What is elacestrant studying for early breast cancer?

Elacestrant is being studied to see how it compares to standard endocrine therapy in adults with node-positive, estrogen receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The trial aims to evaluate if elacestrant can improve breast cancer outcomes. The study is sponsored by Stemline Therapeutics, Inc.

Who may be eligible for this breast cancer clinical trial?

Adults aged 18 or older with ER-positive, HER2-negative early breast cancer and a high risk of recurrence may be eligible. Participants should have completed 24 to 60 months of prior endocrine therapy. There is no gender restriction. Please review eligibility criteria for more details.

Is there any cost to participate in this breast cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06492616

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

Led by Stemline Therapeutics, Inc. · Updated on 2026-05-27

4220

Participants Needed

541

Research Sites

165 weeks

Total Duration

AI-Summary

What this Trial Is About

This trial investigates the effectiveness of elacestrant compared to standard endocrine therapy for adults with node-positive, estrogen receptor-positive ER, HER2-negative early breast cancer who are at high risk of recurrence. The study aims to understand if elacestrant can improve outcomes in this group over standard treatments. Participants will be randomly assigned to receive either 345 mg of elacestrant once daily for five years or continue with their previous standard endocrine therapy, which may include anastrozole, letrozole, exemestane, or tamoxifen. Both treatments are taken orally, and the study is open-label, meaning participants and researchers know which treatment is given. During the study, participants will be monitored for up to five years for outcomes such as invasive breast cancer-free survival, distant relapse-free survival, overall survival, and quality of life changes. Assessments include questionnaires on health status and physical functioning, symptom evaluation, and blood tests to measure elacestrant levels. Safety and adverse events will be tracked throughout and for 28 days after treatment ends.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry), HER2-negative early stage invasive breast cancer without recurrence or metastases
Considered high risk of recurrence at initial staging
Received at least 24 months but not more than 60 months of endocrine therapy (aromatase inhibitors or tamoxifen) with or without CDK4/6 inhibitors
Prior CDK4/6 or PARP inhibitor treatment completed or discontinued

You will not qualify if you...

Inflammatory breast cancer
History of prior invasive breast cancer in either breast
History of other malignancy within 3 years except treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
More than 6 months interruption of prior standard adjuvant endocrine therapy or off endocrine therapy more than 6 months before randomization

Research Team

Stemline Trials

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