A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer (monarcHER)

I3Y-MC-JPBZ -

The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant or chemotherapy in women with HR+, HER2+ locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Breast Cancer
What the trial is testing?
Abemaciclib (LY2835219), Trastuzumab, Fulvestrant, Standard of care chemotherapy
Could I receive a Placebo?
No
Enrollment Goal
237
Trial Dates
May 23, 2016 - Nov 9, 2023
How long will I be in the trial?
The duration of your participation depends on how well your disease responds to the study treatment and how many cycles of treatment you receive.
Trial Phase
II

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 a diagnosis of HR+, HER2+ advanced breast cancer

  • Participant must have unresectable, locally advanced, recurrent breast cancer or metastatic breast cancer

  • Participant must provide adequate tumor tissue prior to participation

  • Participant must have previously received at least two HER2-directed therapies for advanced disease

  • Participant must have received a taxane and trastuzumab emtansine (T-DM1) in any disease setting

  • Participant must have received any endocrine therapy (excluding fulvestrant)

  • Participant must have postmenopausal status

Participants Must Not:

  • Participant must not have received prior treatment with any cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor

  • Participant must not have had symptomatic congestive heart failure, heart attack, or unstable angina within the last 6 months

  • Participant must not have known central nervous system (CNS) metastases that are untreated, symptomatic, or require steroids to control symptoms

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