NCT05382286

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

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 443 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Triple Negative Breast Cancer
• PD-L1 Positive

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan-hziy	Administered intravenously
DRUG	Pembrolizumab	Administered intravenously
DRUG	Paclitaxel	Administered intravenously
DRUG	nab-Paclitaxel	Administered intravenously
DRUG	Gemcitabine	Administered intravenously
DRUG	Carboplatin	Administered intravenously

Timeline

• Start date: 2022-07-25
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2022-05-19
• Last updated: 2025-09-18

Locations

504 sites across 28 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Puerto Rico, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study