A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
Trial Status: active
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.
Inclusion Criteria
- Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
- Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
- Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
- Must have an increased risk of disease recurrence based on clinical-pathological risk features.
- Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
- Have adequate organ function.
Exclusion Criteria
- Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
- Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
- Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening.
- Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.
- 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.
- Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
- Participants with a history of any other cancer.
- Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.
Additional locations may be listed on ClinicalTrials.gov for NCT05514054.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not AvailableTucson
Banner University Medical Center - Tucson
Status: Active
Name Not AvailableCalifornia
Berkeley
UCSF Cancer Center - Berkeley
Status: Active
Contact: UCSF
Phone: 877-827-3222
Email: cancertrials@ucsf.edu
Fremont
Washington Hospital
Status: Active
Contact: UCSF Cancer Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Status: Active
Name Not AvailableSacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Name Not AvailableSan Francisco
University of California San Francisco
Status: Active
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu
Colorado
Aurora
UCHealth University of Colorado Hospital
Status: Active
Contact: Robyn Swing
Phone: 720-848-0607
Email: robyn.swing@cuanschutz.edu
Highlands Ranch
UCHealth Highlands Ranch Hospital
Status: Active
Contact: Anna E Lamport
Phone: 303-724-6231
Email: anna.lamport@cuanschutz.edu
Lone Tree
UCHealth Lone Tree Health Center
Status: Active
Contact: Anna E Lamport
Phone: 303-724-6231
Email: anna.lamport@cuanschutz.edu
Connecticut
Derby
Smilow Cancer Hospital-Derby Care Center
Status: Active
Name Not AvailableFairfield
Smilow Cancer Hospital Care Center-Fairfield
Status: Active
Name Not AvailableGlastonbury
Smilow Cancer Hospital Care Center at Glastonbury
Status: Active
Name Not AvailableGreenwich
Smilow Cancer Hospital Care Center at Greenwich
Status: Active
Name Not AvailableGuilford
Smilow Cancer Hospital Care Center - Guilford
Status: Active
Name Not AvailableHartford
Smilow Cancer Hospital Care Center at Saint Francis
Status: Active
Name Not AvailableNew Haven
Yale University
Status: Active
Name Not AvailableNorth Haven
Yale-New Haven Hospital North Haven Medical Center
Status: Active
Name Not AvailableStamford
Smilow Cancer Hospital Care Center at Long Ridge
Status: Active
Name Not AvailableTorrington
Smilow Cancer Hospital-Torrington Care Center
Status: Active
Name Not AvailableTrumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not AvailableWaterbury
Smilow Cancer Hospital-Waterbury Care Center
Status: Active
Name Not AvailableWaterford
Smilow Cancer Hospital Care Center - Waterford
Status: Active
Name Not AvailableDistrict of Columbia
Washington
MedStar Washington Hospital Center
Status: Active
Name Not AvailableMedStar Georgetown University Hospital
Status: Active
Name Not AvailableFlorida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not AvailableGeorgia
Atlanta
Emory University Hospital Midtown
Status: Active
Name Not AvailableEmory Saint Joseph's Hospital
Status: Active
Name Not AvailableEmory University Hospital/Winship Cancer Institute
Status: Active
Name Not AvailableIllinois
Chicago
Northwestern University
Status: Active
Name Not AvailableMassachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not AvailableBrigham and Women's Hospital
Status: Active
Name Not AvailableMassachusetts General Hospital Cancer Center
Status: Active
Name Not AvailableDanvers
Mass General/North Shore Cancer Center
Status: Active
Name Not AvailableFoxborough
Dana-Farber Cancer Institute at Foxborough
Status: Active
Name Not AvailableMethuen
Dana Farber-Merrimack Valley
Status: Active
Name Not AvailableMilford
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Status: Active
Name Not AvailableNewton
Newton-Wellesley Hospital
Status: Active
Name Not AvailableSouth Weymouth
Dana-Farber/Brigham and Women's Cancer Center at South Shore
Status: Active
Name Not AvailableMinnesota
Minneapolis
University of Minnesota/Masonic Cancer Center
Status: Active
Name Not AvailableRochester
Mayo Clinic in Rochester
Status: Active
Name Not AvailableMissouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not AvailableNew Hampshire
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Status: Active
Name Not AvailableLondonderry
The Dana-Farber Cancer Institute at Londonderry
Status: Active
Name Not AvailableNew Jersey
Sewell
Sidney Kimmel Cancer Center Washington Township
Status: Approved
Name Not AvailableNew Mexico
Albuquerque
University of New Mexico Cancer Center
Status: Active
Name Not AvailableLas Cruces
Memorial Medical Center-Las Cruces
Status: Active
Name Not AvailableNew York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not AvailableLaura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not AvailableRochester
University of Rochester
Status: Active
Name Not AvailableOregon
Portland
OHSU Knight Cancer Institute
Status: Active
Name Not AvailablePennsylvania
Philadelphia
Jefferson Torresdale Hospital
Status: Approved
Name Not AvailableThomas Jefferson University Hospital
Status: Active
Name Not AvailableWillow Grove
Asplundh Cancer Pavilion
Status: Active
Name Not AvailableRhode Island
Westerly
Smilow Cancer Hospital Care Center - Westerly
Status: Active
Name Not AvailableTexas
San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Status: Active
Contact: Sonia Lisa Creighton
Phone: 210-450-1366
Email: creighton@uthscsa.edu
Virginia
Charlottesville
University of Virginia Cancer Center
Status: Active
Name Not AvailableTrial PhasePhase III
Trial Typetreatment
Lead OrganizationEli Lilly and Company
- Primary ID18459
- Secondary IDsNCI-2022-08126, 2022-501007-28, J2J-MC-JZLH
- ClinicalTrials.gov IDNCT05514054