Take part in a breast cancer study

The investigational drug being researched in this study is elacestrant. Elacestrant is an oral hormonal therapy called a SERD (selective estrogen receptor degrader). SERD drugs act by degrading (ie, breaking down) the estrogen receptor which is a driving force in the progression of ER+ breast cancer.

Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics in the areas of osteoporosis and oncology.

What is a clinical study?

• A clinical study is a scientific study on how a new or existing medicine, product, procedure or treatment works in people.
• Through clinical studies, doctors can find new and better ways to prevent, detect, diagnose, control and treat illnesses.
• All clinical studies are carefully monitored and regulated to protect participant well-being.
• Participating in a clinical study is completely voluntary and will not affect the normal standard of care you receive.

What is investigational about this study?

This study is evaluating the safety and efficacy of an investigational drug called elacestrant compared to standard of care hormonal treatments that are commonly used to treat advanced or metastatic breast cancer. The study is investigational because one of the drugs being studied (elacestrant) has not been approved by the FDA or other health authorities in other countries to be sold because it has not yet been shown to be safe and effective. The purpose of this study is to evaluate whether elacestrant is safe and effective for the treatment of ER+ HER2- advanced or metastatic breast cancer in men and postmenopausal women. This will be done by comparing safety and efficacy data collected in this study for participants who receive elacestrant to the same data for participants who receive one of the standard of care treatment options.

What happens if you decide to participate?

If you decide you would like to be considered to take part in the study, you will need to visit one of the study sites that is participating in the study to determine if you meet all eligibility criteria; this will include obtaining X-ray studies (eg, CT scan) and blood work. If you meet all criteria and agree to participate, you will need to receive all study treatment and undergo all study procedures at that study site. 

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

• The screening period can last up to 5 weeks (35 days); you will have to come to the study center at least one time during the screening period for tests to determine if you are eligible to participate.
• The study treatment period will be the period when you are taking one of the study drugs and are evaluated regularly at the study center.
• Each study treatment cycle lasts 28 days. During the first study treatment cycle (28 days) you will have to come to the study center 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 center at least once every 28 days.
• After you stop taking study drug, you will be asked to come to the study center for an End of Study Treatment visit within 14 days after your last dose.
• The follow- up period will begin after you stop the study drug.  You will be asked to come to the study center 30 days after your last dose of study drug for a safety follow-up visit.  In addition, you will be contacted every 8 weeks by phone to check in with you and collect information about the first new cancer treatments you may be undergoing until the study is completed for all subjects. If your cancer did not worsen before you came off study treatment, you will also be asked to come to the study center every 8 weeks for assessment of your tumor until your cancer worsens, or you begin a new cancer treatment.

What happens when you come for study visits?

During the study, the following tests and procedures will be performed, although not every test will be performed at every visit.  Most of the tests and procedures outlined below would likely be part of your regular medical care, however they may be performed more frequently for the purposes of the study. 

If you have any questions about any of these tests and procedures, ask your study doctor and/or study staff at any time.

• Health and Medication Questions
• Physical Examination
• Blood Pressure, Pulse, Breathing rate, and Temperature (vital signs)
• Blood Tests:  You will be asked to give blood to assess your general health and measure tumor DNA in your blood. 
• Urine test:  A urine sample will be collected to assess your general health.
• ECG:  Electrocardiograms (ECGs) will be performed to check the health of your heart.  An ECG is a test that measures the electrical activity of your heart. 
• Tumor assessments:  Tumor assessments will be done by taking pictures of your tumor using one or more of the following methods depending on where your tumor is located:
• CT Scan (Computerized Tomography):  A CT scan is a test that uses x-rays and a computer to take 3 dimensional (3-D) pictures of your body.
• MRI (Magnetic Resonance Imaging):  An MRI is a test that uses magnets, radio waves, and a computer to make pictures of body tissues and structures.
• Bone scan: A test that uses radioactive compound injected into your blood to detect cancer that may have spread to your bone.
• Brain Imaging: You may have MRI or CT scans of your brain if cancer is known or suspected to be in your brain.
• Color Photographs: A camera may be used to take pictures of parts of your body if you have tumors that are visible on your skin.

How many people will be in this study and for how long?

It is anticipated that approximately 466 postmenopausal women and men with advanced or metastatic breast cancer will be enrolled in this study.

This study will be conducted in many medical centers in North America and Europe and in other regions as well. 

Your time on the study treatment will vary depending on how you respond to the study drug.  

What is ER positive HER2 negative advanced or metastatic breast cancer?

Not all breast cancers are the same. Breast cancers are treated differently depending on the type of hormone receptor found on the tumor cells: the estrogen receptor (ER positive or negative), the HER2 receptor (HER2 positive or negative) or no receptor, often referred to as “triple negative” breast cancer. Receptor presence is determined based on a tumor tissue biopsy. Breast cancer is also staged as early or advanced and metastatic, with different treatment options available based on stage. Metastatic breast cancer is cancer that has spread beyond the breast to other organs such as lymph nodes, bone, and liver. Advanced and metastatic breast cancer cannot be cured.

The EMERALD study is only evaluating patients with ER positive (ER+) and HER2 negative (HER2-) advanced or metastatic breast cancer.

What do I need to know about this study?

