The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
IV infusion
IV infusion
IV infusion
IV infusion
oral tablet
IV infusion
Buenos Aires, Buenos Aires F.D., Argentina
Study Coordinator · +541132218900
Rosario, Santa Fe Province, Argentina
Study Coordinator · +543412221472
Buenos Aires, Argentina
Study Coordinator · 52990100
La Rioja, Argentina
Study Coordinator · 543804436443 x108