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NCT05654623 · ClinicalTrials.gov registry record · Phase 3
A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer
A Phase 3 study of Advanced Breast Cancer, sponsored by Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 624
- Enrollment target
- 20
- Study locations
NCT05654623: Active Phase 3 study of Advanced Breast Cancer, sponsored by Pfizer.
NCT05654623 is a Phase 3 study of Advanced Breast Cancer that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 624 participants, above the 442-participant average among 28 other Advanced Breast Cancer trials with a reported enrollment target (41% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05654623, a Phase 3 study of Advanced Breast Cancer, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 624 participants
- Enrollment target
- 20
- Study locations
Study Summary
A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.
Primary Outcome
PFS assessed by BICR was defined as the time from the date of randomization to the date of the first documentation of objective progression of disease (PD) per RECIST v1.1, or death due to any cause, whichever occurred first. PD as per RECIST v1.1 was defined as at least a 20% increase in the sum of diameters of target measurable lesions above nadir (smallest sum observed considering baseline and all assessments prior to the timepoint under evaluation), with a minimum absolute increase of 5 mill
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG ARV-471
Study Locations (20)
Florida
- Florida Cancer Specialists - Altamonte Springs
- Florida Cancer Specialists BON - Bonita Springs
- Florida Cancer Specialists BCC - Bradenton
- Florida Cancer Specialists LRS - Bradenton
- Florida Cancer Specialists - Brandon
- Florida Cancer Specialists NFM - Cape Coral
- Morton Plant Hospital - BayCare Health System - Clearwater
- Florida Cancer Specialists - Clearwater
- Florida Cancer Specialists - Daytona Beach
California
- California Cancer Associates for Research and Excellence, Inc. (cCARE) - Encinitas
- Orange Coast Memorial Medical Center - Fountain Valley
- California Cancer Associates for Research and Excellence - Fresno
- Providence Queen of the Valley Medical Center - Napa
- California Cancer Associates for Research and Excellence - San Marcos
- Olive View-UCLA Medical Center - Sylmar
Connecticut
- Smilow Cancer Hospital Care Center at Fairfield - Fairfield
- Smilow Cancer Hospital at Yale-New Haven - New Haven
- Yale-New Haven Hospital - New Haven
- Smilow Cancer Hospital Care Center at North Haven - North Haven
- Smilow Cancer Hospital Care Center at Trumbull - Trumbull
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 624 participants |
| Start Date | 2023-03-03 |
| Est. Completion | 2028-05-15 |
| Phase | Phase 3 |
What the registry record for NCT05654623 still lists
NCT05654623 is an interventional study that assigns participants to a tested intervention. The registered 624 participants enrollment target is mid-sized for trials with a published cap, above the 442-participant average among 28 other Advanced Breast Cancer trials with a reported enrollment target (41% higher).
The record links to 1 condition, with Advanced Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Fulvestrant is the first listed.
NCT05654623 names 20 study sites across 3 states, led by Florida, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT05654623 about?
NCT05654623 is a clinical study titled "A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer". A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.
What is the current status of trial NCT05654623?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 624 participants. The study started on 2023-03-03. Estimated completion is 2028-05-15.
What conditions does trial NCT05654623 study?
This clinical trial studies the following conditions: Advanced Breast Cancer.
What interventions are being tested in trial NCT05654623?
The interventions under investigation include: Fulvestrant (DRUG), ARV-471 (DRUG).
Who is sponsoring clinical trial NCT05654623?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05654623 being conducted?
This trial has 20 study locations across California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05654623's enrollment target sits among peer trials
624 3rd of 28 higher than 26 of 28 other Advanced Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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