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
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.
Arms & interventions
- DrugElacestrant
Administered as oral tablets
- DrugAnastrozole
Administered as oral tablets
- DrugLetrozole
Administered as oral tablets
- DrugExemestane
Administered as oral tablets
- DrugTamoxifen
Administered as oral tablets
Outcome measures
Primary
Invasive Breast Cancer-Free Survival (IBCFS)
Assessed by the time from date of randomization to the date of first occurrence of: * Ipsilateral invasive breast tumor recurrence * Local/regional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive breast cancer, or * Death attributable to any cause
Time frame: Up to 5 years
Secondary
Distant Relapse-Free Survival (DRFS)
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
Invasive Disease-Free Survival (IDFS)
Time frame: Up to 5 years
Number of Participants With Adverse Events (AEs)
Time frame: Up to 5 years plus 28 days
Change from Baseline in Global Health Status Quality of Life Scale score, as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30
Time frame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Change From Baseline in the Breast Cancer Endocrine Therapy Symptoms Sub-Scale Score, as Assessed by the EORTC Quality of Life Breast Cancer Questionnaire module (EORTC QLQ-BR42)
Time frame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Change From Baseline in Side Effects, as Assessed by the Question 168 of the European Organization for the Research and Treatment of Cancer Question Library (EORTC Q168)
Time frame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant
Time frame: Predose up to 4 hours postdose
Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant
Time frame: Predose up to 4 hours postdose
Eligibility criteria
Study locations (165)
Southern Cancer Center, PC
Daphne, Alabama, 36526
Ironwood Cancer and Research Centers
Chandler, Arizona, 85224
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234-2165
Mayo Clinic
Scottsdale, Arizona, 85259-5452
Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85715
University of Arizona Cancer Center
Tucson, Arizona, 85719
Highlands Oncology Group, PA
Springdale, Arkansas, 72762
Comprehensive Blood & Cancer Center
Bakersfield, California, 93309
UCSF Cancer Center Berkeley
Berkeley, California, 94702
Cedars-Sinai Cancer Beverly Hills
Beverly Hills, California, 90211
City of Hope National Medical Center
Duarte, California, 91010
UCSF Wash Cancer CNTR
Fremont, California, 94538
City of Hope at Irvine Lennar
Irvine, California, 92618
UC San Diego Moores Cancer Center
La Jolla, California, 92037
Helios Clinical Research
Long Beach, California, 90805
Cancer and Blood Research Center, LLC
Los Alamitos, California, 90720
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, 90095
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
UC Irvine Health, Chao Family Comprehensive Cancer Center
Orange, California, 92868-3201
Stanford Women's Cancer Center
Palo Alto, California, 94304
Dignity Health dba Health Research Institute
Sacramento, California, 95816
Sutter Institute for Medical Research
Sacramento, California, 95816
UCSF Zuckerberg SF General
San Francisco, California, 94143
University of California, San Francisco (UCSF)
San Francisco, California, 94158
Southern California Kaiser Medical Center-San Marcos Medical
San Marcos, California, 92069
UCSF Cancer Center San Mateo
San Mateo, California, 94402
Sansum Clinic
Solvang, California, 93463
Torrance Memorial Physician Network- Cancer Care
Torrance, California, 90505
St.Joseph Hospital- Cancer Centers of Colorado
Denver, Colorado, 80218-1122
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124
AHMG Hematology and Oncology
Parker, Colorado, 80138
Cancer Care at CommonSpirit St. Anthony North Hospital
Westminster, Colorado, 80023
Yale New Haven Hospital- Yale Cancer Center
New Haven, Connecticut, 06510
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010-3017
The George Washington Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Boca Raton Regional Hospital (BRRH) - Lynn Cancer Institute
Boca Raton, Florida, 33486
Florida Cancer Specialists
Fort Myers, Florida, 33901
Mayo Clinic
Jacksonville, Florida, 32224
Helios Clinical
Lakeland, Florida, 33812
Miami Cancer Institute at Baptist Health Inc.
Miami, Florida, 33176
University of Miami
Miami, Florida, 33176
AdventHealth Orlando Infusion Center
Orlando, Florida, 32804
Cancer Care Centers of Brevard (CCCB) - Palm Bay
Palm Bay, Florida, 32909
Memorial Healthcare System
Pembroke Pines, Florida, 33026
Ascension Sacred Heart
Pensacola, Florida, 32504
Miami Cancer Institute at Plantation
Plantation, Florida, 33324
Florida Cancer Specialists
St. Petersburg, Florida, 33705
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709
Moffitt Cancer Center
Tampa, Florida, 33612
Florida Cancer Specialists
West Palm Beach, Florida, 33401
Cleveland Clinic Florida
Weston, Florida, 33331-3609
University Blood & Cancer Center, LLC
Athens, Georgia, 30607
Winship Cancer Institute
Atlanta, Georgia, 30322
Northside Hospital
Atlanta, Georgia, 30341
Kaiser Permanente Hawaii Moanalua Medical Center
Honolulu, Hawaii, 96819
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
Northwestern Memorial Hospital
Chicago, Illinois, 60611
RUSH MD Anderson Cancer Center
Chicago, Illinois, 60612-3841
Northwest Cancer Centers, PC
Dyer, Indiana, 46311
Mission Cancer and Blood
Des Moines, Iowa, 50309
Cancer Center of Kansas
Wichita, Kansas, 67214
UofL Health Brown Cancer Center
Louisville, Kentucky, 40202
University Medical Center-New Orleans
New Orleans, Louisiana, 70112
Mercy Medical Center
Baltimore, Maryland, 21202
Ascension St. Agnes Hospital
Baltimore, Maryland, 21229
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Mass General North Shore Cancer Center
Danvers, Massachusetts, 01923-3623
Dana Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, 02035
Dana Farber Cancer Institute - Merrimack Valley
Methuen, Massachusetts, 01844
Dana-Farber Cancer Institute at Milford Regional
Milford, Massachusetts, 01757
Mass General Cancer Center at Newton-Wellesley Hospital's Vernon Cancer Center
Newton, Massachusetts, 02462
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital
South Weymouth, Massachusetts, 02190
Mass General - North Shore Cancer Center
Waltham, Massachusetts, 02451
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49503
Mayo Clinic Health System - Albert Lea
Albert Lea, Minnesota, 56007
Mayo Clinic - Mankato
Mankato, Minnesota, 56001-4752
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Mayo Clinic
Rochester, Minnesota, 01842
Baptist Clinical Research Institution
Oxford, Mississippi, 38655
Siteman Cancer Center
St Louis, Missouri, 63108
NHO Revive Research Institute LLC
Lincoln, Nebraska, 68506
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy
Omaha, Nebraska, 68130
University of Nebraska Medical Center
Omaha, Nebraska, 68198
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103
Summit Medical Group
Florham Park, New Jersey, 07932
John Theurer Ctr-Hackensack UMC
Hackensack, New Jersey, 07601
Rutgers Cancer Institute
New Brunswick, New Jersey, 08903
Exigent Research LLC/New Mexico Oncology Hematology Consultants Ltd.
