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A011502

A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer:  The ABC Trial

Inclusion Criteria

  • Histologic documentation of women or men with HER2 negative Breast carcinoma and free of recurrence.  If neoadjuvant therapy was received, either initial clinical stage or post-operative pathologic stage can be used for eligibility purposes, with the higher stage determining eligibility.  Histologic documentation of node positivity is required for ER/PR positive tumors.  Bilateral or synchronous breast cancers are allowed, as long as both cancers are HER2 negative and at least one of the cancers meets eligibility. 
  • If ER and PR negative, tumor must be node positive or >2cm and node negative.  Patients must be registered within 18 months of diagnosis.  pN1mic is eligible.  If ER and/or PR positive, tumor must  be node node positive and within 10 years of diagnosis.  pN1mic is eligible. 
  • 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 30 days prior to study registration. Concurrent hormonal therapy will be allowed.
  • Regular NSAID/aspirin use at any dose (including baby aspirin) (defined as ≥ 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for 30 days 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 18 months 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, heparin/heparin analogues, clopidogrel, oral 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 life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis).
  • No chronic (duration >30 days) daily use of oral steroids
  • No known allergy to aspirin
  • No prior invasive malignancy of any type within the past 5 years except for current diagnosis of breast cancer, and any prior diagnosis of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.  Patients with a prior history of breast cancer greater than 5 years from study screening may participate in this study. 
  • Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use
  • No history of metastatic breast cancer 

Treatment Plan

  • Aspirin vs. Placebo – One 300mg tablet by mouth daily x 5 years

**The Aspirin/Placebo is supplied by the drug company.


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