{"entity":{"id":"nct05596409","kind":"trial","name":"ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study","aka":[],"tldr":"A phase 2 trial of Elacestrant in HR-positive / HER2-negative breast cancer, run by Stemline Therapeutics, Inc., active and no longer recruiting.","summary":"ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study is a phase 2 interventional study registered as NCT05596409 by Stemline Therapeutics, Inc., with 61 participants enrolled, started 2023-05-19 and due to reach its primary completion in 2026-11. Interventions recorded: Elacestrant.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05596409","url":"https://clinicaltrials.gov/study/NCT05596409"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["elacestrant"],"companies":["menarini"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05596409","phase":"2","setting":"ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer: An Open-Label Multicenter Phase 2 Study (ELCIN)","sponsor":"Stemline Therapeutics, Inc.","participation":[{"nct":"NCT05596409","source":"https://clinicaltrials.gov/study/NCT05596409","fetchedAt":"2026-10-07T16:53:47.239Z","studySha256":"5a887200676f3efde58174dfdf3acb4ca9ea73a2653f7e02444497ec4b41d643","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-05-07","leadSponsor":"Stemline Therapeutics, Inc.","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":61,"enrolmentType":"ACTUAL","siteCount":22,"recruitingSiteCount":0,"countries":["Brazil","Bulgaria","Georgia","Mexico","Romania","United States"]}],"started":"2023-05-19","startedType":"actual","enrolled":61,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05596409/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"technology":[{"id":"endocrine-therapy","kind":"technology","name":"Endocrine therapy (SERMs, AIs, SERDs)","route":"/technologies/endocrine-therapy/"}],"drug":[{"id":"elacestrant","kind":"drug","name":"Elacestrant","route":"/drugs/elacestrant/"}],"company":[{"id":"menarini","kind":"company","name":"Menarini / Stemline","route":"/companies/menarini/"}]}}