Abemaciclib + Hormone Therapy for Breast Cancer (eMonarcHER Trial)

Palo Alto (17 mi)

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.

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 completed at least four rounds of chemotherapy as part of my initial cancer treatment.

I have remaining cancer in a lymph node, a tumor larger than 5 cm, or a tumor spreading to my chest wall or skin.

My breast cancer is HR+ and HER2+, without spread beyond the initial site.

I have had surgery to remove my breast cancer.

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

I've completed at least four rounds of chemotherapy as part of my initial treatment.

Exclusion Criteria

My breast cancer has returned or spread to other parts of my body.

My early breast cancer treatment was completely successful.

I have inflammatory breast cancer.

I am not on extra cancer treatments beyond what's standard at study start.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Abemaciclib Plus (+) Endocrine Therapy (ET)Experimental Treatment2 Interventions

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

Group II: Placebo + ETActive Control2 Interventions

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

Abemaciclib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Verzenio for:

Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
HR+, HER2- node-positive early breast cancer

🇪🇺 Approved in European Union as Verzenio for: