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Phase III clinical trial to evaluate RLY-2608 fulvestrant compared to capivasertib fulvestrant as a treatment for locally advanced or metastatic breast cancer.
THE PRIMARY OBJECTIVE IS TO COMPARE THE EFFICACY OF RLY-2608 FULVESTRANT RELATIVE TO CAPIVASERTIB FULVESTRANT BY EVALUATING PFS IN THE OVERALL POPULATION AND IN THE KINASE POPULATION USING BICR.
Technical Summary
- PHASE III RANDOMIZED OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RLY-2608 FULVESTRANT COMPARED TO CAPIVASERTIB FULVESTRANT AS A TREATMENT FOR LOCALLY ADVANCED OR METASTATIC BREAST CANCER WITH A PIK3CA MUTATION, HORMONE RECEPTOR-POSITIVE, AND HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE (HRﱱ) FOLLOWING RECURRENCE OR PROGRESSION DURING OR AFTER TREATMENT WITH A CDK4/6 INHIBITOR
- Code EudraCT: 2025-520785-22-00
- Protocol number: RLY-2608-102
- Promoter: Relay Therapeutics, Inc.
- Molecule/Drug: RLY-2608 Fulvestrant
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