CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 874 enrolled
Drug / intervention
Imlunestrant +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04975308
NCT04975308Phase 3Active

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

Eli Lilly and Company·interventional·Posted Jul 23, 2021·Updated Jul 11, 2025

In Brief

A Phase 3 clinical trial evaluating Imlunestrant, Exemestane, and 2 other interventions for Breast Neoplasms and Neoplasm Metastasis. Active but no longer recruiting, targeting 874 participants across 243 sites in 22 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Austria, Belgium, Brazil, China, Czechia, France, Germany, Greece, India, Italy, Japan, Mexico, Netherlands, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 3Active
202220232024202520262027
First PostedJul 23, 2021
Enrollment StartOct 4, 2021
Primary CompletionJun 24, 2024
Study CompletionAug 1, 2027
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.9 years ago

Interventions

Imlunestrantdrug

Administered orally.

Exemestanedrug

Administered orally.

Fulvestrantdrug

Administered IM.

Abemaciclibdrug

Administered orally.