Dysautonomia International

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

Purpose

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.

Condition

Breast Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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.

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.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Elacestrant	Participants will receive 345 milligrams (mg) elacestrant once daily (QD) for 5 years.	Drug: Elacestrant Administered as oral tablets
Experimental Standard of Care (SoC) Endocrine Therapy	Participants will receive the SoC endocrine therapy that was used prior to randomization: - AI (anastrozole 1 mg QD, letrozole 2.5 mg QD, or exemestane 25 mg QD); or - Tamoxifen 20 mg QD	Drug: Anastrozole Administered as oral tablets Drug: Letrozole Administered as oral tablets Drug: Exemestane Administered as oral tablets Drug: Tamoxifen Administered as oral tablets

Recruiting Locations

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

City of Hope National Medical Center
Duarte, California 91010

UCSF Wash Cancer CNTR
Fremont, California 94538

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

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

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 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 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

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

More Details

Status: Recruiting
Sponsor: Stemline Therapeutics, Inc.

Study Contact

Stemline Trials
1-877-332-7961
clinicaltrials@menarinistemline.com