A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial
- 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. If neoadjuvant therapy was received, either initial clinical stage (determined by physical and or radiologic examination) or post-operative pathologic stage can be used for eligibility purposes, with the higher stage determining eligibility. Histologic documentation of node positivity is required.
- Any ER/PgR status allowed.
- Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by the treating physician, is allowed. The last dose of chemotherapy or radiation therapy must be at least 60 days prior to study registration. Concurrent hormonal therapy will be allowed.
- Regular NSAID/aspirin use (defined as ≥ 5 days per week) is allowed if aspirin and/or
NSAIDs are stopped for one year prior to study entry and throughout the study period.
Participants will be encouraged to use acetaminophen for minor pain and fever.
- Patients must be enrolled within 1 year after diagnosis.
- 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. For patients who are Helicobacter pylori positive, a course of Helicobacter pylori
eradication treatment must have been completed
- 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 or heparin or clopidogrel or oral direct
- No history of atrial fibrillation or myocardial infarction
- No history of grade 4 hypertension, defined as hypertension resulting in life-threatening
consequences (e.g., malignant hypertension, transient or permanent neurologic deficit,
- No chronic (duration >30 days) daily use of oral steroids
- No known allergy to aspirin
- No prior malignancy of any type within the past 5 years other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as
that trial allows concurrent daily aspirin use
- Required Initial Laboratory Values
- Platelet count ≥ 100,000/mm3
- Aspirin vs. Placebo - One 300mg tablet by mouth daily x 5 years
**The Aspirin/Placebo is supplied by the drug company.