A trial using markers to help work out how well new treatments work for triple negative breast cancer (PHOENIX)

The following bullet points list 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 register for this trial if all of the following apply. 
You:

• have triple negative breast cancer 
• have surgery planned after at least 6 cycles  of chemotherapy 
• have cancer that the doctor can measure on a scan
• have an area of cancer that the doctor can take a tissue sample from 
• are well enough to have breast cancer surgery with the aim to cure 
• are fit enough to cope with 2 weeks of treatment after chemotherapy and before surgery 
• have had scans to check how widespread the cancer is if you have stage 2 breast cancer or stage 3 breast cancer 
• are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1) 
• are suitable to give a tumour sample before and after the 2 week treatment period
• are willing to use reliable contraception if there is any chance you or your partner could become pregnant and for up to 6 months after the end of trial treatment 
• are at least 18 years old

As well as the above, to have trial treatment the following must also apply.
You:

• have an area of cancer left behind after chemotherapy that measures more than 2cm across on a scan
• have satisfactory blood test results

Who can’t take part

You cannot register to join trial if any of these apply. 

Cancer related
You:

• have cancer that has spread elsewhere in the body 
• have cancer in both breasts
• have had any other cancer in the last 5 years apart from basal cell skin cancer , squamous cell skin cancer or lentigo malinga melanoma 
• have myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML)
• have had AZD6738 or a similar drug in the past
• have had a PARP inhibitor including olaparib in the past
• have had durvalumab or a similar drug in the past 

Medical conditions
You:

• have a rare condition called ataxia telangiectasia
• have a heart condition called QT prolongation, a family history of QT syndrome or you are taking drugs that cause QT prolongation
• have treatment to thin the blood including drugs such as warfarin or heparin 
• have a problem with your gut that means you can’t absorb medication well 
• have fits (seizures) or a condition that means you might have them
• have had a stem cell transplant  with somebody else’s cells or a cord blood transplant
• have an autoimmune disease  unless it is loss of skin pigment (vitiligo), type 1 diabetes, hair loss (alopecia), thyroid problems that are controlled by medications, a skin condition called psoriasis that doesn’t need treatment, coeliac disease controlled by diet or you have an autoimmune condition but you haven’t had any signs or symptoms in the last 5 years 
• have an active TB infection 
• have a condition causing lung inflammation that was caused by treatment (pneumonitis)
• have an active hepatitis B or hepatitis C infection 
• have HIV
• have any other medical condition or mental health problem that the trial team think would affect you taking part 

Other
You:

• are allergic to any of the treatments in the trial
• can’t swallow tablets 
• are pregnant or breastfeeding

As well as all of the above, to have trial treatment, the following can’t apply.
You:

• have a heart problem such as a heart attack in the last 6 months, angina that isn’t controlled with medication, congestive heart failure, an abnormal heart rhythm or high or low blood pressure that isn’t well controlled with medication
• have fainted (lost consciousness) or had a mini stroke (TIA) within the last 12 months
• have side effects that aren’t getting better unless they are mild, apart from hair loss
• have moderate numbness or tingling in your hands or feet caused by treatment 
• have had major surgery in the last 2 weeks or you aren’t completely better after an operation
• have had an experimental treatment in the last 30 days 
• take medication that blocks an enzyme in the body called CYP3A
• are taking medication that damps down the immune system such as prednisolone in the 14 days before you start treatment unless you take less than 10mg per day
• have had a blood transfusion in the last 4 weeks
• have had a live vaccination in the last 30 days