“I had treatment last year and I want to give something back.”
A trial comparing lapatinib and capecitabine with trastuzumab and capecitabine for breast cancer that has spread - CEREBEL
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing lapatinib (Tyverb) and capecitabine (Xeloda) with trastuzumab (Herceptin) and capecitabine for breast cancer that has spread (secondary breast cancer). It is for women whose breast cancer is HER2 positive. This means the breast cancer cells have tested positive for a protein called HER2.
Doctors often treat HER2 positive breast cancer with trastuzumab. This is a type of biological therapy called a monoclonal antibody. It works by targeting and blocking the HER2 protein on the cancer cell.
Lapatinib is a biological therapy 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.
We know from research that combining the chemotherapy drug capecitabine with these 2 drugs is better at preventing the further spread of HER2 positive breast cancer.
The aim of this trial is to find out which combination is 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.
Who can enter
You may be able to enter this trial if you are a woman and you
- Have breast cancer that has spread to another part of your body (stage 4) apart from the brain and spinal cord – central nervous system
- Have HER2 positive breast cancer
- Have had
- Have satisfactory blood tests
- Are willing to use reliable contraception 2 weeks before starting treatment, during treatment and for 4 weeks after if there is a chance you could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have cancer that has spread to the brain or spinal cord – central nervous system OR have had a primary brain tumour
- Have had lapatinib or similar drugs, apart from trastuzumab
- Have had capecitabine before or are not able to take capecitabine
- Are having chemotherapy, radiotherapy, hormone therapy, immunotherapy or a biological therapy
- Are taking part in another clinical trial
- Are allergic to the drugs used in this trial
- Are taking medication that affects the CYP3A4 enzyme
- Are not able to have MRI scans, for example you are allergic to the contrast dye used, or you have a pacemaker or metal in your body
- Have gut problems that affect the way you absorb tablets
- Have a serious heart problem like congestive heart failure, angina that needs treatment, a problem with your heart rhythm or have had a heart attack in the last 6 months
- Still have side effects from previous anti cancer treatment
- Have an infection that is not controlled by antibiotics
- Have had another cancer in the past 5 years apart from DCIS or LCIS, non melanoma skin cancer or in situ cancer of the cervix
- Have any other serious medical condition that could affect you taking part in this trial
- Are pregnant or breastfeeding
This is a phase 3 international trial. It will recruit about 650 women from different countries around the world.
It is a randomised trial. You will be put into 1 of 2 treatment groups by a computer. Neither you nor your doctor can choose which group you are in.
If you are in group 1 you have lapatinib and capecitabine.
If you are in group 2 you have trastuzumab and capecitabine.
Lapatinib is a tablet. You take it about the same time every day, either 1 hour before breakfast or 1 hour after. You should not eat grapefruit, pomegranate or drink grapefruit or pomegranate juice while having lapatinib because they can affect the way lapatinib works.
Capecitabine is a tablet. You take it twice a day with food or within 30 minutes of having food. You have it for 2 weeks out of every 3. Your third week is a 7 day rest period when you do not take capecitabine. Each 3 week period is a cycle of treatment.
You have trastuzumab as a drip in to a vein. You have it on day 1 of each cycle of treatment.
You continue having treatment as long as you don’t have bad side effects and it is still helping you
The researchers will ask you if they can take some extra blood samples. By studying these samples they hope to learn more about how lapatinib works in the body and how it affects the body. You don’t have to give these extra blood samples if you don’t want to. You can still take part in the main trial.
You will see the doctor first and have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- Heart trace –
- Heart scan –
- Bone scan
- CT scan or MRI scan
- MRI scan of the brain
During treatment you will see the doctor every 3 weeks for a physical examination and blood tests. You will also have a CT or MRI scan and a brain MRI scan every 3 months for up to 20 months after starting treatment. You then have scans every 6 months.
After treatment you see the doctor every 3 months.
The most common side effects of lapatinib and capecitabine are
- Loss of appetite
- Feeling or being sick
- Dry skin or rash
- Sore mouth
- Back or muscle pain
- Tingling, numbness, pain, swelling or reddening of the palms of the hands or soles of the feet (palmar-plantar syndrome)
- A drop in blood cells causing an increased risk of infection, bleeding and bruising
The most common side effects of trastuzumab are
- A reaction to the drug causing fever, chills, low blood pressure, shortness of breath, headache, feeling or being sick
- Heart changes
- Lung changes
- Back pain
- Pain in the tummy (
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