A study looking at lapatinib and capecitabine for breast cancer that is locally advanced or has spread (EGF 103659, LEAP)

Cancer type:

Breast cancer





This study looked at the combination of lapatinib and capecitabine for breast cancer. The study was for people with breast cancer that was locally advanced, or had spread to another part of the body.

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 (also called Tyverb or Tykerb) blocks the activity of 2 of these receptors. The first is called erbB1, or epidermal growth factor receptor (EGFR). The second is called erbB2, or HER2/neu receptor. The theory is that lapatinib will help stop breast cancer cells growing by blocking these receptors. When this study started, lapatinib was not commonly used to treat breast cancer that had spread.

The people who took part in this study had breast cancer that produced too much of the protein HER2 (HER2 positive breast cancer Open a glossary item). They had cancer that had continued to grow despite treatment with all of the following

The aims of this study were to find out

  • How good lapatinib and capecitabine are at stopping breast cancer growing
  • More about the side effects of this combination of treatment

Summary of results

The research team found that the combination of lapatinib and capecitabine was a safe and useful treatment for HER2 positive advanced breast cancer.

This study was something called an ‘expanded access programme’. EAPs are different to other large clinical trials. The list of who can take part (eligibility criteria) is less strict. And everyone taking part has the same treatment so there is no ‘control group’.

The people in this study had had a number of different treatments already. And their cancer had either spread to an area around the breast, or to another part of the body (including the brain).

The study recruited over 4,200 people from around the world, including 25 men. They all had breast cancer that had continued to grow and spread despite treatment.

Everyone taking part had lapatinib once a day every day, and capecitabine twice a day for 2 weeks out of every 3. Each 3 week period is 1 cycle of treatment. The most common time people had treatment for was about 5 months, although some people had treatment for much longer than this.

The research team analysed the results in September 2008 to see how well the treatment worked. They found that the treatment controlled the cancer growth in just over half the patients treated. Overall, the most common time for the cancer to start to grow again was about 5 months (21 weeks).

When they looked in more detail they found that people who had not had capecitabine before generally did better than those who had had it before.

The most common side effects were diarrhoea and feeling or being sick. About 1 in 5 people taking part had a side effect that was classed as serious.

The research team concluded that lapatinib and capecitabine was safe to use and did help to stop breast cancer growing in some 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

Prof D Miles

Supported by

Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK)

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 - 904

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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