NCT04752332

A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer

eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+). Your participation could last up to 10 years depending on how you and your tumor respond.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Abemaciclib	Administered orally.
DRUG	Standard Adjuvant ET	Administered according to label instructions.
DRUG	Placebo	Administered orally.

Timeline

• Start date: 2021-05-10
• Primary completion: 2024-06-26
• Completion: 2024-06-26
• First posted: 2021-02-12
• Last updated: 2025-07-15
• Results posted: 2025-07-15

Locations

115 sites across 20 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, China, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, South Korea, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study