A trial looking at radiotherapy during surgery for early stage breast cancer (TARGIT-A)

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 3

This trial compared external radiotherapy with radiotherapy given during surgery (intra operative radiotherapy) for breast cancer.

When this trial was done, the standard radiotherapy treatment for breast cancer was external radiotherapy. Having radiotherapy reduces the chance of breast cancer coming back after surgery.

With external radiotherapy, you go to the radiotherapy department for daily treatment once you have recovered from surgery. This is a little like having an X-ray and takes a few minutes each time. The usual treatment is radiotherapy 5 days a week, for up to 6 weeks. This is called a course of radiotherapy.

In this trial, some people had a single dose of radiotherapy during surgery instead of a course of radiotherapy afterwards. This is called intra operative radiotherapy, or IORT. The surgeon puts an applicator into the breast during surgery. The applicator delivers radiotherapy directly to the breast tissue.

The main aim of this trial was to see if intra operative radiotherapy is as good as external radiotherapy at stopping breast cancer coming back after surgery.

Summary of results

The research team found that radiotherapy during surgery is a useful treatment option for early stage breast cancer.

This trial recruited 3,451 women from 33 hospitals in several different countries. Everyone who took part was due to have surgery and radiotherapy for early stage breast cancer.

The women taking part were put into 1 of 2 treatment groups at random, and

  • Half had a single dose of radiotherapy during surgery (intra operative radiotherapy)
  • Half had a 3 to 6 week course of radiotherapy after surgery (external radiotherapy).

The research team looked at how often the cancer came back in the breast area (local recurrence), and how many women in each group died. They found these were low and similar in both groups.

There are 2 different ways of giving intra operative radiotherapy. One is during surgery to remove the lump. The other is as a separate operation afterwards. When the research team looked at this, they found that the results were a bit better for women who’d had radiotherapy during surgery to remove the lump.

They found that while the number of women who died from breast cancer was the same in the two groups, there were fewer deaths from causes other than breast cancer in the group who had intraoperative radiotherapy during surgery than in the group who had external radiotherapy.

They also looked at the number of women who had serious problems with their wound healing after surgery, or skin problems after radiotherapy. They found that wound healing was not affected, but skin problems were a little more common in women who had external radiotherapy.

The trial team concluded that doctors should consider intra operative radiotherapy at the same time as surgery as an option for treating women with early stage breast cancer.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor J S Vaidya
Professor J S Tobias
Professor Michael Baum

Supported by

NIHR Health Technology Assessment (HTA) programme
NIHR Clinical Research Network: Cancer
NIHR University College London Hospitals Biomedical Research Centre
UCLH Charities
Ninewells Cancer Campaign
National Health and Medical Research Council, Australia
German Federal Ministry of Education and Research
Carl Zeiss

Other information

There is more information available on the Targit website.

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

500

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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