ClinicalTrials.gov record
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.
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
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 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.
Study identification
- NCT ID
- NCT05514054
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 8,000 participants
Conditions and interventions
Conditions
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, 2022 (Actual)
- Primary completion
- Oct 2027 (Estimated)
- Completion
- Mar 2032 (Estimated)
- Last update posted
- Apr 2, 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 2, 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 NCT05514054 live on ClinicalTrials.gov.