A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Sponsored by Stemline Therapeutics, Inc.
About this study
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.
Where this study is enrolling (10)
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Mayo Clinic
Scottsdale, Arizona
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- Call +1 480-256-6444
Banner MD Anderson Cancer Center
Gilbert, Arizona
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Winship Cancer Institute
Atlanta, Georgia
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RUSH MD Anderson Cancer Center
Chicago, Illinois
- Call 312.926.2000
Northwestern Memorial Hospital
Chicago, Illinois
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Show all 10 locations
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Fox Chase Cancer Center
Philadelphia, Pennsylvania
- Call 713-526-4243
Harris Health System - Smith Clinic
Houston, Texas
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- Call 713-436-7500
Texas Oncology-Gulf Coast
Pearland, Texas
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- Call 877-632-6789
The University of Texas MD Anderson Cancer Center
Houston, Texas
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- Call 855-827-9525
Oncology Consultants, P.A.
Houston, Texas
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Who can participate
Inclusion criteria
- ✓Histopathologically or cytologically confirmed ER+ (≥10% by immunohistochemistry \[IHC\]), HER2- (tumors with an IHC score of 0, 1+, or 2+ with in situ hybridization \[ISH\]-negative \[not amplified\]). ISH-negative without IHC testing will also be eligible 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/College of American Pathologists guidelines.
- ✓Participants must be node positive (microscopic and macroscopic tumor involvement are allowed) and fulfill one of the following criteria:
- ✓1. ≥4 positive axillary lymph nodes or
- ✓2. 1-3 positive axillary lymph nodes and
- ✓1. Histologic grade 3 disease and/or
- ✓2. Tumor size ≥5 centimeters and/or
- ✓3. High genomic risk (identified by Oncotype, MammaPrint, EndoPredict, PAM50)
- ✓Participants who are currently taking endocrine therapy (aromatase inhibitors or tamoxifen) and have received at least 24 months but not more than 60 months of endocrine therapy at the time of randomization (Cycle 1 Day 1 \[C1D1\]) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i) and with or without a luteinizing hormone-releasing hormone agonist.
- ✓Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase inhibitor must have already completed or discontinued these treatments.
Exclusion criteria
- ✕Participants with inflammatory breast cancer.
- ✕History of any prior (ipsilateral and/or contralateral) invasive breast cancer.
- ✕Participant with history of non-breast 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.
- ✕Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.