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All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these. | INTERVENTION 1:
Diagnostic (FLT PET)
Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.
Tracer used in the FLT PET (positron emission tomography) s... | Contradiction |
Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial. | PATIENT CHARACTERISTICS:
ANC 1,500/mm³
Platelet count 100,000/mm³
Hemoglobin 9.0 g/dL | Contradiction |
Heart-related adverse events were recorded in both the primary trial and the secondary trial. | Adverse Events 1:
Supraventricular tachycardia 1/32 (3.13%)
Adverse Events 1:
Atrial fibrillation 1/752 (0.13%)
Atrial flutter 0/752 (0.00%)
Cardiac failure congestive 1/752 (0.13%)
Left ventricular dysfunction 0/752 (0.00%) | Entailment |
Adult Patients with histologic confirmation of invasive bilateral breast carcinoma (T1 N1 M1) are eligible for the primary trial. | Inclusion Criteria:
Patients with histologic confirmation of invasive breast carcinoma.
Patients greater than or equal to 18 years.
Patients should have T1N1-3M0 or T2-4 N0-3M0.
Patients with bilateral breast cancer are eligible. | Contradiction |
Laser Therapy is in each cohort of the primary trial and the secondary trial, along with neoadjuvant chemotherapy. | INTERVENTION 1:
Laser Therapy Alone
therapist administered laser treatment
laser: therapist administered laser
INTERVENTION 2:
Mld Alone
therapist administered manual lymphatic drainage
manual lymphatic drainage: therapist administered massage therapy
INTERVENTION 1:
Part A Abemaciclib: HR+, HER2+ Bre... | Contradiction |
Patients must have already participated in a specific clinical study to participate in the primary trial or the secondary trial. | Inclusion Criteria:
Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and par... | Contradiction |
Patients with Clinical stage II (T2 N1) invasive mammary carcinoma are not eligible for the primary trial. | Inclusion Criteria:
Clinical stage I or II (T1 or T2, N0 or N1) invasive mammary carcinoma
Exclusion Criteria:
Fixed axillary lymph node metastases (N2) | Contradiction |
the primary trial and the secondary trial have Hypnotherapy based interventions, the secondary trial also used pain medication in its intervention. | INTERVENTION 1:
Adjuvant Radiotherapy
Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.
Adjuvant Radiotherapy: Adjuvant radiation therapy
INTERVENTION 1:
Hypnotherapy
Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions... | Contradiction |
Adele is an 85 year old woman with Stage II histologically confirmed ER+ breast cancer with an ECOG of 0, she is eligible for the primary trial | Inclusion Criteria:
Must be female with histologically confirmed breast cancer
Stage II-IV disease
ER and/or PR positive
ECOG Performance Status 0-1
Postmenopausal | Entailment |
Only patients in the primary trial receive 40.5 Gy of brachytherapy, patients in the secondary trial receive no radiotherapy whatsoever. | INTERVENTION 1:
Accelerated Intensity Modulated Radiation Therapy (AIMRT)
All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor b... | Contradiction |
Certain drinks are banned for patients undertaking the primary trial. | Inclusion Criteria:
Agrees not to consume grapefruit juice while on the study | Entailment |
Most of the cases of CHF in the primary trial, were in cohort 1. | Adverse Events 1:
Cardiac failure congestive 1/32 (3.13%)
Adverse Events 2:
Cardiac failure congestive 0/20 (0.00%) | Entailment |
Candidates for the primary trial must have a life expectancy over 6 months. | Life expectancy
Not specified | Contradiction |
Patients eligible for the primary trial must live in the USA. | Inclusion Criteria:
Age 52-75 years old;
Identification as Latina/Hispanic/Chicana female;
Residence in Pilsen, Little Village, East Side or South Chicago; | Entailment |
Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | INTERVENTION 1:
Placebo
Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.
Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)
INTERVEN... | Entailment |
the primary trial administers letrozole for 28 days, whereas the secondary trial administers is intervention over 4 cycles of 21 days. | INTERVENTION 1:
Post-menopausal Women Using Adjuvant Letrozole
Part A Routine Care Letrozole; Part B Double Dose Letrozole in overweight/obese participants
Letrozole: Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In o... | Contradiction |
Candidates for the primary trial must have adequate colon and liver function, and must not be currently receiving amiodarone or have received amiodarone in the last 28 day. Renal function is not relevant for inclusion. | Inclusion Criteria:
The following criteria are to be checked at the time of study entry. The patients may only be included in the study if ALL of the following statements are FULLFILLED:
The patient (male or female) is at least 18 years old at the time of signature of the informed consent form.
Written informed c... | Contradiction |
both the primary trial and the secondary trial administer Bevacizumab to every single HER2+ patient. | INTERVENTION 1:
Arm 1: Yoga Intervention
Yoga Intervention
Yoga: Yoga sessions
INTERVENTION 2:
Arm 2: Educational Wellness Group
Educational Wellness Group
Education: Educational Wellness Group
INTERVENTION 1:
Arm A: Endocrine Therapy (ET)
Endocrine treatment consisting of either letrozole or fulves... | Contradiction |
CO2 is utilised as part of the intervention in a single one of the study groups in the primary trial, and not used in either of the study groups in the secondary trial. | INTERVENTION 1:
AeroForm Tissue Expansion
AeroForm Tissue Expansion inflation with carbon dioxide by remote control
AeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbo... | Entailment |
There were no completed suicides in either the primary trial or the secondary trial, however there was one attempt in cohort 1 of the secondary trial. | Adverse Events 1:
Total: 31/116 (26.72%)
Neutropenia 1/116 (0.86%)
Thrombocytopenia 1/116 (0.86%)
Acute myocardial infarction 1/116 (0.86%)
Myocardial infarction 0/116 (0.00%)
Pericardial effusion 0/116 (0.00%)
Abdominal pain 3/116 (2.59%)
Ascites 1/116 (0.86%)
Diarrhoea 3/116 (2.59%)
Gingival bleed... | Entailment |
the primary trial is testing a chemotherapy treatment whereas the secondary trial is testing a physcotherapy course. | INTERVENTION 1:
Lapatinib With Paclitaxel
Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Par... | Contradiction |
At least 4 patients in both cohorts of the primary trial achieved either complete response (CR) or partial response (PR). | Outcome Measurement:
Objective Response Rate (ORR)
An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation cri... | Entailment |
Less than 1/4 patients in the primary trial experienced adverse events. | Adverse Events 1:
Total: 8/24 (33.33%) | Contradiction |
The both Cohorts of the primary trial receive their treatment via Subcutaneous administration. | INTERVENTION 1:
Initial Cohort
Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms
Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) ... | Entailment |
the primary trial does not accept patients with grade 1 alopecia. | Exclusion Criteria Subjects who meet any of the following criteria will be excluded from participation in the treatment protocol:
Existing anti-cancer therapy-related toxicities of Grade >/= 2, except that alopecia and Grade 2 neuropathy are acceptable. | Entailment |
Participant in cohort 1 of the primary trial undergo a Mammography, whereas patients in cohort 1 of the secondary trial receive 6 mg Estradiol as supplementation for the Mammography. | INTERVENTION 1:
Mammography Only
For this reporting arm, the interpretation and analysis was done with mammography only.
INTERVENTION 1:
Arm 1 (6 mg Estradiol)
6 mg of estradiol daily (2 mg tid). | Contradiction |
A single patient in the primary trial experienced a clinically significant inflammation of the back of the throat. | Adverse Events 1:
Acute Pharyngitis * 1/63 (1.59%) | Entailment |
More than 5% of the primary trial participants achieved partial response (PR). | Outcome Measurement:
Objective Response (OR)
Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .
Time frame: From first dose of study medication to response measurement, up to 34 month
Results 1:
... | Contradiction |
Both the primary trial and the secondary trial at least partly administer their interventions orally. | INTERVENTION 1:
Suramin and Paclitaxel
Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
INTERVENTION 1:
Ipatasertib and Paclitaxel
Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Day... | Contradiction |
Neutropenia affected the majority of patients in cohort 1 of the primary trial. | Adverse Events 1:
Neutropenia 4/69 (5.80%) | Contradiction |
the primary trial has a shorter time frame than the secondary trial, both of these studies employ the same units of measure in their evaluation. | Outcome Measurement:
Duration of Moderate Neurtopenia Post First Chemotherapy Administration
Number of days In which the patient has had an absolute neutrophil count (ANC) Level < 2.0 x 10^9/L after first cycle of chemotherapy
Time frame: The first of 4, 21 Day Chemotherapy Cycles
Unit of Measure: days 0.6 ... | Contradiction |
the primary trial is testing a novel radiotracer called 89Zr-trastuzumab to evaluate its use for visualization of HER2+ lesions. | INTERVENTION 1:
HER2-targeted PET/CT
Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT im... | Entailment |
Participants of the primary trial are assigned an intervention depending on their prior treatments. | INTERVENTION 1:
Neratinib 240, Prior Trastuzumab
Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.
INTERVENTION 2:
Neratinib 240, No Prior Trastuzumab
Neratinib: 80... | Entailment |
the primary trial and the secondary trial use different inclusion criteria for their cohorts, so patients may be eligible for one cohort, but not the other. | Inclusion Criteria:
(Cohort 1) Concurrent systemic cancer therapy (hormones, biologics or chemotherapy) is allowed if distant metastases have been non-progressing (stable or responding) on that regimen for > or = 12 weeks and skin metastases are non-responsive (stable or progressing) as assessed by the investigator.
... | Contradiction |
A patient has recently been receiving Tamoxifen to treat breast cancer, they are excluded from the primary trial. | Exclusion Criteria:
Prior endocrine therapy for any histologically confirmed cancer is not allowed. Prior endocrine therapy that was administered 5 years ago for the prevention of breast cancer in patients with no history of breast cancer is allowed. | Entailment |
Neither the primary trial or NCT0306117 use chemotherapy or radiotherapy in their intervention. | INTERVENTION 1:
Intervention
Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness
Text message management prompts
INTERVENTION 2:
Control
Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness
INTERV... | Entailment |
Agatha had her 50th birthday last week, she has a histologically confirmed adenocarcinoma of the breast, with no evidence of metastatic disease. She is eligible for the primary trial but not the secondary trial. | Inclusion Criteria:
female patients 18-70 years of age;
Inclusion Criteria:
Age 52-75 years old; | Entailment |
several patients in cohort 1 of the primary trial Preferred oral tablets as a Method of Drug Administration. | Outcome Measurement:
Percentage of Participants by Preferred Method of Drug Administration
The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, "All things considered, which method of administratio... | Contradiction |
In the primary trial cohort 2 had more patients with Leukopenia than cohort 1, whereas in the secondary trial cohort 1 had more than cohort 2. Cohort 1 of the primary trial had the highest proportion of patients with leukopenia. | Adverse Events 1:
Leukopenia 0/42 (0.00%)
Adverse Events 2:
Leukopenia 2/61 (3.28%)
Adverse Events 1:
LEUKOPENIA 2/145 (1.38%)
Adverse Events 2:
LEUKOPENIA 0/144 (0.00%) | Contradiction |
There were 7 more cases of Anaemia and 1 more case of Disseminated intravascular coagulation in cohort 1 of the primary trial compared to cohort 2. | Adverse Events 1:
Total: 158/482 (32.78%)
Anaemia 7/482 (1.45%)
Disseminated intravascular coagulation 1/482 (0.21%)
Adverse Events 2:
Total: 37/238 (15.55%)
Anaemia 2/238 (0.84%)
Disseminated intravascular coagulation 0/238 (0.00%) | Contradiction |
There are several types of surgical and therapeutic treatments which are banned for patients wanting to take part in the primary trial. | PRIOR CONCURRENT THERAPY:
No prior thoracic or cardiac surgery
No prior ipsilateral chest tube placement
Contralateral chest tube placement allowed
No prior neoadjuvant chemotherapy
No prior radiotherapy to the mediastinum | Entailment |
The shortest PFS in the Talazoparib group of the primary trial was over a month shorter than the Median PFS for that group. | Outcome Measurement:
Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment
IRF assessed PFS was defined as time (in months) from randomization until the date of first documented radiologic progressive disease per response evaluation criteria in solid tumors (RECIST) version 1.1 or dea... | Entailment |
Participants in group 2 of the primary trial receive taping to anastomosis regions., but no Complex Decongestive Physiotherapy. | INTERVENTION 1:
Decongestive Physiotherapy
This group received Complex Decongestive Physiotherapy.
Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the n... | Contradiction |
None of the patients in cohort 1 of the primary trial had a platlet deficiency, and none of the patients in cohort 2 had Pyrexia. | Adverse Events 1:
Total: 17
Anaemia 2/52 (3.85%)
Febrile neutropenia 4/52 (7.69%)
Pancytopenia 1/52 (1.92%)
Thrombocytopenia 0/52 (0.00%)
Abdominal pain 1/52 (1.92%)
Constipation 1/52 (1.92%)
Pyrexia 2/52 (3.85%)
Hepatic failure 1/52 (1.92%)
Hyperbilirubinaemia 1/52 (1.92%)
Device related infectio... | Contradiction |
The adverse events in the primary trial where all equally prevalent, whereas in the secondary trial, alcohol poisoning was reported as the most common event. | Adverse Events 1:
Total: 8/29 (27.59%)
Leukopenia [1]1/29 (3.45%)
Thrombocytopenia [1]1/29 (3.45%)
Abscess [1]1/29 (3.45%)
Breast Abscess 1/29 (3.45%)
Fever/Sepsis [1]1/29 (3.45%)
Neutropenic Fever [2]1/29 (3.45%)
Peripheral Neuropathy [1]1/29 (3.45%)
Seizure/Syncope [1]1/29 (3.45%)
Hematuria... | Contradiction |
There were only 3 adverse events in the primary trial which occurred more than twice. | Adverse Events 1:
Total: 10/71 (14.08%)
ATRIAL FIBRILLATION 1/71 (1.41%)
CARDIAC TAMPONADE 1/71 (1.41%)
PERICARDIAL EFFUSION 1/71 (1.41%)
SUPRAVENTRICULAR TACHYCARDIA 1/71 (1.41%)
DIARRHOEA 1/71 (1.41%)
NAUSEA 1/71 (1.41%)
VOMITING 1/71 (1.41%)
CHEST PAIN 1/71 (1.41%)
PNEUMONIA 1/71 (1.41%)
MALIGN... | Contradiction |
Most patients in the Letrozole group of the primary trial had a decreased Bone Mineral Density of the Lumbar Spine after 24 months. | Outcome Measurement:
Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)
Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually... | Entailment |
In the primary trial cohort 1 patients must have failed or be intolerant to standard therapy, or have no standard therapy available, and cohort 2 patients must respond well to standard therapy. | INTERVENTION 1:
Monotherapy: Alobresib 0.6 mg
Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determ... | Contradiction |
the primary trial and the secondary trial do not have any overlapping inclusion criteria, apart from the mimimum age limit of 18. | Inclusion Criteria:
Previous participation in study 971-ONC-0028-080.
Exclusion Criteria:
Subjects who had not previously participated in study 971-ONC-0028-080.
