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Active, not recruiting Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT04975308

Public ClinicalTrials.gov record NCT04975308. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 5:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT04975308
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Eli Lilly and Company
Industry
Enrollment
874 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 4, 2021 (Actual)
Primary completion
Jun 24, 2024 (Actual)
Completion
Aug 2027 (Estimated)
Last update posted
Jul 22, 2026

2021 – 2027

United States locations

U.S. sites
48
U.S. states
18
U.S. cities
32
Facility City State ZIP Site status
Ironwood Cancer & Research Centers Chandler Arizona 85224 —
Banner MD Anderson Cancer Center Gilbert Arizona 85234 —
Marin Cancer Care Greenbrae California 94904 —
University of California Davis (UC Davis) Comprehensive Cancer Center Sacramento California 95817 —
Sharp Memorial Hospital San Diego California 92123 —
Banner MD Anderson Cancer Center at McKee Medical Center Loveland Colorado 80538 —
Clermont Oncology Center Clermont Florida 34711 —
University of Florida College of Medicine Gainesville Florida 32610 —
Mid Florida Hematology and Oncology Center Orange City Florida 32763 —
Florida Cancer Specialists Sarasota Florida 34232 —
Florida Cancer Specialists St. Petersburg Florida 33705 —
Kaiser Permanente Moanalua Medical Center Honolulu Hawaii 96819 —
University of Chicago Medical Center Chicago Illinois 60637 —
NorthShore University HealthSystem - Evanston Hospital Evanston Illinois 60201 —
IU Health Ball Memorial Hospital, Inc. Muncie Indiana 47303 —
The University of Louisville, James Graham Brown Cancer Center Louisville Kentucky 40202 —
Jackson Oncology Associates, PLLC Jackson Mississippi 39202 —
Care Access - Clifton Clifton New Jersey 07013 —
Memorial Sloan Kettering - Bergen Montvale New Jersey 07645 —
Columbia University Medical Center New York New York 10032 —
University of North Carolina Medical Center Chapel Hill North Carolina 27599 —
Aultman Hospital Canton Ohio 44710 —
Mercy Health - St. Vincent Medical Center Toledo Ohio 43608 —
Avera Cancer Institute Sioux Falls Sioux Falls South Dakota 57105 —
Florida Cancer Specialists Nashville Tennessee 37203 —
The Mark H Zangmeister Cancer Center Nashville Tennessee 37203 —
USO - Texas Oncology - Allen Allen Texas 75013 —
Texas Oncology - Dallas Presbyterian Hospital Dallas Texas 75231 —
Willamette Valley Cancer Institute & Research Ctr. Houston Texas 77070 —
Texas Oncology - Carrollton Lewisville Texas 75056 —
Texas Oncology - Denison The Woodlands Texas 75020 —
Texas Oncology - Paris The Woodlands Texas 75460 —
Blue Ridge Cancer Care The Woodlands Texas 77380 —
Broome Oncology The Woodlands Texas 77380 —
Minnesota Oncology/Hematology PA The Woodlands Texas 77380 —
Texas Oncology - Carrollton The Woodlands Texas 77380 —
Texas Oncology - McKinney The Woodlands Texas 77380 —
Texas Oncology - Medical City Dallas The Woodlands Texas 77380 —
Texas Oncology - Methodist Charlton Cancer Center The Woodlands Texas 77380 —
Texas Oncology - San Antonio Medical Center The Woodlands Texas 77380 —
Texas Oncology - The Woodlands The Woodlands Texas 77380 —
Texas Oncology - Willowbrook The Woodlands Texas 77380 —
Texas Oncology Fort Worth The Woodlands Texas 77380 —
Texas Oncology-Baylor Charles A. Sammons Cancer Center The Woodlands Texas 77380 —
USO-Rocky Mountain Cancer Center The Woodlands Texas 77380 —
Texas Oncology - Austin Central The Woodlands Texas 78731 —
Utah Cancer Specialists Salt Lake City Utah 84106 —
The University of Vermont Medical Center Inc. Burlington Vermont 05401 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 195 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04975308, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 22, 2026 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04975308 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →