Abemaciclib + Hormone Therapy for Breast Cancer

(eMonarcHER Trial)

Recruiting at717 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+). Your participation could last up to 10 years depending on how you and your tumor respond.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for individuals with early breast cancer that's HR+ and HER2+, who've had surgery, chemotherapy, and specific HER2-targeted therapy. They should have high-risk disease as defined by the study but no recurrence or distant metastases. Pregnant women, those with other cancers not in remission for 5 years, or a history of blood clots are excluded.

Inclusion Criteria

I have had surgery to remove my breast cancer.

I have a tumor sample from my breast or lymph node.

I've completed 9-20 months of HER2 therapy.

Exclusion Criteria

I do not have other serious medical conditions, am not pregnant, and have no history of severe blood clots.

I have inflammatory breast cancer.

I have been treated with specific medications or therapies before.

Treatment Details

Interventions

• Abemaciclib (CDK4/6 Inhibitor)

Trial Overview The study tests how well Abemaciclib works alongside hormone therapy after surgery in patients with early-stage breast cancer. Participants will either receive Abemaciclib or a placebo in addition to standard hormone therapy over up to a decade based on their response.

Participant Groups

Group I: Abemaciclib Plus (+) Endocrine Therapy (ET) Experimental Treatment 2 Interventions

Abemaciclib administered orally and standard adjuvant ET (physician's choice) administered according to package label.

Group II: Placebo + ET Active Control 2 Interventions

Placebo administered orally and standard adjuvant ET (physician's choice) administered according to package label.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University