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enterocolitis was a common condition among participants in both the secondary trial and the primary trial.
Adverse Events 1: Total: 20/167 (11.98%) Cardiac failure acute 0/167 (0.00%) Diarrhoea 5/167 (2.99%) Colitis 2/167 (1.20%) Enterocolitis 1/167 (0.60%) Enterocolitis haemorrhagic 1/167 (0.60%) Stomatitis 1/167 (0.60%) Impaired healing 1/167 (0.60%) Sudden death 1/167 (0.60%) Postoperative wound infec...
Contradiction
in the cohorts of the primary clinical trial, no incidents of death were reported.
Outcome Measurement: Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence) Number of patients event-free Time frame: 12 month period following randomisation Results 1: Arm/Group Title: Fulvestrant + Anastro...
Entailment
patients with a predicted survival of at least one year are qualified to participate in the primary clinical trial
Inclusion criteria: Female patients 18 years of age. Written informed consent given. Histologically confirmed Stage IV breast cancer with at least one bone metastasis radiologically confirmed. Previous treatment with zoledronic acid every 3-4 weeks, for 9-12 infusions over no more than 15 months. Eastern Coo...
Entailment
dose limiting toxicities were suffered by 50% of cohort 2 patients in the primary clinical trial
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 surfa...
Entailment
only those diagnosed with her2-positive breast cancer can participate in the primary clinical trial
Inclusion Criteria: Archival tumor samples must be obtained from primary and/or metastatic sites Able to submit tumor tissue that is evaluable for programmed death- ligand 1 (PD-L1) expression HER-2 positive BC as defined by an immunohistochemistry score of 3 or gene amplified by in-situ hybridization as defined ...
Entailment
a malignant brain tumour diagnosis qualifies a patient for inclusion in the primary clinical trial
Inclusion Criteria: Must have received prior chemotherapy with Taxol (paclitaxel) or Taxotere (docetaxel). Less than 3 different chemotherapy treatments for metastatic disease. Prior treatment with hormonal and/or radiation therapy. Must have disease that can be measured. Must be able to take care of self nee...
Contradiction
most participants in the first and second cohort of the primary clinical trial failed to attain 5 years of disease-free survival.
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 Descr...
Contradiction
everolimus is given intramuscularly (to the deltoid) and fulvestrant orally in the context of the primary clinical trial.
INTERVENTION 1: Fulvestrant + Everolimus Fulvestrant + Everolimus Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses-one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereaf...
Contradiction
if an individual is qualified to participate in the secondary clinical trial, they will also be qualified for the primary clinical trial
Inclusion Criteria: Female or male patients with diagnosis of invasive adenocarcinoma of the breast confirmed at MSKCC. For the phase I portion, patients with any ER/PR/HER2 disease status, no longer eligible for hormonal therapy or HER2-targeted therapy, will be eligible. For the phase II portion, there needs to...
Contradiction
absence of radiographically confirmed metastases to the brain is a prerequisite for eligibility in the primary clinical trial.
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed breast cancer with radiographically confirmed metastases to the brain Extracranial metastases allowed Must have demonstrated progression of brain metastases after prior treatment for brain metastases, including any of the following: External bea...
Contradiction
the incidence of recorded musculoskeletal adverse events was distributed evenly between the two cohorts of the secondary clinical trial
Adverse Events 1: Total: 0/34 (0.00%) 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%) Ulceratio...
Contradiction
the only case of congestive heart failure in the primary clinical trial emerged in cohort 2.
Adverse Events 1: Total: 1/35 (2.86%) congestive heart failure *1/35 (2.86%) Adverse Events 2: Total: 0/40 (0.00%) congestive heart failure *0/40 (0.00%)
Contradiction
vaginal cream dosage form is a cream intended for administration in or around the vagina. The the primary trial intervention involves one drug taken orally and the secondary trial intervention is based on a medical procedure.
INTERVENTION 1: Letrozole Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks. INTERVENTION 1: Sentinel Lymph Node Biopsy [Not Specified]
Contradiction
participants who wish to join the primary clinical trial should have a confirmed tnbc status and an lvef rate of 50% or greater
Inclusion Criteria: For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly-effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and/or partner Histologically or cytologically confirmed and documen...
Contradiction
posterior tibial artery branch is any artery arising from the posterior tibial artery. there is a minimal difference between the results from the two the primary trial cohorts.
Outcome Measurement: Event-free Survival Event free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause. Time frame: 5 years Results 1: Arm/Group Title: Exemesta...
Entailment
to be accepted into the primary clinical trial, patients need to have a tangible carcinoma
Inclusion Criteria Phase 1 Age greater than/equal to 18 years Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ Patient desire to undergo breast surgery 3. Patients will have provided informed consent to participate, documented by their signature on the study consent form 4. Th...
