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Recruiting Phase 3 Interventional

A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

ClinicalTrials.gov ID: NCT06492616

Public ClinicalTrials.gov record NCT06492616. 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.

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ClinicalTrials.gov public records Last synced May 6, 2026, 2:05 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

Study identification

NCT ID
NCT06492616
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Stemline Therapeutics, Inc.
Industry
Enrollment
4,220 participants

Conditions and interventions

Conditions

Interventions

  • Anastrozole Drug
  • Elacestrant Drug
  • Exemestane Drug
  • Letrozole Drug
  • Tamoxifen Drug

Drug

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
Sep 26, 2024
Primary completion
Jul 31, 2029
Completion
Sep 30, 2032
Last update posted
Apr 23, 2026

2024 – 2032

United States locations

U.S. sites
162
U.S. states
40
U.S. cities
131
Facility City State ZIP Site status
Southern Cancer Center, PC Daphne Alabama 36526 Recruiting
Ironwood Cancer and Research Centers Chandler Arizona 85224 Recruiting
Banner MD Anderson Cancer Center Gilbert Arizona 85234-2165 Recruiting
Mayo Clinic Scottsdale Arizona 85259-5452 Recruiting
Arizona Clinical Research Center, Inc. Tucson Arizona 85715 Recruiting
University of Arizona Cancer Center Tucson Arizona 85719 Recruiting
Highlands Oncology Group, PA Springdale Arkansas 72762 Recruiting
Comprehensive Blood & Cancer Center Bakersfield California 93309 Recruiting
UCSF Cancer Center Berkeley Berkeley California 94702 Recruiting
City of Hope National Medical Center Duarte California 91010 Recruiting
UCSF Wash Cancer CNTR Fremont California 94538 Recruiting
UC San Diego Moores Cancer Center La Jolla California 92037 Recruiting
Helios Clinical Research Long Beach California 90805 Recruiting
Cancer and Blood Research Center, LLC Los Alamitos California 90720 Recruiting
USC/Norris Comprehensive Cancer Center Los Angeles California 90033 Recruiting
UCLA Department of Medicine - Hematology/Oncology Los Angeles California 90095 Recruiting
Hoag Memorial Hospital Presbyterian Newport Beach California 92663 Recruiting
UC Irvine Health, Chao Family Comprehensive Cancer Center Orange California 92868-3201 Recruiting
Stanford Women's Cancer Center Palo Alto California 94304 Recruiting
Dignity Health dba Health Research Institute Sacramento California 95816 Recruiting
Sutter Institute for Medical Research Sacramento California 95816 Recruiting
UCSF Zuckerberg SF General San Francisco California 94143 Recruiting
University of California, San Francisco (UCSF) San Francisco California 94158 Recruiting
Southern California Kaiser Medical Center-San Marcos Medical San Marcos California 92069 Recruiting
UCSF Cancer Center San Mateo San Mateo California 94402 Recruiting
Sansum Clinic Solvang California 93463 Recruiting
Torrance Memorial Physician Network- Cancer Care Torrance California 90505 Recruiting
St.Joseph Hospital- Cancer Centers of Colorado Denver Colorado 80218-1122 Recruiting
Rocky Mountain Cancer Centers, LLP Lone Tree Colorado 80124 Recruiting
AHMG Hematology and Oncology Parker Colorado 80138 Recruiting
Cancer Care at CommonSpirit St. Anthony North Hospital Westminster Colorado 80023 Recruiting
Yale New Haven Hospital- Yale Cancer Center New Haven Connecticut 06510 Recruiting
MedStar Washington Hospital Center Washington D.C. District of Columbia 20010-3017 Recruiting
The George Washington Medical Faculty Associates Washington D.C. District of Columbia 20037 Recruiting
Boca Raton Regional Hospital (BRRH) - Lynn Cancer Institute Boca Raton Florida 33486 Recruiting
Florida Cancer Specialists Fort Myers Florida 33901 Recruiting
Mayo Clinic Jacksonville Florida 32224 Recruiting
Helios Clinical Lakeland Florida 33812 Recruiting
Miami Cancer Institute at Baptist Health Inc. Miami Florida 33176 Recruiting
University of Miami Miami Florida 33176 Recruiting
AdventHealth Orlando Infusion Center Orlando Florida 32804 Recruiting
Cancer Care Centers of Brevard (CCCB) - Palm Bay Palm Bay Florida 32909 Recruiting
Memorial Healthcare System Pembroke Pines Florida 33026 Recruiting
Ascension Sacred Heart Pensacola Florida 32504 Recruiting
