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Comparing elacestrant to standard hormone therapy for early breast cancer

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

Phase 3 Interventional Stemline Therapeutics, Inc. · NCT06492616

This study is testing if a new drug called elacestrant can help women with early-stage breast cancer do better than standard hormone treatments after they've already been on therapy for at least two years.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment4220 (estimated)
Ages18 Years and up
SexAll
SponsorStemline Therapeutics, Inc. Industry-sponsored
Locations536 sites (Daphne, Alabama and 535 other locations)
Trial IDNCT06492616 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of elacestrant compared to standard endocrine therapies in patients with early-stage, hormone receptor-positive, HER2-negative breast cancer who are at high risk of recurrence. Participants will be those who have already undergone a minimum of 24 months of endocrine therapy and are considered at high risk based on initial staging. The study aims to determine if elacestrant can provide better outcomes than traditional treatments such as anastrozole, letrozole, exemestane, or tamoxifen.

Who should consider this trial

Good fit: Ideal candidates include women and men with ER-positive, HER2-negative early breast cancer who have completed a specified duration of prior endocrine therapy and are at high risk of recurrence.

Not a fit: Patients with inflammatory breast cancer or those who do not meet the specific eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a more effective treatment option for patients with high-risk early breast cancer, potentially reducing recurrence rates.

How similar studies have performed: Other studies have shown promising results with similar approaches in targeting hormone receptor-positive breast cancer, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Daphne, Alabama and 535 other locations

+486 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerELEGANTBreast Cancer Stage IIBreast Cancer Stage IIIBreast Cancer FemaleBreast Cancer, MaleHigh-Risk Breast CancerHigh Risk Breast Carcinoma
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.