{"entity":{"id":"nct02747004","kind":"trial","name":"A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer","aka":["Next MONARCH 1"],"tldr":"A phase 2 trial of Abemaciclib and Tamoxifen in advanced solid tumours, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer is a phase 2 interventional study registered as NCT02747004 by Eli Lilly and Company, with 234 participants enrolled, started 2016-09-14 and due to reach its primary completion in 2018-06-15. Interventions recorded: Abemaciclib, Tamoxifen and Prophylactic Loperamide. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02747004","url":"https://clinicaltrials.gov/study/NCT02747004"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy"],"targets":[],"drugs":["abemaciclib","tamoxifen"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02747004","phase":"2","setting":"A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer","sponsor":"Eli Lilly and Company","started":"2016-09-14","startedType":"actual","yearReported":2019,"enrolled":234,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"150mg Abemaciclib + 20mg Tamoxifen","n":78,"value":9.07,"note":"95% CI 6.90 to 10.95; Figures from the ClinicalTrials.gov results section (first posted 2019-07-12), not from a publication"},{"name":"150mg Abemaciclib","n":79,"value":6.48,"note":"95% CI 4.77 to 9.21"},{"name":"200mg Abemaciclib + 2mg Prophylactic Loperamide","n":77,"value":7.43,"note":"95% CI 5.42 to 9.17"}],"source":"https://clinicaltrials.gov/study/NCT02747004?tab=results"},{"endpoint":"Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)","unit":"%","arms":[{"name":"150mg Abemaciclib + 20mg Tamoxifen","n":78,"value":34.6,"note":"95% CI 24.1 to 45.2; Figures from the ClinicalTrials.gov results section (first posted 2019-07-12), not from a publication"},{"name":"150mg Abemaciclib","n":79,"value":24.1,"note":"95% CI 14.6 to 33.5"},{"name":"200mg Abemaciclib + 2mg Prophylactic Loperamide","n":77,"value":32.5,"note":"95% CI 22 to 42.9"}],"source":"https://clinicaltrials.gov/study/NCT02747004?tab=results"}]},"route":"/trials/nct02747004/","neighbours":{"cancer":[{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"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":"tamoxifen","kind":"drug","name":"Tamoxifen","route":"/drugs/tamoxifen/"}],"company":[{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. Loxo)","route":"/companies/eli-lilly/"}]}}