzed: 7', ' Measure Type: Number', ' Unit of Measure: participants Dose Limiting Toxicity (DLT) during Cycle 1: 2', ' TEAE related to ramucirumab: 7', ' SAE related to ramucirumab: 4', ' TEAE of Grade 3 related to ramucirumab: 6', ' TEAE resulting in ramucirumab discontinuation: 3', ' TEAE with ramucirumab dose modification/delay: 5'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/7 (100.00%)', ' Febrile neutropenia 3/7 (42.86%)', ' Cardiac failure 1/7 (14.29%)', ' Neutrophil count decreased 1/7 (14.29%)', ' Muscular weakness 1/7 (14.29%)', ' Epistaxis 1/7 (14.29%)', ' Interstitial lung disease 1/7 (14.29%)', ' Pleural effusion 2/7 (28.57%)']}

{'Clinical Trial ID': 'NCT01926886', 'Intervention': ['INTERVENTION 1: ', ' Trastuzumab', ' Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).'], 'Eligibility': ['Inclusion Criteria:', ' Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast', ' HER2-positive disease immunohistochemistry (IHC)3+ or in situ hybridization (ISH) positive, in line with local reimbursement criteria and determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay', ' Eastern Cooperative Oncology Group (ECOG) performance status 0-1', ' Hormonal therapy will be allowed as per institutional guidelines', ' Left ventricular ejection fraction (LVEF) of greater than or equal to (>/=) 50% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab SC, or, for those who were receiving trastuzumab when beginning the study, documented results within an acceptable limit from a cardiac assessment within 3 months prior to enrollment', ' Participants have completed the first 6 cycles of trastuzumab IV as part of the (neo)adjuvant treatment', ' No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, (neo-adjuvant or adjuvant)', ' Use of concurrent curative radiotherapy will be permitted', 'Exclusion Criteria:', ' History of other malignancy which could affect compliance with the protocol or interpretation of results. Participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and patients with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible', ' Participants with severe dyspnea at rest or requiring supplementary oxygen therapy', ' Participants with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness', ' Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension', ' Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV)', ' Pregnant or lactating women', ' Women of childbearing potential and male participants with partners of childbearing potential who are unable or unwilling to use adequate contraceptive measures during study treatment', ' Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment', ' Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma', ' Inadequate bone marrow, hepatic or renal function'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', ' An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non- serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An emergent AE was defined as occurring within 35 days after last treatment administration.', ' Time frame: Up to 45 months', 'Results 1: ', ' Arm/Group Title: Trastuzumab', ' Arm/Group Description: Participants received trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (Cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).', ' Overall Number of Participants Analyzed: 101', ' Measure Type: Number', ' Unit of Measure: percentage of participants Emergent AEs: 90.1', ' Emergent SAEs: 7.9'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/101 (7.92%)', ' Vertigo * 1/101 (0.99%)', ' Infected lymphocele * 1/101 (0.99%)', ' Ejection fraction decreased * 5/101 (4.95%)', ' Lymphoedema * 1/101 (0.99%)']}

e00b0ccc-e53b-44ba-9555-b6f8d6d5e55a

Single

Eligibility

NCT00093795

Patients with cancer cells in lymph nodes above the collarbone cannot enter the primary trial.

Entailment

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

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

97812fde-57f3-4299-be34-dd436757adde

Comparison

Eligibility

NCT00213980

NCT02536339

Adequate blood, kidney, and hepatic function are required to participate in the secondary trial, however this condition is not specified in the primary trial.

