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
← catalyst calendarNCT05382286 · readout ≤ 193 d
Sponsored by Gilead Sciences (industry) · GILD — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
443actual
Sites
504
Countries
Argentina, Australia, Austria +25
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-07-25 | actual | When the study began enrolling |
| Primary completion | Feb 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Feb 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-05-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-09-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Triple Negative Breast Cancer
- PD-L1 Positive
Interventions
- Drug: Sacituzumab Govitecan-hziy — also filed as IMMU-132, Trodelvy™, GS-0132
- Drug: Pembrolizumab — also filed as KEYTRUDA®
- Drug: Paclitaxel — also filed as Taxol®
- Drug: nab-Paclitaxel — also filed as Abraxane®
- Drug: Gemcitabine — also filed as Gemzar
- Drug: Carboplatin
Primary outcome
what the primary-completion date above is the date OFProgression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
measured Randomization up to approximately 33 months
Publications
- PMID 41564397 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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