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer at high risk for recurrence, defined by one of the following:
Stage IV that is free of all known ... | Contradiction |
1 patient in the primary trial had toxic hepatitis. | Adverse Events 1:
Hepatotoxicity 1/112 (0.89%) | Entailment |
the secondary trial is testing for the DLT of its interventions, whereas the primary trial is evaluating the efficacy of lymph node detection through the use of SentiMag and SiennaXP. | Outcome Measurement:
Number of Participants With Detected Lymph Nodes
The proportion of lymph nodes detected intraoperatively by SentiMag and SiennaXP in relation the proportion of lymph nodes detected by the combination of Technetium Sulfur Colloid and Isosulfan blue dye
Outcome Measurement:
Number of Partici... | Entailment |
Participants of the primary trial must be older than 18, have histologically confirmed stage 4 breast cancer, ECOG<2 and a life expectancy exceeding 6 months. | Inclusion Criteria:
Histologically confirmed Stage IV breast cancer
ECOG performance status 0 or 1
Estimated life expectancy of greater than or equal to 6 months
18 years of age or older | Entailment |
All the primary trial participants receive the same dose of Letrozole, and all patients in the secondary trial are administered the same dose of Tamoxifen. | INTERVENTION 1:
Letrozole
Letrozole 2.5 mg/day for 3 years
INTERVENTION 2:
Letrozole + Zoledronic Acid
Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
INTERVENTION 1:
Tamoxifen
Tamoxifen 20mg orally daily for 5 years
INTERVENTION 2:
Ovarian Function Suppression
Tamoxifen 20m... | Contradiction |
There were 2 cases of severe back pain observed in the primary trial. | Adverse Events 1:
Total: 3/25 (12.00%)
Anemia 0/25 (0.00%)
Sinus tachycardia 0/25 (0.00%)
Pericardial effusion 1/25 (4.00%)
Gastrointestinal disorders - Other, specify -stomatitis) 0/25 (0.00%)
Vomiting 1/25 (4.00%)
Fever 0/25 (0.00%)
Injection site reaction 1/25 (4.00%)
Catheter related infection 0/2... | Contradiction |
Across all cohorts of the secondary trial and the primary trial there was only a single recorded case of Myocarditis and Thrombosis. | Adverse Events 1:
Total: 3/73 (4.11%)
Chest Pain - cardiac 1/73 (1.37%)
Myocarditis 1/73 (1.37%)
Pericarditis 1/73 (1.37%)
Ventricular tachycardia 1/73 (1.37%)
Skin infection 0/73 (0.00%)
Dermatitis radiation 0/73 (0.00%)
Dyspnea 1/73 (1.37%)
Adverse Events 2:
Total: 3/70 (4.29%)
Chest Pain -... | Contradiction |
Participants in cohort 1 of the primary trial weighing less than 45 kg receive 5 million units/m^2 less of IL-2, than participants over 45 kg, but all participants will be administered Methylprednisolone 3 times per week for 6 doses. | INTERVENTION 1:
Arm 1: CsA
Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.
Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural Kil... | Contradiction |
One patient in the primary trial had abnormally low red blood cells, white blood cells, and platelets. | Pancytopenia * 1/56 (1.79%) | Entailment |
The adverse events in the primary trial where all equally prevalent, whereas in the secondary trial, progression of disease was reported as the most common event. | Adverse Events 1:
Total: 8/29 (27.59%)
Leukopenia [1]1/29 (3.45%)
Thrombocytopenia [1]1/29 (3.45%)
Abscess [1]1/29 (3.45%)
Breast Abscess 1/29 (3.45%)
Fever/Sepsis [1]1/29 (3.45%)
Neutropenic Fever [2]1/29 (3.45%)
Peripheral Neuropathy [1]1/29 (3.45%)
Seizure/Syncope [1]1/29 (3.45%)
Hematuria... | Entailment |
Less than 5% of cohort 1 of the primary trial had High blood sugar, 0% of the secondary trial patients were recorded as having High blood sugar. | 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%)
Adverse Events 1:
Total: 24/101 (23.76%)
LYMPHADENOPATHY 0/101 (0.00%)
FEBRILE NEUTROPENIA 20/101 (... | Entailment |
Radiotherapy and healing touch therapy is used in all cohorts of the primary trial and the secondary trial. | INTERVENTION 1:
Radiotherapy/Supportive Care (A)
Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy
INTERVENTION 2:
Control ARM (B)
Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch ther... | Contradiction |
There was 38% more patients with DLT in cohort 2 of the primary trial than in cohort 1. | Outcome Measurement:
Number of Participants With Dose Limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)
The following events, if considered to be study-treatment-related by the Investigator, were considered a DLT:
Hematologi... | Contradiction |
In total there were 5x more adverse events in cohort 1 of the primary trial, than in cohort 2. | Adverse Events 1:
Total: 4/26 (15.38%)
Febrile neutropenia * 1/26 (3.85%)
Gastric volvulus * 20/26 (0.00%)
General Malaise * 21/26 (3.85%)
Hospitalisation for intrapleuric chemotherapy and thoracentesis * 21/26 (3.85%)
Acute renal failure * 21/26 (3.85%)
Adverse Events 2:
Total: 1/28 (3.57%)
Febrile neu... | Contradiction |
the primary trial and the secondary trial are not studying PFS, PBR or DLTs. | Outcome Measurement:
Concordance of Blue Dye and Lymphoseek
The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.
