
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
This trial is looking at adding pembrolizumab to chemotherapy for breast cancer that has come back or spread.
It is for people whose cancer has:
Doctors can use chemotherapy to treat HER2 negative breast cancer that has come back or spread. Sometimes it stops working so they are looking for ways to improve treatment for this group of people.
In this trial they are looking at the combination of pembrolizumab and chemotherapy. Pembrolizumab is a type of immunotherapy. It helps your to find and kill cancer cells.
Having pembrolizumab and chemotherapy together is a new combination of treatment for breast cancer in this group of people. The researchers aren’t sure how well it will work so they are doing this trial to find out more.
In this trial, some people have chemotherapy and pembrolizumab. And some have chemotherapy and a dummy drug ().
The main aims of the trial are to find out:
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply.
You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply.
You have:
Medical conditions
You cannot join this trial if any of these apply.
You:
Other
You cannot join this trial if any of these apply.
You:
This phase 3 trial is taking part worldwide. The team need 800 people to join including 32 from the UK.
It is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. Nor will you know which treatment you are having. The doctor can find this out if necessary.
There are 2 treatment groups. You have 1 of the following:
You have pembrolizumab or the dummy drug as a drip into a vein. You have it once every 3 weeks.
You also have one of the following chemotherapy drugs:
These are all standard treatments. Your doctor will talk to you about which one they think will work best.
You have:
You have paclitaxel, nab-paclitaxel or liposomal doxorubicin as a drip into a vein. Capecitabine is a tablet.
Everyone has treatment for up to 2 years as long as it is safe and the side effects aren’t too bad. Some people in the pembrolizumab group might be suitable to have treatment for another year. Your doctor will talk to you if this applies.
You stop treatment if the cancer gets worse. Your doctor will talk to you about other treatment options.
Samples for research
The researchers might ask you to give a tissue sample if there isn’t already a suitable one they can access. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
They plan to use the samples to:
Quality of life
The trial team ask you to fill out some questionnaires:
The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the doctor and have tests before you can take part. These include:
You see the doctor for regular blood tests and check ups.
You have a CT or MRI scan every:
You stop having the trial scans if your cancer gets worse.
You see the team a month after you stop treatment. After that they follow you up every 9 to 12 weeks. This might be at a hospital appointment or they might call you to see how you are getting on.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
Pembrolizumab can affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
The common side effects of pembrolizumab include:
The trial doctor will talk to you about all the possible side effects of treatment. You will have a chance to ask them any questions you may have.
We have more information about the following drugs and their side effects:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Samreen Ahmed
Merck, Sharp & Dohme LLC
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.