Completed Enrollment

Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer (postMONARCH)

I3Y-MC-JPEF -

This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Breast Cancer
What the trial is testing?
Abemaciclib, Fulvestrant
Could I receive a Placebo?
Yes
Enrollment Goal
368
Trial Dates
Mar 11, 2022 - Feb 2026
How long will I be in the trial?
Your participation could last up to 5 years, depending on how you and your tumor respond.
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:

  • Participants must have HR+, HER2- breast cancer

  • Participants must have breast cancer that is advanced or has spread to another part of the body

  • Participants must have already received endocrine therapy and a CDK4/6 inhibitor

  • Participants must have adequate organ function

  • Participants must be in fair to good health

  • Participants must be able to swallow capsules/tablets

Participants Must Not:

  • Participants must not have received chemotherapy or some targeted therapies for advanced breast cancer

  • Participants must not have cancer that has spread to the brain that has not been treated or is causing symptoms

  • Participants must not have another serious medical condition

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