Entailment

{'Clinical Trial ID': 'NCT00213980', 'Intervention': ['INTERVENTION 1: ', ' Zoledronic Acid (ZA)', ' ZA', ' Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles', 'INTERVENTION 2: ', ' Observation', ' Observation only for 12 months'], 'Eligibility': ['Inclusion Criteria:', ' Postmenopausal women, Stage III or axillary node positive', ' Currently disease free of breast cancer and other invasive malignancies at the time of registration', ' No concurrent use of bisphosphonates', 'Exclusion Criteria:', 'Metastatic disease'], 'Results': ['Outcome Measurement: ', ' Change in Bone Mineral Density (BMD) From Baseline to 1 Year', ' To determine whether zoledronate 4 mg IV every 12 weeks x 4 doses is associated with increases in bone mineral density at the lumbar spine and femoral head, calculated from baseline and 1 year data. Participants who missed one or more DXA were not evaluated.', ' Time frame: Up to 1 year', 'Results 1: ', ' Arm/Group Title: Zoledronic Acid (ZA)', ' Arm/Group Description: ZA', ' Zoledronic acid (ZA): 4 mg IV over 15 minutes administered once every 12 weeks for 4 cycles', ' Overall Number of Participants Analyzed: 29', ' Mean (95% Confidence Interval)', ' Unit of Measure: grams per cubic centimeter Lumbar Spine L1-L4 (L1-L4): 0.048 (0.034 to 0.062)', ' Femoral neck (FN): 0.014 (0.002 to 0.027)', ' Total femur (TF): 0.019 (0.011 to 0.026)', ' Trochanter (T): 0.023 (0.013 to 0.34)', ' Calcaneal (OC): 0.010 (0.004 to 0.015)', 'Results 2: ', ' Arm/Group Title: Observation', ' Arm/Group Description: Observation only for 12 months', ' Overall Number of Participants Analyzed: 27', ' Mean (95% Confidence Interval)', ' Unit of Measure: grams per cubic centimeter Lumbar Spine L1-L4 (L1-L4): 0.007 (-0.020 to 0.034)', ' Femoral neck (FN): 0.005 (-0.012 to 0.023)', ' Total femur (TF): 0.004 (-0.006 to 0.015)', ' Trochanter (T): 0.005 (-0.007 to 0.017)', ' Calcaneal (OC): 0.001 (-0.007 to 0.005)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 0/32 (0.00%)', 'Adverse Events 2:', ' Total: ']}

{'Clinical Trial ID': 'NCT02536339', 'Intervention': ['INTERVENTION 1: ', ' Pertuzumab + Trastuzumab', ' Participants with CNS metastases secondary to HER2-positive MBC, who had disease progression in the brain following previous treatment with radiotherapy (whole-brain radiation therapy or stereotactic radiosurgery) for brain metastases, received treatment with pertuzumab in combination with high-dose trastuzumab until disease progression, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor, whichever occurred first.'], 'Eligibility': ['Inclusion Criteria:', ' Pathologically confirmed HER2-positive MBC', ' Progression of or new brain metastases after completion of whole-brain radiotherapy or stereotactic radiosurgery', ' Completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days prior to enrollment', ' Stable systemic disease', ' Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', ' LVEF at least 50%', ' Adequate hematologic, renal, and hepatic function', ' Life expectancy more than 12 weeks', 'Exclusion Criteria:', ' Progression of systemic disease at Screening', ' Leptomeningeal disease', ' History of intolerance or hypersensitivity to study drug', ' Use of certain investigational therapies within 21 days prior to enrollment', ' Current anthracycline use', ' Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use', ' Active infection', ' Pregnant or lactating women', ' Significant history or risk of cardiac disease', ' Symptomatic intrinsic lung disease or lung involvement', ' History of other malignancy within the last 5 years'], 'Results': ['Outcome Measurement: ', ' Percentage of Participants With Objective Response in the CNS, Assessed Using Response Assessment in Neuro-Oncology-Brain Metastases (RANO-BM) Criteria', ' Responses were assessed by the investigator, based on magnetic resonance imaging (MRI) of the brain, physical examinations, routine neurological examinations, and corticosteroid dosing. An objective response in the central nervous system (CNS) was a complete response (CR) or partial response (PR) confirmed by repeat assessment, according to RANO-BM criteria. A CR was defined as the disappearance of all CNS target lesions sustained for at least 4 weeks; no new lesions; no corticosteroids; and stable or improved clinically; for non-target lesions, a CR was the disappearance of all enhancing CNS non-target lesions and no new CNS lesions. A PR was defined as at least a 30% decrease in the sum longest diameter (LD) of CNS target lesions, taking as reference the baseline sum LD sustained for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; and stable or improved clinically. The 95% Clopper-Pearson exact confidence intervals were calculated for responses.', ' Time frame: From Baseline until disease progression (assessed every 6 weeks for first 2 scans, followed by every 8 weeks for 2 scans, then every 12 weeks until disease progression; up to approximately 3.5 years)', 'Results 1: ', ' Arm/Group Title: Pertuzumab + Trastuzumab', ' Arm/Group Description: Participants with CNS metastases secondary to HER2-positive MBC, who had disease progression in the brain following previous treatment with radiotherapy (whole-brain radiation therapy or stereotactic radiosurgery) for brain metastases, received treatment with pertuzumab in combination with high-dose trastuzumab until disease progression, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor, whichever occurred first.', ' Overall Number of Participants Analyzed: 37', ' Measure Type: Number', ' Unit of Measure: Percentage of Participants With Objective Response (Confirmed CR or PR): 10.8 (3.03 to 25.42)', ' Confirmed Complete Response (CR): 0.0 (0.00 to 9.49)', ' Confirmed Partial Response (PR): 10.8 (3.03 to 25.42)', ' Without Objective Response: 89.2 [1] (NA to NA)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 7/39 (17.95%)', ' Gastroenteritis viral 1/39 (2.56%)', ' Parainfluenzae virus infection 1/39 (2.56%)', ' Seizure 4/39 (10.26%)', ' Headache 1/39 (2.56%)', ' Hydrocephalus 1/39 (2.56%)', ' Hypertension 1/39 (2.56%)']}

