Phase 3Active, not recruiting
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer (MONARCH 2)
MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
- Sponsor
- Eli Lilly and Company (Industry)
- Enrolment
- 669 enrolled
- Conditions
- Breast Neoplasms
- Interventions
- Abemaciclib; Fulvestrant; Placebo
- Ages
- adults, older adults
- Registry
- NCT02107703, EUCTR2013-004728-13
Full record on ClinicalTrials.gov
From the registry
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant. For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.
Primary outcomes
- Progression-Free Survival (PFS)
History
Study completion expected
Last registry update
Results first posted
Primary completion
Started
Registered