Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy
Summary
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.
Timeline
- Start
- 2016-12-08
- Primary completion
- 2021-12-13
- Completion
- 2023-02-15
Outcome
Missed primary endpoint
Stopped: “DSMB review”
paper yielding a hazard ratio of 1.27 (95% CI, 0.99-1.63; P = .06). PMID 38683596 ↗
paper daily aspirin therapy did not improve risk of breast cancer recurrence or survival in early follow-up. PMID 38683596 ↗
Publications
- Chen WY, Ballman KV, Partridge AH, Hahn OM, Briccetti FM, Irvin WJ, Symington B, Visvanathan K, Pohlmann PR, Openshaw TH, Weiss A, Winer EP, Carey LA, Holmes MD. Aspirin vs Placebo as Adjuvant Therapy for Breast Cancer: The Alliance A011502 Randomized Trial. JAMA. 2024 May 28;331(20):1714-1721. doi: 10.1001/jama.2024.4840.
- Iyer HS, James P, Valeri L, Bajunirwe F, Nankya-Mutyoba J, Njelekela M, Chiwanga F, Sewram V, Ajayi I, Adebamowo C, Dalal S, Reid TG, Rebbeck TR, Adami HO, Holmes MD. Neighborhood greenness and burden of non-communicable diseases in Sub-Saharan Africa: A multi-country cross-sectional study. Environ Res. 2021 May;196:110397. doi: 10.1016/j.envres.2020.110397. Epub 2020 Oct 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 300 mg | Oral |