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

NCT06492616 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4220

Last updated 2026-04-24

No results posted yet for this 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.

Conditions

Interventions

DRUG

Elacestrant

Administered as oral tablets

DRUG

Anastrozole

Administered as oral tablets

DRUG

Letrozole

Administered as oral tablets

DRUG

Exemestane

Administered as oral tablets

DRUG

Tamoxifen

Administered as oral tablets

Sponsors & Collaborators

  • Stemline Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Stemline Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-27
Primary Completion
2029-08-31
Completion
2032-10-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Malaysia
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06492616 on ClinicalTrials.gov