A trial of pembrolizumab for triple negative breast cancer (KEYNOTE 086)
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 pembrolizumab to treat triple negative breast cancer. If breast cancer doesn’t have receptors for the hormones oestrogen or progesterone, or for the protein HER2, it is called triple negative breast cancer.
The trial is for people whose cancer has spread to another part of their body.
More about this trial
Doctors can treat triple negative breast cancer the same way as other breast cancers. But they are always looking for better ways to treat this breast cancer.
Pembrolizumab (pem-broe-LIZ-ue-mab) is a type of biological therapy called a monoclonal antibody. It can seek out cancer cells by looking for particular proteins. Pembrolizumab is already being used to treat some other cancers such as advanced melanoma.
In this trial the researchers want to find out if pembrolizumab can help people with triple negative breast cancer that has spread to other parts of the body.
Who can enter
The following bullet points list the entry conditions for this trial. If you are unsure about any of these speak with your doctor or the trial team. They will be able to advise you.
You may be able to join this trial if all of the following apply
- You have triple negative breast cancer that has spread to another part of the body
- If you have had treatment it must have included an
anthracycline 
chemotherapy drug and a taxane chemotherapy drug - You have an area of cancer spread that can be measured on a scan
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You have satisfactory blood test results
- You are willing to use reliable contraception during treatment and for 4 months afterwards if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot join this trial if any of these apply. You
- Have cancer spread to your brain or spinal cord
- Have had chemotherapy, biological therapy or radiotherapy within 2 weeks of joining the trial. For a type of biological therapy called a monoclonal antibody it is 4 weeks
- Still have side effects from any treatment
- Have already had pembrolizumab (MK3475) or a another drug that works in a similar way
- Have had an experimental drug, or used a device, as part of another clinical trial within 4 weeks of starting treatment in this clinical trial
- Have an
autoimmune disease that has needed treatment, such as steroids, in the past 2 years. You may be able to join if your treatment was to replace something in the body, for example insulin - Have taken steroids within the 2 weeks of starting treatment in this trial
- Have had another cancer in the past 5 years apart from successfully treated
non melanoma skin cancer and in situ carcinoma of the cervix - Have certain lung diseases
- Have an infection that needs treatment
- Have HIV, hepatitis B or hepatitis C
- Have had a
live vaccine in the past month - Have any other medical or mental health condition that the trial team think could affect you taking part
- Are pregnant or breastfeeding
Trial design
This is a phase 2 trial. The researchers need 245 people to join. Everyone has pembrolizumab.
You have pembrolizumab as a drip into a vein once every 3 weeks. You can have pembrolizumab for up to 3 years as long as it is helping and the side effects aren’t too bad.
The researchers will ask for a sample of your cancer that was removed when you had surgery or a . This is to check for a protein called PD-L1 which may help researchers understand more about triple negative breast cancer.
They will also ask for some blood samples. This is to find out what happens to pembrolizumab in the body.
Hospital visits
You see the doctor to have some tests before taking part in the trial. These tests include
You go to hospital to have pembrolizumab every 3 weeks. It takes about 30 minutes to have the drug. At these visits you also see the doctor and have a physical examination and blood tests.
You have a CT scan every 9 weeks for the first year and then every 12 weeks until your cancer starts to grow again.
At the end of treatment you see the doctor for
- A physical examination
- Blood tests
- CT scan or MRI scan
After treatment a member of the research team will phone you every 3 months to see how you are.
Side effects
The most common side effects of pembrolizumab are
- Itchy skin, rash
- Tiredness
- Loss of appetite
- Shortness of breath
- Cough
- Joint pain
- High temperature (fever)
- Swelling of the legs and feet
- Weakness
- Back pain
- Low level of salt in the blood
- Stomach pain
- Feeling or being sick
- Diarrhoea or constipation
- A drop in the number of red blood cells causing tiredness and breathlessness
We have information about the side effects of pembrolizumab.
Your doctor will talk to you about the possible side effects before you agree to take part in this trial.
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
Professor Peter Schmid
Supported by
Experimental Cancer Medicine Centre (ECMC)
Merck, Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