Time frame: Surgery after injections of Lymphoseek and blue dye
Outcome Measurement:
Patient Benefit Rate at 12 Weeks
Percentage of patients... | Contradiction |
Patients with at most stage 3 cancer are eligible for the secondary trial and the primary trial. | Evidence of metastatic involvement (stage IV disease)
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary adenocarcinoma of the breast
Locally recurrent or metastatic disease
Must have HER-2-negative breast cancer or, if HER-2-positive, must be unable to receive trastuzumab (Herceptin®) ... | Contradiction |
Patients with a prior malignancy of skin cancer are excluded from the primary trial. | EXCLUSION CRITERIA (Patient Characteristics):
Other prior malignancies except skin cancer | Contradiction |
None of the patients in Cohort 1 of the primary trial suffered from Hypotension. | Adverse Events 1:
Hypotension 0/50 (0.00%) | Entailment |
Only White and Asian patients are eligible for both the primary trial and the secondary trial. | Inclusion Criteria:
Diagnosis of breast cancer
Part 1 only: Surgery for breast cancer within the past eight weeks (mastectomy or lumpectomy with either sentinel or axillar dissection), including those women with a history of previous surgery for breast cancer, radiation therapy or chemotherapy
Part 2 only: Comple... | Contradiction |
In total, across both cohorts of the primary trial, there were at least 2 patients with a fever. | Adverse Events 1:
Total: 2/6 (33.33%)
Febrile neutropenia * 1/6 (16.67%)
Neutropenia * 0/6 (0.00%)
Thrombocytopenia * 1/6 (16.67%)
Diarrhoea * 0/6 (0.00%)
Pyrexia * 0/6 (0.00%)
Thrombosis in device * 1/6 (16.67%)
Fatigue * 0/6 (0.00%)
Mucosal inflammation * 0/6 (0.00%)
Device deployment issue * 0/6 ... | Entailment |
We cannot compare results between the two Arms of the primary trial as there were no patients in cohort 1. | Outcome Measurement:
Maximum Tolerated Dose Determined by Dose-limiting Toxicities
1st 3 pts will be treated on arm 2. If 0/3 DLTs observed, the dose will be escalated to arm 3. If 1/3 DLTs onserved on arm 2, 3 more pts will be treated on arm 2. If no additional DLTs are observed on arm 2, the dose will be escalat... | Entailment |
Only one patient cohort of the primary trial had a positive median Insulin change from baseline. | Outcome Measurement:
Insulin
Insulin measured as percent change from baseline
Time frame: change from baseline to 6 months
Results 1:
Arm/Group Title: Metformin + Lifestyle Intervention
Arm/Group Description: Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morn... | Contradiction |
Cohort 2 of the primary trial had one more patient with Stable disease than cohort 1. | Outcome Measurement:
Clinical Benefit Rate (CR Plus PR Plus SD)
Complete response (CR) + partial response (PR) + stable disease (SD) using RECIST 1.0
CR = disappearance of all target lesions
PR = at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum l... | Entailment |
Left ventricular ejection fraction > 50% is required for participation in the primary trial. | LVEF 50% as measured by echocardiogram or MUGA scan | Entailment |
Patients with cancer in situ of the cervix are eligible for the primary trial and the secondary trial. | Exclusion Criteria:
History of cancer other than breast cancer within 5 years excluding basal/squamous cell skin carcinoma in situ of the cervix
Exclusion Criteria:
Any other malignancy in the last 5 years, except for basal cell cancer or cancer in situ of the cervix | Entailment |
the primary trial requires participants to have undergone PTR. | Inclusion Criteria:
Patients must have completed definitive resection of primary tumor with adequate excision of gross disease. | Entailment |
participants of cohort 1 in the primary trial and all participants of the secondary trial take 1 milligram of anastrozole and 40 milligrams of simvastatin PO QD. | INTERVENTION 1:
Arimidex Group
Anastrozole(ARIMIDEX): 1 mg once daily oral dose
INTERVENTION 1:
anastrozole : 1 milligram tablet PO QD for 14 days | Contradiction |
A female patient over the age of 18 suffering from chronic viral hepatitis would be eligible for the primary trial. | Inclusion Criteria:
Age 18 years or older
Exclusion Criteria:
Known chronic liver disease | Contradiction |
Women classified as high-risk of developing breast cancer within the next 5 years and within her lifetime by the Gail model are eligible for the primary trial. | Inclusion Criteria:
Gail risk >= 1.7% and/or relative risk >= 3 times that for 5-year age group | Entailment |
Cohort 1 of the primary trial recorded more optical adversse events than cohort 2. | Adverse Events 1:
Total: 61/202 (30.20%)
FEBRILE NEUTROPENIA 1/202 (0.50%)
LEUKOPENIA 0/202 (0.00%)
NEUTROPENIA 2/202 (0.99%)
CARDIAC FAILURE CONGESTIVE 0/202 (0.00%)
CARDIO-RESPIRATORY ARREST 1/202 (0.50%)
PERICARDIAL EFFUSION 1/202 (0.50%)
CATARACT 1/202 (0.50%)
OPTIC NEUROPATHY 0/202 (0.00%)
ABDO... | Contradiction |
Less than 0.25% of patients in cohort 1 of the primary trial suffered from Hyperbilirrubinemia. | Adverse Events 1:
Hyperbilirrubinemia [1]1/436 (0.23%) | Entailment |
Patients with dementia or schizophrenia may be eligible for the primary trial and the secondary trial. | 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 C... | Contradiction |
the primary trial and the secondary trial use ECOG to evaluate potential candidates' performance status. | World Health Organization (WHO) performance status of 0, 1, or 2
Zubrod performance status less than 2 | Contradiction |
More than 5% of the primary trial participants achieved Objective Response (OR). | Outcome Measurement:
Objective Response (OR)
Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .
Time frame: From first dose of study medication to response measurement, up to 34 month
Results 1:
... | Entailment |
Every patient in the primary trial is given tipifarnib PO, along with paclitaxel, doxorubicin hydrochloride and acyclophosphamide IV, but only a subset of participants undergo axillary lymph node dissection. | INTERVENTION 1:
Arm I
See Detailed Description
tipifarnib: Given orally
paclitaxel: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
pegfilgrastim: Given SC
conventional surgery: surgical procedures performed on patients
axillary lymph node dissection: correlative study | Contradiction |
None of the patients in the primary trial or the secondary trial committed suicide. | Adverse Events 1:
Total: 6
Atrial fibrillation 1/67 (1.49%)
Ventricular fibrillation 1/67 (1.49%)
Gastrointestinal perforation 1/67 (1.49%)
Periproctitis 1/67 (1.49%)
General physical health deterioration 1/67 (1.49%)
Escherichia sepsis 1/67 (1.49%)
Pneumonia 1/67 (1.49%)
Tumour pain 1/67 (1.49%)
Re... | Contradiction |
Stephanie has been living with her husband for 31 years, she is eligible for the primary trial. | Inclusion Criteria:
Has a partner or spouse who is > 21
Lives with a romantic partner > 6 months | Entailment |
All of the adverse events recorded in the primary trial were cardiac related. | Adverse Events 1:
Total: 5/45 (11.11%)
Neutrophils/granulocytes (ANC/AGC) * [1]0/45 (0.00%)
Neutrophils/granulocytes (ANC/AGC) * [2]0/45 (0.00%)
Diabetes decompensation * 0/45 (0.00%)
Diarrhea * [2]0/45 (0.00%)
Mucositis/stomatitis and Vomiting * [3]0/45 (0.00%)
Pancreatitis * [4]1/45 (2.22%)
Febri... | Contradiction |
Pre and Post menopausal women can enter the primary trial, as long as they do not have prior hormone replacement therapy. | Inclusion Criteria:
Female 18 + years of age
Confirmed diagnosis of DCIS on core or excisional/incisional biopsy and scheduled for definitive surgery
Pre or Post menopausal women reporting no use of hormone replacement therapy, tamoxifen or raloxifene within the prior 6 months to eligibility screening | Entailment |
