RECRUITING

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

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Conditions

Breast CancerELEGANTBreast Cancer Stage IIBreast Cancer Stage IIIBreast Cancer FemaleBreast Cancer, MaleHigh-Risk Breast CancerHigh Risk Breast CarcinomaER-positive Breast CancerER-positive HER-2 Negative Breast CancerER Positive/HER2 Low Breast CancerBreast Cancer, ER+, HER2-AdjuvantAdjuvant Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-27
Study Completion:2032-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06492616

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry \[IHC\]), HER2-negative \[IHC = 0 or 1, or (IHC = 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
  2. * Participants considered at high risk of recurrence at initial staging
  3. * 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)
  4. * Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments.
  1. * Participants with inflammatory breast cancer
  2. * History of any prior (ipsilateral and/or contralateral) invasive breast cancer
  3. * 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
  4. * Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who discontinued adjuvant endocrine therapy more than 6 months prior to randomization

Contacts and Locations

Study Contact

Stemline Trials
CONTACT
1-877-332-7961
clinicaltrials@menarinistemline.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Stemline Therapeutics, Inc.

Study Locations (Sites)

Cancer Centers of Kansas
Wichita, Kansas, 67214
United States
Mercy Medical Center
Baltimore, Maryland, 21202
United States
Miami Valley Hospital South
Centerville, Ohio, 45459
United States
Virginia Cancer Institute
Mechanicsville, Virginia, 23116
United States

Collaborators and Investigators

Sponsor: Stemline Therapeutics, Inc.

  • Medical Director, STUDY_DIRECTOR, Stemline Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-27
Study Completion Date2032-10

Study Record Updates

Study Start Date2024-09-27
Study Completion Date2032-10

Terms related to this study

Keywords Provided by Researchers

  • ELEGANT
  • Breast Cancer Stage II
  • Breast Cancer Stage III
  • Breast Cancer Female
  • Breast Cancer, Male
  • High-Risk Breast Cancer
  • High Risk Breast Carcinoma
  • ER-positive Breast Cancer
  • ER-positive HER-2 Negative Breast Cancer
  • ER Positive/HER2 Low Breast Cancer
  • Breast Cancer, ER+, HER2-
  • Adjuvant
  • Adjuvant Therapy

Additional Relevant MeSH Terms

  • Breast Cancer