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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
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial sites expanded: 231 → 243 locations
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 3 of 10 entries
  2. Trial sites expanded: 222 → 231 locationsv14
  3. Trial sites expanded: 211 → 222 locations
    • Interventions: Capivasertib (Drug), Fulvestrant (Drug), RLY-2608 (Drug) to Capivasertib (Drug), Fulvestrant (Drug), Zovegalisib (Drug)
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints revised (10)
    v13
  4. Trial sites expanded: 192 → 211 locationsv12
  5. Trial sites expanded: 158 → 192 locationsv11
  6. Trial sites expanded: 120 → 158 locationsv10
  7. Trial sites expanded: 76 → 120 locationsv9
  8. Study sites: 56 to 76v8
  9. Study sites: 41 to 56v7
  10. Study sites: 26 to 41v6
  11. Study sites: 8 to 26v5
  12. Study sites: 3 to 8
    • Start date changed from estimate of Jul 31, 2025 to Aug 26, 2025
    v4
  13. Study sites: 2 to 3v3
  14. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    v2
  15. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06982521
Lead Sponsor Relay Therapeutics, Inc.
Conditions
(from sponsor)		 PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer
Related terms Breast Neoplasms
Enrollment 540 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov