A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 17 Oct 2017
At a glance
- Drugs Abemaciclib (Primary) ; Anastrozole; Letrozole
- Indications Advanced breast cancer
- Focus Registrational; Therapeutic Use
- Acronyms MONARCH 3
- Sponsors Eli Lilly
- 12 Oct 2017 According to a company media release, the US FDA has granted Priority Review designation for Eli Lilly's NDA for abemaciclib (Verzenio™) as initial endocrine-based therapy for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. The NDA was based upon the positive interim results from this trial.
- 06 Oct 2017 Interim results presented in an Eli Lilly media release.
- 06 Oct 2017 According to an Eli Lilly media release, final PFS results are expected at the end of the year and will be presented at a scientific congress in the first half of 2018.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History