A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Trial Status: active
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.
Inclusion Criteria
- Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry [IHC]), HER2-negative [IHC = 0 or 1, or (IHC = 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 discontinued adjuvant endocrine therapy more than 6 months prior to randomization Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Additional locations may be listed on ClinicalTrials.gov for NCT06492616.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not AvailableCalifornia
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Name Not AvailableLos Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Ashley Tung
Phone: 310-998-4747ext16903
Email: AMTung@mednet.ucla.edu
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Kimberly Arieli
Phone: 916-752-6331
Email: Kimberly.Arieli@med.usc.edu
Newport Beach
USC Norris Oncology/Hematology-Newport Beach
Status: Active
Contact: Kimberly Arieli
Phone: 916-752-6331
Email: Kimberly.Arieli@med.usc.edu
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Status: Approved
Name Not AvailableSan Francisco
University of California San Francisco
Status: Active
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu
Connecticut
Derby
Smilow Cancer Hospital-Derby Care Center
Status: Active
Name Not AvailableFairfield
Smilow Cancer Hospital Care Center-Fairfield
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 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 AvailableTrumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not AvailableFlorida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not AvailableTampa
Moffitt Cancer Center
Status: Active
Name Not AvailableGeorgia
Atlanta
Emory University Hospital Midtown
Status: Active
Name Not AvailableEmory University Hospital/Winship Cancer Institute
Status: Active
Name Not AvailableMaryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not AvailableMassachusetts
Boston
Brigham and Women's Hospital
Status: Active
Name Not AvailableDana-Farber Cancer Institute
Status: Active
Name Not AvailableMinnesota
Albert Lea
Mayo Clinic Health System in Albert Lea
Status: Active
Name Not AvailableMankato
Mayo Clinic Health Systems-Mankato
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 Jersey
Hackensack
Hackensack University Medical Center
Status: Active
Name Not AvailableNew Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Contact: Coral Oghenerukevwe Omene
Phone: 732-235-3374
Email: co273@cinj.rutgers.edu
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not AvailableMount Sinai West
Status: Active
Name Not AvailableNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not AvailableMount Sinai Chelsea
Status: Active
Name Not AvailableIcahn School of Medicine at Mount Sinai
Status: Active
Name Not AvailableOhio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not AvailableSouth Carolina
Charleston
Medical University of South Carolina
Status: Active
Name Not AvailableTexas
Houston
M D Anderson Cancer Center
Status: Active
Name Not AvailableSan 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
Utah
Salt Lake City
Huntsman Cancer Institute/University of Utah
Status: Active
Name Not AvailableWashington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Approved
Name Not AvailableWisconsin
Eau Claire
Mayo Clinic Health System-Eau Claire Clinic
Status: Active
Name Not AvailableLa Crosse
Mayo Clinic Health System-Franciscan Healthcare
Status: Active
Name Not AvailableMadison
University of Wisconsin Carbone Cancer Center - University Hospital
Status: Active
Name Not AvailableTrial PhasePhase III
Trial Typetreatment
Lead OrganizationStemline Therapeutics, Inc.
- Primary IDSTML-ELA-0422
- Secondary IDsNCI-2025-00399, 2024-515445-42-00
- ClinicalTrials.gov IDNCT06492616