f37774f4-db96-4aa6-b3a1-626953faeecf

Single

Results

NCT01605396

The Ridaforolimus + Dalotuzumab + Exemestane group of the primary trial had a median PFS of over 38.43 months.

Contradiction

{'Clinical Trial ID': 'NCT01605396', 'Intervention': ['INTERVENTION 1: ', ' Ridaforolimus + Dalotuzumab + Exemestane', ' Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity.', 'INTERVENTION 2: ', ' Ridaforolimus + Exemestane', ' Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.'], 'Eligibility': ['Inclusion Criteria:', ' Females with a histologically confirmed diagnosis of breast cancer that is metastatic or locally advanced (locally advanced tumors must not be amenable to', ' surgery or radiation therapy with curative intent) with the following pathological characteristics determined locally: estrogen receptor positive and Human Epidermal Growth Factor Receptor 2 (HER-2) negative, and Ki67 (a tumor marker) 15% determined by the central study laboratory', ' Post-menopausal', ' With advanced breast cancer whose disease was refractory to previous letrozole or anastrozole', ' Has at least one confirmed measurable metastatic lesion', ' Has a performance status 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale', ' Has a life expectancy of at least 3 months', ' Adequate organ function', 'Exclusion Criteria:', ' Is receiving any other concurrent systemic tumor therapy, including', ' hormonal agents and HER-2 inhibitors', ' Previously received rapamycin or rapamycin analogs, including', ' ridaforolimus, temsirolimus, or everolimus', ' Received prior treatment with Insulin-like Growth Factor 1 Receptor (IGF-1R) inhibitors, Phosphatidylinositol 3-Kinase (PI3K) inhibitors, or', ' other experimental agents that target PI3K, Protein Kinase B (AKT), or Mammalian Target of Rapamycin (mTOR) pathway', ' Is receiving chronic corticosteroids administered at doses greater than', ' those used for normal replacement therapy', ' Has active brain metastasis or leptomeningeal carcinomatosis; patients', ' with adequately treated brain metastases are eligible if they meet certain criteria', ' Known allergy to macrolide antibiotics', ' Has an active infection requiring antibiotics', ' Significant or uncontrolled cardiovascular disease', ' Poorly controlled Type 1 or 2 diabetes', ' Is known to be Human Immunodeficiency Virus (HIV) positive', ' Has a known history of active hepatitis B or C. Healthy carriers of hepatitis B are not allowed on this study'], 'Results': ['Outcome Measurement: ', ' 1. Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR)', ' PFS was defined as the time from randomization to progressive disease, or death, whichever occurs first. Response was assessed according to RECIST 1.1 by BICR. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% confidence interval [CI]) in weeks was reported for each treatment arm. Per protocol, participants remained on assigned treatment until disease progression. Participants who discontinued study treatment for reasons other than disease progression continued to be assessed by imaging until objective documentation of progression. All participants (including participants who discontinued study treatment) were followed for survival until investigator notification to discontinue.', ' Time frame: From Day 1 through last post-study efficacy follow-up (up to ~19 months)', 'Results 1: ', ' Arm/Group Title: Ridaforolimus + Dalotuzumab + Exemestane', ' Arm/Group Description: Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 40', ' Median (95% Confidence Interval)', ' Unit of Measure: Weeks 23.29 (8.71 to 38.43)', 'Results 2: ', ' Arm/Group Title: Ridaforolimus + Exemestane', ' Arm/Group Description: Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.', ' Overall Number of Participants Analyzed: 40', ' Median (95% Confidence Interval)', ' Unit of Measure: Weeks 31.86 (16.00 to 39.29)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 8/39 (20.51%)', ' Myocardial infarction 0/39 (0.00%)', ' Sinus tachycardia 0/39 (0.00%)', ' Diarrhoea 1/39 (2.56%)', ' Haematochezia 0/39 (0.00%)', ' Vomiting 1/39 (2.56%)', ' Asthenia 0/39 (0.00%)', ' Disease progression 0/39 (0.00%)', ' Jaundice cholestatic 0/39 (0.00%)', ' Appendicitis 0/39 (0.00%)', ' Escherichia sepsis 1/39 (2.56%)', ' Gastroenteritis 0/39 (0.00%)', 'Adverse Events 2:', ' Total: 17/40 (42.50%)', ' Myocardial infarction 1/40 (2.50%)', ' Sinus tachycardia 1/40 (2.50%)', ' Diarrhoea 0/40 (0.00%)', ' Haematochezia 1/40 (2.50%)', ' Vomiting 1/40 (2.50%)', ' Asthenia 1/40 (2.50%)', ' Disease progression 1/40 (2.50%)', ' Jaundice cholestatic 1/40 (2.50%)', ' Appendicitis 1/40 (2.50%)', ' Escherichia sepsis 0/40 (0.00%)', ' Gastroenteritis 1/40 (2.50%)']}

