A study looking at pembrolizumab for triple negative breast cancer (KEYNOTE-119)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is for people with triple negative breast cancer that has spread elsewhere in the body. They must have already had 1 or 2 treatments since the cancer spread.
Triple negative breast cancers are cancers that don’t have 
for oestrogen, progesterone or Her2. When it has spread to another part of the body it is called metastatic triple negative breast cancer.
More about this trial
Chemotherapy is the usual treatment for people with triple negative breast cancer. Doctors are looking for ways they can improve treatment.
Pembrolizumab (pem-bro-lee-zoo-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 study the doctors want to compare pembrolizumab with 4 different types of chemotherapy. These drugs are used to treat triple negative breast cancer that has spread elsewhere in the body.
The aims of this study are to find
- how well pembrolizumab works for people with triple negative breast cancer
- how safe it is
- what the side effects are
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
You may be able to join this study if all of the following apply. You
- Have triple negative breast cancer that has spread elsewhere in the body
- Have had 1 or 2 treatments that reach the whole body (systemic treatments) and your cancer has continued to get worse
- Have had treatment with a type of chemotherapy drug called an
anthracycline or a taxane - Have an area of cancer that can be measured on a scan
- Are willing to have a sample of your cancer taken (a
biopsy ) for testing. If it is not possible to do a biopsy the doctors might be able to use a sample that has already been taken since your cancer has spread. The study doctors will explain this more. - Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood test results
- Are willing to use reliable contraception during the study and for 4 months afterwards if there is any chance that you or your partner could become pregnant
- Are aged 18 or older
You cannot join this study if any of these apply. You
- Have cancer spread to your brain that is causing symptoms, has got worse or you have new areas seen on a scan in the last 4 weeks. Or you had steroid treatment for cancer spread to your brain in the last 28 days
- Have inflammation of the covering of the brain (carcinomatous meningitis) caused by your cancer
- Have had treatment with an experimental drug or device in the last 4 weeks
- Have had a monoclonal antibody in the last 4 weeks
- Have had chemotherapy, another type of biological therapy or radiotherapy in the past 2 weeks
- Have side effects for any previous cancer treatment apart from hair loss and mild numbness and tingling in your fingers and toes (peripheral neuropathy)
- Have not recovered from any major surgery
- Have had previous treatment with any anti-PD1, anti-PDL1, anti-PD2 drugs or any similar drugs (your doctors can advise you about this)
- Have had any other cancer in the last 5 years apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
- Have an
autoimmune disease and have had drugs that suppress your immune system in the last 2 years (some other types of drugs are allowed and your doctor can advise you) - Have problems with your
immune system or have taken drugs that suppress your immune system in the last 7 days - Have a lung condition called pneumonitis and you need steroids or you have interstitial lung disease
- Have an infection which needs treatment
- Have had a live vaccine in the last 30 days
- Have or have had hepatitis B or hepatitis C
- Have HIV
- Have any other serious medical condition or mental health problem that the study team think could affect you taking part
- Are pregnant or breastfeeding
Trial design
This is an international phase 3 trial. Researchers need 600 people to take part.
It is a randomised trial. The people taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- one group have pembrolizumab every 3 weeks
- the other group has 1 of the following chemotherapy drugs
o capecitabine
o eribulin
o gemcitabine
o vinorelbine
If you are in the group having chemotherapy, your doctor will explain which drug they think is best for you. They will also explain how often you have the drug. You have chemotherapy for as long as it is helping you and you don’t have any severe side effects.
You have pembrolizumab through a drip into a vein once every 3 weeks. Each 3 week period is called a cycle of treatment. You have it for up to 2 years as long as it is helping you and you don’t have any severe side effects.
After you have finished treatment with pembrolizumab, you may restart it if your cancer starts to grow again. Your doctors will discuss this with you.
Tissue samples (biopsies)
Before starting treatment you need to have a biopsy of your cancer from an area where it has spread to. If it is not possible to get a sample or enough tissue the doctors might be able to use an older tissue sample. They will discuss this with you.
The sample is used to
- confirm you have triple negative breast cancer
- look for substances called
biomarkers that can help the doctors see how a treatment is working
You will be asked if any remaining tissue can be used for future research purposes.
If you are in the group having pembrolizumab you might also be asked to have a biopsy
- after your 2nd cycle of treatment
- if your cancer gets worse
You don’t need to give these 2 samples if you don’t want to. You can still take part in the study.
Hospital visits
You’ ll see the doctors and have some tests before you start treatment. The tests include
You go to hospital to have your treatment. You probably won’t need to stay overnight. If you have capecitabine you won’t need to go to hospital to have your treatment as these are tablets that you take at home. You can also have vinorelbine as capsules.
You see the doctors and have blood tests during the time you have treatment. This is to see how you are. You have a CT or MRI scan every 9 weeks for the first year, then every 12 weeks.
If the scan shows your cancer has got worse you may be asked to have another scan 4 to 6 weeks later to confirm this. If your cancer has got worse you will stop treatment in this study and your doctor will discuss other options with you.
Once you have finished treatment you see the doctors every 9 weeks for the first year and then every 12 weeks. You have a scan every 12 weeks
You see the doctors until either your cancer gets worse or you start another anti cancer treatment.
Side effects
The most common side effects of pembrolizumab are
- ichy skin
- tiredness and lacking energy (fatigue)
- loss of appetite
- shortness of breath
- cough
- pain in your joints
- high temperature (fever)
- swelling in your legs and feet
- weakness
- back pain
- rash
- low levels of salt in your blood
- pain in your tummy (stomach)
- feeling or being sick
- diarrhoea
- constipation
- a drop in red blood cells (anaemia)
We have information about the side effects of
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
Dr Nicholas Turner
Supported by
Experimental Cancer Medicine Centre (ECMC)
Merck, Sharp and Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