• You will have no choice in deciding what treatment you will receive in this study. You will be randomized (flip of a coin) to elacestrant or one of the standard of care drugs. You must agree to receive the drug you are assigned for the duration of the study.
• You will receive the study procedures at no cost to you.
• You will be monitored closely throughout the study.
• It is essential that you go to all the study appointments and follow study instructions.
• You can withdraw from the EMERALD study at any time and for any reason. This will not affect the standard of care you receive.
• You can talk to the study team at any time about any questions or concerns you may have.

What is a clinical study?

• A clinical study is a scientific study on how a new or existing medicine, product, procedure or treatment works in people.
• Through clinical studies, doctors can find new and better ways to prevent, detect, diagnose, control and treat illnesses.
• All clinical studies are carefully monitored and regulated to protect participant well-being.
• Participating in a clinical study is completely voluntary and will not affect the normal standard of care that you receive.

What is investigational about this study?

This study is evaluating the safety and efficacy of an investigational drug called elacestrant compared with standard of care hormonal treatments that are commonly used to treat advanced or metastatic breast cancer. The study is investigational because one of the drugs being studied (elacestrant) has not been approved by the FDA or other health authorities in other countries to be sold, because it has not yet been shown to be safe and effective. The purpose of this study is to evaluate whether elacestrant is safe and effective for the treatment of ER+/HER2- advanced or metastatic breast cancer in men and post-menopausal women. This will be done by comparing safety and efficacy data collected in this study for participants who receive elacestrant with the same data for participants who receive one of the standard of care treatment options.

What happens if you decide to participate?

If you decide that you would like to be considered to take part in the study, you will need to visit one of the study sites that is participating in the study to determine whether you meet all eligibility criteria; this will include obtaining X-ray studies (e.g. CT scans) and blood work. If you meet all criteria and agree to participate, you will need to receive all study treatment and undergo all study procedures at that study site.

The study is divided into 3 parts. There is a screening period, a study treatment period and a 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 for tests to determine whether you are eligible to participate.
• The study treatment period will be the period when you are taking one of the study drugs and are 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.
• The follow-up period will begin after you stop the study drug. You will be asked to come to the study centre 30 days after your last dose of the study drug for a safety follow-up visit. In addition, you will be contacted every 8 weeks by phone to check in with you and collect information about the first new cancer treatments that you may be undergoing until the study is completed for all subjects. If your cancer did not worsen before you came off study treatment, you will also be asked to come to the study centre every 8 weeks for assessment of your tumour until your cancer worsens or you begin a new cancer treatment.

What happens when you come for study visits?

During the study, the following tests and procedures will be performed, although not every test will be performed at every visit. Most of the tests and procedures outlined below would likely be part of your regular medical care; however, they may be performed more frequently for the purposes of the study.

If you have any questions about any of these tests and procedures, ask your study doctor and/or study staff at any time.

• Health and Medication Questions
• Physical Examination
• Blood Pressure, Pulse, Breathing Rate and Temperature (vital signs)
• Blood Tests: You will be asked to give blood to assess your general health and measure tumour DNA in your blood.
• Urine test: A urine sample will be collected to assess your general health.
• ECG: Electrocardiograms (ECGs) will be performed to check the health of your heart. An ECG is a test that measures the electrical activity of your heart.
• Tumour assessments: Tumour assessments will be done by taking pictures of your tumour using one or more of the following methods, depending on where your tumour is located.
• CT Scan (Computerised Tomography): A CT scan is a test that uses X-rays and a computer to take 3-dimensional (3-D) pictures of your body.
• MRI (Magnetic Resonance Imaging): An MRI is a test that uses magnets, radio waves and a computer to make pictures of body tissues and structures.
• Bone Scan: A bone scan is a test that uses radioactive compound injected into your blood to detect cancer that may have spread to your bone.
• Brain Imaging: You may have MRI or CT scans of your brain if cancer is known or suspected to be in your brain.
• Colour Photographs: A camera may be used to take pictures of parts of your body if you have tumours that are visible on your skin.

How many people will be in this study and for how long?

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

This study will be conducted in many medical centres in North America and Europe and in other regions as well.

Your time on the study treatment will vary depending on how you respond to the study drug.

What is ER-positive/HER2-negative advanced or metastatic breast cancer?

Not all breast cancers are the same. Breast cancers are treated differently depending on the type of hormone receptor found on the tumour cells: the oestrogen receptor (ER-positive or -negative), the HER2 receptor (HER2-positive or -negative) or no receptor, often referred to as ’triple negative’ breast cancer. Receptor presence is determined based on a tumour tissue biopsy. Breast cancer is also staged as early or advanced and metastatic, with different treatment options available based on stage. Metastatic breast cancer is cancer that has spread beyond the breast to other organs such as lymph nodes, bone and liver. Advanced and metastatic breast cancer cannot be cured.

The EMERALD study is only evaluating patients with ER-positive (ER+) and HER2-negative (HER2-) advanced or metastatic breast cancer.

What do I need to know about this study?

• You will have no choice in deciding what treatment you will receive in this study. You will be randomised (flip of a coin) to elacestrant or one of the standard of care drugs. You must agree to receive the drug that you are assigned for the duration of the study.
• You will receive the study procedures at no cost to you.
• You will be monitored closely throughout the study.
• It is essential that you go to all the study appointments and follow study instructions.
• You can withdraw from the EMERALD study at any time and for any reason. This will not affect the standard of care that you receive.
• You can talk to the study team at any time about any questions or concerns that you may have.