A trial of AZD5363 with paclitaxel for advanced breast cancer (BEECH)

You may be able to join this trial if all of the following apply. You

• Are a woman who has breast cancer that has spread into tissue surrounding the breast or to another part of your body
• Can’t have surgery or radiotherapy with the aim of curing your cancer
• Have at least one area of cancer that can be seen on a CT scan or MRI scan
• Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
• Have satisfactory blood test results
• Are at least 18 years old
• Are willing to use reliable contraception during the trial and for 4 weeks afterwards if you haven’t been through the menopause and there is any chance you could become pregnant

As well as the above, to join the 2nd part of the trial the following must also apply

• You have breast cancer that has receptors for the hormone oestrogen (oestrogen receptor positive breast cancer) and has come back since having other treatment
• There is a sample of your cancer available that the trial team can test for changes to a gene called PIK3CA
• You have at least one area of cancer that hasn’t been treated with radiotherapy and is at least 10mm across (or at least 15mm if it is in a lymph node )

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

• Have cancer that has spread to your brain or is pressing on your spinal cord (spinal cord compression) unless this has been treated, is not causing symptoms and you haven’t needed to take steroids for at least  4 weeks
• Have had radiotherapy or major surgery in the last 4 weeks
• Have had any other cancer treatment in the last 3 weeks, or in the last 6 weeks if you had 1 of a group of drugs called nitrosoureas or a drug called mitomycin (you may have had treatment for cancer spread - the trial doctor can advise you about this)
• Have already taken part in this trial
• Have already had AZD5363 or another drug that works in a similar way (the trial team can confirm this)
• Have had another experimental drug in the last month (or earlier if there is any chance some of the drug could still be in your body)
• Are going to have hormone therapy drugs called aromatase inhibitors, or any other cancer treatment at the same time as the trial treatment (you can take drugs called bisphosphonates or a drug called denosumab)
• Haven’t recovered from the side effects of other treatment (apart from hair loss) unless they are very mild
• Take drugs that significantly affect certain body proteins called CYP chromosomes in the 2 weeks before starting the trial treatment
• Take St John’s wort in the 3 weeks before starting the trial treatment
• Have diabetes or high levels of sugar in your blood (the trial team will take blood samples to check this)
• Have high blood pressure that can’t be controlled with medication
• Have (or have had) certain heart or lung problems (the trial team can advise you about this)
• Have had a bone marrow transplant using cells from a donor
• Are known to have problems with your immune system
• Have any other medical condition or mental health problem that the trial team think could affect your taking part
• Can’t swallow or absorb tablets for any reason
• Are known to be very sensitive to anything in AZD5363, paclitaxel, or similar drugs
• Are pregnant or breastfeeding

As well as the above, you can’t join the 1st part of the trial if you have had either of the following

• More than 2 types of chemotherapy for breast cancer that has spread to another part of your body
• Large doses of drugs called anthracyclines or of a drug called mitoxantrone (the trial team can advise you about this)

You can’t join the 2nd part of the trial if you’ve had any chemotherapy for breast cancer that has spread to another part of your body. You may have had chemotherapy before or after surgery to remove early stage breast cancer to help to stop it coming back, but if this included a taxane drug , you must have finished the treatment at least a year ago.