ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05514054

Public ClinicalTrials.gov record NCT05514054. 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 May 9, 2026, 12:18 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-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

Study identification

NCT ID
NCT05514054
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Eli Lilly and Company
Industry
Enrollment
8,000 participants

Conditions and interventions

Interventions

  • Anastrozole Drug
  • Exemestane Drug
  • Imlunestrant Drug
  • Letrozole Drug
  • Tamoxifen Drug

Drug

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 3, 2022
Primary completion
Sep 30, 2027
Completion
Feb 29, 2032
Last update posted
Apr 1, 2026

2022 – 2032

United States locations

U.S. sites
137
U.S. states
32
U.S. cities
118
Facility City State ZIP Site status
USO - Southern Cancer Center Daphne Alabama 36526
Clearview Cancer Institute Huntsville Alabama 35805
Infirmary Cancer Care Mobile Alabama 36607
Banner MD Anderson Cancer Center Gilbert Arizona 85234
USO - Arizona Oncology Associates - HAL Glendale Arizona 85308
St. Joseph's Hospital and Medical Center Phoenix Arizona 85004
Mayo Clinic in Arizona - Phoenix Phoenix Arizona 85054
TMC HealthCare Tucson Arizona 85711
The University of Arizona Cancer Center - North Campus Tucson Arizona 85719
Highlands Oncology Group Springdale Arkansas 72762
UCSF - John Muir Health Cancer Center Berkeley Berkeley California 94702
Washington Health Fremont California 94538
Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine Irvine California 92612
Loma Linda University Cancer Center Loma Linda California 92350-1700
Pacific Cancer Care Monterey California 93940
St. Joseph Hospital Orange California 92868
University of California, Irvine (UCI) Health - UC Irvine Medical Center Orange California 92868
University of California Davis (UC Davis) Comprehensive Cancer Center Sacramento California 95817
Kaiser Permanente San Diego Mission Road San Diego California 92108
Zuckerberg San Francisco General Hospital and Trauma Center San Francisco California 94110
UCSF Medical Center at Mission Bay San Francisco California 94158
Saint Joseph's Medical Center Stockton California 95204
Anschutz Cancer Pavilion Aurora Colorado 80045
UCHealth Memorial Hospital Colorado Springs Colorado 80909
UCHealth Harmony Fort Collins Colorado 80528
Banner MD Anderson Cancer Center at North Colorado Medical Center Greeley Colorado 80631
USO - Rocky Mountain Cancer Centers Lakewood Colorado 80228
Banner MD Anderson Cancer Center at McKee Medical Center Loveland Colorado 80538
Yale-New Haven Hospital New Haven Connecticut 06510
Georgetown University Medical Center Washington D.C. District of Columbia 20007
MedStar Washington Hospital Center Washington D.C. District of Columbia 20010
AdventHealth Altamonte Springs Altamonte Springs Florida 32701
Memorial Regional Hospital Hollywood Florida 33021
Millennium Oncology Research Clinic Hollywood Florida 33024
Mayo Clinic in Florida Jacksonville Florida 32224
Miami Cancer Institute at Baptist Health, Inc. Miami Florida 33176
USO - Cancer Care Centers of Brevard Palm Bay Florida 32901
USO - Woodlands Medical Specialists Pensacola Florida 32503
Miami Cancer Institute - Plantation Plantation Florida 33324
Tampa General Hospital Tampa Florida 33606
Winship Cancer Institute, Emory University Atlanta Georgia 30322
Northside Hospital Atlanta Georgia 30342
Summit Cancer Care, PC Savannah Georgia 31405
Kaiser Permanente Moanalua Medical Center Honolulu Hawaii 96819
Kapiolani Medical Center for Women and Children Honolulu Hawaii 96826
Northwestern Memorial Hospital Chicago Illinois 60611
University of Illinois at Chicago Chicago Illinois 60612
Illinois Cancer Care Peoria Illinois 61615
Simmons Cancer Institute at SIU Springfield Illinois 62702
The University of Kansas Cancer Center - Westwood Westwood Kansas 66205
Ochsner Clinic Foundation Covington Louisiana 70433
Pontchartrain Cancer Center Hammond Louisiana 70403
Ochsner Clinic Foundation New Orleans Louisiana 70121
York Hospital York Village Maine 03909
Walter Reed National Military Medical Center Bethesda Maryland 20889
Massachusetts General Hospital Boston Massachusetts 02114
Dana-Farber Cancer Institute Boston Massachusetts 02215
Mass General/North Shore Cancer Center Danvers Massachusetts 01923
Southcoast Centers for Cancer Care Fairhaven Massachusetts 02719
Dana-Farber Cancer Institute - Foxborough Foxborough Massachusetts 02035
Dana-Farber Cancer Institute - Merrimack Valley Methuen Massachusetts 01844
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center Milford Massachusetts 01757
Mass General Cancer Center at Newton-Wellesley Newton Massachusetts 02462
