A trial comparing radiotherapy and surgery for women with breast cancer which has spread to their lymph nodes (AMAROS)

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 3

This trial compared surgery with radiotherapy as a treatment for women with breast cancer that has spread to the lymph nodes.

As part of treatment for breast cancer, doctors often remove some or all of the lymph nodes under the arm, to find out whether the breast cancer has spread to these lymph nodes.

The first lymph node that cancer cells reach is known as the sentinel node. In this trial the doctors removed the sentinel node and checked it for cancer cells. This is called a sentinel node biopsy.

Women who have cancer cells in their sentinel node need further treatment to the lymph nodes. This reduces the risk of breast cancer coming back.

When this trial was done, doctors often used surgery to treat women in this situation. But some women had radiotherapy instead, and the research team wanted to find out if one treatment was better than the other.

In this trial, some women had radiotherapy and some had surgery so the research team could compare the 2 treatments.

The aims of this trial were to

  • Find out if radiotherapy is as good as surgery at stopping breast cancer coming back
  • Compare the side effects of the 2 treatments

Summary of results

The research team found that there wasn’t much difference between radiotherapy and surgery for breast cancer that had spread to the lymph nodes.

This trial recruited 4,823 women from 9 different countries. They had all been diagnosed with breast cancer and were due to have surgery to remove their sentinel lymph node. They were put into 1 of 2 groups at random in case they needed more treatment after their sentinel node biopsy.

When the research team looked at the biopsy results, they found that 1,425 of these women (30%) had breast cancer that had spread to their lymph nodes.  These women needed to have more treatment to the rest of their lymph nodes, and

  • 744 women had more surgery
  • 681 women had radiotherapy

 

The research team looked at how many women had cancer in their lymph nodes 5 years after treatment. It was a small number of women in both groups, with

  • About 1 out of every 250 women (0.4%) who’d had surgery
  • About 3 out of every 250 women (1.2%) who’d had radiotherapy

They found that the side effects were similar in both groups, but more women who had surgery developed a condition called lymphoedema. This is a when fluid builds up in the arm and causes it to swell up. When they looked at how many women had lymphoedema 5 years after treatment, they found it was

  • 23% of women who had surgery
  • 11% of women who had radiotherapy

The research team concluded that fewer women having radiotherapy had lymphoedema, but that either treatment could be used for women who have breast cancer that has spread to their lymph nodes.

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) 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 Robert Mansel

Supported by

European Organisation for Research and Treatment of Cancer (EORTC)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

564

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

Harriet wanted to try new treatments

Picture of Harriet

“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

Last reviewed:

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