Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
← catalyst calendarNCT05840211 · readout ≤ 620 d
Sponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
654estimated
Sites
288
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 | 2023-05-08 | actual | When the study began enrolling |
| Primary completion | Apr 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2023-05-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Locally Advanced or Unresectable Metastatic Breast Cancer
- Stage IV Breast Cancer
Interventions
- Drug: Sacituzumab Govitecan-hziy — also filed as Trodelvy™, GS-0132, IMMU-132
- Drug: Paclitaxel — also filed as Taxol®
- Drug: Nab-paclitaxel — also filed as Abraxane®
- Drug: Capecitabine — also filed as Xeloda®
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 Version 1.1 (RECIST v1.1)
measured Up to approximately 29 months
Publications
- PMID 37499870 — 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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