NCT05514054

A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,000 (estimated)
• 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 in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Imlunestrant	Administered orally.
DRUG	Tamoxifen	Administered per local approved label.
DRUG	Anastrozole	Administered per local approved label.
DRUG	Letrozole	Administered per local approved label.
DRUG	Exemestane	Administered per local approved label.

Timeline

• Start date: 2022-10-04
• Primary completion: 2027-10-01
• Completion: 2032-03-01
• First posted: 2022-08-24
• Last updated: 2026-04-02

Locations

672 sites across 31 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Romania, Singapore, Slovakia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study