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Site for A RANDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR HER2 NEGATIVE BREAST CANCER: THE ABC TRIAL.
This is a drug study with a primary outcome of testing aspirin as therapy versus a placebo pill for patients for breast cancer.
This is a drug study with a primary outcome of testing aspirin as therapy versus a placebo pill for patients for breast cancer.
All
18 year(s) or older
NCT02927249
SITE00000491
Inclusion Criteria:
Histologic documentation of women or men with HER2 negative breast carcinoma and free of recurrence.Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by the treating physician, is allowed.
Age > 18 and < 70 years of age.
ECOG performance status 0-2.
Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention.
Exclusion Criteria:
No history of GI bleeding requiring a blood transfusion, endoscopic or operative intervention.No history of any prior stroke (hemorrhagic or ischemic).
No concurrent anticoagulation with warfarin, heparin/heparin analogues, clopidogrel, direct thrombin inhibitors, or direct factor XA inhibitors.
No history of atrial fibrillation or myocardial infarction.
No history of grade 4 hypertension, defined as hypertension resulting in lifethreatening consequences
Cancer