{"entity":{"id":"nct06982521","kind":"trial","name":"Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer","aka":["ReDiscover-2"],"tldr":"A phase 3 trial testing Zovegalisib in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer is a phase 3 interventional study registered as NCT06982521, led by Relay Therapeutics, and recruiting on the registry. Official title: A Phase 3 Open-Label Randomised 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. Planned enrolment is 540 participants (estimated). The study started in 2025-08-26 and primary completion is expected in 2028-04-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06982521","url":"https://clinicaltrials.gov/study/NCT06982521"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":[],"targets":[],"drugs":["zovegalisib"],"companies":["relay-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06982521","phase":"3","setting":"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","sponsor":"Relay Therapeutics","participation":[{"nct":"NCT06982521","source":"https://clinicaltrials.gov/study/NCT06982521","fetchedAt":"2026-10-07T16:55:20.203Z","studySha256":"6ee682d6a83bfc5c1d34e80cf2ec01be22e073291a9d23f5b4d4869c52664af1","overallStatus":"RECRUITING","lastUpdatePosted":"2026-10-05","leadSponsor":"Relay Therapeutics, Inc.","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":540,"enrolmentType":"ESTIMATED","siteCount":243,"recruitingSiteCount":243,"countries":["Argentina","Australia","Austria","Belgium","Brazil","Bulgaria","Canada","Czechia","Denmark","France","Germany","Greece","Hong Kong","Ireland","Italy","Netherlands","Poland","Portugal","Romania","Singapore","South Korea","Spain","Switzerland","Taiwan","Turkey (Türkiye)","United Kingdom","United States"]}],"started":"2025-08-26","startedType":"actual","enrolled":540,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06982521/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"hr-positive-metastatic-post-cdk46","kind":"cancer","name":"HR-positive metastatic breast cancer after CDK4/6 inhibitors","route":"/cancers/hr-positive-metastatic-post-cdk46/"}],"drug":[{"id":"zovegalisib","kind":"drug","name":"Zovegalisib","route":"/drugs/zovegalisib/"}],"company":[{"id":"relay-therapeutics","kind":"company","name":"Relay Therapeutics","route":"/companies/relay-therapeutics/"}],"institution":[{"id":"ucsf","kind":"institution","name":"UCSF Helen Diller Family Comprehensive Cancer Center","route":"/institutions/ucsf/"}]}}