the primary trial and the secondary trial are testing completely different modalities of interventions, but utilising the same 21 day cycle. | INTERVENTION 1:
Treatment (Tivantinib)
Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEG... | Contradiction |
Patients with ERBB2 positive tumors are eligible for the primary trial. | INCLUSION CRITERIA
erbB-2 gene amplified tumor (FISH or CISH) or erbB-2 overexpression (IHC 3+, or IHC2+ with FISH or CISH confirmation), based on local testing, or based on centralized FISH testing prior to day 1. | Entailment |
Most patients in the primary trial treated with Eribulin Mesylate did not achieve complete response (CR) or partial response (PR). | Outcome Measurement:
Objective Response Rate (ORR)
The ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Targeted lesions were assessed by compu... | Entailment |
Patients with invasive breast cancer with a diameter of less than 4 cm are included in the primary trial. | Ipsilateral biopsy-proven invasive breast cancer <5 cm in maximal dimension by Ultrasound or Mammography. | Entailment |
Fiona's sister, who is 34 years old was diagnosed with a ductal carcinoma, therefore fiona may be eligible for the primary trial. | Inclusion Criteria
A first degree relative with breast cancer under the age of 60 or multiple second degree relatives with breast cancer. | Entailment |
For some adverse event types in the primary trial, there were no recorded cases. | Adverse Events 1:
Total: 6/8 (75.00%)
Thrombocytopenia 1/8 (12.50%)
Hypertension 1/8 (12.50%)
Hepatotoxicity 3/8 (37.50%)
Pancreatectomy * 1/8 (12.50%) | Contradiction |
Cohort 1 of the primary trial had more cases of Hepatic encephalopathy and Pneumonia than cohort 2. | Adverse Events 1:
Total: 5/26 (19.23%)
Febrile neutropenia 1/26 (3.85%)
Abdominal pain 0/26 (0.00%)
Constipation 0/26 (0.00%)
Nausea 1/26 (3.85%)
Pancreatitis 1/26 (3.85%)
Vomiting 2/26 (7.69%)
Pain 0/26 (0.00%)
Pneumonia 0/26 (0.00%)
Urinary tract infection 1/26 (3.85%)
Lumbar vertebral fracture ... | Contradiction |
Patients with HER2 positive breast tumors are eligible for the primary trial, but excluded from the secondary trial. | Inclusion Criteria:
Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
Tumors over-expressing Her-2
Candidate for treatment with docetaxel/trastuzumab
HER2-positive by fluorescence in situ hybridization (FISH) or immunohistochemistry 3+ staining confirmed in the adjuvant or ... | Contradiction |
The intervention for the primary trial does not require patients to undergo any medical treatment during the study, whereas in the secondary trial, all patients receive Radiation Therapy. | INTERVENTION 1:
Arm 1: BREASTChoice (Decision Tool)
Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive ... | Entailment |
Patients with cytologically confirmed breast cancer, who's Locally recurrent disease is amenable to radiation with curative intent are not eligible for the primary trial. | Inclusion Criteria:
Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.
Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent. | Entailment |
the primary trial does not have an intervention section. | INTERVENTION 1:
Study Participants
There are no arms or subgroups in this study. | Entailment |
the primary trial's intervention section does not describe the intervention dosage, frequency or duration for cohort 2, however cohort 1 recieves placebo twice daily for two months. | INTERVENTION 1:
Recruitment Population
Pre-randomization recruitment and enrollment | Contradiction |
the primary trial had a higher percentage of patients with at least partial response than either cohort of the secondary trial. | Outcome Measurement:
Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Those who achieved either complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of the longest diameter (LD) of target les... | Entailment |
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