NCT04975308

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 874 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.

Conditions

• Breast Neoplasms
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	Imlunestrant	Administered orally.
DRUG	Exemestane	Administered orally.
DRUG	Fulvestrant	Administered IM.
DRUG	Abemaciclib	Administered orally.

Timeline

• Start date: 2021-10-04
• Primary completion: 2024-06-24
• Completion: 2027-08-01
• First posted: 2021-07-23
• Last updated: 2025-07-11
• Results posted: 2025-07-11

Locations

243 sites across 22 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, China, Czechia, France, Germany, Greece, India, Italy, Japan, Mexico, Netherlands, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study