Clinical Trial

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

Study acronym: ASCENT-04
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
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).
Protocol Amendment History 25 amendments
This ClinicalTrials.gov record has been amended 25 times since 2022-05-16; most recent amendment 2025-09-16.
Status change: Recruiting → Active, Not Recruiting 2024-09-10
Trial Details
NCT Number NCT05382286
Lead Sponsor Gilead Sciences
Collaborators: Merck Sharp & Dohme LLC
Conditions Triple Negative Breast Cancer, PD-L1 Positive
Enrollment 443 participants
Start Date 2022-07-25
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2025-09-18