A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
624actual
Sites
312
Countries
Argentina, Australia, Austria +28
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 | 2023-03-03 | actual | When the study began enrolling |
| Primary completion | 2025-01-31 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-05-15 | estimated | The whole study's end, after follow-up |
| First posted | 2022-12-16 | actual | When this record first appeared on the registry |
| Results posted | 2026-02-03 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-03-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Breast Cancer
Interventions
- Drug: ARV-471 — also filed as PF-07850327
- Drug: Fulvestrant
Primary outcomes
what the primary-completion date above is the date OFProgression Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1- All Randomized Participants
measured From date of randomization to date of first documentation of objective PD or death (any cause) or censoring date, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively)
PFS by BICR Assessment Per RECIST v1.1-Participants With ESR1 Mutation
measured From date of randomization to date of first documentation of objective PD or death (any cause) or censoring date, whichever occurred first (up to 18.56 months and 19.38 months of treatment exposure for vepdegestrant and fulvestrant arms respectively)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-11-06 · 1.3 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-11-05 · 625 KB · SAP_001.pdf
Publications
- PMID 40454645 — linked by the registry
- PMID 39072356 — 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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