E-Newsletter - December 2020
Alliance Trial Update


Closed to Accrual: Alliance A011502 (ABC Breast Trial)

The Alliance for Clinical Trials in Oncology is pleased to announce that Alliance A011502 (led by Wendy Chen, MD, MPH, of the Dana-Farber Cancer Institute) has met its accrual goal of 2,936 patients and has been closed to accrual. effective December 4, 2020. Alliance A011502: A randomized phase III double-blinded placebo-controlled trial of aspirin as adjuvant therapy for HER2 negative breast cancer: The ABC trial.

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) negative 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.

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 distant disease-free survival, overall survival, and 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 for whom there is greater benefit of aspirin versus placebo upon iDFS.

Patients are followed up to 10 years after study enrollment.

For more information, visit the Alliance A011502 trial page.

 

 

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