Study Condition(s): Breast Cancer
A Study to Compare Treatment After Surgery of Abemaciclib (LY2835219) Combined With Standard Endocrine Therapy Versus Endocrine Therapy Alone in Participants With Breast Cancer (monarchE)
Study Alias: JPCF
The purpose of this study is to test whether the combination of the study drug abemaciclib plus adjuvant endocrine therapy improves outcomes in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer compared to adjuvant endocrine therapy alone.
Key Participation Requirements
All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria
· Participant must have confirmed hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-) breast cancer · Participant must have received surgery for this breast cancer · Participant must start study treatment within 12 weeks of completing their last non-endocrine treatment · Female participant of child-bearing potential must have a negative serum pregnancy test and agree to use highly effective birth control methods · Female participant must not be pregnant or breastfeeding · Participant must be able to swallow oral medications · Participant must not have metastatic or lymph node negative disease · Participant must not have previously received treatment with any CDK4 and CDK6 inhibitor · Participant must start study treatment within 12 weeks of completing their last non-endocrine treatment · Participant must not have received an experimental treatment in a clinical trial within the last 30 days