RECRUITING

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

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Conditions

Breast Neoplasms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-10-04
Study Completion:2032-03-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05514054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
  2. * Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
  3. * Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
  4. * Must have an increased risk of disease recurrence based on clinical-pathological risk features.
  5. * Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
  6. * Have adequate organ function.
  1. * Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
  2. * Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
  3. * Participants who have completed or discontinued prior adjuvant ET \>6 months prior to screening.
  4. * Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.
  5. * Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.
  6. * Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
  7. * Participants with a history of any other cancer.
  8. * Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
ClinicalTrials.gov@lilly.com

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

USO - Southern Cancer Center
Daphne, Alabama, 36526
United States
Clearview Cancer Institute
Huntsville, Alabama, 35805
United States
Infirmary Cancer Care
Mobile, Alabama, 36607
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
USO - Arizona Oncology Associates - HAL
Glendale, Arizona, 85308
United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85004
United States
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, 85054
United States
USO - Arizona Oncology Associates - HOPE
Tucson, Arizona, 85711
United States
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719
United States
Highlands Oncology Group
Springdale, Arkansas, 72762
United States
UCSF - John Muir Health Cancer Center Berkeley
Berkeley, California, 94702
United States
Washington Hospital Healthcare System
Fremont, California, 94538
United States
Loma Linda University Cancer Center
Loma Linda, California, 92350-1700
United States
Mercy UC Davis Cancer Center
Merced, California, 95340
United States
Pacific Cancer Care
Monterey, California, 93940
United States
St. Joseph Hospital
Orange, California, 92868
United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868
United States
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, 95817
United States
Kaiser Permanente San Diego Mission Road
San Diego, California, 92108
United States
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
United States
UCSF Medical Center at Mission Bay
San Francisco, California, 94158
United States
Saint Joseph's Medical Center
Stockton, California, 95204
United States
Anschutz Cancer Pavilion
Aurora, Colorado, 80045
United States
UCHealth Memorial Hospital
Colorado Springs, Colorado, 80909
United States
UCHealth Harmony
Fort Collins, Colorado, 80528
United States
Banner MD Anderson Cancer Center at North Colorado Medical Center
Greeley, Colorado, 80631
United States
USO - Rocky Mountain Cancer Centers
Lakewood, Colorado, 80228
United States
Banner MD Anderson Cancer Center at McKee Medical Center
Loveland, Colorado, 80538
United States
Yale-New Haven Hospital
New Haven, Connecticut, 06510
United States
Georgetown University Medical Center
Washington, District of Columbia, 20007
United States
MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
AdventHealth Altamonte Springs
Altamonte Springs, Florida, 32701
United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
United States
Memorial Regional Hospital
Hollywood, Florida, 33021
United States
Millennium Oncology Research Clinic
Hollywood, Florida, 33024
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224
United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
United States
USO - Cancer Care Centers of Brevard
Palm Bay, Florida, 32901
United States
USO - Woodlands Medical Specialists
Pensacola, Florida, 32503
United States
Miami Cancer Institute - Plantation
Plantation, Florida, 33324
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
United States
Northside Hospital
Atlanta, Georgia, 30342
United States
Augusta University
Augusta, Georgia, 30912
United States
Summit Cancer Care DBA Candler Medical Oncology Practice
Savannah, Georgia, 31405
United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Illinois Cancer Care
Peoria, Illinois, 61615
United States
Simmons Cancer Institute at SIU
Springfield, Illinois, 62702
United States
Alliance for Multispecialty Research, LLC
Merriam, Kansas, 66204
United States
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205
United States
Sarah Cannon Research Institute
Baton Rouge, Louisiana, 70809
United States
Ochsner Clinic Foundation
Covington, Louisiana, 70433
United States
Pontchartrain Cancer Center
Hammond, Louisiana, 70403
United States
Care Access - Marrero
Marrero, Louisiana, 70072
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
Central Maine Medical Center
Lewiston, Maine, 04240
United States
York Hospital
York, Maine, 03909
United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Mass General/North Shore Cancer Center
Danvers, Massachusetts, 01923
United States
Southcoast Centers for Cancer Care
Fairhaven, Massachusetts, 02719
United States
Dana-Farber Cancer Institute - Foxborough
Foxboro, Massachusetts, 02035
United States
Dana-Farber Cancer Institute - Merrimack Valley
Methuen, Massachusetts, 01844
United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
Milford, Massachusetts, 01757
United States
