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

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.

Trial Details

NCT ID
NCT06982521
Phase
PHASE3
Sponsor
Relay Therapeutics, Inc.
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • RLY-2608
  • Capivasertib
  • Fulvestrant
Locations (sample)
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Beverly Hills, California, United States|34.07362,-118.40036
  • Duarte, California, United States|34.13945,-117.97729
  • Los Angeles, California, United States|34.05223,-118.24368
  • Palo Alto, California, United States|37.44188,-122.14302

Key Eligibility Criteria

  • Patient has ECOG performance status of 0-1
  • One or more known primary oncogenic PIK3CA mutation(s)
  • Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment wi…
  • Histologically or cytologically confirmed diagnosis of HR+/HER2- locally advanced or metastatic breast cancer (ABC) with radiological or objective …

For full eligibility, visit ClinicalTrials.gov.

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