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โ† Trials
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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

RecruitingPhase 3Ages 18 Years - anyAllStemline Therapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: * Histopathologically or cytologically confirmed ER+ (โ‰ฅ10% 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. โ‰ฅ4 positive axillary lymph nodes or 2. 1-3 positive axillary lymph nodes and 1. Histologic grade 3 disease and/or 2. Tumor size โ‰ฅ5 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. Key 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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What it tests

  • Elacestrant
  • Anastrozole
  • Letrozole
  • Exemestane
  • Tamoxifen
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Where

567 sites
Southern Cancer Center, PC
Daphne, United States
Ironwood Cancer and Research Centers
Chandler, United States
Banner MD Anderson Cancer Center
Gilbert, United States
Banner University Medical Center - Phoenix Campus (Banner Good Samaritan Medical Center)
Phoenix, United States
Mayo Clinic
Scottsdale, United States
Arizona Clinical Research Center, Inc.
Tucson, United States
University of Arizona Cancer Center
Tucson, United States
Highlands Oncology Group, PA
Springdale, United States

โ€ฆand 559 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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