drugset / 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
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-08-26
- Primary completion
- 2028-04-30
- Completion
- 2031-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capivasertib | Small molecule | 400 mg | Oral |
| Subject | RLY-2608 | Small molecule | 400 mg | Oral |
| Background | Fulvestrant | Small molecule | 500 mg | Intramuscular |