“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."
A trial comparing lapatinib and capecitabine with trastuzumab and capecitabine for breast cancer that has spread (CEREBEL)
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
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
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
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
The side effects for both groups were similar which included:
- a drop in white blood cells
- feeling or being sick
- loss of appetite
- sore mouth
- hand foot syndrome
- 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 (
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.
Dr S Chan
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer