
“I had treatment last year and I want to give something back.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is trying to find out if radiotherapy (after surgery to remove the breast) helps to stop breast cancer coming back in women who have an ‘intermediate risk’ of recurrence.
Doctors usually treat breast cancer with surgery, sometimes followed by chemotherapy, hormone therapy or radiotherapy, or a combination of these treatments. The treatment will depend on the stage of the cancer, and the likelihood that the cancer will come back in the future.
Some women who have surgery to remove their breast (a mastectomy) have breast cancer at ‘high risk’ of coming back. They have radiotherapy to help stop this happening. Women with breast cancer at ‘low risk’ of coming back after a mastectomy don’t need radiotherapy.
Some women with breast cancer at ‘intermediate risk’ of coming back after a mastectomy have radiotherapy, and some don’t. But doctors aren’t really sure whether it helps or not. All treatments have some side effects, so it is important that women don’t have treatment they don’t need.
The aim of this trial is to find out if radiotherapy is necessary to stop intermediate risk breast cancer coming back after a mastectomy. And to see how radiotherapy affects quality of life for this group of women.
You can enter this trial if you are a woman and you have
You cannot enter this trial if you
This is a randomised trial. It will recruit 1,600 women into 2 groups. The women taking part will be put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
All women will have some treatment after their mastectomy. This could be hormone therapy, chemotherapy or both.
If you are in group 1 you will also have radiotherapy to the . You have treatment once a day (Monday to Friday) for 3 to 5 weeks. The actual treatment will take a few minutes each time.
If you are in group 2 you won’t have radiotherapy.
You may be asked to fill out a questionnaire before you start treatment and then at 1 year, 2 years, 5 years and 10 years. This will ask you how you have been feeling and about any side effects you have had. It is called a quality of life questionnaire.
The research team are running a health economics sub study as part of this trial. This means they want to find out if giving radiotherapy as well is cost effective. If you take part in this you will need to complete a diary recording every visit you make to a health professional until 5 months after surgery or until you finish chemotherapy.
The research team would also like to store a sample of your cancer and of your blood. They would like to use the samples in their research to find out more about breast cancer. You don’t have to do this - you can still take part in the rest of trial if you decide not to agree to this.
You will see the doctor and have some tests before you start the trial. These tests include
You may have chemotherapy or hormone therapy (or both) after your operation. If you do, your doctor will tell you about the specific drugs you will have, and how often you need to go to hospital.
You will see the doctors again before and after your course of radiotherapy (or at a similar time if you do not have radiotherapy).
If you are in group 1 you will go to the hospital every week day for 3 to 5 weeks to have radiotherapy.
After treatment, everyone taking part in the trial will see the doctors and have a physical examination once a year for 10 years. You will have a mammogram at least once every 2 years for 10 years.
The side effects of radiotherapy depend on the area of the body being treated. The side effects of radiotherapy for breast cancer include
Rarely, you can become short of breath due to radiation fibrosis in your lungs. Or perhaps have rib fractures in the future because of damage to your ribs.
We have more information about the side effects of radiotherapy for breast cancer.
There is more information about this trial on the Supremo trial website.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Prof Ian Kunkler
Breast International Group (BIG)
European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
Trans Tasman Radiation Oncology Group
Freephone 0808 800 4040
“I had treatment last year and I want to give something back.”