A trial looking at capecitabine and Herceptin or capecitabine alone for advanced breast cancer (GBG 26)

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 3

This trial was to see if a combination of capecitabine and Herceptin is better than capecitabine alone for advanced breast cancer that has started to grow again while being treated with Herceptin.

Trastuzumab (Herceptin) is a monoclonal antibody. Doctors use it to treat breast cancers that produce too much of a protein called HER2. This is called ‘HER2 positive’ breast cancer. Sometimes breast cancer starts to grow again during treatment with Herceptin. In this situation, doctors may decide to stop the treatment and give chemotherapy instead.

Researchers in this trial wanted to find out if it was better for women to have both Herceptin and the chemotherapy drug capecitabine (Xeloda), rather than stopping Herceptin first. They hoped that the combination of Herceptin and capecitabine would work better than capecitabine alone.

The aims of this trial were to find out

  • If capecitabine and Herceptin together work better than capecitabine alone for advanced breast cancer that has started to grow again during Herceptin treatment
  • More about the side effects of giving these two treatments together

Summary of results

The research team found that Herceptin and capecitabine did work better for advanced breast cancer than capecitabine alone.

This trial recruited 156 women with breast cancer that had either come back in the breast area (locally advanced) or had spread to another part of the body (metastasised). They had all had Herceptin already, but their cancer had started to grow again.

  • 78 women had capecitabine alone
  • 78 women had capecitabine and Herceptin

When the research team looked at the results in 2009, they found that the cancer had got smaller or gone away in

  • 20 out of 78 women who had capecitabine
  • 37 out of 78 women who had capecitabine and Herceptin

The research team also looked at how long it was before the cancer started to grow again. They found it was

  • 5.6 months for those who had capecitabine
  • 8.2 months for those who had capecitabine and Herceptin

The women in the Herceptin group did not have any more side effects than the women who had capecitabine alone.

The research team looked at the results again in 2010 to see how long people lived for. They found that, on average, the people who had capecitabine and Herceptin lived for a few months longer. But this was not significant in statistical terms. But they did find that the women who started (or continued) taking Herceptin even after their cancer started to grow again did better than those who didn’t.

They concluded that capecitabine and Herceptin was better at stopping cancer growing than capecitabine alone for this group of patients.

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

Dr R Stein
Dr T Perren

Supported by

Cancer Research UK
Clinical Trials Research Unit (CTRU)
University of Leeds
German Breast Group (GBG)
National Institute for Health Research Cancer Research Network (NCRN)
Roche

Other information

This is Cancer Research UK trial number CRUKE/04/019.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 542

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

Deborah wanted to help other breast cancer patients in the future

A picture of Deborah

“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."

Last reviewed:

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