NCT06982521Phase 3Recruiting

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

Study sponsor: Relay Therapeutics, Inc. · RLAY

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2028-04-30Estimated

Enrollment · participants540Estimated

Source updated2026-09-03Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

PIK3CA Mutation; HER2- Negative Breast Cancer; Hormone Receptor Positive Tumor; Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer

Treatments or interventions studied

ZovegalisibDrug
CapivasertibDrugAlso known as TRUQAP
FulvestrantDrugAlso known as Faslodex

Primary outcomes · main study measures

measure: Progression-Free Survival (PFS) within the overall and kinase population by blinded independent central review (BICR); timeFrame: The time from date of randomization until radiographic progression per RECIST v1.1, or death due to any cause, up to approximately 77 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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