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

4fef4cdf-53bf-4239-9d31-4710fd3edc6f

Single

Intervention

NCT00181363

The only difference between the interventions used in the primary trial is the patients position.

Entailment

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

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

331affb2-f8e9-4a55-ac4c-62d2ecc4f80b

Single

Eligibility

NCT00834678

Patients must have a white blood cell count above 1,500/mm³ to participate in the primary trial.

Entailment

{'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%)']}

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

a577e819-c928-4217-8743-f4809e852919

Comparison

Results

NCT01004172

NCT00802945

the primary trial and the secondary trial both use tumor Objective response rate to measure the effects of their different interventions.

Contradiction

{'Clinical Trial ID': 'NCT01004172', 'Intervention': ['INTERVENTION 1: ', ' Carboplatin, Bevacizumab, Trastuzumab (if HER2+)', ' Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration is 28 days.', ' carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle', ' bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle', ' trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only', ' *8mg/kg loading dose in cycle 1 for some participants', ' HER-2: human epidermal growth factor receptor 2'], 'Eligibility': ['Inclusion Criteria:', ' Histologically or cytologically confirmed invasive breast cancer, with metastatic disease. patients without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis by physical exam or radiologic study', ' Measurable disease. Patients must have measurable CNS disease, defined as at least one parenchymal brain lesion that can be accurately measured in at least one dimension with longest dimension >/= 10mm by local radiology review', " New or progressive CNS lesions, as assessed by the patient's treating physician", ' No increase in corticosteroid dose in the week prior to the baseline brain MRI', ' 18 years of age or older', ' Life expectancy of greater than 12 weeks', ' Eastern Cooperative Oncology Group Performance Score (ECOG PS) performance status 0-2', ' Normal organ and marrow function as outlined in the protocol', ' Left ventricular ejection fraction >/= 50%, as determined by radionuclide ventriculography (RVG) or echocardiogram within 60 days prior to initiation of protocol therapy', ' Prior carboplatin is allowed if it was not given in conjunction with bevacizumab', ' Prior trastuzumab is allowed', ' No prior bevacizumab since diagnosis of CNS metastases or within 6 months prior to diagnosis of CNS metastases', ' Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation', 'Exclusion Criteria:', ' Patients who have had chemotherapy within 14 days prior to entering the study, or those who have not recovered adequately from adverse events due to agents administered earlier', ' Patients may not receive any concurrent investigational agents while on study', ' Patients may not receive any cancer-directed concurrent therapy , such as concurrent chemotherapy, radiotherapy, or hormonal therapy while on study. Concurrent treatment with bisphosphonates is allowed', ' History of Grade 3 or 4 allergic reactions attributed to compounds of similar or identical biologic composition to bevacizumab, carboplatin, or trastuzumab', ' Known contraindication to MRI with gadolinium contrast, such as cardiac pacemaker, shrapnel, or ocular foreign body', ' Leptomeningeal carcinomatosis as the only site of CNS involvement', ' More than 2 seizures over last 4 weeks prior to study entry', ' Grade 1 or