NCT02675231

A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician's Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

Conditions

• Hormone Receptor Positive Breast Cancer
• HER-2 Positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Abemaciclib	Administered Orally
DRUG	Trastuzumab	Administered IV
DRUG	Fulvestrant	Administered IM
DRUG	Standard of Care Single Agent Chemotherapy	Standard-of-care single-agent chemotherapy of physician's choice administered according to product label

Timeline

• Start date: 2016-05-23
• Primary completion: 2019-04-08
• Completion: 2023-11-09
• First posted: 2016-02-05
• Last updated: 2024-11-26
• Results posted: 2020-05-26

Locations

93 sites across 14 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Greece, Italy, Mexico, South Korea, Spain, United Kingdom