RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares elacestrant with standard hormone therapy for early breast cancer. It is for women and men with ER-positive, HER2-negative cancer that has spread to nearby lymph nodes and has a high risk of coming back.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Tests show early breast cancer that uses estrogen to grow (ER-positive) and is HER2-negative. At least 10% of cancer cells must test ER-positive.
  • The breast cancer was removed by surgery. There must be no sign that it has come back or spread to distant parts of the body.
  • Cancer was found in 4 or more underarm lymph nodes, or in 1–3 underarm lymph nodes with at least one added risk: grade 3 cancer (cells that look very abnormal), a tumor at least 5 centimeters wide, or a high-risk result on a tumor gene test.
  • You are taking hormone therapy with an aromatase inhibitor or tamoxifen and have received it for 24–60 months when assigned to a study group. Treatment with or without other listed hormone-blocking medicines or CDK4/6 inhibitors is allowed.
  • If you took a CDK4/6 inhibitor or PARP inhibitor, which are targeted cancer medicines, that treatment must already be finished or stopped.

Who can't join

  • You have inflammatory breast cancer.
  • You previously had invasive breast cancer in either breast, meaning cancer that grew into nearby breast tissue.
  • You had another type of cancer within the past 3 years. Exceptions include certain skin cancers, surface-level bladder cancer, or abnormal cells limited to the cervix, if properly treated.
  • You had a break longer than 6 months in hormone therapy given after surgery, or stopped your current hormone therapy more than 6 months before study group assignment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * Histopathologically or cytologically confirmed ER+ (≥10% by immunohistochemistry \[IHC\]), HER2- (tumors with an IHC score of 0, 1+, or 2+ with in situ hybridization \[ISH\]-negative \[not amplified\]). ISH-negative without IHC testing will also be eligible 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/College of American Pathologists guidelines. * Participants must be node positive (microscopic and macroscopic tumor involvement are allowed) and fulfill one of the following criteria: 1. ≥4 positive axillary lymph nodes or 2. 1-3 positive axillary lymph nodes and 1. Histologic grade 3 disease and/or 2. Tumor size ≥5 centimeters and/or 3. High genomic risk (identified by Oncotype, MammaPrint, EndoPredict, PAM50) * Participants who are currently taking endocrine therapy (aromatase inhibitors or tamoxifen) and have received at least 24 months but not more than 60 months of endocrine therapy at the time of randomization (Cycle 1 Day 1 \[C1D1\]) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i) and with or without a luteinizing hormone-releasing hormone agonist. * Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase 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 non-breast 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 sites (176)

AL

  • Southern Cancer Center, PC · Daphne, AL 36526Michael Meshad · Principal investigatorMore trials in Daphne

AR

AZ

  • Ironwood Cancer and Research Centers · Chandler, AZ 85224Anu Batra · Principal investigatorMore trials in Chandler
  • Banner MD Anderson Cancer Center · Gilbert, AZ 85234-2165Hung Khong · Principal investigatorMore trials in Gilbert
  • Banner University Medical Center - Phoenix Campus (Banner Good Samaritan Medical Center) · Phoenix, AZ 85006Hung Khong · Principal investigatorMore trials in Phoenix
  • Mayo Clinic · Scottsdale, AZ 85259-5452Brenda Ernst · Principal investigatorMore trials in Scottsdale
  • Arizona Clinical Research Center, Inc. · Tucson, AZ 85715Manuel Modiano-Revah · Principal investigatorMore trials in Tucson
  • University of Arizona Cancer Center · Tucson, AZ 85719Sima Ehsani · Principal investigatorMore trials in Tucson

CA

CO

  • St. Joseph Hospital-Cancer Centers of Colorado · Denver, CO 80218-1122Sami Diab · Principal investigatorMore trials in Denver
  • Rocky Mountain Cancer Centers, LLP · Lone Tree, CO 80124Mabel Mardones · Principal investigatorMore trials in Lone Tree
  • AHMG Hematology and Oncology · Parker, CO 80138Nadine Mikhaeel-Kamel · Principal investigatorMore trials in Parker
  • Cancer Care at CommonSpirit St. Anthony North Hospital · Westminster, CO 80023More trials in Westminster

CT

  • Yale New Haven Hospital- Yale Cancer Center · New Haven, CT 06510Mariya Rozenblit · Principal investigatorMore trials in New Haven

DC

FL

GA

HI

  • Kaiser Permanente Hawaii Moanalua Medical Center · Honolulu, HI 96819Jennifer Carney · Principal investigatorMore trials in Honolulu

IA

IL

IN

  • Northwest Cancer Centers, PC · Dyer, IN 46311Shruti Singh · Principal investigatorMore trials in Dyer