higher CNS hemorrhage on baseline brain MRI', ' History of grade 2 or higher CNS hemorrhage within 12 months of study entry', ' Inadequately controlled hypertension', ' Prior history of hypertensive crisis or hypertensive encephalopathy', ' New York Heart Association (NYHA) Grade II or greater congestive heart failure', ' History of myocardial infraction or unstable angina within 6 months prior to day 1', ' Significant vascular disease within 6 months prior to day 1', ' History of hemoptysis within 1 month prior to day 1', ' Evidence of bleeding diathesis or significant coagulopathy', ' Current, ongoing treatment with full-dose warfarin or its equivalent', ' Use of aspirin (>325 mg/day) within 10 days prior to day 1', ' Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 or anticipation of need for major surgical procedure during the course of the study.', ' Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to day 1', ' History of abdominal fistula or gastrointestinal perforation within 6 months prior to day 1', ' Serious, non-healing wound, active ulcer, or untreated bone fracture', ' Proteinuria as demonstrated by a urine protein-creatinine ratio >/= 1.0 at screening', ' Known hypersensitivity to any component of bevacizumab', ' Pregnancy or lactation'], 'Results': ['Outcome Measurement: ', ' Central Nervous System (CNS) Objective Response Rate', ' CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows:', ' CNS complete response (CR) is achieved if all of the following are satisfied:', ' Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases', ' No new CNS lesions (defined as any new lesion >= 6 mm in LD)', ' Stable or decreasing steroid dose', ' No new/progressive tumor-related neurologic signs or symptoms', ' No progression of extra-CNS disease as assessed by RECIST', ' CNS partial response (PR) is achieved if all of the following are satisfied:', ' ->/= 50% reduction in the volumetric sum of all measurable (>/= 1 cm in LD) brain metastases compared to baseline', ' No progression on non-measurable lesions', ' No new CNS lesions (defined as any new lesion >/= 6 mm in LD)', ' Stable or decreasing steroid dose', ' No new/progressive tumor-related neurologic signs or symptoms', ' No progression of extra-CNS disease as assessed by RECIST', ' Time frame: Response was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment duration for this study cohort was a median (range) of 8 cycles (1-20) which approximates months given the 4 week cycle length.', 'Results 1: ', ' Arm/Group Title: Carboplatin, Bevacizumab, Trastuzumab (if HER2+)', ' Arm/Group Description: Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration is 28 days.', ' carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle', ' bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle', ' trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only', ' *8mg/kg loading dose in cycle 1 for some participants', ' HER-2: human epidermal growth factor receptor 2', ' Overall Number of Participants Analyzed: 38', ' Measure Type: Number', ' Unit of Measure: percentage of participants 63 (47 to 77)'], 'Adverse Events': ['Adverse Events 1:', ' Total: 16/38 (42.11%)', ' Hemoglobin 1/38 (2.63%)', ' Ocular-other 1/38 (2.63%)', ' Fatigue 6/38 (15.79%)', ' Leukocytes 1/38 (2.63%)', ' Neutrophils 3/38 (7.89%)', ' Platelets 4/38 (10.53%)', ' ALT, SGPT 1/38 (2.63%)', ' AST, SGOT 2/38 (5.26%)', ' Hypercalcemia 1/38 (2.63%)', ' Hyponatremia 1/38 (2.63%)', ' Nonneuropathic generalized weakness 1/38 (2.63%)', ' Joint, pain 1/38 (2.63%)']}

{'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%)']}

bd073d05-3ba2-4898-9d86-a51951a7ad1f