ABC – A RANDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR NODE-POSTIVE HER2 NEGATIVE BREAST CANCER: THE ABC TRIAL
Primary Objective: To compare the effect of aspirin (300 mg daily) versus placebo upon invasive disease free survival in early stage node-positive HER2 negative breast cancer patients.
Secondary Objectives: To compare the effect of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients upon: a) Distant disease-free survival b) Overall survival c) Cardiovascular disease.
- Required Initial Laboratory Values Histologic documentation of women or men with node-positive, HER2 negative, anatomic Stage II or III breast carcinoma within one year of diagnosis and free of recurrence.
- Platelet Count ≥ 100,000/mm3
- Any ER/PgR status allowed.
- Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined the treating physician, is allowed.
- Regular NSAID/aspirin use allowed if stopped for 1 year period prior to study entry and throughout study period.
- Patients must be enrolled within 1 year after diagnosis.
- Patients must be > 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.
- Basic understanding of spoken or written English will be required to complete the Quality of Life questionnaires.
- No history of prior stroke (hemorrhagic or ischemic).
- No history of GI bleeding.
- No concurrent anticoagulation with warfarin or heparin or clopidogrel or oral direct thrombin inhibitors.
- No history of atrial fibrillation or myocardial infarction.
- No history of grade IV hypertension.
- No chronic (duration >30 days) daily use of oral steroids. No prior malignancy of any type within the past 5 years. Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use.
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