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A Study of Elacestrant for Early Breast Cancer

This study is looking at how well a drug called elacestrant works compared to standard hormone therapies like anastrozole, letrozole, exemestane, or tamoxifen. It's for women and men who have early-stage breast cancer that is Estrogen Receptor-positive (ER+) and HER2-negative (meaning it doesn't have too much of the HER2 protein). You might be able to join if your breast cancer has a high chance of coming back. The main goal is to see if elacestrant can help you live longer without the breast cancer returning. The study plans to enroll 4220 participants, but its current status is unclear.

Study design
This is an interventional study comparing elacestrant to standard endocrine therapies. It plans to enroll 4220 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to measure Invasive Breast Cancer-Free Survival (IBCFS).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06492616

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Stemline Therapeutics, Inc.
~4,220 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:ElacestrantAnastrozoleLetrozoleExemestaneTamoxifen

At a glance

Recruiting sites
499 of 562 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Invasive Breast Cancer-Free Survival (IBCFS)
Measured over Up to 5 years

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

562 sites across 218 states
Italy31
Spain24
California23
Florida16
New York12
Texas12
Massachusetts11
Turkey (Türkiye)11

Study leadership

  • Medical Director · STUDY_DIRECTOR · Stemline Therapeutics, Inc.

Who to contact

Stemline Trials
[email protected]
1-877-332-7961
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • 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