Albuquerque, New Mexico, 87109
Kings County Hospital Center
Brooklyn, New York, 11203
Hematology Oncology Associates of Central New York, PC
East Syracuse, New York, 13057
Cayuga Medical Center
Ithaca, New York, 14850
NYU Langone Hospital-Long Island
Mineola, New York, 11501
The Blavatnik Family - Chelsea Medical Center at Mount Sinai
New York, New York, 10011
Laura and Isaac Perlmutter Cancer Center/NYU Langone Health
New York, New York, 10016
Mount Sinai West
New York, New York, 10019
Icahn School of Medicine Mount Sinai
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032-3729
University of Rochester Medical
Rochester, New York, 14642
Stony Brook University Cancer Center
Stony Brook, New York, 11794
Clinical Research Alliance, Inc.
Westbury, New York, 11590
Duke Cancer Institute
Durham, North Carolina, 27710
Cape Fear Valley Medical Center
Fayetteville, North Carolina, 28304
Cone Health Cancer Center at Wesley Long
Greensboro, North Carolina, 27403
Miami Valley Hospital South
Centerville, Ohio, 45459
MetroHealth
Cleveland, Ohio, 44109
Cleveland Clinic
Cleveland, Ohio, 44195
Oncology_Hematology Care Clinical Trials, LLC
Fairfield, Ohio, 45014
Oklahoma Cancer Specialists and Research Institute (OCSRI) - Tulsa Cancer Center
Tulsa, Oklahoma, 74146
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
Oregon Oncology Specialists
Salem, Oregon, 97301
Northwest Cancer Specialists, P.C.
Tigard, Oregon, 97223
Lehigh Valley Health Network - Cedar Crest
Allen, Pennsylvania, 18103
Consultants In Medical Oncology and Hematology, P.C.
Broomall, Pennsylvania, 19008
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Holy Redeemer Hospital And Medical Center
Meadowbrook, Pennsylvania, 19046
Alliance Cancer Specialists, PC
Media, Pennsylvania, 19044-1134
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Cancer Care Associates of York, Inc.
York, Pennsylvania, 17403
Rhode Island Hospital
Providence, Rhode Island, 02903
Hollings Cancer Center
Charleston, South Carolina, 29425
Avera St. Mary's Hospital
Pierre, South Dakota, 57501
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Baptist Cancer Center
Memphis, Tennessee, 38120
SCRI Oncology Partners
Nashville, Tennessee, 37203
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Henry - Joyce Cancer Clinic
Nashville, Tennessee, 37232
Hendrick Cancer Center
Abilene, Texas, 79601
Texas Oncology-Northeast Texas
Allen, Texas, 75013
Texas Oncology - DFW
Dallas, Texas, 75246
Oncology Consultants, P.A.
Houston, Texas, 77024
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
Harris Health System - Smith Clinic
Houston, Texas, 77054
O'Quinn Medical Tower - McNair Campus
Houston, Texas, 77054
Covenant Children's Hospital- Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410
Texas Oncology - San Antonio
New Braunfels, Texas, 78130
Texas Oncology-Gulf Coast
Pearland, Texas, 77584
Mays Cancer Center
San Antonio, Texas, 78229
Texas Oncology- Central South
Weslaco, Texas, 78596
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
University of Vermont Medical Center
Burlington, Vermont, 05401
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Virginia Oncology Associates
Newport News, Virginia, 23606
Virginia Cancer Institute
Richmond, Virginia, 23229
Oncology & Hematology Associates of Southwest Virginia, Inc
Wytheville, Virginia, 24382
Vista Oncology
Olympia, Washington, 98506
Virginia Mason Medical Center
Seattle, Washington, 98101
Swedish Cancer Institute
Seattle, Washington, 98104
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Fred Hutch CC at UWMC-Northwest
Seattle, Washington, 98133
Cancer Care Northwest
Spokane Valley, Washington, 99216
MultiCare Cancer Institute - Tacoma
Tacoma, Washington, 98405
Northwest Medical Specialties PLLC
Tacoma, Washington, 98405
Mayo Clinic Health System - Eau Claire
Eau Claire, Wisconsin, 54703
Mayo Clinic Health System - La Crosse
La Crosse, Wisconsin, 54601
University of Wisconsin Carbone Cancer Center- University Hospital
Madison, Wisconsin, 53792
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188