A trial looking at MK-2870 and pembrolizumab for triple negative breast cancer

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:

• have triple negative breast cancer 
• have had pembrolizumab with certain chemotherapy drugs before surgery. This is carboplatin with a taxane drug and anthracycline chemotherapy before surgery. You must have had at least 5 doses of pembrolizumab and chemotherapy and at least one dose of an anthracycline.
• have some cancer cells in the tissue samples taken at surgery
• have had all your breast cancer removed including any lymph nodes that contained cancer 
• are fully recovered from your surgery 
• are suitable to have more pembrolizumab after surgery 
• are put into a treatment group within 12 weeks of having surgery 
• have recovered after radiotherapy if you had this 
• have had a previous tissue sample  that the trial team can use to do some tests on
• have satisfactory blood test results 
• are fit and active but might not be able to do heavy physical work (performance status 0 or 1)
• are willing to use reliable contraception during the trial and for a period after. You must be willing not to donate sperm or eggs during this time as well.
• are at least 18 years old 

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

• have cancer that has come back in the same place or has spread to other parts of the body 
• have had a type of drug called a PARP inhibitor in the past
• have had treatment with a drug that works in the same way as MK-2870
• have had an immunotherapy or another treatment that works in a similar way before surgery. This does not apply to pembrolizumab.
• have had another cancer treatment or experimental treatment to the whole body before surgery. This is within 4 weeks of being put into a treatment group. This does not apply to the standard chemotherapy you have before surgery.
• have already had cancer treatment after surgery. This is treatment that was to the whole body (systemic treatment ). You can take part if you had radiotherapy after surgery. 
• have had radiotherapy within 3 weeks of starting trial treatment or you have side effects from radiotherapy and you need to take steroids
• are taking an experimental drug or using a device as part of a clinical trial. This is within 4 weeks of being put into a treatment group.
• have another cancer that is getting worse or needed treatment in the last 5 years. You can take part if you had successfully treated non melanoma skin cancer and any carcinoma in situ except for carcinoma in situ of the bladder.

Medical conditions
You cannot join this trial if any of these apply. You:

• have had a heart attack in the last 6 months or a significant heart problem that needs treatment. The trial team check if you have a heart condition before you join the trial.
• have a problem with how your immune system works or you are having treatment to damp down the immune system unless it is a low dose 
• have moderate to severe numbness or tingling in your hands or feet
• have severe dry eyes, inflammation of the eyelids or a problem with the clear covering in your eye (cornea)
• have inflammatory bowel disease and you are taking medication to damp down the immune system or you have had inflammatory bowel disease in the past
• have had a stroke in the last 6 months 
• have high blood pressure that isn’t well controlled with medication 
• have diabetes that isn’t well controlled with medication 
• have fluid on the lungs or around the heart or tummy that is causing symptoms and needs to be drained regularly 
• have HIV that isn’t well controlled with medication. You can’t take part if you have had Kaposi’s sarcoma or a disease called multicentric Castleman’s disease.
• have a hepatitis B or hepatitis C infection that isn’t well controlled with medication. Or you have hepatitis B or hepatitis C at the same time. 
• have an autoimmune condition that needed treatment in the last 2 years apart from certain ones. Your doctor will know about this.
• have had scarring of the lungs or active inflammation of the lungs that needed steroid treatment in the past or you have these conditions now and you need steroid treatment
• have an active infection that needs treatment 
• have side effects from past treatments unless they are mild. You can take part if you have hair loss. 
• have side effects from surgery that aren’t better 
• have another medical condition or mental health condition that the trial team think could affect you taking part

Other
You cannot join this trial if any of these apply. You:

• are severely allergic to capecitabine, MK-2870, another targeted cancer drug or anything they contain
• have had a live vaccination within 30 days of starting trial treatment. Please note this doesn’t apply to the seasonal flu or the approved COVID-19 vaccines as these aren’t live.
• have had a transplant with somebody else’s cells (allogeneic transplant ) or you have had an organ transplant .