Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
A phase 3 trial testing Zovegalisib in HR-positive / HER2-negative breast cancer, now recruiting.
Overview
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer is a phase 3 interventional study registered as NCT06982521, led by Relay Therapeutics, and recruiting when checked on 2026-09-11. Official title: A Phase 3 Open-Label Randomised 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. Planned enrolment is 540 participants (estimated). The study started in 2025-08-26 and primary completion is expected in 2028-04-30. No results have been posted on ClinicalTrials.gov.
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