{"entity":{"id":"nct02107703","kind":"trial","name":"A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer","aka":["MONARCH 2"],"tldr":"A phase 3 trial of Abemaciclib and Fulvestrant in HR-positive / HER2-negative breast cancer, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer is a phase 3 interventional study registered as NCT02107703 by Eli Lilly and Company, with 669 participants enrolled, started 2014-07-22 and due to reach its primary completion in 2017-02-14. Interventions recorded: Abemaciclib, Fulvestrant and Placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02107703","url":"https://clinicaltrials.gov/study/NCT02107703"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy"],"targets":[],"drugs":["abemaciclib","fulvestrant"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct02107703-j-clin-oncol-2017","paper-nct02107703-jama-oncol-2020-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02107703","phase":"3","setting":"MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer","sponsor":"Eli Lilly and Company","started":"2014-07-22","startedType":"actual","yearReported":2018,"enrolled":669,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Abemaciclib + Fulvestrant","n":446,"value":16.4,"note":"95% CI 14.4 to 19.3; Figures from the ClinicalTrials.gov results section (first posted 2018-03-13), not from a publication"},{"name":"Placebo + Fulvestrant","n":223,"value":9.3,"note":"95% CI 7.4 to 11.4"}],"hr":0.553,"ci":[0.449,0.681],"p":"<0.0000001","source":"https://clinicaltrials.gov/study/NCT02107703?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Abemaciclib + Fulvestrant","n":446,"value":45.8,"note":"95% CI 38.96 to 52.64; Figures from the ClinicalTrials.gov results section (first posted 2018-03-13), not from a publication"},{"name":"Placebo + Fulvestrant","n":223,"value":37.25,"note":"95% CI 34.36 to 43.20"}],"source":"https://clinicaltrials.gov/study/NCT02107703?tab=results"},{"endpoint":"Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])","unit":"%","arms":[{"name":"Abemaciclib + Fulvestrant","n":446,"value":35.2,"note":"95% CI 30.8 to 39.6; Figures from the ClinicalTrials.gov results section (first posted 2018-03-13), not from a publication"},{"name":"Placebo + Fulvestrant","n":223,"value":16.1,"note":"95% CI 11.3 to 21.0"}],"source":"https://clinicaltrials.gov/study/NCT02107703?tab=results"}]},"route":"/trials/nct02107703/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"technology":[{"id":"cdk46-inhibitor","kind":"technology","name":"CDK4/6 inhibitors","route":"/technologies/cdk46-inhibitor/"},{"id":"endocrine-therapy","kind":"technology","name":"Endocrine therapy (SERMs, AIs, SERDs)","route":"/technologies/endocrine-therapy/"}],"drug":[{"id":"abemaciclib","kind":"drug","name":"Abemaciclib","route":"/drugs/abemaciclib/"},{"id":"fulvestrant","kind":"drug","name":"Fulvestrant","route":"/drugs/fulvestrant/"}],"company":[{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. Loxo)","route":"/companies/eli-lilly/"}],"paper":[{"id":"paper-nct02107703-j-clin-oncol-2017","kind":"paper","name":"MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy","route":"/key-papers/paper-nct02107703-j-clin-oncol-2017/"},{"id":"paper-nct02107703-jama-oncol-2020-update","kind":"paper","name":"The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy-MONARCH 2: A Randomized Clinical Trial","route":"/key-papers/paper-nct02107703-jama-oncol-2020-update/"}]}}