Miami Cancer Institute at Plantation Plantation Florida 33324 Recruiting
Florida Cancer Specialists St. Petersburg Florida 33705 Recruiting
Comprehensive Hematology Oncology St. Petersburg Florida 33709 Recruiting
Moffitt Cancer Center Tampa Florida 33612 Recruiting
Florida Cancer Specialists West Palm Beach Florida 33401 Recruiting
Cleveland Clinic Florida Weston Florida 33331-3609 Recruiting
University Blood & Cancer Center, LLC Athens Georgia 30607 Recruiting
Winship Cancer Institute Atlanta Georgia 30322 Recruiting
Northside Hospital Atlanta Georgia 30341 Recruiting
Kaiser Permanente Hawaii Moanalua Medical Center Honolulu Hawaii 96819 Recruiting
Illinois Cancer Specialists Arlington Heights Illinois 60005 Recruiting
Northwestern Memorial Hospital Chicago Illinois 60611 Recruiting
RUSH MD Anderson Cancer Center Chicago Illinois 60612-3841 Recruiting
Northwest Cancer Centers, PC Dyer Indiana 46311 Recruiting
Mission Cancer and Blood Des Moines Iowa 50309 Recruiting
Cancer Center of Kansas Wichita Kansas 67214 Recruiting
University Medical Center-New Orleans New Orleans Louisiana 70112 Recruiting
Mercy Medical Center Baltimore Maryland 21202 Recruiting
Ascension St. Agnes Hospital Baltimore Maryland 21229 Recruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland 21287 Recruiting
Maryland Oncology Hematology, P.A. Columbia Maryland 21044 Recruiting
Massachusetts General Hospital Boston Massachusetts 02114 Recruiting
Boston Medical Center Boston Massachusetts 02118 Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 Recruiting
Dana Farber Cancer Institute Boston Massachusetts 02215 Recruiting
Mass General North Shore Cancer Center Danvers Massachusetts 01923-3623 Recruiting
Dana Farber Cancer Institute at Foxborough Foxborough Massachusetts 02035 Recruiting
Dana Farber Cancer Institute - Merrimack Valley Methuen Massachusetts 01844 Recruiting
Dana-Farber Cancer Institute at Milford Regional Milford Massachusetts 01757 Recruiting
Mass General Cancer Center at Newton-Wellesley Hospital's Vernon Cancer Center Newton Massachusetts 02462 Recruiting
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital South Weymouth Massachusetts 02190 Recruiting
Mass General - North Shore Cancer Center Waltham Massachusetts 02451 Recruiting
The Cancer & Hematology Centers Grand Rapids Michigan 49503 Recruiting
Mayo Clinic Health System - Albert Lea Albert Lea Minnesota 56007 Recruiting
Mayo Clinic - Mankato Mankato Minnesota 56001-4752 Recruiting
Allina Health Cancer Institute - Abbott Northwestern Hospital Minneapolis Minnesota 55407 Recruiting
Mayo Clinic Rochester Minnesota 01842 Recruiting
Baptist Clinical Research Institution Oxford Mississippi 38655 Recruiting
Siteman Cancer Center St Louis Missouri 63108 Recruiting
NHO Revive Research Institute LLC Lincoln Nebraska 68506 Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy Omaha Nebraska 68130 Recruiting
University of Nebraska Medical Center Omaha Nebraska 68198 Recruiting
MD Anderson Cancer Center at Cooper Camden New Jersey 08103 Recruiting
Summit Medical Group Florham Park New Jersey 07932 Recruiting
John Theurer Ctr-Hackensack UMC Hackensack New Jersey 07601 Recruiting
Rutgers Cancer Institute New Brunswick New Jersey 08903 Recruiting
Exigent Research LLC/New Mexico Oncology Hematology Consultants Ltd. Albuquerque New Mexico 87109 Recruiting
Kings County Hospital Center Brooklyn New York 11203 Recruiting
Hematology Oncology Associates of Central New York, PC East Syracuse New York 13057 Recruiting
Cayuga Medical Center Ithaca New York 14850 Recruiting
NYU Langone Hospital-Long Island Mineola New York 11501 Recruiting
The Blavatnik Family - Chelsea Medical Center at Mount Sinai New York New York 10011 Recruiting
Laura and Isaac Perlmutter Cancer Center/NYU Langone Health New York New York 10016 Recruiting
Mount Sinai West New York New York 10019 Recruiting
Icahn School of Medicine Mount Sinai New York New York 10029 Recruiting
Columbia University Medical Center New York New York 10032-3729 Recruiting
University of Rochester Medical Rochester New York 14642 Recruiting
Stony Brook University Cancer Center Stony Brook New York 11794 Recruiting
Clinical Research Alliance, Inc. Westbury New York 11590 Recruiting
Duke Cancer Institute Durham North Carolina 27710 Recruiting
