clinical trial · NCT06982521
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
PIK3CA MutationHER2- Negative Breast CancerHormone Receptor Positive TumorBreast CancerMetastatic Breast CancerAdvanced Breast CancerRLY-2608CapivasertibFulvestrant
brief summary
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 + 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.
started
Aug 26, 2025
primary completion
Apr 30, 2028
completion
Dec 31, 2031
last updated
Apr 2, 2026
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol