A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Recruiting · NCT06492616 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry \[IHC\]), HER2-negative \[IHC = 0, 1+, 2 and in situ hybridization \[ISH\]-negative)\] on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
- Participants considered at high risk of recurrence at initial staging
- Participants who have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i)
- Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments.
- Key
Exclusion criteria
- Participants with inflammatory breast cancer
- History of any prior (ipsilateral and/or contralateral) invasive breast cancer
- Participant with history of malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
- Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who are off current adjuvant endocrine therapy more than 6 months prior to randomization
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Where it is running
60 locations listed across 41 US states.
- Southern Cancer Center, PC - Daphne, Alabama, United States
- Ironwood Cancer and Research Centers - Chandler, Arizona, United States
- Banner MD Anderson Cancer Center - Gilbert, Arizona, United States
- Banner University Medical Center - Phoenix Campus (Banner Good Samaritan Medical Center) - Phoenix, Arizona, United States
- Mayo Clinic - Scottsdale, Arizona, United States
- Arizona Clinical Research Center, Inc. - Tucson, Arizona, United States
- University of Arizona Cancer Center - Tucson, Arizona, United States
- Highlands Oncology Group, PA - Springdale, Arkansas, United States
- Comprehensive Blood & Cancer Center - Bakersfield, California, United States
- UCSF Cancer Center Berkeley - Berkeley, California, United States
- Cedars-Sinai Cancer Beverly Hills - Beverly Hills, California, United States
- City of Hope National Medical Center - Duarte, California, United States
- UCSF Wash Cancer CNTR - Fremont, California, United States
- City of Hope at Irvine Lennar - Irvine, California, United States
- UC San Diego Moores Cancer Center - La Jolla, California, United States
- Helios Clinical Research - Long Beach, California, United States
- Cancer and Blood Research Center, LLC - Los Alamitos, California, United States
- USC/Norris Comprehensive Cancer Center - Los Angeles, California, United States
- UCLA Department of Medicine - Hematology/Oncology - Los Angeles, California, United States
- Pacific Cancer Care - Oncology - Monterey, California, United States
- Hoag Memorial Hospital Presbyterian - Newport Beach, California, United States
- UC Irvine Health, Chao Family Comprehensive Cancer Center - Orange, California, United States
- Stanford Women's Cancer Center - Palo Alto, California, United States
- Dignity Health dba Health Research Institute - Sacramento, California, United States
- Sutter Institute for Medical Research - Sacramento, California, United States
- UCSF Zuckerberg SF General - San Francisco, California, United States
- University of California, San Francisco (UCSF) - San Francisco, California, United States
- Southern California Kaiser Medical Center-San Marcos Medical - San Marcos, California, United States
- UCSF Cancer Center San Mateo - San Mateo, California, United States
- Sansum Clinic - Solvang, California, United States
- Torrance Memorial Physician Network- Cancer Care - Torrance, California, United States
- St.Joseph Hospital- Cancer Centers of Colorado - Denver, Colorado, United States
- Rocky Mountain Cancer Centers, LLP - Lone Tree, Colorado, United States
- AHMG Hematology and Oncology - Parker, Colorado, United States
- Cancer Care at CommonSpirit St. Anthony North Hospital - Westminster, Colorado, United States
- Yale New Haven Hospital- Yale Cancer Center - New Haven, Connecticut, United States
- Georgetown University Medical Center - Washington D.C., District of Columbia, United States
- MedStar Washington Hospital Center - Washington D.C., District of Columbia, United States
- Sibley Memorial Hospital - Washington D.C., District of Columbia, United States
- The George Washington Medical Faculty Associates - Washington D.C., District of Columbia, United States
- Boca Raton Regional Hospital (BRRH) - Lynn Cancer Institute - Boca Raton, Florida, United States
- Florida Cancer Specialists - Fort Myers, Florida, United States
- Mayo Clinic - Jacksonville, Florida, United States
- Helios Clinical - Lakeland, Florida, United States
- Miami Cancer Institute at Baptist Health Inc. - Miami, Florida, United States
- University of Miami - Miami, Florida, United States
- AdventHealth Orlando Infusion Center - Orlando, Florida, United States
- Cancer Care Centers of Brevard (CCCB) - Palm Bay - Palm Bay, Florida, United States
- Memorial Healthcare System - Pembroke Pines, Florida, United States
- Ascension Sacred Heart - Pensacola, Florida, United States
- Miami Cancer Institute at Plantation - Plantation, Florida, United States
- Florida Cancer Specialists - St. Petersburg, Florida, United States
- Comprehensive Hematology Oncology - St. Petersburg, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Florida Cancer Specialists - West Palm Beach, Florida, United States
- Cleveland Clinic Florida - Weston, Florida, United States
- University Blood & Cancer Center, LLC - Athens, Georgia, United States
- Winship Cancer Institute - Atlanta, Georgia, United States
- Northside Hospital - Atlanta, Georgia, United States
- Kaiser Permanente Hawaii Moanalua Medical Center - Honolulu, Hawaii, United States
Showing 60 of 562 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →