Completed Enrollment

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer (monarchE)

I3Y-MC-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.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Breast Cancer
What the trial is testing?
Abemaciclib, Standard Adjuvant Endocrine Therapy
Could I receive a Placebo?
No
Enrollment Goal
5637
Trial Dates
Jul 12, 2017 - May 2029
How long will I be in the trial?
Your study participation is expected to be approximately 10 years.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • 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

Participants Must Not:

  • 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

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Clinical Trial Resources

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