
“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at using a new drug called abiraterone with exemestane for breast cancer that has spread to another part of the body. This trial is for women who have oestrogen receptor positive (ER positive) breast cancer.
Doctors often use hormone therapy to treat breast cancer. Two drugs they use are anastrozole and letrozole. But sometimes the cancer starts to grow again and then doctors may use exemestane.
Abiraterone is a new type of hormone therapy. It stops the body from making certain hormones. The researchers think that using abiraterone with exemestane may be better than exemestane alone.
The aim of this trial is to compare exemestane alone with abiraterone and exemestane. The researchers want to find out which is best for women whose breast cancer has continued to grow during or after treatment with anastrozole or letrozole.
You may be able to enter this trial if
You cannot enter this trial if you
This is a phase 2 trial. It will recruit 300 women from different countries around the world. It is a randomised trial. Women who take part will be put into 1 of 3 treatment groups by a computer. Neither you nor your doctor can choose which group you are in.
In group 1 you have abiraterone, prednisolone and exemestane. In group 2 you have abiraterone and prednisolone. In group 3 you have exemestane alone.
Abiraterone is a tablet. You take 4 tablets daily on an empty stomach. You can’t eat for at least 2 hours before or 1 hour after taking your tablets. You take your tablets about the same time each day.
Prednisolone is a tablet. You take 1 tablet daily at the same time as you take abiraterone. When you stop taking abiraterone you keep taking prednisolone. Your doctor will tell you when and how to stop taking prednisolone.
Exemestane is a tablet. You take 1 tablet daily after a meal.
You can continue having treatment as long as the side effects aren’t bad and the treatment is still helping you.
If you are taking exemestane alone and it stops helping, you may be able to switch to abiraterone. Your doctor will talk to you about this.
The researchers will ask you to fill in 3 questionnaires once a month during treatment, at the end of treatment and then every 3 months after that. They will ask about how you are feeling, what you can do and side effects you might have. This is called a quality of life study.
The researchers will also ask your permission to take a small piece of tissue from when you had your biopsy or surgery. This is to look at the genes in the cancer cells.
You see the doctor and have some tests before taking part in this trial. These tests include
During the first 3 months of treatment you see the doctor fortnightly for a blood test. You have a physical examination every 4 weeks.
After this you see the doctor every month for a blood test and physical examination. You will not be able to eat before this appointment, so that your doctor can measure the amount of sugar in your blood (a fasting blood test). You have a CT scan or MRI scan and heart trace regularly while having treatment.
At the end of treatment you see the doctor and have the same tests. After treatment you see the doctor every 3 months.
The most common side effects of abiraterone may include
The side effects of exemestane may include
The most common side effects of prednisolone may include
We have more information on abiraterone, exemestane and prednisolone in our cancer drugs section.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Andreas Makris
Experimental Cancer Medicine Centre (ECMC)
Janssen-Cilag
National Institute for Health Research Cancer Research Network (NCRN)
Freephone 0808 800 4040
“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."