RCT: Aspirin fails to improve invasive disease-free survival in breast cancer patients

This randomized clinical trial assessed the efficacy of daily aspirin (300 mg) as adjuvant therapy in reducing breast cancer recurrence among 3020 participants with high-risk nonmetastatic breast cancer across the United States and Canada. The study, which followed participants for a median of 33.8 months, found no significant benefit of aspirin on invasive disease-free survival or overall survival, with the hazard ratio for disease-free survival being 1.27 (95% CI, 0.99-1.63; P = .06) and for overall survival 1.19 (95% CI, 0.82-1.72). Given these findings, aspirin is not recommended as an adjuvant treatment for breast cancer, challenging earlier observational data that suggested a potential survival benefit in breast cancer survivors. The trial was concluded early due to the lack of observed benefits, with adverse event rates being similar in both the aspirin and placebo groups.

Commentary on X:

Among participants with high-risk nonmetastatic breast cancer, daily aspirin therapy did not improve risk of breast cancer recurrence or survival in early follow-up. https://t.co/uPWTeaqXdJ pic.twitter.com/x6Qb4bRlqF

— JAMA (@JAMA_current) April 29, 2024

Reference (link to abstract – $ for full-text):

Wendy Y. Chen et al. (2024). Aspirin vs Placebo as Adjuvant Therapy for Breast Cancer: The Alliance A011502 Randomized Trial. JAMA, Published online April 29, 2024. doi:10.1001/jama.2024.4840