A trial comparing a combination of capecitabine and lapatinib (GW 572016) with capecitabine alone for advanced breast cancer (EGF 100151)

Cancer type:

Breast cancer




Phase 3

This trial was looking at capecitabine (Xeloda), with or without lapatinib, for advanced breast cancer.

Doctors usually treat breast cancer with surgery, and one or more of chemotherapy, radiotherapy, hormone therapy or biological therapy. But sometimes these treatments don’t work and the cancer comes back (recurs) or spreads (metastasises) to another part of the body. This is known as advanced, metastatic or secondary breast cancer.

Capecitabine is a chemotherapy drug that was already in use for advanced breast cancer. Lapatinib (GW 572016) was a new drug that was being looked at as a possible treatment for various types of cancer.

There are a number of growth factor receptors on breast cancer cells. When these receptors are triggered, they tell the cell to grow and divide into 2 new cells. Lapatinib targets 2 of these receptors. The first is called erbB1, or epidermal growth factor receptor (EGFR). The second is called erbB2, or HER2/neu receptor. Doctors hoped that by targeting 2 different receptors at the same time, the drug would be better at treating breast cancer. But they didn’t know for sure how well it would work.

The aim of this trial was to compare capecitabine alone to capecitabine and lapatinib to see which was better for advanced breast cancer.

Summary of results

The researchers found that advanced breast cancer responded to capecitabine and lapatinib more often than it responded to capecitabine alone. And in women who had both drugs, it took longer for the cancer to start growing again.

This was a randomised trial.

  • 399 women had treatment in this trial
  • Half had lapatinib and capecitabine
  • Half had capecitabine alone

The researchers looked at how many women responded to the treatment. For the group having both drugs,

  • In 1 women the cancer disappeared completely – researchers call this a complete response Open a glossary item
  • In 46 women, the cancer had got smaller – researchers call this a partial response Open a glossary item

In the group of women who had capecitabine alone, there were no complete responses, and 28 partial responses.

Most of the women in both groups had some side effects. Side effects such as diarrhoea, sickness and a rash happened more often in the group of women who had both drugs.

The researchers found that the average time it took for the cancer to start growing again was

  • Just over 27 weeks in the group of women who had both drugs
  • Just over 18 and a half weeks in the group of women who had capecitabine alone

We have based this summary on information from the team who ran the trial. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed Open a glossary item) or published in a medical journal yet. 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 Rob Coleman

Supported by

Cancer Research UK
GlaxoSmithKline (GSK)
National Institute for Health Research Cancer Research Network (NCRN)

Other information

This is Cancer Research UK trial number CRUKE/05/027.

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 429

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

A 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:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think