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Alliance A011502


Clinical Trial Title

A randomized phase III double blinded placebo-controlled trial of aspirin as adjuvant therapy for HER2 negative breast cancer: The ABC trial

Trial Status

Closed to Enrollment

Start Date

December 8, 2016

Trial Type

Cancer - Adult Oncology

Specific Condition

Breast cancer


This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

Eligibility Criteria

Eligibility 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 (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 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.
  • 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 is 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.
  • Age > 18 and < 70 years of age.
  • ECOG performance status 0-2.
  • No history of any prior stroke
  • No history of atrial fibrillation or myocardial infarction.
  • No history of grade 4 hypertension
  • No known allergy to aspirin.
  • Patients with a prior history of any type of breast cancer greater than 5 years from study screening may participate in this study.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Jacqueline Vuky, MD

Contact Name

Oncology Clinical Research



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Last Updated: Tuesday, February 2, 2021 01:21:49 PM