{"entity":{"id":"nct06016738","kind":"trial","name":"OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer","aka":["OPERA-01"],"tldr":"A phase 3 trial of Fulvestrant and Exemestane in HR-positive / HER2-negative breast cancer, run by Olema Pharmaceuticals, Inc., active and no longer recruiting.","summary":"OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer is a phase 3 interventional study registered as NCT06016738 by Olema Pharmaceuticals, Inc., with 510 participants enrolled, started 2023-11-16 and due to reach its primary completion in 2026-10-31. Interventions recorded: Palazestrant, Fulvestrant, Anastrozole, Letrozole and Exemestane.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06016738","url":"https://clinicaltrials.gov/study/NCT06016738"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":[],"targets":[],"drugs":["fulvestrant","exemestane"],"companies":["olema-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06016738","phase":"3","setting":"A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)","sponsor":"Olema Pharmaceuticals, Inc.","participation":[{"nct":"NCT06016738","source":"https://clinicaltrials.gov/study/NCT06016738","fetchedAt":"2026-10-07T16:54:05.353Z","studySha256":"657682a65ed4d37baf40901514d73709ac071c3328013c32cee12b8a5d74109a","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-08-13","leadSponsor":"Olema Pharmaceuticals, Inc.","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":510,"enrolmentType":"ESTIMATED","siteCount":233,"recruitingSiteCount":0,"countries":["Argentina","Australia","Austria","Belgium","Brazil","Bulgaria","Canada","Czechia","France","Germany","Hong Kong","Hungary","Italy","Malaysia","Mexico","Netherlands","Poland","Portugal","Puerto Rico","Romania","South Korea","Spain","Taiwan","Thailand","United Kingdom","United States"]}],"started":"2023-11-16","startedType":"actual","enrolled":510,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06016738/","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":"exemestane","kind":"drug","name":"Exemestane","route":"/drugs/exemestane/"},{"id":"fulvestrant","kind":"drug","name":"Fulvestrant","route":"/drugs/fulvestrant/"}],"company":[{"id":"olema-pharmaceuticals","kind":"company","name":"Olema Pharmaceuticals","route":"/companies/olema-pharmaceuticals/"}]}}