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

Please note this trial is no longer recruiting patients.

This trial is looking at ways of improving radiotherapy treatment for low risk early stage breast cancer. Research has shown that having radiotherapy after breast conserving surgery lowers the risk of the cancer coming back (recurrence).

But there are some possible long term side effects from having radiotherapy to your breast. For example, your breasts may become harder or smaller.

Doctors want to reduce the risk of these long term side effects. They hope that they can do this by giving standard radiotherapy to the area of the breast where the cancer was. But giving less radiotherapy to the rest of the breast.

At present, radiotherapy is given in the same way, whether you are considered to be at ‘high risk’ or ‘low risk’ of recurrence. This trial is only for women considered to be at low risk.

The aims of this trial are to see if

New ways of giving radiotherapy to the breast can reduce the long term side effects
It is as effective as standard radiotherapy

Recruitment

Start 03/05/2007

End 13/09/2010

Phase

Phase 3

Who can enter

You can enter this trial if

You have been diagnosed with breast cancer
You have had breast conserving surgery
Your breast cancer was no bigger than 3cm across
You only had one area of cancer in your breast
Your surgeon was able to remove the cancer with a clear margin of at least 2mm
You are female
You are at least 50 years of age

You cannot enter this trial if you

Have invasive lobular breast cancer
Have breast cancer that has spread to other parts of the body
Have had a mastectomy to remove the cancer
Had chemotherapy before your surgery
Are having chemotherapy and radiotherapy at the same time
Have had any other type of cancer apart from non melanoma skin cancer

Trial design

About 2000 women will take part in this trial around the UK. This is a randomised trial. You will be put into 1 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 the standard dose of radiotherapy to the whole of your breast.

If you are in group 2, you will have standard radiotherapy to the area of your breast where the cancer was, and a lower dose of radiotherapy to the rest of your breast.

If you are in group 3, you will have the standard dose of radiotherapy, but only to the area of your breast where the cancer was.

Your doctors will ask you to give an extra blood sample. This will be safely stored and may be used in the future for research purposes only. If you agree to this, they will also ask you about any other members of your family who have had cancer. This is so that the researchers can try to find out if certain inherited genetic differences make some people more sensitive to the effects of radiotherapy. If you don’t want to give a blood sample for this study, you don’t have to. You can still take part in the trial.

The researchers also want to look at why cancer sometimes comes back again. Your doctors will ask you to let them keep a small sample of the cancer removed when you had your operation. This sample will be safely stored.

It is very unlikely that your breast cancer will come back, but if it does, the doctors would take another sample of tissue. They would then be able to compare the two samples. The researchers hope that this will help them to understand more about why cancer sometimes comes back. If you don’t want to donate a tissue sample, you don’t have to. You can still take part in the main trial.

Some hospitals are doing 2 extra studies (known as sub studies). One of these aims to help the doctors learn more about the long term side effects of radiotherapy. If your doctor asks you take part in this study, they will take photographs of your breasts after your surgery. Your doctor will then examine your breasts again and take more photographs 2 years and 5 years after you finish radiotherapy. The photographs will help the researchers to see if there are any changes in how your breasts look. These photographs will not show your face. If you don’t want to take part in this sub study, you can still take part in the trial.

The other sub study is a ‘quality of life’ study. Your doctor may ask you to fill in a questionnaire at the beginning of the trial, and again after

6 months
1 year
2 years
5 years

These will ask how you have been feeling and how you think your treatment has affected you.

Hospital visits

Everybody taking part in this trial will go to hospital for radiotherapy treatment every day from Monday to Friday for 3 weeks. You will have a total of 15 treatments.

After you finish treatment, you will see the trial doctors every year for the next 10 years.