Ireland
--:--IST
Active, not recruiting Phase 3

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

NCT06492616 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2024-09-27
Last updated
2026-11-04

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Elacestrant →Anastrozole →Letrozole →Exemestane →Tamoxifen →

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Invasive Breast Cancer-Free Survival (IBCFS) — Up to 5 years
    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

Trial sites (555)

FacilityCityRegionStatus
Southern Cancer Center, PC Daphne Alabama
Ironwood Cancer and Research Centers Chandler Arizona
Banner MD Anderson Cancer Center Gilbert Arizona
Banner University Medical Center - Phoenix Campus (Banner Good Samaritan Medical Center) Phoenix Arizona
Mayo Clinic Scottsdale Arizona
Arizona Clinical Research Center, Inc. Tucson Arizona
University of Arizona Cancer Center Tucson Arizona
Highlands Oncology Group, PA Springdale Arkansas
UCSF Cancer Center Berkeley Berkeley California
Cedars-Sinai Cancer Beverly Hills Beverly Hills California
City of Hope National Medical Center Duarte California
UCSF Wash Cancer CNTR Fremont California
City of Hope at Irvine Lennar Irvine California
UC San Diego Moores Cancer Center La Jolla California
Helios Clinical Research Long Beach California
Cancer and Blood Research Center, LLC Los Alamitos California
USC/Norris Comprehensive Cancer Center Los Angeles California
UCLA Department of Medicine - Hematology/Oncology Los Angeles California
Pacific Cancer Care - Oncology Monterey California
Hoag Memorial Hospital Presbyterian Newport Beach California
UC Irvine Health, Chao Family Comprehensive Cancer Center Orange California
Stanford Women's Cancer Center Palo Alto California
Dignity Health dba Health Research Institute Sacramento California
Sutter Institute for Medical Research Sacramento California
UCSF Zuckerberg SF General San Francisco California
University of California, San Francisco (UCSF) San Francisco California
Southern California Kaiser Medical Center-San Marcos Medical San Marcos California
UCSF Cancer Center San Mateo San Mateo California
Sansum Clinic Solvang California
Torrance Memorial Physician Network- Cancer Care Torrance California
St. Joseph Hospital-Cancer Centers of Colorado Denver Colorado
Rocky Mountain Cancer Centers, LLP Lone Tree Colorado
AHMG Hematology and Oncology Parker Colorado
Yale New Haven Hospital- Yale Cancer Center New Haven Connecticut
Georgetown University Medical Center Washington D.C. District of Columbia
MedStar Washington Hospital Center Washington D.C. District of Columbia
Sibley Memorial Hospital Washington D.C. District of Columbia
The George Washington Medical Faculty Associates Washington D.C. District of Columbia
Florida Cancer Specialists Fort Myers Florida
Mayo Clinic Jacksonville Florida

+ 515 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06492616 on ClinicalTrials.gov ↗ ← All trials in Spain