KS

KY

LA

MA

  • Massachusetts General Hospital · Boston, MA 02114Neelima Vidula · Principal investigatorMore trials in Boston
  • Boston Medical Center · Boston, MA 02118Jose Acevedo Mejia · Principal investigatorMore trials in Boston
  • Beth Israel Deaconess Medical Center · Boston, MA 02215Emily Gatof · Principal investigatorMore trials in Boston
  • Dana Farber Cancer Institute · Boston, MA 02215Sara Tolaney · Principal investigatorMore trials in Boston
  • Mass General North Shore Cancer Center · Danvers, MA 01923-3623Seth Wander · Principal investigatorMore trials in Danvers
  • Dana Farber Cancer Institute at Foxborough · Foxborough, MA 02035Natalie Sinclair · Principal investigatorMore trials in Foxborough
  • Dana Farber Cancer Institute - Merrimack Valley · Methuen, MA 01844Ankur Mehta · Principal investigatorMore trials in Methuen
  • Dana-Farber Cancer Institute at Milford Regional · Milford, MA 01757Natalie Sinclair · Principal investigatorMore trials in Milford
  • Mass General Cancer Center at Newton-Wellesley Hospital's Vernon Cancer Center · Newton, MA 02462Aron Rosenstock · Principal investigatorMore trials in Newton
  • Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital · South Weymouth, MA 02190James Stoeckle · Principal investigatorMore trials in South Weymouth
  • Mass General - North Shore Cancer Center · Waltham, MA 02451Neelima Vidula · Principal investigatorMore trials in Waltham

MD

  • Mercy Medical Center · Baltimore, MD 21202David Riseberg · Principal investigatorMore trials in Baltimore
  • Ascension St. Agnes Hospital · Baltimore, MD 21229Suman Rao · Principal investigatorMore trials in Baltimore
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, MD 21287Jessica Tao · Principal investigatorMore trials in Baltimore
  • Maryland Oncology Hematology, P.A. · Columbia, MD 21044Andrew Mener · Principal investigatorMore trials in Columbia

MI

MN

MO

MS

  • Baptist Clinical Research Institution · Oxford, MS 38655Philip Lammers · Principal investigatorMore trials in Oxford

NC

NE

  • NHO Revive Research Institute LLC · Lincoln, NE 68506Kailash Mosalpuria · Principal investigatorMore trials in Lincoln
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy · Omaha, NE 68130Margaret Block · Principal investigatorMore trials in Omaha
  • University of Nebraska Medical Center · Omaha, NE 68198Samia Asif · Principal investigatorMore trials in Omaha

NJ

NM

  • Exigent Research LLC/New Mexico Oncology Hematology Consultants Ltd. · Albuquerque, NM 87109Katherine Sanchez · Principal investigatorMore trials in Albuquerque

NY

  • Kings County Hospital Center · Brooklyn, NY 11203Jose Alberty-Oller · Principal investigatorMore trials in Brooklyn
  • Hematology Oncology Associates of Central New York, PC · East Syracuse, NY 13057Steven Duffy · Principal investigatorMore trials in East Syracuse
  • Cayuga Medical Center · Ithaca, NY 14850Anthony Mato · Principal investigatorMore trials in Ithaca
  • NYU Langone Hospital-Long Island · Mineola, NY 11501Nancy Chan · Principal investigatorMore trials in Mineola
  • The Blavatnik Family - Chelsea Medical Center at Mount Sinai · New York, NY 10011Rima Patel · Principal investigatorMore trials in New York
  • Laura and Isaac Perlmutter Cancer Center/NYU Langone Health · New York, NY 10016Nancy Chan · Principal investigatorMore trials in New York
  • Mount Sinai West · New York, NY 10019Rima Patel · Principal investigatorMore trials in New York
  • Icahn School of Medicine Mount Sinai · New York, NY 10029Rima Patel · Principal investigatorMore trials in New York
  • Columbia University Medical Center · New York, NY 10032-3729Claire Sathe · Principal investigatorMore trials in New York
  • University of Rochester Medical · Rochester, NY 14642Ajay Dhakal · Principal investigatorMore trials in Rochester
  • Stony Brook University Cancer Center · Stony Brook, NY 11794Lea Baer · Principal investigatorMore trials in Stony Brook
  • Clinical Research Alliance, Inc. · Westbury, NY 11590Jonathan Goldberg · Principal investigatorMore trials in Westbury

OH

OK

  • Oklahoma Cancer Specialists and Research Institute (OCSRI) - Tulsa Cancer Center · Tulsa, OK 74146Charles Taylor · Principal investigatorMore trials in Tulsa