Entailment
kbtbd4 small in-frame insertion mutation is an in-frame nucleotide insertion affecting six codons or less in the kbtbd4 gene. there is a 13.2% difference between the results from the two the primary trial cohorts.
Outcome Measurement: Event-free Survival Event free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause. Time frame: 5 years Results 1: Arm/Group Title: Exemesta...
Contradiction
no diarrhea was identified among the patients of the secondary trial, whereas multiple instances were detected among the participants of the primary trial
Adverse Events 1: Total: 59/373 (15.82%) Neutropenia 14/373 (3.75%) Febrile neutropenia 10/373 (2.68%) Leukopenia 1/373 (0.27%) Anaemia 2/373 (0.54%) Lymphadenopathy 0/373 (0.00%) cardiac failure 2/373 (0.54%) Atrial fibrillation 1/373 (0.27%) Pericardial effusion 2/373 (0.54%) Cardiac failure conge...
Contradiction
22q12.2 is a chromosome band present on 22q Most patients in the primary trial experienced a grade 1 adverse events, the least common severity was grade 4.
Outcome Measurement: Severity of Adverse Events Adverse events (AEs) grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Time frame: From cycle 1 up to approximately 3 years Results 1: Arm/Group Title: Trastuzumab Emtansi...
Entailment
the outcome measurement of the primary clinical trial is the rate of patients' response to the treatment
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 as...
Contradiction
occurrence of hot flashes is not a prerequisite for patient participation in the primary or secondary clinical trials.
DISEASE CHARACTERISTICS: Women with a history of breast cancer (currently without malignant disease) Bothersome hot flashes (defined by their occurrence 28 times per week and of sufficient severity to make the patient desire therapeutic intervention) Presence of hot flashes for 30 days prior to study registrati...
Contradiction
either surgical procedures or oral medication treatments are necessary components for participation in the primary clinical trial
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
Contradiction
the primary trial involves administering medication through nasal and rectal routes, whereas the secondary trial delivers treatment via transdermal patches.
INTERVENTION 1: Positron Emission Mammography Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. ...
Contradiction
only female patients diagnosed with advanced colon cancer are considered eligible candidates for the primary clinical trial and the secondary clinical trial
Inclusion Criteria: Females with histologic or cytologic diagnosis of advanced breast cancer. Lesions should not be amenable to surgery or radiation of curative intent. Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale. One prior chemotherapy containing anthrac...
Contradiction
the least progression free survival(pfs) observed in cohort 1 of the primary clinical trial was lesser than 3 weeks
Outcome Measurement: Progression Free Survival PFS is defined as the period from the day of randomization until the first observation of lesion progression or death from any cause. Disease progression is defined as PD according to RECIST Ver. 1.1. Assessment period was from the day of randomisation until the fir...
Contradiction
the primary trial reports the percentage of patients treated with Neratinib in Combination With Paclitaxel that suffer side effects that are serious enough to prevent an increase in dose or level of that treatment. cerebral blood flow assessment is an evaluation of the perfusion of blood through the brain.
Outcome Measurement: Dose Limiting Toxicity Incidence of Neratinib in Combination With Paclitaxel Dose Limiting Toxicity in subjects with solid tumors treated with neratinib, administered daily, in combination with paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle. Time frame: From first dose date th...
Entailment
a patient group involved in the primary clinical trial underwent a placebo treatment
INTERVENTION 1: Lapatinib 1500 mg Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal. IN...
Entailment
glucose urine excretion rate is a determination of the amount of glucose being excreted in urine over a defined period of time. eliane is a 56 year old woman, and alex is a 32 year old man, both eliane and alex can both be eligible for the primary trial.
Inclusion Criteria: women >=18 years of age; newly diagnosed; infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer. Exclusion Criteria: evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes; previous systemic or local primary treatment.
Contradiction
ability to participate in sexual activities is a question about an individual's ability to participate in sexual activities. The only case of congestive heart failure in the primary trial occurred in cohort 1.
Adverse Events 1: Total: 1/35 (2.86%) congestive heart failure *1/35 (2.86%) Adverse Events 2: Total: 0/40 (0.00%) congestive heart failure *0/40 (0.00%)
Entailment
candidates under the age of 18 are eligible for the primary clinical trial, even if their karnofsky score is below 80.
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 d...
Contradiction
the conclusions drawn from the primary clinical trial and secondary clinical trial are not equivalent or comparable.
Outcome Measurement: Number of Participants With Complete Pathologic Response. Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR. Although clinical ex...
Entailment
the primary clinical trial and the secondary clinical trial do not admit women currently under endocrine therapy
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% ...
Entailment
grade 3b follicular lymphoma is a grade 3 follicular lymphoma composed of solid sheets of centroblasts. Patients must be able to undergo a PET scan to participate in the primary trial.
Inclusion Criteria: Pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy Locally advanced breast cancer, not stage IV, and with a tumor size >= 2 cm (as measure...
Entailment