Dana-Farber/Brigham and Women's Cancer Center - South Shore Hospital South Weymouth Massachusetts 02190
University of Massachusetts Medical School Worcester Massachusetts 01655
M Health Fairview Cancer Clinic -Edina Edina Minnesota 55435
USO - Minnesota Oncology Hematology Minneapolis Minnesota 55404
Allina Health Cancer Institute Minneapolis Minnesota 55407
Mayo Clinic in Rochester, Minnesota Rochester Minnesota 55905
University of Missouri Hospital Columbia Missouri 65212
Washington University School of Medicine St Louis Missouri 63108
Nebraska Methodist Hospital Omaha Nebraska 68114
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03756
Dana-Farber - New Hampshire Oncology/Hematology Londonderry New Hampshire 03053
MD Anderson Cancer Center at Cooper Camden New Jersey 08103
Astera Cancer Care East Brunswick New Jersey 08816
Regional Cancer Care Associates Little Silver New Jersey 07739
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey 08901
Capital Health Medical Center - Hopewell Pennington New Jersey 08534
New Mexico Oncology Hematology Consultants Ltd. Albuquerque New Mexico 87109
University of New Mexico Comprehensive Cancer Center Albuquerque New Mexico 87131
New York Oncology Hematology Associate Albany New York 12206
Maimonides Cancer Center Brooklyn New York 11220
NYU Langone Health - Brooklyn Brooklyn New York 11220
R.J. Zuckerberg Cancer Center Lake Success New York 11042
Perlmutter Cancer Center at NYU Langone Hospital - Long Island Mineola New York 11501
Northern Westchester Hospital Mount Kisco New York 10549
Laura and Isaac Perlmutter Cancer Center New York New York 10016
NYC Health + Hospitals / Bellevue New York New York 10016
Memorial Sloan Kettering Cancer Center New York New York 10065
Queens Medical Associates Queens New York 11374
University of Rochester - Wilmot Cancer Institute Rochester New York 14642
Phelps Hospital Sleepy Hollow New York 10591
Staten Island University Hospital Staten Island New York 10305
Clinical Research Alliance Westbury New York 11590
Messino Cancer Center Asheville North Carolina 28806
Aultman Hospital Canton Ohio 44710
USO - Oncology Hematology Care Cincinnati Ohio 45242
Mercy Health - St. Vincent Medical Center Toledo Ohio 43608
Good Samaritan Regional Medical Center Corvallis Oregon 97330
USO - Oncology Associates of Oregon Eugene Oregon 97401
Oregon Health and Science University Portland Oregon 97239
USO - Compass Oncology Tigard Oregon 97223
St. Luke's University Health Network Bethlehem Pennsylvania 18015
USO - Alliance Cancer Specialists, PC Horsham Pennsylvania 19044
Thomas Jefferson University - Clinical Research Institute Philadelphia Pennsylvania 19107
Lifespan Cancer Institute Providence Rhode Island 02906
St Francis Cancer Center Greenville South Carolina 29607
The West Clinic, PLLC dba West Cancer Center Germantown Tennessee 38138
University of Tennessee Medical Center Knoxville Tennessee 37920
Sarah Cannon Research Institute Nashville Tennessee 37203
USO - Texas Oncology Austin Texas 78731
USO - Texas Oncology Dallas Texas 75231
USO - Texas Oncology Dallas Texas 75246
USO - Texas Oncology Denison Texas 75020
Texas Oncology - West Texas El Paso Texas 79902
William Beaumont Army Medical Center El Paso Texas 79918
USO - Texas Oncology Flower Mound Texas 75028
Brooke Army Medical Center Fort Sam Houston Texas 78234
John Peter Smith Hospital Fort Worth Texas 76104
The Center for Cancer and Blood Disorders Fort Worth Texas 76104
USO - Texas Oncology Fort Worth Texas 76104
USO - Texas Oncology Fredericksburg Texas 78624
USO - Texas Oncology McAllen Texas 78503
USO - Texas Oncology Plano Texas 75075
Scott & White Hospital - Round Rock Round Rock Texas 78665
Mays Cancer Center San Antonio Texas 78229
Baylor Scott & White Medical Center - Temple Temple Texas 76508
US Oncology Research Network The Woodlands Texas 77380
USO - Texas Oncology Webster Texas 77598
University of Virginia Health System Charlottesville Virginia 22908
Inova Schar Cancer Institute Fairfax Virginia 22031
Fort Belvoir Community Hospital Fort Belvoir Virginia 22060
Bon Secours St. Francis Medical Center Midlothian Virginia 23114
USO - Virginia Oncology Associates Norfolk Virginia 23502
USO - Virginia Cancer Specialists Reston Virginia 20190
USO - Oncology & Hematology Associates of Southwest Virginia Roanoke Virginia 24014

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 535 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05514054, 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 Apr 1, 2026 · Synced May 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05514054 live on ClinicalTrials.gov.

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