Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange 5379513, California 5332921 and other locations
Dates
study started
study ends around
Principal Investigator
by Ritesh Parajuli

Description

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.

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

Keywords

Breast Cancer, 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, Breast Neoplasms, Male Breast Neoplasms, elacestrant, Anastrozole, Letrozole, exemestane, Tamoxifen

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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
  • 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.

You CAN'T join if...

  • 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 discontinued adjuvant endocrine therapy more than 6 months prior to randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • UC Irvine Health, Chao Family Comprehensive Cancer Center accepting new patients
    Orange 5379513 California 5332921 92868-3201 United States
  • Hoag Memorial Hospital Presbyterian accepting new patients
    Newport Beach 5376890 California 5332921 92663 United States
  • Cancer and Blood Research Center, LLC accepting new patients
    Los Alamitos 5368304 California 5332921 90720 United States
  • UCLA Department of Medicine - Hematology/Oncology accepting new patients
    Los Angeles 5368361 California 5332921 90095 United States

Lead Scientist at UC Irvine

  • Ritesh Parajuli
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 18 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Stemline Therapeutics, Inc.
ID
NCT06492616
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 4220 study participants
Last Updated