Mass General Cancer Center at Newton-Wellesley
Newton, Massachusetts, 02462
United States
Dana-Farber/Brigham and Women's Cancer Center - South Shore Hospital
South Weymouth, Massachusetts, 02190
United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
United States
M Health Fairview Cancer Clinic -Edina
Edina, Minnesota, 55435
United States
USO - Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404
United States
Allina Health Cancer Institute
Minneapolis, Minnesota, 55407
United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
United States
University of Missouri Hospital
Columbia, Missouri, 65212
United States
Washington University
Saint Louis, Missouri, 63110
United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Dana-Farber - New Hampshire Oncology/Hematology
Londonderry, New Hampshire, 03053
United States
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103
United States
Astera Cancer Care
East Brunswick, New Jersey, 08816
United States
Regional Cancer Care Associates
Little Silver, New Jersey, 07739
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Capital Health Medical Center - Hopewell
Pennington, New Jersey, 08534
United States
New Mexico Oncology Hematology Consultants Ltd.
Albuquerque, New Mexico, 87109
United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131
United States
Memorial Medical Center
Las Cruces, New Mexico, 88011
United States
USO - New York Oncology Hematology
Albany, New York, 12206
United States
Maimonides Cancer Center
Brooklyn, New York, 11220
United States
NYU Langone Health - Brooklyn
Brooklyn, New York, 11220
United States
R.J. Zuckerberg Cancer Center
Lake Success, New York, 11042
United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501
United States
Northern Westchester Hospital
Mount Kisco, New York, 10549
United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
United States
NYC Health + Hospitals / Bellevue
New York, New York, 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Queens Medical Associates
Queens, New York, 11374
United States
University of Rochester - Wilmot Cancer Institute
Rochester, New York, 14642
United States
Phelps Hospital
Sleepy Hollow, New York, 10591
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
Clinical Research Alliance
Westbury, New York, 11590
United States
Messino Cancer Center
Asheville, North Carolina, 28806
United States
Aultman Hospital
Canton, Ohio, 44710
United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219
United States
USO - Oncology Hematology Care
Cincinnati, Ohio, 45242
United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219
United States
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, 43608
United States
St. Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501
United States
Good Samaritan Regional Medical Center
Corvallis, Oregon, 97330
United States
USO - Oncology Associates of Oregon
Eugene, Oregon, 97401
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
USO - Compass Oncology
Tigard, Oregon, 97223
United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
United States
USO - Alliance Cancer Specialists, PC
Horsham, Pennsylvania, 19044
United States
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, 19107
United States
Thomas Jefferson University, Aria Jefferson Health
Philadelphia, Pennsylvania, 19114
United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
United States
Lifespan Cancer Institute
Providence, Rhode Island, 02906
United States
St Francis Cancer Center
Greenville, South Carolina, 29607
United States
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, 38138
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
USO - Texas Oncology
Austin, Texas, 78731
United States
USO - Texas Oncology
Dallas, Texas, 75231
United States
USO - Texas Oncology
Dallas, Texas, 75246
United States
USO - Texas Oncology
Denison, Texas, 75020
United States
USO - Texas Oncology
Denton, Texas, 76201
United States
William Beaumont Army Medical Center
El Paso, Texas, 79918
United States
USO - Texas Oncology
Flower Mound, Texas, 75028
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
John Peter Smith Hospital
Fort Worth, Texas, 76104
United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
United States
USO - Texas Oncology
Fort Worth, Texas, 76104
United States
USO - Texas Oncology
Fredericksburg, Texas, 78624
United States
USO - Texas Oncology
McAllen, Texas, 78503
United States
USO - Texas Oncology
McKinney, Texas, 75071
United States
USO - Texas Oncology
Plano, Texas, 75075
United States
Scott & White Hospital - Round Rock
Round Rock, Texas, 78665
United States
Mays Cancer Center
San Antonio, Texas, 78229
United States
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508
United States
US Oncology Research Network
The Woodlands, Texas, 77380
United States
USO - Texas Oncology
Tyler, Texas, 75702
United States
USO - Texas Oncology
Webster, Texas, 77598
United States
University of Virginia Health System
Charlottesville, Virginia, 22908
United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
United States
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060
United States
Bon Secours St. Francis Medical Center
Midlothian, Virginia, 23114
United States
USO - Virginia Oncology Associates
Norfolk, Virginia, 23502
United States
USO - Virginia Cancer Specialists
Reston, Virginia, 20190
United States
USO - Oncology & Hematology Associates of Southwest Virginia
Roanoke, Virginia, 24014
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-04
Study Completion Date2032-03-15

Study Record Updates

Study Start Date2022-10-04
Study Completion Date2032-03-15

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Neoplasms