Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Summary

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.

Timeline

Start

2022-07-20

Primary completion

2028-07

Completion

2028-07

Publications

• Cortes J, Punie K, Barrios C, Hurvitz SA, Schneeweiss A, Sohn J, Tokunaga E, Brufsky A, Park YH, Xu B, Hegg R, Oliveira M, Fabi A, Vaksman N, Valdez T, Zhang X, Lai C, Tolaney SM; ASCENT-03 Clinical Trial Investigators. Sacituzumab Govitecan in Untreated, Advanced Triple-Negative Breast Cancer. N Engl J Med. 2025 Nov 13;393(19):1912-1925. doi: 10.1056/NEJMoa2511734. Epub 2025 Oct 19.

Drugs

Indications