
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
This trial is looking at adding a drug called pembrolizumab to chemotherapy and hormone therapy for newly diagnosed breast cancer.
It is for people whose cancer is HER2 negative and oestrogen (ER) positive. This means the breast cancer cells:
You might have surgery for breast cancer. Sometimes you have chemotherapy before surgery. This is called neo adjuvant chemotherapy. It can shrink the cancer and make the surgery more successful.
Some people have a higher risk of the cancer coming back afterwards. So, you might also have treatment after surgery such as . This is to keep the cancer under control for longer.
Chemotherapy, surgery and hormone therapy are all usual or for breast cancer. Researchers are looking for ways to improve treatment. In this trial, they are looking at adding a drug called pembrolizumab. It is a type of immunotherapy. It stimulates the body’s
to fight cancer cells.
In this trial, everyone has surgery, chemotherapy and hormone therapy. And some people have pembrolizumab and some don’t.
The main aims of the trial are to:
The following bullet points list 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 the following apply.
You:
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related.
You:
Medical conditions
You:
Other
You:
This is a phase 3 trial. The researchers need 1,140 people to take part including 32 from the UK.
It is a randomised trial. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither you nor your doctor will know which treatment you are having. This is a double blind trial.
You have 1 of the following:
People in group A have treatment as follows:
People in group B have treatment as follows:
You are put into 1 of the following groups at random:
Each treatment cycle takes 21 days (3 weeks). You have each cycle in the following way:
Then you have 4 more cycles of chemotherapy and pembrolizumab or the dummy drug.
You have:
Some people might have treatment in 2 week rather than 3 week cycles. Your doctor will tell you if this applies and how often you have treatment.
Surgery
About 3 to 6 weeks after you finish chemotherapy, you have surgery. You have surgery in the same way as if you weren’t taking part in this trial. Your doctor can tell you more about this and what to expect.
Hormone therapy with pembrolizumab or the dummy drug
About 4 weeks after your surgery, you have pembrolizumab or the dummy drug. This is followed by the hormone therapy.
You have 9 cycles of pembrolizumab or the dummy drug. You have this on day 1 of each treatment cycle.
You have hormone therapy for up to 10 years. You might have a drug called tamoxifen or a type of drug called an . Your doctor will tell you:
Some people might also have radiotherapy. Your doctor will tell you how often you will have it and for how long.
You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.
Quality of life
The trial team will ask you to fill out 3 questionnaires before you start treatment and at set times during treatment. You use an electronic tablet to do this. The questionnaires will ask about side effects and how you’ve been feeling. This is called a study.
Samples for research
You give some extra blood samples during treatment. You give the samples at specific times and the trial team will give you more information about this. They plan to use the samples to:
MRI sub study
About 150 people have MRIs of the breast. They have this:
You don’t have to agree to join this part of the trial if you don’t want to.
You see a doctor and have some tests before you can take part. These include:
You see the doctor regularly through treatment:
Follow up
When you finish treatment the trial team follow you up for about 12 years to see how you are getting on.
This happens:
As pembrolizumab is a new drug for breast cancer, there may be some side effects we don’t know about yet. The trial team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything.
Pembrolizumab has an effect on the immune system. This may cause inflammation in different parts of the body which can cause serious side effects.
These side effects could happen during treatment, or some months after treatment has finished. In some people, these side effects could be life threatening.
The most common side effects of pembrolizumab are:
We have information about the side effects of:
The trial doctors will explain all the possible side effects before you join the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Peter Schmid
Merck, Sharp & Dohme
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.”