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:

Breast cancer




Phase 2

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 Open a glossary item chemotherapy drug and a taxane Open a glossary item 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 Open a glossary item 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 Open a glossary itemand 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 Open a glossary item 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 biopsy Open a glossary item. 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

  • A physical examination
  • Blood tests
  • Heart trace (ECG Open a glossary item)
  • CT scan or MRI scan

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

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Peter Schmid

Supported by

Experimental Cancer Medicine Centre (ECMC)
Merck, Sharp & Dohme

Freephone 0808 800 4040

Last review date

CRUK internal database number:


Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Harriet wanted to try new treatments

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“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

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