CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 623 enrolled
Drug / intervention
Sacituzumab Govitecan-hziy +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05382299
NCT05382299Phase 3Active

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

Gilead Sciences·interventional·Posted May 19, 2022·Updated Apr 6, 2026

In Brief

A Phase 3 clinical trial evaluating Sacituzumab Govitecan-hziy, Paclitaxel, and 3 other interventions for Triple Negative Breast Cancer and PD-L1 Negative. Active but no longer recruiting, targeting 623 participants across 363 sites in 30 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3Active
202320242025202620272028
First PostedMay 19, 2022
Enrollment StartJul 20, 2022
Primary CompletionJul 1, 2028
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 4.1 years agoPrimary completion in 2.0 years

Interventions

Sacituzumab Govitecan-hziydrug

Administered intravenously

Paclitaxeldrug

Administered intravenously

nab-Paclitaxeldrug

Administered intravenously

Gemcitabinedrug

Administered intravenously

Carboplatindrug

Administered intravenously