NCT05382299

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

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 623 (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) 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.

Conditions

• Triple Negative Breast Cancer
• PD-L1 Negative

Interventions

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

Timeline

• Start date: 2022-07-20
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2022-05-19
• Last updated: 2026-04-06

Locations

363 sites across 30 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Romania, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study