{"entity":{"id":"nct02763566","kind":"trial","name":"A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer","aka":[],"tldr":"A phase 3 trial of Abemaciclib and Fulvestrant in advanced solid tumours, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer is a phase 3 interventional study registered as NCT02763566 by Eli Lilly and Company, with 463 participants enrolled, started 2016-12-05 and due to reach its primary completion in 2019-03-29. Interventions recorded: Abemaciclib, Anastrozole, Letrozole, Placebo and Fulvestrant. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02763566","url":"https://clinicaltrials.gov/study/NCT02763566"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cdk46-inhibitor","endocrine-therapy"],"targets":[],"drugs":["abemaciclib","fulvestrant","anastrozole"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02763566","phase":"3","setting":"A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer","sponsor":"Eli Lilly and Company","started":"2016-12-05","startedType":"actual","yearReported":2020,"enrolled":463,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)","primary":true,"unit":"months","arms":[{"name":"Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)","n":207,"note":"Median and Upper bound were not estimable due to Immature data.; Figures from the ClinicalTrials.gov results section (first posted 2020-03-30), not from a publication"},{"name":"Placebo + NSAI","n":99,"value":14.73,"note":"95% CI 11.21 to 18.87"}],"hr":0.499,"ci":[0.346,0.719],"p":"0.0001","source":"https://clinicaltrials.gov/study/NCT02763566?tab=results"},{"endpoint":"Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]","unit":"%","arms":[{"name":"Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)","n":207,"value":56,"note":"95% CI 49.3 to 62.8; Figures from the ClinicalTrials.gov results section (first posted 2020-03-30), not from a publication"},{"name":"Placebo + NSAI","n":99,"value":30.3,"note":"95% CI 21.3 to 39.4"},{"name":"Abemaciclib + Fulvestrant","n":104,"value":38.5,"note":"95% CI 29.1 to 47.8"},{"name":"Placebo + Fulvestrant","n":53,"value":7.5,"note":"95% CI 0.4 to 14.7"}],"source":"https://clinicaltrials.gov/study/NCT02763566?tab=results"}]},"route":"/trials/nct02763566/","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":"anastrozole","kind":"drug","name":"Anastrozole","route":"/drugs/anastrozole/"},{"id":"fulvestrant","kind":"drug","name":"Fulvestrant","route":"/drugs/fulvestrant/"}],"company":[{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. Loxo)","route":"/companies/eli-lilly/"}]}}