A trial comparing lapatinib and capecitabine with trastuzumab and capecitabine for breast cancer that has spread (CEREBEL)

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 3

This trial compared lapatinib (Tyverb) and capecitabine (Xeloda) with trastuzumab (Herceptin) and capecitabine for breast cancer. It was open to women whose breast cancer had spread to another part of the body (secondary breast cancer) apart from the brain or spinal cord. Their cancer also had to be HER2 positive Open a glossary item. This means the breast cancer cells had tested positive for a protein called HER2.

More about this trial

Doctors often treat HER2 positive breast cancer with trastuzumab. This is a type of targeted cancer drug (a biological therapy) called a monoclonal antibody. It works by targeting and blocking the HER2 protein on the cancer cell.

Researchers knew from other studies that women treated with trastuzumab had a higher risk of their cancer spreading to the brain. Researchers think this is because trastuzumab can’t get through the blood brain barrier Open a glossary item that protects the brain from harmful substances. So they looked for new ways to help women in this situation. 

Lapatinib is a targeted cancer drug called a tyrosine kinase inhibitor (TKI). TKIs block tyrosine kinase which is a chemical messenger (an enzyme) that sends messages to tell cells to divide and grow. Blocking the effect of tyrosine kinase may stop cancer cells growing.

Researchers knew that combining the chemotherapy drug capecitabine with these 2 drugs was better at preventing the further spread of HER2 positive breast cancer.

The aim of this trial was to find out which combination was better at preventing the spread of HER2 positive breast cancer to the brain. And to find out more about the side effects of this combination of treatments. 

Summary of results

The researchers found that it was uncertain which combination was better at preventing the spread of HER 2 positive breast cancer to the brain. 

This was a phase 3 trial. It was a randomised trial. The people were put into 1 of 2 treatment groups by a computer. Of the 540 people recruited the researchers were able to look at the results of 501. 

  • 251 people had lapatinib and capecitabine
  • 250 people had trastuzumab and capecitabine

As the trial did not include people who already had cancer spread to the brain or spinal cord the researchers looked at the number of people whose cancer spread there first. This was:

  • 8 people in the lapatinib and capecitabine group 
  • 12 people in the trastuzumab and capecitabine group

The researchers then looked at the total number of people in each group whose cancer had spread to the brain or spinal cord at any time. They found it was:  

  • 17 people in the lapatinib and capecitabine group
  • 15 people in the trastuzumab and capecitabine group

study results

They also looked at the average length of time it took in both groups for the cancer to spread to the brain or spinal cord. It was just under: 

  • 6 months for those who had lapatinib and capecitabine
  • 4½ months for those who had trastuzumab and capecitabine

study diagram

The side effects for both groups were similar which included:

  • a drop in white blood cells
  • feeling or being sick
  • diarrhoea
  • loss of appetite
  • sore mouth
  • hand foot syndrome
  • rash
  • tiredness
  • feeling weak
  • a change to the way the liver worked

The trial team concluded that it was uncertain which combination of drugs was better at preventing HER 2 breast cancer from spreading to the brain and spinal cord. 

We have based this summary on information from the research team. 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 who did the research. 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 S Chan

Supported by

Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

5641

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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