Cape Fear Valley Medical Center Fayetteville North Carolina 28304 Recruiting
Cone Health Cancer Center at Wesley Long Greensboro North Carolina 27403 Recruiting
Miami Valley Hospital South Centerville Ohio 45459 Recruiting
MetroHealth Cleveland Ohio 44109 Recruiting
Cleveland Clinic Cleveland Ohio 44195 Recruiting
Oncology_Hematology Care Clinical Trials, LLC Fairfield Ohio 45014 Recruiting
Oklahoma Cancer Specialists and Research Institute (OCSRI) - Tulsa Cancer Center Tulsa Oklahoma 74146 Recruiting
Providence Cancer Institute Franz Clinic Portland Oregon 97213 Recruiting
Oregon Oncology Specialists Salem Oregon 97301 Recruiting
Northwest Cancer Specialists, P.C. Tigard Oregon 97223 Recruiting
Lehigh Valley Health Network - Cedar Crest Allen Pennsylvania 18103 Recruiting
Consultants In Medical Oncology and Hematology, P.C. Broomall Pennsylvania 19008 Recruiting
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania 17033 Recruiting
Holy Redeemer Hospital And Medical Center Meadowbrook Pennsylvania 19046 Recruiting
Alliance Cancer Specialists, PC Media Pennsylvania 19044-1134 Recruiting
Lankenau Medical Center Wynnewood Pennsylvania 19096 Recruiting
Cancer Care Associates of York, Inc. York Pennsylvania 17403 Recruiting
Rhode Island Hospital Providence Rhode Island 02903 Recruiting
Hollings Cancer Center Charleston South Carolina 29425 Recruiting
Avera St. Mary's Hospital Pierre South Dakota 57501 Recruiting
Avera Cancer Institute Sioux Falls South Dakota 57105 Recruiting
Baptist Cancer Center Memphis Tennessee 38120 Recruiting
SCRI Oncology Partners Nashville Tennessee 37203 Recruiting
Tennessee Oncology, PLLC Nashville Tennessee 37203 Recruiting
Henry - Joyce Cancer Clinic Nashville Tennessee 37232 Recruiting
Hendrick Cancer Center Abilene Texas 79601 Recruiting
Texas Oncology-Northeast Texas Allen Texas 75013 Recruiting
Texas Oncology - DFW Dallas Texas 75246 Recruiting
Oncology Consultants, P.A. Houston Texas 77024 Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas 77030-4009 Recruiting
Harris Health System - Smith Clinic Houston Texas 77054 Recruiting
O'Quinn Medical Tower - McNair Campus Houston Texas 77054 Recruiting
Covenant Children's Hospital- Joe Arrington Cancer Research and Treatment Center Lubbock Texas 79410 Recruiting
Texas Oncology - San Antonio New Braunfels Texas 78130 Recruiting
Texas Oncology-Gulf Coast Pearland Texas 77584 Recruiting
Mays Cancer Center San Antonio Texas 78229 Recruiting
Texas Oncology- Central South Weslaco Texas 78596 Recruiting
Utah Cancer Specialists Salt Lake City Utah 84106 Recruiting
Huntsman Cancer Institute, University of Utah Salt Lake City Utah 84112 Recruiting
University of Vermont Medical Center Burlington Vermont 05401 Recruiting
Inova Schar Cancer Institute Fairfax Virginia 22031 Recruiting
Virginia Cancer Specialists Fairfax Virginia 22031 Recruiting
Virginia Oncology Associates Newport News Virginia 23606 Recruiting
Virginia Cancer Institute Richmond Virginia 23229 Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc Wytheville Virginia 24382 Recruiting
Vista Oncology Olympia Washington 98506 Recruiting
Virginia Mason Medical Center Seattle Washington 98101 Recruiting
Swedish Cancer Institute Seattle Washington 98104 Recruiting
Fred Hutchinson Cancer Center Seattle Washington 98109 Recruiting
Fred Hutch CC at UWMC-Northwest Seattle Washington 98133 Recruiting
Cancer Care Northwest Spokane Valley Washington 99216 Recruiting
MultiCare Cancer Institute - Tacoma Tacoma Washington 98405 Recruiting
Northwest Medical Specialties PLLC Tacoma Washington 98405 Recruiting
Mayo Clinic Health System - Eau Claire Eau Claire Wisconsin 54703 Recruiting
Mayo Clinic Health System - La Crosse La Crosse Wisconsin 54601 Recruiting
University of Wisconsin Carbone Cancer Center- University Hospital Madison Wisconsin 53792 Recruiting
Froedtert Hospital & the Medical College of Wisconsin Milwaukee Wisconsin 53226 Recruiting
UW Cancer Center at ProHealth Care Waukesha Wisconsin 53188 Withdrawn

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 374 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06492616, 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 23, 2026 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06492616 live on ClinicalTrials.gov.

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