Elacestrant versus Standard Endocrine Therapy Early Breast Cancer (Elegant) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to test the safety and efficacy of elacestrant compared to standard of care therapy in people with node-positive, estrogen receptor-positive (ER+), HER2-negative (HER2-) early breast cancer with a high risk of coming back. We want to compare the effect of elacestrant to standard of care therapy. We want to know which option is most helpful for patient in doing their normal day to day activities, and to assess what the study drug does to the tumor markers that can be measured in your blood.
What is the Condition Being Studied?
Breast Cancer
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with breast cancer that is ER-positive and HER2-negative
- Have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK4/6i and with or without an LHRH agonist
For more information, contact the study team at sam.womack@duke.edu.
Age Group
Adults
What is Involved?
The study will have 3 phases:
- Screening Phase: This period will last for up to 28 days and will confirm your eligibility to take part in the study.
- Study Procedure Phase: During this period, you will get a random assignment (like a coin flip) to take elacestrant or the standard of care therapy.
- Long-Term Follow-Up Phase: This period will begin after you stop taking your assigned study regimen, and we will be in touch with you during this period to monitor your health and see how you are doing.
Study Details
Full 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 (ELEGANT)
Principal Investigator
Rani Bansal, MD
Medical Oncologist
Protocol Number
IRB:
PRO00118599
NCT:
NCT06492616
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment