A trial comparing a boost of radiotherapy given during surgery and standard radiotherapy after surgery for early breast cancer (TARGIT-B)

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:

Other

This trial is looking at giving some radiotherapy during surgery (intra operative radiotherapy) for breast cancer that has a higher than average risk of coming back.

More about this trial

If you have early breast cancer, you may have surgery to remove the cancer from your breast. This is called a lumpectomy or wide local excision. Having radiotherapy after this type of surgery lowers the risk of the cancer coming back in your breast.

The standard radiotherapy treatment for early breast cancer is external beam radiotherapy after surgery. You have radiotherapy to the whole breast, and you may also have a boost dose to the tissues in the area where the cancer was.

In this trial, researchers are looking at a new way of giving the boost dose during surgery. This is called intra operative radiotherapy, or IORT. The surgeon puts an applicator into the breast tissue when you are in the operating theatre. The applicator delivers radiotherapy directly to the breast tissue.

Everybody taking part in this trial has external beam radiotherapy. Some people have the standard external beam boost dose of radiotherapy. Some have the boost dose as intra operative radiotherapy during surgery.

The trial is for people whose doctors think they have a higher than average risk of the cancer coming back after treatment. The aim of the study is to see if having the radiotherapy boost dose during your operation lowers the chance of cancer coming back in the breast and if it lowers the risk of long term changes to the breast.

Who can enter

You may be able to enter this trial if you have been diagnosed with breast cancer, are able to have breast conserving surgery followed by radiotherapy and your doctors think you have a higher than average risk of the cancer coming back in your breast for at least 1 of the reasons below

You are 45 or younger
You are over 45 and 1 or more of the following apply to you – your breast cancer doesn't have receptors for the female hormones oestrogen or progesterone (it is hormone receptor negative), your cancer cells are fast growing (you have grade 3 breast cancer), your breast cancer has spread into your blood vessels or lymph vessels, you have more than 1 tumour in your breast, you have lobular breast cancer or ductal breast cancer and more than a quarter of the tumour is in between the ducts of the breast, or there is anything else that puts you at high risk of your cancer coming back – the trial team can advise you about this
You had a larger tumour which has responded to chemotherapy or hormone therapy before surgery making breast conserving surgery possible

You cannot enter this trial if you

Have cancer in both breasts
Have another serious medical condition – the trial team can advise you about this
Have had any other type of cancer unless your doctors think there is a very high chance it has been completely cured

Trial design

This is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

After surgery, everybody has external beam radiotherapy to the whole breast. This takes 4 to 6 weeks.

Half the people taking part have an external beam radiotherapy boost to the area where the cancer was. You have this over 5 to 8 days at the end of your radiotherapy course.

The other half have the boost as intra operative radiotherapy (IORT) when they have surgery. If you have the boost in this way, your surgery will take about 45 minutes longer.

You may also have other treatments to try to stop the cancer coming back such as chemotherapy or hormone therapy. They are not part of the trial and you have them in the normal way.

The trial team will ask you to fill out a questionnaire before you are put into your treatment group, 6 months, 1 year, 18 months and 2 years later, and then once a year for the next 3 years. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.

They will also ask you to fill in a diary 7 times over 3 years. This will help the trial team to assess any costs associated with the treatment.

Hospital visits

Everybody taking part in the trial goes to hospital once a day (Monday to Friday) for 4 to 6 weeks to have radiotherapy to the whole breast. If you have the external beam boost dose, you will have an extra 5 to 8 hospital visits at the end of this treatment.

When you finish treatment, you have follow up appointments every 6 months for the first 3 years and then once a year for the next 7 years.