A trial looking at a new drug called inavolisib for breast cancer that has spread (WO41554)

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 adenocarcinoma of the breast that has spread into surrounding tissues or elsewhere in the body. And you can’t have surgery or radiotherapy with the aim to cure.
• have cancer that is oestrogen receptor positive  and, or progesterone receptor positive 
• have cancer that is HER2 negative
• have breast cancer that has a change (mutation ) in the PIK3CA gene
• have a sample of tissue (biopsy ) available or you are willing to give a new one
• have cancer that got worse while having hormone therapy  or within 12 months of having an aromatase inhibitor  or tamoxifen
• have been through the menopause if you are female or you are having a type of hormone therapy called a luteinising hormone releasing hormone (LHRH). For example you are having goserelin or leuprolide or you may be asked to start this before you have trial treatment.
• have cancer that the doctor can see and measure on a scan 
• have satisfactory blood test results
•  are willing to use reliable contraception during treatment and for a period afterwards if there is any chance you or your partner could become pregnant
• are well enough to carry out all your normal activities, but might not be able to do heavy physical work (performance status of 0 or 1) 
• 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 had previous treatment for breast cancer that included:

• chemotherapy, radiotherapy or any other cancer treatment within 2 weeks of joining the trial
• fulvestrant or a similar drug, unless you had this for a short time for early breast cancer 
• treatment with certain types of targeted drugs called cancer growth blockers or drugs that work in a similar way. Your doctor will know this. 
• treatment for breast cancer that reaches the whole body (systemic treatment )

As well as the above, none of the following can apply. You:

• have a rare type of breast cancer called metaplastic breast cancer
• are suitable to have chemotherapy to treat your cancer 
• have cancer that has spread to the brain or spinal cord unless it isn’t causing symptoms, has been treated and is stable. Or you have cancer that has spread to the tissues that surround the brain.
• have had an experimental drug within 4 weeks of joining the trial 
• have had any other cancer in the last 5 years. This is apart from CIS  of the cervix, non melanoma skin cancer  or early womb cancer.

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

• can’t swallow tablets or have injections into a muscle
• have a condition that means your digestive system  can’t absorb tablets
• have type 2 diabetes  that needs treatment, or you have type 1 diabetes
• have areas of fluid on the lung, in the heart or around the tummy that need regular draining 
• have a problem with your eyes that would affect you taking part in the trial. You have an eye examination to check this.    
• have oxygen at home everyday  
• have an active lung condition that needs treatment including inflammation of the lung (pneumonitis )
• have had a heart attack, stroke or mini stroke in the last 6 months or a significant heart problem . The trial team check if you have a heart condition before you join the trial.
• have a problem with your liver
• have an inflammatory condition of the bowel such as Crohn’s disease or ulcerative colitis
• take long term steroids unless it is a low dose
• take medication that blocks an enzyme called CYP3A4 
• have HIV, active hepatitis or a severe infection that needs treatment 
• have had radiotherapy to a quarter of your bone marrow, a stem cell transplant , bone marrow transplant  or organ transplant
• have low levels of calcium and need to take bisphosphonates or denosumab to prevent bone problems
• have side effects from past treatments that aren’t getting better apart from hair loss, hot flashes or mild to moderate tingling in your hands or feet
• have had major surgery, a recent traumatic injury or you plan to have surgery 
• have any other medical condition or mental health problem that your doctor or the trial team think could affect you taking part

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

• are allergic to any of the treatments in the trial or anything they contain
• are pregnant or breastfeeding or intend to become pregnant