A trial looking at different ways of giving radiotherapy for women with early breast cancer (FAST)

Please note this trial is no longer recruiting patients.

This trial will compare standard radiotherapy for early breast cancer with 2 new ways of giving radiotherapy to see which is best at stopping the cancer from coming back.

If you had breast conserving surgery for early breast cancer, you may also have radiotherapy. Tests may show that there are no cancer cells in the margin of healthy tissue around your cancer, but there is still a risk that some cancer cells have been left behind. The aim of your radiotherapy is to destroy any cancer cells left at the site of the operation.

Radiotherapy is measured in units called ‘Grays’ (Gy) and given in daily doses, called fractions. Women who have radiotherapy for breast cancer usually have a fraction every day for 5 days, over a period of 5 weeks. These smaller more frequent doses are the standard treatment because doctors think this causes fewer side effects to normal tissue. But recent results of a large clinical trial suggest that these smaller doses may not be strong enough to kill off the cancer cells.

Researchers in this trial want to find out if increasing the dose of each fraction (and using fewer fractions) while decreasing the total dose, will reduce the risk of the cancer coming back.

This trial will compare the standard treatment of

25 doses of 2 Gray (total dose 50 Gray) with
5 doses of 6 Gray (total dose 30 Gray) and
5 doses of 5.7 Gray (total dose 28.5. Gray)

Recruitment

Start 01/10/2004

End 09/03/2007

Phase

Phase 3

Who can enter

You can enter this trial if you

Have been diagnosed with early breast cancer
Your breast cancer was less than 3cm in width
Have had had breast preserving surgery, such as a lumpectomy or wide local excision and your cancer has been completely removed
You have had lymph nodes removed from your armpit (axilla) and all of these were free of cancer cells
Are at least 50 years of age, or older

You cannot enter this trial if you

If you have had a mastectomy to remove your breast cancer
Need to have radiotherapy to the lymph nodes in your armpit
Your doctor has told you that you need an extra treatment of radiotherapy, called a ‘boost’, as part of your radiotherapy treatment to your breast
Have had chemotherapy

Trial design

This trial will recruit 900 women after they have had surgery for breast cancer.

There are 3 different treatment groups in this trial and it is randomised. The people taking part are put into one of these groups by a computer. Neither you nor your doctor will be able to decide which group you are in. All women will have radiotherapy.

If you are in group 1, you will have radiotherapy every day (2 Gray) from Monday to Friday, for 5 weeks. You will have a total dose of 50 Gray in divided doses of 2 Gray.

If you are in group 2, you will have radiotherapy one day a week for 5 weeks. You will have a total of 30 Gray in divided doses of 6 Gray.

If you are in group 3, you will have radiotherapy one day a week for 5 weeks. You will have a total of 28.5 Gray in divided doses of 5.7 Gray.

Hospital visits

Before you start treatment, you will visit the hospital radiotherapy department for ‘planning’. The doctor will take measurements of the treatment area and make marks on your skin so that the same area is treated every day. Planning is important so that your treatment is given safely and accurately. This appointment will take between 30 and 60 minutes.

If you are in group 1, you will visit the hospital for radiotherapy every day (Monday to Friday) for 5 weeks.

If you are in group 2 or 3, you will visit the hospital for radiotherapy one day a week for 5 weeks.

Whichever group you are in, each treatment will take about 10 to 15 minutes.

You will be asked to have a photograph taken of your breast

At the start of your treatment and
At your 2 year follow up appointment
At your 5 years follow up appointment

These photographs help the doctors to keep a record of any changes in appearance to your breast since it was treated.

The researchers would like to continue to collect information about you for about 10 years after your treatment has finished. A form will be sent to your consultant every year and they will fill in details about your follow up appointments and any side effects you are having.

Side effects

All treatments have side effects. The more common side effects of radiotherapy to the breast include

Reddening, soreness and swelling of the skin in the area being treated
Tiredness

These side effects may develop about 2 weeks into the treatment and may last for a couple of weeks after treatment has finished. Long term side effects may develop many years after treatment. These include shrinkage and firmness of the breast, breast pain and tenderness.

The researchers do not expect side effects to be worse in the weekly treatments (group 2 and 3) compared to the standard daily treatments (group 1).

There is more information about the side effects of radiotherapy to the breast on CancerHelp UK.