Recruiting
Phase 3

Elacestrant vs. Standard Endocrine Therapy

Sponsor:

Stemline Therapeutics, Inc.

Code:

NCT06492616

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elacestrant

Anastrozole

Letrozole

Exemestane

Tamoxifen

Study Details

Brief 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.

Conditions

Breast Cancer

Study ID

NCT06492616

Start date

Sep 27, 2024

Status verified date

Aug, 2026

Completion date

Oct, 2032

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key 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.

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 are off current adjuvant endocrine therapy more than 6 months prior to randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

4220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Elacestrant

Participants will receive 345 milligrams (mg) elacestrant once daily (QD) for 5 years.

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

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

Primary outcome measure

  • Invasive Breast Cancer-Free Survival (IBCFS) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Locations

Southern Cancer Center, PC

Recruiting

Daphne, Alabama, United States, 36526

Principal Investigator:

Michael Meshad

Ironwood Cancer and Research Centers

Recruiting

Chandler, Arizona, United States, 85224

Principal Investigator:

Anu Batra

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234-2165

Principal Investigator:

Hung Khong

Banner University Medical Center - Phoenix Campus (Banner Good Samaritan Medical Center)

Recruiting

Phoenix, Arizona, United States, 85006

Principal Investigator:

Hung Khong

Mayo Clinic

Recruiting

Scottsdale, Arizona, United States, 85259-5452

Principal Investigator:

Brenda Ernst

Arizona Clinical Research Center, Inc.

Recruiting

Tucson, Arizona, United States, 85715

Principal Investigator:

Manuel Modiano-Revah

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85719

Principal Investigator:

Sima Ehsani

Highlands Oncology Group, PA

Recruiting

Springdale, Arkansas, United States, 72762

Principal Investigator:

Joseph Beck

Comprehensive Blood & Cancer Center

Recruiting

Bakersfield, California, United States, 93309

Principal Investigator:

Ravindranath Patel

UCSF Cancer Center Berkeley

Recruiting

Berkeley, California, United States, 94702

Principal Investigator:

Michelle Melisko

Cedars-Sinai Cancer Beverly Hills

Recruiting

Beverly Hills, California, United States, 90211

Principal Investigator:

Jin Bitar

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010

Principal Investigator:

Thanh Nga Doan

UCSF Wash Cancer CNTR

Recruiting

Fremont, California, United States, 94538

Principal Investigator:

Michelle Melisko

City of Hope at Irvine Lennar

Recruiting

Irvine, California, United States, 92618

Principal Investigator:

Thanh Nga Doan

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

Principal Investigator:

Rebecca Shatsky

Helios Clinical Research

Recruiting

Long Beach, California, United States, 90805

Principal Investigator:

Omkar Marathe

Cancer and Blood Research Center, LLC

Recruiting

Los Alamitos, California, United States, 90720

Principal Investigator:

Nihal Abdulla

USC/Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Principal Investigator:

Daphne Stewart

UCLA Department of Medicine - Hematology/Oncology

Recruiting

Los Angeles, California, United States, 90095

Principal Investigator:

Marla Lipsyc-Sharf

Pacific Cancer Care - Oncology

Recruiting

Monterey, California, United States, 93940

Principal Investigator:

Nancy Rubin

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Principal Investigator:

Chaitali Nangia

UC Irvine Health, Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868-3201

Principal Investigator:

Ritesh Parajuli

Stanford Women's Cancer Center

Recruiting

Palo Alto, California, United States, 94304

Principal Investigator:

Fauzia Riaz

Dignity Health dba Health Research Institute

Recruiting

Sacramento, California, United States, 95816

Principal Investigator:

Shazad Siddique

Sutter Institute for Medical Research

Recruiting

Sacramento, California, United States, 95816

Principal Investigator:

Nitin Rohatgi

UCSF Zuckerberg SF General

Recruiting

San Francisco, California, United States, 94143

Principal Investigator:

Michelle Melisko

University of California, San Francisco (UCSF)

Recruiting

San Francisco, California, United States, 94158

Principal Investigator:

Michelle Melisko

Southern California Kaiser Medical Center-San Marcos Medical

Recruiting

San Marcos, California, United States, 92069

Principal Investigator:

Sujatha Murali

UCSF Cancer Center San Mateo

Recruiting

San Mateo, California, United States, 94402

Principal Investigator:

Michelle Melisko

Sansum Clinic

Recruiting

Solvang, California, United States, 93463

Principal Investigator:

Constance Stoehr

Torrance Memorial Physician Network- Cancer Care

Recruiting

Torrance, California, United States, 90505

Principal Investigator:

David Chan

St.Joseph Hospital- Cancer Centers of Colorado

Recruiting

Denver, Colorado, United States, 80218-1122

Principal Investigator:

Sami Diab

Rocky Mountain Cancer Centers, LLP

Recruiting

Lone Tree, Colorado, United States, 80124

Principal Investigator:

Mabel Mardones

AHMG Hematology and Oncology

Recruiting

Parker, Colorado, United States, 80138

Principal Investigator:

Nadine Mikhaeel-Kamel

Yale New Haven Hospital- Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Principal Investigator:

Mariya Rozenblit

Georgetown University Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20007

Principal Investigator:

Katia Khoury

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010-3017

Principal Investigator:

Ami Chitalia

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Principal Investigator:

Jessica Tao

The George Washington Medical Faculty Associates

Recruiting

Washington D.C., District of Columbia, United States, 20037

Principal Investigator:

Pavani Chalasani

Boca Raton Regional Hospital (BRRH) - Lynn Cancer Institute

Recruiting

Boca Raton, Florida, United States, 33486

Principal Investigator:

Zdenka Segota

Florida Cancer Specialists

Recruiting

Fort Myers, Florida, United States, 33901

Principal Investigator:

Kristen Gonter-Aubin

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Principal Investigator:

Rohit Rao

Helios Clinical

Recruiting

Lakeland, Florida, United States, 33812

Principal Investigator:

Kamal Sharma

Miami Cancer Institute at Baptist Health Inc.

Recruiting

Miami, Florida, United States, 33176

Principal Investigator:

Naomi Dempsey

University of Miami

Recruiting

Miami, Florida, United States, 33176

Principal Investigator:

Alejandra Perez

AdventHealth Orlando Infusion Center

Recruiting

Orlando, Florida, United States, 32804

Principal Investigator:

Wassim Mchayleh

Cancer Care Centers of Brevard (CCCB) - Palm Bay

Recruiting

Palm Bay, Florida, United States, 32909

Principal Investigator:

Venkat Pavan Kancharla

Memorial Healthcare System

Recruiting

Pembroke Pines, Florida, United States, 33026

Principal Investigator:

Adriana Milillo- Naraine

Ascension Sacred Heart

Recruiting

Pensacola, Florida, United States, 32504

Principal Investigator:

Zachary Wright

Miami Cancer Institute at Plantation

Recruiting

Plantation, Florida, United States, 33324

Principal Investigator:

Naomi Dempsey

Florida Cancer Specialists

Recruiting

St. Petersburg, Florida, United States, 33705

Principal Investigator:

Mamta Choksi

Comprehensive Hematology Oncology

Recruiting

St. Petersburg, Florida, United States, 33709

Principal Investigator:

Neeharika Makani

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Hatem Soliman

Florida Cancer Specialists

Recruiting

West Palm Beach, Florida, United States, 33401

Principal Investigator:

Shaachi Gupta

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331-3609

Principal Investigator:

Diana Saravia

University Blood & Cancer Center, LLC

Recruiting

Athens, Georgia, United States, 30607

Principal Investigator:

Amanda Hathaway

Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator:

Jade Jones

Northside Hospital

Recruiting

Atlanta, Georgia, United States, 30341

Principal Investigator:

Amelia Zelnak

Kaiser Permanente Hawaii Moanalua Medical Center

Recruiting

Honolulu, Hawaii, United States, 96819

Principal Investigator:

Jennifer Carney

Illinois Cancer Specialists

Recruiting

Arlington Heights, Illinois, United States, 60005

Principal Investigator:

Urszula Sobol

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

William Gradishar

RUSH MD Anderson Cancer Center

Recruiting

Chicago, Illinois, United States, 60612-3841

Principal Investigator:

Melody Cobleigh

Northwest Cancer Centers, PC

Recruiting

Dyer, Indiana, United States, 46311

Principal Investigator:

Shruti Singh

Mission Cancer and Blood

Recruiting

Des Moines, Iowa, United States, 50309

Principal Investigator:

Seema Harichand-Hertd

Cancer Center of Kansas

Recruiting

Wichita, Kansas, United States, 67214

Principal Investigator:

Shaker Dakhil

UofL Health Brown Cancer Center

Recruiting

Louisville, Kentucky, United States, 40202

Principal Investigator:

Brian Dong

University Medical Center-New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Principal Investigator:

Michelle Loch

Mercy Medical Center

Recruiting

Baltimore, Maryland, United States, 21202

Principal Investigator:

David Riseberg

Ascension St. Agnes Hospital

Recruiting

Baltimore, Maryland, United States, 21229

Principal Investigator:

Suman Rao

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Principal Investigator:

Jessica Tao

Maryland Oncology Hematology, P.A.

