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Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 5, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06982521). This is a study registration, not published results. Lead sponsor: Relay Therapeutics, Inc.. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 540 participants (ESTIMATED). Conditions: PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer. Interventions: DRUG: Zovegalisib; DRUG: Capivasertib; DRUG: Fulvestrant. Primary outcome measures: Progression-Free Survival (PFS) within the overall and kinase population by blinded independent central review (BICR) , The time from date of randomization until radiographic progression per RECIST v1.1, or death due to any cause, up to approximately 77 months. Brief summary: This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + 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.