A trial of capivasertib for triple negative breast cancer (CAPItello 290)

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 join this trial if all of the following apply. 

You:

• have triple negative breast cancer (your cancer doesn’t have receptors for the hormones oestrogen and progesterone or the Her2 protein)
• have breast cancer that has come back and can’t be removed with an operation or it has spread elsewhere in the body 
• are suitable to have paclitaxel chemotherapy 
• have cancer that the doctor can measure on a scan 
• have a tumour sample (biopsy ) available for the trial team to do some tests on 
• are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
• can swallow tablets 
• have satisfactory blood test results 
• are willing to use 2 forms of reliable contraception for up to 6 months after stopping treatment if there is any chance you or your partner could become pregnant
• are at least 18 years

Who can’t take part

You cannot join this trial if any of these apply. 

Cancer related
You:

• have already had treatment for breast cancer that has come back or spread elsewhere in the body
• have spinal cord compression  or cancer spread to the brain unless it has been treated, you don’t have symptoms and you haven’t had steroids in the last 4 weeks 
• have had certain targeted drugs which affect how your cells grow 
• have had capivasertib in the past
• have had chemotherapy before or after surgery in the 12 months before starting the treatment in this trial 
• have had any other chemotherapy, immunotherapy  or treatment to damp down the immune system  within the 3 weeks of the first dose of the trial treatment (6 weeks if you had a drug called mitomycin C or a nitrosoureas )
• have had radiotherapy to a large area of the breast within 4 weeks of starting the trial medication 
• have taken part in a clinical trial in the last 30 days or the trial drug hasn’t cleared your body yet 
• have side effects from past treatments that aren’t getting better unless they are mild, apart from hair loss
• have had any other cancer in the last 5 years apart from CIS  of the cervix, basal cell skin cancer , squamous skin cell cancer  or early stage cancer of the womb

Medical conditions
You:

• have a problem with how your immune system works 
• had major surgery in the last 4 weeks
• have numbness or tingling in your hands or feet unless it is mild 
• have or had a condition called interstitial lung disease or pneumonitis and you had or are having steroids
• have extra risk factors for a heart condition called torsade de pointes, a family history of an abnormal heart rhythm called long QT syndrome or some other heart related conditions
• have problems with your heart, such as a heart attack in the last 6 months, high blood pressure and/or angina that is not well controlled 
• have diabetes
• have a problem with the way your blood clots 
• have sickness that isn’t controlled, a problem with your digestive system  and you can’t absorb medication properly or you have had your bowel or part of your bowel removed 
• have had a bone marrow transplant  with somebody else’s cells or an organ transplant  in the past
• 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 in this trial

Other
You:

• are allergic to capivasertib, paclitaxel or anything they contain 
• are pregnant or breastfeeding