A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without LY2835219, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 17 Oct 2017
At a glance
- Drugs Abemaciclib (Primary) ; Fulvestrant
- Indications Advanced breast cancer
- Focus Registrational; Therapeutic Use
- Acronyms MONARCH 2
- Sponsors Eli Lilly
- 28 Sep 2017 Based on the data from this trial, the US FDA has approved Verzenio (abemaciclib) in combination with fulvestrant to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient's hormones (endocrine therapy), as reported in a media release.
- 12 Sep 2017 Results assessing efficacy and safety of abemaciclib plus fulvestrant in exploratory cohort of HR1/HER2-endocrine therapy naive, were presented at the 42nd European Society for Medical Oncology Congress.
- 29 Aug 2017 According to an Eli Lilly media release, results from this trial will be presented at the European Society for Medical Oncology (ESMO) 2017 Congress.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History