NCT02441946

A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination With Anastrozole to Those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy With Abemaciclib in Combination With Anastrozole in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (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 biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.

Conditions

• Breast Cancer
• Hormone Receptor Positive Tumor
• Early-Stage Breast Carcinoma

Interventions

Type	Name	Description
DRUG	Abemaciclib	Administered orally
DRUG	Loperamide	Administered orally
DRUG	Anastrozole	Administered orally

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-08-16
• Completion: 2018-02-12
• First posted: 2015-05-12
• Last updated: 2020-06-17
• Results posted: 2018-01-30

Locations

66 sites across 10 countries: United States, Austria, Belgium, Canada, Germany, Italy, Netherlands, South Korea, Spain, Taiwan