
“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."
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 . This means the breast cancer cells had tested positive for a protein called HER2.
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 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.
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.
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:
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:
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:
The side effects for both groups were similar which included:
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 () 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.
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)
GlaxoSmithKline (GSK)
NIHR Clinical Research Network: Cancer
Freephone 0808 800 4040
“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."