Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
← catalyst calendarNCT06982521 · readout in 619 d
Sponsored by Relay Therapeutics, Inc. (industry) · RLAY — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
540estimated
Sites
222
Countries
Argentina, Australia, Austria +21
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-08-26 | actual | When the study began enrolling |
| Primary completion | 2028-04-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2025-05-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- PIK3CA Mutation
- HER2- Negative Breast Cancer
- Hormone Receptor Positive Tumor
- Breast Cancer
- Metastatic Breast Cancer
- Advanced Breast Cancer
Interventions
- Drug: Zovegalisib
- Drug: Capivasertib — also filed as TRUQAP
- Drug: Fulvestrant — also filed as Faslodex
Primary outcome
what the primary-completion date above is the date OFProgression-Free Survival (PFS) within the overall and kinase population by blinded independent central review (BICR)
measured The time from date of randomization until radiographic progression per RECIST v1.1, or death due to any cause, up to approximately 77 months
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