What to expect

The ELEGANT Study is testing elacestrant to see if it could help people with early-stage breast cancer that could recur. Elacestrant will be compared with the endocrine therapy you usually take for your node-positive, ER-positive, HER2-negative early-stage breast cancer.

The ELEGANT Study could last up to 8 years, including:

  • 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 endocrine therapy 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 drug elacestrant and a 50% chance of continuing to take endocrine therapy that is considered standard of care. You cannot choose but you will know what you are receiving.

Elacestrant and endocrine therapy come in tablet/pill form, which you will be asked to take every day for 5 years.

During the study treatment period, you will visit the study center for tests approximately 12 times over 5 years.

What happens during study visits?


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:

Evaluation of your bone density at screening and at years 2 and 4 of the study.

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.

Scans of your body will be taken 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.

4,220

participants

7.5–8

years

28

countries

500

study centers