Elacestrant versus Standard Endocrine Therapy Early Breast Cancer (Elegant)

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.

Who Can Participate?

Eligibility

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 Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital
Duke Raleigh Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

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

Protocol Number

PRO00118599

NCT ID

NCT06492616

Phase

III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov