Cancer Clinical Trials
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence (ELEGANT)
Learn moreWhat is the purpose of 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.
Eligibility
Key Inclusion Criteria:
- Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry [IHC]), HER2-negative [IHC = 0, 1+, 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.
- 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 are off current adjuvant endocrine therapy more than 6 months prior to randomization
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
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
- Disease Type/ConditionBreast Cancer
- Principal InvestigatorChaitali S. Nangia, MD
- Co-InvestigatorsTara E. Seery, MD, Laura Beals, NP, Monica M. Mita, MD, Yaser Homsi, MD, Sharmeen Mahmood, DO, Cori Chastain, NP, Nisha Patel, NP-C
- Age GroupAdult, Older Adult
- PhaseIII
- ClinicalTrials.gov IDNCT06492616
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Lauren Wagner
lauren.wagner@hoag.org
Hoag Family Cancer Institute
Hoag Family Cancer Institute delivers advanced, compassionate cancer care across Orange County, with multidisciplinary specialists, precision therapies, support services, and access to 125+ cancer clinical trials. Patients benefit from research-driven care across a wide range of cancers, including breast, lung, gynecologic, prostate, gastrointestinal, and blood cancers.
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