Trials / Recruiting
RecruitingNCT06982521
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 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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 540 (estimated)
- Sponsor
- Relay Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- PIK3CA Mutation
- HER2- Negative Breast Cancer
- Hormone Receptor Positive Tumor
- Breast Cancer
- Metastatic Breast Cancer
- Advanced Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RLY-2608 | 400 mg orally BID administered daily on a 28-day treatment cycle |
| DRUG | Capivasertib | 400mg orally BID administered on an intermittent weekly dosing schedule. Patients will dose on Days 1 through 4 each week of a 28-day treatment cycle |
| DRUG | Fulvestrant | 500 mg intramuscularly administered on Cycle 1 Day 1, Day 15, and Day 1 of each subsequent cycle (28-day treatment cycle) |
Timeline
- Start date
- 2025-08-26
- Primary completion
- 2028-04-30
- Completion
- 2031-12-31
- First posted
- 2025-05-21
- Last updated
- 2026-04-02
Locations
120 sites across 19 countries: United States, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Hong Kong, Italy, Netherlands, Poland, Singapore, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06982521. Inclusion in this directory is not an endorsement.