Clinical Trial

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

Study acronym: ReDiscover-2
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 5 changes
notable Trial sites expanded: 211 -> 222 locations 2026-08-06
notable Trial sites expanded: 192 -> 211 locations 2026-07-09
notable Trial sites expanded: 158 -> 192 locations 2026-06-12
notable Trial sites expanded: 120 -> 158 locations 2026-05-09
notable Trial sites expanded: 76 -> 120 locations 2026-04-03
Trial Details
NCT Number NCT06982521
Lead Sponsor Relay Therapeutics, Inc.
Conditions PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer
Enrollment 540 participants
Start Date 2025-08-26
Primary Completion 2028-04-30 (estimated)
Study Completion 2031-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-05