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

Phase 3 Active not recruiting 443 enrolled Gilead Sciences Merck Sharp & Dohme LLC · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).

Timeline

Start: 2022-07-25
Primary completion: 2027-02
Completion: 2027-02

Publications

Tolaney SM, de Azambuja E, Kalinsky K, Loi S, Kim SB, Yam C, Rapoport B, Im SA, Pistilli B, Mchayleh W, Cescon DW, Watanabe J, Banuelas MAL, Freitas-Junior R, Salvador Bofill J, Afshari M, Gary D, Wang L, Lai C, Schmid P; ASCENT-04/KEYNOTE-D19 Clinical Trial Investigators. Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer. N Engl J Med. 2026 Jan 22;394(4):354-366. doi: 10.1056/NEJMoa2508959.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Carboplatin	Small molecule	2 unknown	Intravenous
Comparator	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Comparator	Paclitaxel	Small molecule	90 mg/m2	Intravenous
Comparator	Paclitaxel	Small molecule	100 mg/m2	Intravenous
Subject	Sacituzumab Govitecan	Monoclonal antibody	10 mg/kg	Intravenous
Background	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications