A trial looking at trastuzumab and capecitabine with or without pertuzumab for advanced HER2 positive breast cancer - PHEREXA
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at adding a new drug called pertuzumab to trastuzumab (Herceptin) and capecitabine for women with 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.
Pertuzumab is a monoclonal antibody which also targets HER2 and works with trastuzumab in a complementary way.
We know from research that giving both these drugs together to women with HER2 positive breast cancer may be better than just giving one.
We also know from research that combining capecitabine with trastuzumab is better than capecitabine alone for women with HER2 positive breast cancer.
The aim of this trial is to find out if giving pertuzumab with trastuzumab and capecitabine is better than trastuzumab and capecitabine for women with HER2 positive breast cancer. 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 have HER2 positive breast cancer that has spread to another part of your body
- Your cancer has continued to grow while having trastuzumab
- You have already had chemotherapy that included a
taxane 
drug like paclitaxel or docetaxel - Your heart works well enough – your doctor will test for this
- You have satisfactory blood results
- You can take care of yourself (performance status 0,1)
- You are willing to use reliable contraception during the trial and for 6 months after if there is a chance you could become pregnant
- You are at least 18 years old
You cannot enter this trial if you
- Have already had pertuzumab or capecitabine
- Are having hormone therapy or
immunotherapy - Have cancer that has spread to your brain or spinal cord (central nervous system) that is not well controlled – you may join the trial if you do not have any symptoms and are not taking steroids or anti cancer drugs
- Have had more than the maximum acceptable dose of
anthracycline chemotherapy – you can check this with your doctor - Have high blood pressure that is not controlled
- 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
- Have had heart problems during, or after having trastuzumab before
- Are known to be sensitive to any of the study drugs used in this trial
- Have had chemotherapy in the last 3 weeks, radiotherapy in the last 4 weeks, major surgery or a major injury in the last 4 weeks and have not fully recovered
- Have had another cancer in the last 5 years apart from carcinoma in situ of the cervix and non melanoma skin cancer
- Need insulin to control diabetes
- Have an infection and have been taking antibiotics in the last 2 weeks
- Are known to be HIV, hepatitis B or hepatitis C positive
- Are taking steroids daily – you may join the trial if you take inhaled steroids for asthma or a similar breathing condition
- Have gut problems that affect the way you absorb tablets
- Have another serious medical condition that could affect you taking part in this trial
- Are pregnant or breastfeeding
Trial design
This is a phase 2 international trial. It aims to recruit 450 women from different countries around the world.
It is a randomised trial. You will be put into 1 of 2 treatment groups. Neither you nor your doctor can choose which group you are in.
If you are in group 1 you have trastuzumab and capecitabine.
If you are in group 2 you have trastuzumab, capecitabine and pertuzumab.
Capecitabine is a tablet. You take the tablets twice a day 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 and pertuzumab as a drip in to a vein.
If you are in group 1 you have trastuzumab on day 1 of each cycle of treatment. The first time you have it over 90 minutes. You then stay for an hour to make sure you don’t have a reaction to it.
If you are in group 2 you have pertuzumab on day 1 and trastuzumab on day 2 of the first cycle of treatment. You have pertuzumab over 60 minutes. You then stay for another hour to make sure you don’t have a reaction to it. The following day you have trastuzumab over 90 minutes, with an hour of observation to make sure you don’t react. If you don’t have a reaction to either drug, you can have pertuzumab and trastuzumab on the same day for the rest of the treatment cycles.
If you have no problems with trastuzumab and pertuzumab, you can have these drugs over a shorter time with a shorter observation period after. If you react to either of them, they may be slowed down or stopped. If you stop either because of side effects, you may start that drug again when the side effect has gone.
If you need to permanently stop having trastuzumab or pertuzumab you can no longer take part in the trial and your doctor will discuss your treatment options with you.
If you need to permanently stop taking capecitabine you can continue to take part in the trial. If you are in group 1 you will continue with trastuzumab only. If you are in group 2 you will continue with trastuzumab and pertuzumab.
You continue having treatment as long as you don’t have bad side effects and it is still helping you.
The researchers will ask your permission to store some tissue samples from when you were first diagnosed. They will also ask to store some blood samples. By studying these samples they hope to learn more about how trastuzumab and pertuzumab works in the body and how it affects the body.
You don’t have to give permission for this if you don’t want to. You can still take part in the main trial.
Hospital visits
You will see the doctor and have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- Urine test
- Heart scan –
ECHO or MUGA - Heart trace –
ECG - CT scan or MRI scan
- Bone scan
During treatment you see the doctor every 3 weeks for a physical examination and blood tests. You have a heart trace in cycle 1, 2 and 3. Then you have a heart trace and heart scan every 3 cycles until cycle 6 and then every 4 cycles. You have a CT scan or MRI scan every 9 weeks for 27 weeks then every 12 weeks until your cancer starts to grow again.
About 28 to 42 days after your last cycle of treatment you see the doctor and have
- A physical examination
- Blood tests
- Urine test
- Heart scan
- Heart trace
You then see the doctor every 3 months.
Side effects
The most common side effects of pertuzumab are
- Diarrhoea
- A reaction to the drug causing fever, chills, low blood pressure, shortness of breath, headache, feeling or being sick
- Rash
Common side effects of trastuzumab are
- Diarrhoea
- A reaction to the drug causing fever, chills, low blood pressure, shortness of breath, headache, feeling or being sick
A less common side effect of trastuzumab is that it can cause the heart not to pump as well as it should. Doctors call this heart failure. The symptoms of heart failure may include breathlessness, tiredness, swelling of the ankles or feet and constant coughing. Pertuzumab and capecitabine may also affect the way your heart works. Your doctor will check your heart regularly while you are having treatment. And if they are concerned they may stop your treatment for a short period of time or if necessary stop it completely.
The most common side effects of capecitabine are
- Diarrhoea
- Redness and pain in the palms of the hands and soles of the feet
- Rash
- Feeling or being sick
- Sore mouth
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Tiredness
- Liver changes
- Heart changes
You can find more information about capecitabine, pertuzumab and trastuzumab in our cancer drugs section.
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.
Chief Investigator
Dr Andrew Wardley
Supported by
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Roche
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
Last reviewed:
Dangoor Education since 2010.