OR

  • Providence Cancer Institute Franz Clinic · Portland, OR 97213David Page · Principal investigatorMore trials in Portland
  • Providence Cancer Institute Franz Clinic · Portland, OR 97225David Page · Principal investigatorMore trials in Portland
  • Oregon Oncology Specialists · Salem, OR 97301Janelle Meyer · Principal investigatorMore trials in Salem
  • Northwest Cancer Specialists, P.C. · Tigard, OR 97223Nora Bucher · Principal investigatorMore trials in Tigard

PA

  • Lehigh Valley Health Network - Cedar Crest · Allen, PA 18103Ranju Gupta · Principal investigatorMore trials in Allen
  • Consultants In Medical Oncology and Hematology, P.C. · Broomall, PA 19008Alexander Deak · Principal investigatorMore trials in Broomall
  • Penn State Milton S. Hershey Medical Center · Hershey, PA 17033Cristina Truica · Principal investigatorMore trials in Hershey
  • Holy Redeemer Hospital And Medical Center · Meadowbrook, PA 19046Rabia Cattie · Principal investigatorMore trials in Meadowbrook
  • Alliance Cancer Specialists, PC · Media, PA 19044-1134Sramila Aithal · Principal investigatorMore trials in Media
  • Fox Chase Cancer Center · Philadelphia, PA 19111Joyce Habib · Principal investigatorMore trials in Philadelphia
  • Lankenau Medical Center · Wynnewood, PA 19096Paul Gilman · Principal investigatorMore trials in Wynnewood
  • Cancer Care Associates of York, Inc. · York, PA 17403Haiyun Wang · Principal investigatorMore trials in York

RI

SC

SD

TN

TX

  • Hendrick Cancer Center · Abilene, TX 79601Jose Velasco · Principal investigatorMore trials in Abilene
  • Texas Oncology-Northeast Texas · Allen, TX 75013Vibha Thomas · Principal investigatorMore trials in Allen
  • Texas Oncology - DFW · Dallas, TX 75246Joyce O'Shaughnessy · Principal investigatorMore trials in Dallas
  • Oncology Consultants, P.A. · Houston, TX 77024Ricardo Alvarez · Principal investigatorMore trials in Houston
  • The University of Texas MD Anderson Cancer Center · Houston, TX 77030-4009Carlos Barcenas · Principal investigatorMore trials in Houston
  • Harris Health System - Smith Clinic · Houston, TX 77054Mothaffar Rimawi · Principal investigatorMore trials in Houston
  • O'Quinn Medical Tower - McNair Campus · Houston, TX 77054Mothaffar Rimawi · Principal investigatorMore trials in Houston
  • Covenant Children's Hospital- Joe Arrington Cancer Research and Treatment Center · Lubbock, TX 79410Ibrahim Shalaby · Principal investigatorMore trials in Lubbock
  • Texas Oncology - San Antonio · New Braunfels, TX 78130Emmalind Aponte · Principal investigatorMore trials in New Braunfels
  • Texas Oncology-Gulf Coast · Pearland, TX 77584Michelina Cairo · Principal investigatorMore trials in Pearland
  • Mays Cancer Center · San Antonio, TX 78229Virginia Kaklamani · Principal investigatorMore trials in San Antonio
  • Texas Oncology- Central South · Weslaco, TX 78596Alvaro Restrepo · Principal investigatorMore trials in Weslaco

UT

VA

  • Inova Schar Cancer Institute · Fairfax, VA 22031Melissa Yacur · Principal investigatorMore trials in Fairfax
  • Virginia Cancer Specialists · Fairfax, VA 22031Shruti Tiwari · Principal investigatorMore trials in Fairfax
  • Virginia Oncology Associates · Newport News, VA 23606Christina Alencar · Principal investigatorMore trials in Newport News
  • Virginia Cancer Institute · Richmond, VA 23229Purvi Shah · Principal investigatorMore trials in Richmond
  • Oncology & Hematology Associates of Southwest Virginia, Inc · Wytheville, VA 24382Amanda Gillespie-Twardy · Principal investigatorMore trials in Wytheville

VT

WA

WI

  • Mayo Clinic Health System - Eau Claire · Eau Claire, WI 54703Eyad Al-Hattab · Principal investigatorMore trials in Eau Claire
  • Mayo Clinic Health System - La Crosse · La Crosse, WI 54601Scott Okuno · Principal investigatorMore trials in La Crosse
  • University of Wisconsin Carbone Cancer Center- University Hospital · Madison, WI 53792Kim Dittus · Principal investigatorMore trials in Madison
  • Froedtert Hospital & the Medical College of Wisconsin · Milwaukee, WI 53226Lubna Chaudhary · Principal investigatorMore trials in Milwaukee
  • UW Cancer Center at ProHealth Care · Waukesha, WI 53188More trials in Waukesha