A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
This study is for people with early-stage, hormone-receptor-positive, HER2-negative breast cancer that has spread to lymph nodes and has a high risk of coming back. It compares the oral drug elacestrant with standard hormone therapy taken after surgery.
SponsorStemline Therapeutics, Inc.
Study typeInterventional
Started2024-09-27
Primary completion2029-08
Planned enrolment4220
Sites3 Acıbadem · 564 other
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
What this study is about
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
Interventions
Elacestrant
Anastrozole
Letrozole
Exemestane
Tamoxifen
Primary outcome measures
Invasive Breast Cancer-Free Survival (IBCFS) — Up to 5 years
Who can take part
SexAllAge18 Years to no upper limitHealthy volunteersNo
Inclusion
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
* 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.
Criteria are written for physicians. Do not rule yourself out: send your reports and the study team will check.
Acıbadem study sites
Acıbadem Maslak Hospital, IstanbulActive, closed to enrolment
Acıbadem Atasehir Hospital, IstanbulActive, closed to enrolment
Acıbadem Altunizade Hospital, IstanbulActive, closed to enrolment
Also running at 564 other sites in 28 countries.
Source: ClinicalTrials.gov NCT06492616 · last updated 2026-09-15 · View registry record ↗