Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab

Summary

Phase III randomized trial of the anti-PD-L1 antibody avelumab as adjuvant or post-neoadjuvant treatment for high-risk triple negative breast cancer patients. The overall protocol-defined patient population will include the following two strata of patients: * Stratum A - Patients who have completed treatment with curative intent including surgery of the primary tumor followed by adjuvant chemotherapy . * Stratum B - Patients who have completed treatment with curative intent including neoadjuvant chemotherapy followed by surgery of the primary tumor and (if indicated) further adjuvant chemotherapy.

Timeline

Start

2016-06-17

Primary completion

2024-06

Completion

2025-10-09

Publications

• Dieci MV, Gasparini E, Nicole L, Schmid P, Zambelli A, Favaretto A, Piacentini F, Bianchi GV, Mion M, Ferro A, Arpino G, Emiliani A, Cinieri S, Zamagni C, Gennari A, Spazzapan S, Sartori D, Zustovich F, Tamberi S, Del Mastro L, De Laurentiis M, Musolino A, Cagossi K, Generali D, Giarratano T, Giovanardi F, De Salvo GL, Conte P, Guarneri V. Tumor infiltrating lymphocytes as a predictor of adjuvant avelumab efficacy in patients with high-risk triple negative breast cancer. Clin Cancer Res. 2026 Jul 17. doi: 10.1158/1078-0432.CCR-26-0975. Online ahead of print.

Drugs

Indications