Imlunestrant + Abemaciclib for Breast Cancer

(EMBER-3 Trial)

Recruiting at395 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

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called imlunestrant, alone and in combination with another drug, abemaciclib, for patients with advanced breast cancer that is ER+ and HER2-. Imlunestrant works by blocking estrogen receptors on cancer cells, while abemaciclib stops the cells from multiplying. The goal is to see if these treatments work better than standard hormone therapy.

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 postmenopausal women with advanced breast cancer that's ER+ and HER2-. They should have seen their cancer progress after aromatase inhibitor treatment, possibly combined with a CDK4/6 inhibitor. Participants must be able to take pills, have measurable disease or bone-only disease, and be in good physical condition (ECOG 0-1). They can't join if they've had certain prior treatments like chemotherapy or specific inhibitors, have severe brain metastasis, visceral crisis, lung complications from cancer spread, or serious medical conditions.

Inclusion Criteria

My breast cancer is ER+ and HER2-, and has spread beyond the breast.

My cancer progressed after treatment with an aromatase inhibitor and possibly a CDK4/6 inhibitor.

My kidney, blood, and liver functions are all within normal ranges.

Exclusion Criteria

I have previously been treated with specific cancer therapies, excluding early-stage chemotherapy.

My cancer has spread to my organs, lungs, or brain/spinal cord linings.

Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study

Treatment Details

Interventions

• Abemaciclib (CDK4/6 Inhibitor)
• Exemestane (Aromatase Inhibitor)
• Fulvestrant (Selective Estrogen Receptor Downregulator (SERD))
• Imlunestrant (Selective Estrogen Receptor Downregulator (SERD))

Trial Overview The study tests the effectiveness of Imlunestrant against standard hormone therapy and combines Imlunestrant with Abemaciclib versus Imlunestrant alone in treating ER+, HER2- advanced breast cancer. The goal is to see which treatment works better for patients whose cancer has spread. Participation could last up to five years.

Participant Groups

Group I: Imlunestrant plus Abemaciclib Experimental Treatment 2 Interventions

Imlunestrant plus abemaciclib administered orally.

Group II: Imlunestrant Experimental Treatment 1 Intervention

Imlunestrant administered orally.

Group III: Investigator's Choice of Endocrine Therapy Active Control 2 Interventions

Investigator's choice of exemestane administered orally or fulvestrant administered intramuscularly (IM). See local approved label for additional instructions.

Exemestane is already approved in Canada, Japan for the following indications:

Approved in Canada as Aromasin for:

• Early breast cancer
• Advanced breast cancer

Approved in Japan as Aromasin for:

• Early breast cancer
• Advanced breast cancer

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