A trial looking at MK-2870 for breast cancer that has spread (MK-2870-010)

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 breast cancer that has spread into surrounding tissues or to other parts of the body. This is locally advanced  or secondary breast cancer .
• can’t have surgery to treat your breast cancer
• have breast cancer that is HER2 negative
• have cancer that is oestrogen receptor positive , progesterone receptor positive or both. Your doctor will know this.
• have cancer that got worse after at least one course of hormone treatment  in combination with a targeted cancer drug  such as palbociclib, ribociclib or abemaciclib. This was treatment for locally advanced or secondary breast cancer. Or you have had hormone therapy with one of these targeted cancer drugs and your cancer has come back. The trial team check when you had these treatments to see if you are suitable for the trial.
• have cancer that the doctor can see on a scan
• are suitable to have the chemotherapy drugs in the trial
• are on a stable dose of bisphosphonates  or denosumab if you are having these drugs. This must be for at least 4 weeks before you are put into a treatment group.
• are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant 
• have satisfactory blood test results
• are fit and active but might not be able to do heavy physical work (performance status 0 or 1). This is within 7 days of being put into a treatment group.
• are willing not to donate sperm during the trial and for a period after
• are willing not to donate eggs during the trial and for a period after
• 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 breast cancer that can be treated with the aim to cure
• have already had chemotherapy for breast cancer that has spread and can’t be treated with surgery. This is locally advanced breast cancer or secondary breast cancer.
• have cancer that has come back within 6 months of chemotherapy before or after surgery. This means you are suitable to have a second standard treatment.
• have breast cancer that has spread only into the skin
• have had treatment with a drug that works in the same way as MK-2870
• have had another cancer treatment within 4 weeks of being put into a treatment group. This is treatment that was to the whole body (systemic treatment ).
• have cancer that has spread to the brain or spinal cord or the thin tissue layers that cover them. You can take part if you have had treatment, the cancer is stable and you have stopped taking steroids .
• have had recent radiotherapy  for cancer that hasn’t spread to the brain. This is within 2 weeks of starting trial treatment. Or you had side effects from radiotherapy and you had recent steroid treatment.
• have a gene change (mutation ) called ESR1 in the breast cancer cells and you haven’t had a drug called elacestrant. Your doctor will know about this.
• have a change in the BRCA1  or BRCA2  genes and you have not had treatment with a PARP inhibitor . This is either after surgery or for breast cancer that has spread to another part of the body.
• have breast cancer that is spreading very quickly into the soft tissues, is causing significant symptoms and you are at risk of developing life threatening complications. Your doctor will know this.
• 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  or early cancer of the bladder or prostate.

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

• 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 treatment that damps down the immune system. This includes steroids within 7 days of starting trial treatment unless it was a low dose.
• 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 severe dry eyes, inflammation of the eyelids or a problem with the clear covering in your eye (cornea)
• have had a stroke  in the last 6 months
• have moderate to severe numbness and tingling in your hands or feet (peripheral neuropathy )
• 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 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 an active hepatitis B or hepatitis C unless you have had or are having treatment and it is under control. You can’t take part if you have both hepatitis B and hepatitis C.
• have another active infection that needs treatment that reaches the whole body
• have moderate to severe side effects from past treatments that aren’t getting better. This does not apply to hair loss or white patches on your skin (vitiligo).
• take medication that affects substances in the body called CYP enzymes within 2 weeks of starting trial treatment. Your doctor can tell you more about this.
• have a COVID infection that is causing symptoms
• have had major surgery and you aren’t better yet
• have any other medical condition or mental health problem that could affect you taking part or there is any other reason you can’t take part 

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

• are severely allergic to pembrolizumab, MK-2870, another targeted cancer drug or anything they contain
• have had a transplant with somebody else’s cells (allogeneic transplant)  or you have had an organ transplant
• are pregnant or breastfeeding