A trial comparing different ways of giving radiotherapy for early stage breast cancer (IMPORT HIGH)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at ways of improving radiotherapy treatment for early breast cancer. This trial is supported by Cancer Research UK.

We know from research that having radiotherapy after surgery to remove a breast lump lowers the risk of the cancer coming back (recurrence). But there are some possible long term side effects and there is still a risk that the cancer could come back.

Doctors want to reduce the risk of long term side effects. They hope they can do this by giving a higher dose of radiotherapy to the area of the breast where the cancer was. And giving a lower dose of radiotherapy to the rest of the breast.

This trial is for women whose doctors think have a higher than average risk of breast cancer coming back after treatment. The aim of the trial is to see if new ways of giving radiotherapy help to stop cancer coming back in the breast and if they can reduce the risk of long term side effects.

Who can enter

You can enter this trial if you

Have been diagnosed with breast cancer in one breast
Have had breast conserving surgery and all your cancer has been successfully removed
Are going to have radiotherapy including a boost dose as part of your treatment
Are at least 18 years old

You cannot enter this trial if you

Have breast cancer that has spread to other parts of your body (apart from some lymph nodes close to your breast)
Have had a mastectomy to remove the cancer
Are having chemotherapy and radiotherapy at the same time
Have an implant in the breast you have cancer in
Have had any other type of cancer in the last 5 years apart from non melanoma skin cancer or carcinoma in situ of the cervix

Trial design

The trial will recruit 2,568 people in the UK. It is a randomised trial. Everybody taking part will be put into one of 3 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you will have standard treatment Open a glossary item . You have

15 daily doses of radiotherapy to the whole breast
8 doses of radiotherapy to the area of your breast where the tumour was

The treatment takes 4 and a half weeks altogether.

If you are in group 2, you will have

A lower dose of radiotherapy to the breast tissue furthest away from where the tumour was
A standard dose of radiotherapy to the breast tissue nearer to where the tumour was
More radiotherapy to the exact area of the breast where the tumour was

You have these different doses each day and the treatment takes 3 weeks altogether.

If you are in group 3, you will have the same treatment as group 2, except that you have a slightly higher dose of radiotherapy to the exact area of the breast where the tumour was.

The trial team have asked some people taking part to fill in a questionnaire at the beginning of the trial, and again after 6 months, 1, 3 and 5 years. This asked about how you have been feeling and how you think your treatment has affected you. This is called a quality of life study.

They also asked some women to have photographs taken of their breasts after surgery and then 3 and 5 years later. The photographs will help the researchers see any changes to their breasts over the years following radiotherapy. The photographs will not show the women's faces.

The trial team ask everybody to fill in a questionnaire about their family history. This includes questions about whether any close relatives have had cancer. It may help the researchers to see if there is a link between having a family history of cancer and how people react to radiotherapy.

The trial team will ask you to give an extra blood sample. They will look at the DNA in your blood to try and find out if certain inherited genetic differences make some people more sensitive to the effects of radiotherapy.

The researchers also want to learn more about why cancer sometimes comes back again. They will ask you to let them keep a small sample of the cancer removed when you had your operation. This sample will be stored safely and used only for research purposes.

It is very unlikely that your breast cancer will come back, but if it does, the doctors would take another sample of tissue to compare with the first. The researchers hope that this will help them to understand more about why cancer sometimes comes back and improve treatment in the future.

Please note - The family history questionnaire, blood sample and tissue sample are all optional. You don’t have to take part in any of these if you don’t want to. You can still take part in the trial.

Hospital visits

You will go to hospital for radiotherapy treatment everyday from Monday to Friday. This will last for either 3 weeks or 4 and a half weeks, depending on which treatment group you are in.

After you finish treatment, you will see the trial doctors and have your breast examined every year for the next 10 years.

Side effects

All treatments have side effects. Radiotherapy for breast cancer can lead to some long term side effects. These include

Your breast getting smaller
Your breast feeling harder
Your breast being tender
Stiffness in your chest muscles

There is a risk that you may have a cracked rib later in life. But this is rare. There is more information about side effects of radiotherapy for breast cancer on CancerHelp UK.