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.
Primary Objective:
Evaluate the efficacy of elacestrant relative to standard endocrine therapy in terms of IBCFS in participants with node-positive, estrogen receptor-positive, HER2-negative early breast cancer with high risk of recurrence.
Key Secondary Objectives:
- Evaluate the efficacy of elacestrant relative to standard of care (SoC) in terms of distant relapse-free survival (DRFS).
- Evaluate the efficacy of elacestrant relative to SoC in terms of overall survival (OS).
Secondary Objectives:
- Evaluate the efficacy of elacestrant relative to SoC in terms of invasive disease-free survival (IDFS).
- Characterize the safety of elacestrant in the trial patient population.
- Evaluate the effect of elacestrant relative to SoC on patient-reported outcomes (PROs).
- Characterize elacestrant steady-state pharmacokinetics (PK) and exposure-response relationships (efficacy and safety) in a subset of participants enrolled in the elacestrant arm at United States (US) clinical sites.
- RWJBarnabas Health
- Cooperman Barnabas, Livingston
- Jersey City Medical Center, Jersey City
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Somerset
- Trinitas Hospital and Comprehensive Cancer Center
- Rutgers University
Key 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. 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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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