Take part in a breast cancer study

Doctors are conducting a research study called EMERALD to determine whether an investigational oral endocrine treatment called elacestrant can help people with advanced or metastatic breast cancer. If you have ER+/HER2- advanced or metastatic breast cancer and have received 1 or 2 hormonal therapies, as well as a type of drug called a CDK4/6 inhibitor (e.g. Ibrance, Verzenio and Kisqali), you may be eligible to participate.

What is the EMERALD Study?

EMERALD is the name given to a phase 3 study (the last phase in development before a drug can be approved to be sold) that is being conducted by Radius Pharmaceuticals, Inc. to evaluate safety and efficacy of an investigational oral endocrine therapy called elacestrant.

This study is evaluating elacestrant compared with standard of care hormonal treatments that are commonly used to treat advanced or metastatic breast cancer.

Who can take part?

You might be eligible for the EMERALD Study if:

• You have been diagnosed with ER-positive (ER+), HER2-negative (HER2-) advanced or metastatic breast cancer.
• You are an adult male or post-menopausal female.
• You have already been treated with at least 1 and no more than 2 lines (a treatment regimen that may consist of one or more drugs) of hormonal therapy.
• You have received a drug called a CDK4/6 inhibitor (tradenames are Ibrance, Verzenio and Kisqali).

There are other specific requirements for participation, which your study doctor will discuss with you.

It is anticipated that approximately 466 post-menopausal women and men with advanced breast cancer will be enrolled in this study. 

What happens if you decide to participate?

The study treatment is divided into 3 parts: screening period, treatment period and follow-up period.

• The screening period can last up to 5 weeks (35 days); you will have to come to the study centre at least one time during the screening period.
• The study treatment period will be the period when you are taking one of the study drugs; during this time, you will be evaluated regularly at the study centre. Each study treatment cycle lasts 28 days. During the first study treatment cycle (28 days), you will have to come to the study centre at least two times. If study drug treatment continues to be helpful and safe for you, and you choose to stay in the study, you will continue to come to the study centre at least once every 28 days.
• After you stop taking the study drug, you will be asked to come to the study centre for an End of Study Treatment visit within 14 days after your last dose.

You will receive:

• The study procedures at no cost to you.
• Close monitoring throughout the study.

• A possible stipend for study visits to reimburse certain expenses.

How to apply

If you would like to learn more about the study and whether you may be able to take part, please register on this website and answer the subsequent questions. If you are eligible, a Link2Trials employee or one of the participating clinics will contact you to schedule an appointment and will also be happy to answer any questions that you may have.