Canadian Cancer Trials Group Bulletins

Trial Management Group


Central Activation: MAC.21 (Alliance A011502)

CCTG Trial MAC.21 (Alliance 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 has been centrally activated.

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:

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. Patients must be enrolled within 1 year after diagnosis. Patients must be > 18 and < 70 years of age. ECOG performance status 0-2. Any ER/PgR status allowed.

Objectives:

Primary Objective: To compare the effect of aspirin (300 mg daily) versus placebo upon invasive disease free survival (iDFS) 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, To compare the toxicity of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients. To assess adherence to aspirin and placebo among early stage node-positive HER2 negative breast cancer patients. To bank tumor and germline deoxyribonucleic acid (DNA), plasma and urine collected at baseline and sequential plasma and urine collected 2 years later for future measurement of inflammatory markers. To determine if there are subgroups of participants characterized by lifestyle factors associates with greater inflammation.

If you have questions please contact CTG Study Coordinator: Magda Monreal mmonreal@ctg.queensu.ca