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VERITAC-2: ARV-471 vs Fulvestrant in Advanced Breast Cancer
NCT05654623Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Mar 2023
- Primary completion
- Jan 2025
- Countries
- 31
- Sponsor
- Pfizer
- Modality
- Bivalent/Multivalent Binders, PROTACs (E3 ligase recruitment)
- Drugs
- vepdegestrant
- Conditions
- breast cancer
01
Overview
Phase 3, randomised, open-label trial of vepdegestrant in breast cancer (2 arms), sponsored by Pfizer. Primary endpoint: Progression Free Survival up to 19.38 months. Started Mar 2023; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
ARV-471
Participants receive ARV-471 orally, once daily on a 28-day continuous dosing schedule.
Fulvestrant
Participants receive Fulvestrant intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from C2D1 (28-day cycle).
03
Who it enrols
Adults with ER+/HER2- advanced breast cancer who progressed after 1 line of CDK4/6 inhibitor + endocrine therapy, with ECOG 0-1, and no prior chemotherapy for advanced disease or prior fulvestrant/elacestrant/mTOR/PI3K/AKT/PARP inhibitors.
04
Endpoints
Primary
Progression Free Survival
Secondary
Overall Survival
Objective Response
Clinical Benefit Rate
Duration of Response
Treatment Emergent Adverse Events
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Specific
EuroQol 5 Dimensions 5 Level
05
Results
Not all primary endpoints met
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