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
Phase of Trial: Phase III
Latest Information Update: 29 Dec 2017
At a glance
- Drugs Abemaciclib (Primary) ; Anastrozole; Fulvestrant; Letrozole
- Indications Advanced breast cancer
- Focus Registrational; Therapeutic Use
- Acronyms MONARCH plus
- Sponsors Eli Lilly
- 03 Jun 2017 According to an Eli Lilly and Company Ltd. media release, this trial will support registration of abemaciclib in China.
- 13 Dec 2016 Status changed from not yet recruiting to recruiting.
- 02 Nov 2016 Planned End Date changed from 1 Dec 2019 to 1 Jan 2020.