What to expect
What participation in the ELEGANT Study involves
Treatment
with an elacestrant tablet once daily or standard of care endocrine therapy
Regular testing
including periodic physical exams, bone density scans, and blood tests
Monitoring
by your doctor and
health
care team
Reporting
daily activities
through questionnaires
Health tests performed during the study
During study visits, you will have tests to check your health and well-being. The following tests will occur at some point in the study.
The rate and rhythm of your heart beats will be recorded through small pads attached to your chest, arms and legs.
Your blood will be collected (through a needle inserted into a vein) to check your overall health and to see how you are responding to
study treatment.
Your pulse, blood pressure, breathing rate and temperature will be taken to measure your body’s basic functions.
You will receive physical exams, bone density scans and blood tests will be taken periodically to check your condition.
You will complete questionnaires about how breast cancer is impacting your life and how you are feeling after receiving study treatment.
How elacestrant works
Elacestrant is a treatment designed to block and break down the estrogen receptors (ERs) in cancer cells, inhibiting their growth. Elacestrant can potentially avoid the spread of breast cancer while reducing hot flashes and protecting bone health.1,2
How estrogen receptors work
How elacestrant blocks estrogen receptors
How estrogen receptors work
How elacestrant blocks estrogen receptors
ELEGANT Study
at a glance
4,200
participants
5
year study
treatment duration*
28
countries
500+
study centers
*This is a fixed duration study.
Frequently asked questions
Learning more about the ELEGANT Study can help you decide if you’d like to participate. Explore frequently asked questions from potential participants and reach out to your nearest study location for more information.
The ELEGANT study is a clinical trial that compares the investigational study drug elacestrant to standard-of-care endocrine therapy in people with node-positive, early-stage breast cancer
that have a high risk of
recurrence.
The ELEGANT Study duration may last up to 8 years, including a:
- 4-week screening period: you will have tests at your nearest study center to see if you can take part.
- 5-year study treatment period: if eligible, you will take the investigational drug or hormonal therapy for breast cancer and visit the study center for further tests.
- Safety follow-up: 4 weeks after your last dose of study treatment, you will return to the study center for final tests.
- Long-term follow-up: the study team will contact you every year for about 5 years to check on your health.
You will have a 50% (1 in 2) chance of receiving the investigational study drug elacestrant and a 50% chance of continuing standard-of-care endocrine therapy. This is done by random assignment.
The investigational study drug and standard-of-care endocrine therapy come in tablet/pill form, which you will be asked to take once daily for 5 years.
During the study treatment period, you will visit the study center for tests approximately 12 times over 5 years.
Disclaimers
ER=estrongen receptor; HER2=human epidermal growth factor receptor 2. The safety and efficacy in this patient population is investigational and has not be established; marketing approval has not been granted by regulatory authorities for this early breast cancer indication. Ask your doctor for more information about elacestrant.
References
- Estrogen-dependent cancers: Causes, diagnosis & treatment. Cleveland Clinic. https://
my.clevelandclinic.org/health/diseases/10312-estrogen-dependent-cancers. Accessed December 10, 2024. - Bidard FC, et al. J Clin Oncol. 2022;40(28):3246-3256.
- Feng Y, et al. Genes Dis. 2018;5(2):77-106.
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