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A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Sponsor: Stemline Therapeutics, Inc.
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
4556
Start Date
2024-09-27
Completion Date
2032-10
Last Updated
2026-11-04
Healthy Volunteers
No
Conditions
Interventions
Elacestrant
Administered as oral tablets
Anastrozole
Administered as oral tablets
Letrozole
Administered as oral tablets
Exemestane
Administered as oral tablets
Tamoxifen
Administered as oral tablets
Locations (555)
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
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
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
Florida Cancer Specialists
Fort Myers, Florida, United States
Mayo Clinic
Jacksonville, 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
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
RUSH MD Anderson Cancer Center
Chicago, Illinois, United States
Northwest Cancer Centers, PC
Dyer, Indiana, United States
Mission Cancer and Blood
Des Moines, Iowa, United States
Cancer Center of Kansas
Wichita, Kansas, United States
UofL Health Brown Cancer Center
Louisville, Kentucky, United States
University Medical Center-New Orleans
New Orleans, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Ascension St. Agnes Hospital
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mass General North Shore Cancer Center
Danvers, Massachusetts, United States
Dana Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, United States
Dana Farber Cancer Institute - Merrimack Valley
Methuen, Massachusetts, United States
Dana-Farber Cancer Institute at Milford Regional
Milford, Massachusetts, United States
Mass General Cancer Center at Newton-Wellesley Hospital's Vernon Cancer Center
Newton, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital
South Weymouth, Massachusetts, United States
Mass General - North Shore Cancer Center
Waltham, Massachusetts, United States
The Cancer & Hematology Centers
Grand Rapids, Michigan, United States
Mayo Clinic Health System - Albert Lea
Albert Lea, Minnesota, United States
Mayo Clinic - Mankato
Mankato, Minnesota, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Metro-MN Comm. Onc. Res Consortium
Saint Louis Park, Minnesota, United States
Baptist Clinical Research Institution
Oxford, Mississippi, United States
Siteman Cancer Center
St Louis, Missouri, United States
NHO Revive Research Institute LLC
Lincoln, Nebraska, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
MD Anderson Cancer Center at Cooper
Camden, New Jersey, United States
Summit Medical Group
Florham Park, New Jersey, United States
John Theurer Ctr-Hackensack UMC
Hackensack, New Jersey, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
Exigent Research LLC/New Mexico Oncology Hematology Consultants Ltd.
Albuquerque, New Mexico, United States
Kings County Hospital Center
Brooklyn, New York, United States
Hematology Oncology Associates of Central New York, PC
East Syracuse, New York, United States
Cayuga Medical Center
Ithaca, New York, United States
NYU Langone Hospital-Long Island
Mineola, New York, United States
The Blavatnik Family - Chelsea Medical Center at Mount Sinai
New York, New York, United States
Laura and Isaac Perlmutter Cancer Center/NYU Langone Health
New York, New York, United States