Recruiting

Columbia, Maryland, United States, 21044

Principal Investigator:

Andrew Mener

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Neelima Vidula

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Principal Investigator:

Jose Acevedo Mejia

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Emily Gatof

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Sara Tolaney

Mass General North Shore Cancer Center

Recruiting

Danvers, Massachusetts, United States, 01923-3623

Principal Investigator:

Seth Wander

Dana Farber Cancer Institute at Foxborough

Recruiting

Foxborough, Massachusetts, United States, 02035

Principal Investigator:

Natalie Sinclair

Dana Farber Cancer Institute - Merrimack Valley

Recruiting

Methuen, Massachusetts, United States, 01844

Principal Investigator:

Ankur Mehta

Dana-Farber Cancer Institute at Milford Regional

Recruiting

Milford, Massachusetts, United States, 01757

Principal Investigator:

Natalie Sinclair

Mass General Cancer Center at Newton-Wellesley Hospital's Vernon Cancer Center

Recruiting

Newton, Massachusetts, United States, 02462

Principal Investigator:

Aron Rosenstock

Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital

Recruiting

South Weymouth, Massachusetts, United States, 02190

Principal Investigator:

James Stoeckle

Mass General - North Shore Cancer Center

Recruiting

Waltham, Massachusetts, United States, 02451

Principal Investigator:

Neelima Vidula

The Cancer & Hematology Centers

Recruiting

Grand Rapids, Michigan, United States, 49503

Principal Investigator:

Amy Vander Woude

Mayo Clinic Health System - Albert Lea

Recruiting

Albert Lea, Minnesota, United States, 56007

Principal Investigator:

Mina Hanna

Mayo Clinic - Mankato

Recruiting

Mankato, Minnesota, United States, 56001-4752

Principal Investigator:

Amrit Singh

Allina Health Cancer Institute - Abbott Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Principal Investigator:

Daniel Carlson

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 01842

Principal Investigator:

Grace Choong

Metro-MN Comm. Onc. Res Consortium

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Principal Investigator:

Yan Ji

Baptist Clinical Research Institution

Recruiting

Oxford, Mississippi, United States, 38655

Principal Investigator:

Philip Lammers

Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63108

Principal Investigator:

Cynthia Ma

NHO Revive Research Institute LLC

Recruiting

Lincoln, Nebraska, United States, 68506

Principal Investigator:

Kailash Mosalpuria

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy

Recruiting

Omaha, Nebraska, United States, 68130

Principal Investigator:

Margaret Block

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Principal Investigator:

Samia Asif

MD Anderson Cancer Center at Cooper

Recruiting

Camden, New Jersey, United States, 08103

Principal Investigator:

Ahmed Kamel Abou Hussein

Summit Medical Group

Recruiting

Florham Park, New Jersey, United States, 07932

Principal Investigator:

Steven Papish

John Theurer Ctr-Hackensack UMC

Recruiting

Hackensack, New Jersey, United States, 07601

Principal Investigator:

Deena Graham

Rutgers Cancer Institute

Recruiting

New Brunswick, New Jersey, United States, 08903

Principal Investigator:

Coral Omene

Exigent Research LLC/New Mexico Oncology Hematology Consultants Ltd.

Recruiting

Albuquerque, New Mexico, United States, 87109

Principal Investigator:

Katherine Sanchez

Kings County Hospital Center

Recruiting

Brooklyn, New York, United States, 11203

Principal Investigator:

Jose Alberty-Oller

Hematology Oncology Associates of Central New York, PC

Recruiting

East Syracuse, New York, United States, 13057

Principal Investigator:

Steven Duffy

Cayuga Medical Center

Recruiting

Ithaca, New York, United States, 14850

Principal Investigator:

Anthony Mato

NYU Langone Hospital-Long Island

Recruiting

Mineola, New York, United States, 11501

Principal Investigator:

Nancy Chan

The Blavatnik Family - Chelsea Medical Center at Mount Sinai

Recruiting

New York, New York, United States, 10011

Principal Investigator:

Rima Patel

Laura and Isaac Perlmutter Cancer Center/NYU Langone Health

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Nancy Chan

Mount Sinai West

Recruiting

New York, New York, United States, 10019

Principal Investigator:

Rima Patel

Icahn School of Medicine Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Rima Patel

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032-3729

Principal Investigator:

Claire Sathe

University of Rochester Medical

Recruiting

Rochester, New York, United States, 14642

Principal Investigator:

Ajay Dhakal

Stony Brook University Cancer Center

Recruiting

Stony Brook, New York, United States, 11794

Principal Investigator:

Lea Baer

Clinical Research Alliance, Inc.

