A trial of enobosarm for women with early breast cancer (EMERALD)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is for women with hormone receptor positive breast cancer who are going to have surgery. Hormone receptor positive means that cancer cells respond to changes in the levels of:
oestrogen 
androgen
It is for women who can no longer become pregnant ().
Cancer Research UK supports this trial.
More about this trial
Women with often have surgery to try to cure their cancer. This is the .
Doctors are looking at new ways to help women with early breast cancer. In this trial, they are looking at a new called enobosarm in women newly diagnosed with early breast cancer.
Both men and women’s bodies make . In women, androgens can convert into oestrogen. Some cancers use oestrogen to grow.
Enobosarm works by activating the androgen in breast cancer cells. The androgen receptor can slow the growth of breast cancer cells in people with oestrogen receptor positive cancer. Doctors think that activating the androgen receptor might stop the breast cancer from growing.
Everyone taking part in this trial has 1 of the following:
- enobosarm and surgery
- surgery (standard treatment)
The main aims of this trial are to find out how well enobosarm works and learn more about the side effects.
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if all of the following apply:
- You are a woman
- You have oestrogen and androgen receptor positive breast cancer
- Your cancer measures at least 14 mm across
- You can no longer become pregnant (post menopausal)
- You have satisfactory blood tests results
- You are well enough to be up and about for at least half the day (performance status of 0, 1 or 2)
- You are at least 16 years old
You can’t join this trial if any of these apply:
Cancer related
- Your doctor thinks you can’t have surgery to remove breast cancer
- Your cancer has spread to other parts of the body (metastatic)
- You have inflammatory breast cancer
- You have had chemotherapy or hormone therapy
- You have had another cancer in the past 5 years apart from
carcinoma in situ of the cervix or basal or squamous cell skin cancer that have been successfully treated
Medical conditions
- You have a condition that makes you bleed very easily called bleeding diathesis
- You have an infection that needs treatment
- You have had an oestrogen
implant in the past - You have had
hormone replacement therapy or any other drug that contains oestrogen in the past 3 months - You have changes in the levels of salt or minerals in your blood such as potassium, sodium, calcium or magnesium
- You have had an experimental treatment as part of another clinical trial in the past month
- You have any other serious medical condition that the trial team thinks could affect you taking part
Trial design
This is a phase 2 trial. The researchers need about 146 people from the UK to take part.
This trial is randomised. The people taking part are put into 1 of the following treatment groups (arms) by computer:
- enobosarm and surgery (arm 1)
- no additional treatment and surgery (arm 2)
Neither you nor your doctor are able to decide which group you are in. You are 3 times more likely to have enobosarm and surgery than surgery alone.
Enobosarm are capsules you take every day. You swallow them whole, with or without food.
You take enobosarm for up to 18 days. You stop taking it before surgery.
Everyone taking part has surgery. This is the same as the usual (standard) treatment. Your doctor can tell you more about this.
Blood tests
You have some extra blood tests as part of this trial. Researchers are looking at hormone levels. They may also use the blood samples in future studies to learn more about breast cancer.
You have the extra blood tests:
- before starting enobosarm (if you have this)
- after 7 days of the start of enobosarm
- on the day of surgery
Tissue sample
The trial team will ask to use a tissue sample of your cancer that they take:
- when you were diagnosed (archived sample)
- during surgery
Researchers want to look at tumour cells and the hormone levels. They may also use it in future studies to learn more about breast cancer.
Hospital visits
You see a doctor and have some tests before taking part. These tests will include:
- physical examination
- blood tests
- heart trace
(ECG ) - breast ultrasound or mammogram
You go to hospital to collect the study drug. Then after 7 days of taking enobosarm, you go back to the hospital for a physical examination, blood tests and a heart trace.
You take enobosarm for up to 18 days before your surgery.
Then you have surgery. After this, you see the trial doctor or research nurse 2 weeks after surgery.
Side effects
The trial team monitor you while you are having enobosarm. They will give you a phone number to call them if you are worried about anything.
The team will tell you about all the possible side effects before you start the trial.
The most common side effects of enobosarm are:
- headaches
- shortness of breath (this was seen mostly in studies with patients with advanced lung cancer, who were taking enobosarm for a longer period of time)
- constipation
We have information about side effects of breast cancer surgery.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Carlo Palmieri
Supported by
Cancer Research UK
GTx, Inc
Liverpool Cancer Trials Unit
University of Liverpool
Other information
This is Cancer Research UK trial number CRUK/15/075
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
