At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 224 enrolled
Drug / intervention
Abemaciclib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Abemaciclib, Loperamide, and 1 other intervention for Breast Cancer and 2 related conditions. Completed, enrolled 224 participants across 66 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Canada, Germany, Italy, Netherlands, South Korea, Spain, Taiwan, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartAug 2015
Primary CompletionAug 2016
Study CompletionFeb 2018
TodayJul 2026
First PostedMay 12, 2015
Enrollment StartAug 1, 2015
Primary CompletionAug 16, 2016
Study CompletionFeb 12, 2018
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 11.1 years ago
Interventions
Abemaciclibdrug
Administered orally
Loperamidedrug
Administered orally
Anastrozoledrug
Administered orally