Phase 3Recruiting
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer (ReDiscover-2)
A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor
- Sponsor
- Relay Therapeutics, Inc. (Industry)
- Enrolment
- 540 planned
- Conditions
- PIK3CA Mutation; HER2- Negative Breast Cancer; Hormone Receptor Positive Tumor; Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer
- Interventions
- Zovegalisib; Capivasertib; Fulvestrant
- Ages
- adults, older adults
- Registry
- NCT06982521
Full record on ClinicalTrials.gov
From the registry
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4/6 inhibitor.
Primary outcomes
- Progression-Free Survival (PFS) within the overall and kinase population by blinded independent central review (BICR)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered