
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
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.
You may be able to enter this trial if
You cannot enter this trial if you
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.
You will see the doctor and have some tests before taking part in this trial. These tests include
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
You then see the doctor every 3 months.
The most common side effects of pertuzumab are
Common side effects of trastuzumab are
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
You can find more information about capecitabine, pertuzumab and trastuzumab in our cancer drugs section.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Andrew Wardley
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
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”