Protocol Summary

Protocol No.: OCR15537

Sponsor Protocol No.: A011502

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

Principal Investigator(s)
Daily Weinstein, Karen

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.

Phase: Phase III

Age Group: Adult

Scope: National

Arm I (aspirin)
Patients receive aspirin PO QD for five years in the absence of disease progression or unacceptable toxicity.

Arm II (Placebo)
Patients receive placebo PO QD for five years in the absence of disease progression or unacceptable toxicity.

Detailed Eligibility
1. Ages 18 to 70 years old.
2. Documentation of Disease - Histologic Documentation: 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.
3. Disease status - Any ER/PgR status allowed.
4. Prior Treatment - Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined 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.
5. 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.
6. Patients must be enrolled within 1 year after diagnosis.
7. ECOG performance status 0-2.
8. 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.
9. For patients who are Helicobacter pylori positive, a course of Helicobacter pylori eradication treatment must have been completed.
10. No history of GI bleeding requiring a blood transfusion, endoscopic or operative intervention.
11. No history of any prior stroke (hemorrhagic or ischemic).
12. No concurrent anticoagulation with warfarin or heparin or clopidogrel or oral direct thrombin inhibitors.
13. No history of atrial fibrillation or myocardial infarction.
14. 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).
15. No chronic (duration >30 days) daily use of oral steroids.
16. No known allergy to aspirin.
17. 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.
18. Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use.
19. Required Initial Laboratory Values Platelet count >= 100,000/mm3.

Applicable Disease Sites
Breast Cancer

Participating Institutions
UF Gainesville : Brandi Lattinville

Brandi Lattinville
Phone: +1 352-265-0680 ext. 87665


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