Recruiting

Westbury, New York, United States, 11590

Principal Investigator:

Jonathan Goldberg

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

Rani Bansal

Cape Fear Valley Medical Center

Recruiting

Fayetteville, North Carolina, United States, 28304

Principal Investigator:

Kenneth Manning

Cone Health Cancer Center at Wesley Long

Recruiting

Greensboro, North Carolina, United States, 27403

Principal Investigator:

Vinay Gudena

Miami Valley Hospital South

Recruiting

Centerville, Ohio, United States, 45459

Principal Investigator:

Jhansi Koduri

MetroHealth

Recruiting

Cleveland, Ohio, United States, 44109

Principal Investigator:

Tonjeh Bah

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

Azka Ali

Oncology_Hematology Care Clinical Trials, LLC

Recruiting

Fairfield, Ohio, United States, 45014

Principal Investigator:

Roma Srivastava

Oklahoma Cancer Specialists and Research Institute (OCSRI) - Tulsa Cancer Center

Recruiting

Tulsa, Oklahoma, United States, 74146

Principal Investigator:

Charles Taylor

Providence Cancer Institute Franz Clinic

Recruiting

Portland, Oregon, United States, 97213

Principal Investigator:

David Page

Providence Cancer Institute Franz Clinic

Recruiting

Portland, Oregon, United States, 97225

Principal Investigator:

David Page

Oregon Oncology Specialists

Recruiting

Salem, Oregon, United States, 97301

Principal Investigator:

Janelle Meyer

Northwest Cancer Specialists, P.C.

Recruiting

Tigard, Oregon, United States, 97223

Principal Investigator:

Nora Bucher

Lehigh Valley Health Network - Cedar Crest

Recruiting

Allen, Pennsylvania, United States, 18103

Principal Investigator:

Ranju Gupta

Consultants In Medical Oncology and Hematology, P.C.

Recruiting

Broomall, Pennsylvania, United States, 19008

Principal Investigator:

Alexander Deak

Penn State Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Principal Investigator:

Cristina Truica

Holy Redeemer Hospital And Medical Center

Recruiting

Meadowbrook, Pennsylvania, United States, 19046

Principal Investigator:

Rabia Cattie

Alliance Cancer Specialists, PC

Recruiting

Media, Pennsylvania, United States, 19044-1134

Principal Investigator:

Sramila Aithal

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Principal Investigator:

Joyce Habib

Lankenau Medical Center

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Principal Investigator:

Paul Gilman

Cancer Care Associates of York, Inc.

Recruiting

York, Pennsylvania, United States, 17403

Principal Investigator:

Haiyun Wang

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Principal Investigator:

Stephanie Graff

Hollings Cancer Center

Recruiting

Charleston, South Carolina, United States, 29425

Principal Investigator:

Abirami Sivapiragasam

Avera St. Mary's Hospital

Recruiting

Pierre, South Dakota, United States, 57501

Principal Investigator:

Jason Jones

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Principal Investigator:

Jason Jones

Baptist Cancer Center

Recruiting

Memphis, Tennessee, United States, 38120

Principal Investigator:

Philip Lammers

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator:

Erika Hamilton

Tennessee Oncology, PLLC

Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator:

Sara Nunnery

Henry - Joyce Cancer Clinic

Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator:

Vandana Abramson

Hendrick Cancer Center

Recruiting

Abilene, Texas, United States, 79601

Principal Investigator:

Jose Velasco

Texas Oncology-Northeast Texas

Recruiting

Allen, Texas, United States, 75013

Principal Investigator:

Vibha Thomas

Texas Oncology - DFW

Recruiting

Dallas, Texas, United States, 75246

Principal Investigator:

Joyce O'Shaughnessy

Oncology Consultants, P.A.

Recruiting

Houston, Texas, United States, 77024

Principal Investigator:

Ricardo Alvarez

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-4009

Principal Investigator:

Carlos Barcenas

Harris Health System - Smith Clinic

Recruiting

Houston, Texas, United States, 77054

Principal Investigator:

Mothaffar Rimawi

O'Quinn Medical Tower - McNair Campus

Recruiting

Houston, Texas, United States, 77054

Principal Investigator:

Mothaffar Rimawi

Covenant Children's Hospital- Joe Arrington Cancer Research and Treatment Center

Recruiting

Lubbock, Texas, United States, 79410

Principal Investigator:

Ibrahim Shalaby

Texas Oncology - San Antonio

Recruiting

New Braunfels, Texas, United States, 78130

Principal Investigator:

Emmalind Aponte

Texas Oncology-Gulf Coast

Recruiting

Pearland, Texas, United States, 77584

Principal Investigator:

Michelina Cairo

Mays Cancer Center

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Virginia Kaklamani

Texas Oncology- Central South

Recruiting

Weslaco, Texas, United States, 78596

Principal Investigator:

Alvaro Restrepo

Utah Cancer Specialists

Recruiting

Salt Lake City, Utah, United States, 84106

Principal Investigator:

Stephan Kendall

Huntsman Cancer Institute, University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Principal Investigator:

Christos Vaklavas

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Principal Investigator:

Peter Kaufman

Inova Schar Cancer Institute

Recruiting

Fairfax, Virginia, United States, 22031

Principal Investigator:

Melissa Yacur

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Principal Investigator:

Shruti Tiwari

Virginia Oncology Associates

Recruiting

Newport News, Virginia, United States, 23606

Principal Investigator:

Christina Alencar

Virginia Cancer Institute

Recruiting

Richmond, Virginia, United States, 23229

Principal Investigator:

Purvi Shah

Oncology & Hematology Associates of Southwest Virginia, Inc

Recruiting

Wytheville, Virginia, United States, 24382

Principal Investigator:

Amanda Gillespie-Twardy

Fred Hutch CC at Evergreen HMC

Recruiting

Kirkland, Washington, United States, 98034

Principal Investigator:

Hannah Linden

Vista Oncology

Recruiting

Olympia, Washington, United States, 98506

Principal Investigator:

Joseph Ye

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Principal Investigator:

Nanette Robinson

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

Principal Investigator:

Fengting Yan

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Principal Investigator:

Hannah Linden

Fred Hutch CC at UWMC-Northwest

Recruiting

Seattle, Washington, United States, 98133

Principal Investigator:

Hannah Linden

MultiCare Deaconess Hospital

Recruiting

Spokane, Washington, United States, 99204

Principal Investigator:

Jennifer Slim

Cancer Care Northwest

Recruiting

Spokane Valley, Washington, United States, 99216

Principal Investigator:

Kristine Rinn

MultiCare Cancer Institute - Tacoma

Recruiting

Tacoma, Washington, United States, 98405

Principal Investigator:

Jennifer Slim

Northwest Medical Specialties PLLC

Recruiting

Tacoma, Washington, United States, 98405

Principal Investigator:

Sibel Blau

Mayo Clinic Health System - Eau Claire

Recruiting

Eau Claire, Wisconsin, United States, 54703

Principal Investigator:

Eyad Al-Hattab

Mayo Clinic Health System - La Crosse

Recruiting

La Crosse, Wisconsin, United States, 54601

Principal Investigator:

Scott Okuno

University of Wisconsin Carbone Cancer Center- University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Principal Investigator:

Kim Dittus

Froedtert Hospital & the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Principal Investigator:

Lubna Chaudhary

BC Cancer -Surrey

Recruiting

Surrey, British Columbia, Canada, V3V 1Z2

Principal Investigator:

Aalok Kumar

BC Cancer Agency

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Principal Investigator:

Stephen Chia

Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials

Recruiting

Barrie, Ontario, Canada, L4M 6M2

Principal Investigator:

Zachary Veitch

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 4G5

Principal Investigator:

Danilo Giffoni de Mello Morais Mata

St. Michaels Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Principal Investigator:

Ronita Lee

Mount Sinai Hospital - Study Supplies

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Principal Investigator:

Christine Brezden-Masley

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Principal Investigator:

Jean Boileau

Centre hospitalier régional de Lanaudière

Recruiting

Saint-Charles-Borromée, Quebec, Canada, J6E 6J2

Principal Investigator:

Elise Martel

Regional Hospital Saint-Jerome

Recruiting

Saint-Jérôme, Quebec, Canada, J7Z 5T3

Principal Investigator:

Ghislain Cournoyer

Hôpital du Saint-Sacrement

Recruiting

Québec, Canada, G1S 4L8

Principal Investigator:

Eric Poirier

More Information

Sponsor

Stemline Therapeutics, Inc.

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • ELEGANT
  • Breast Cancer Stage II
  • Breast Cancer Stage III
  • Breast Cancer Female
  • Breast Cancer, Male
  • High-Risk Breast Cancer
  • High Risk Breast Carcinoma
  • ER-positive Breast Cancer
  • ER-positive HER-2 Negative Breast Cancer
  • ER Positive/HER2 Low Breast Cancer
  • Breast Cancer, ER+, HER2-
  • Adjuvant
  • Adjuvant Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stemline Therapeutics, Inc. on 2026-08-17.