“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."
A trial looking at the effect a drug called AZD5363 has on breast cancer cells (STAKT)
This trial is looking at the short term effects of having a drug called AZD5363 before chemotherapy for breast cancer. The women taking part have breast cancer that is sensitive to the female hormone oestrogen (
More about this trial
Body cells normally divide in an orderly way. But in cancer cells, some proteins which help control cell growth start to behave abnormally. This means that the cancer cells grow and divide much faster. One of the proteins that can affect cell growth is called AKT.
In this trial, researchers are looking at a drug called AZD5363 which can block the action of the AKT protein and may stop cancer growing. The aims of the trial are to
- See how much AZD5363 affects the levels of proteins in breast cancer cells
- Measure how much of the drug gets into your bloodstream and how it affects your body
Who can enter
You may be able to enter this trial if
- You are a women who has been diagnosed with breast cancer that is sensitive to the female hormone oestrogen (
oestrogen receptor positiveor ER positive)
- The trial team are able to take a large enough sample of tissue (a
biopsy) from the cancer in your breast
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You are able to swallow capsules or tablets
- You have satisfactory blood test results
- You are going to have chemotherapy (you may be having chemotherapy alone, or chemotherapy followed by surgery or chemotherapy is planned for after surgery)
- You are at least 18 years old
- You are willing to use 2 forms of reliable contraception during the trial and for 4 weeks afterwards if you haven't been through the
menopauseand there is any chance that you could become pregnant
You cannot enter this trial if you
- Have already had any treatment for breast cancer. If you have had hormone therapy for a previous primary breast cancer you may be able to take part as long as it has been 12 months since you finished treatment
- Have taken St John’s wort in the last 3 weeks, or any other medication that affects body substances called cytochrome P (CYP) enzymes in the last 2 weeks
- Have had major surgery in the last 4 weeks
- Have had a bone marrow transplant using cells from a donor
- Have cancer that has spread to your brain, or is putting pressure on your spine (spinal cord compression)
diabetesor higher than normal levels of sugar in your blood
- Have a condition affecting your lungs called interstitial lung disease, or have had swelling in your lungs due to radiotherapy (
radiation pneumonitis) if it needed steroidtreatment
- Have high or low blood pressure that can’t be controlled with medication, or certain other heart problems (the trial team can advise you about this)
- Have HIV, hepatitis B, hepatitis C, or problems with your immune system
- Have another serious medical condition or mental health problem that the trial team think could affect your taking part
- Are known to be very sensitive to AZD5363 (or anything it contains) or to similar drugs
- Have sickness that can't be controlled with medication, or have any other problem that means you couldn't swallow or absorb the trial drug
- Are pregnant or breastfeeding
This trial will recruit up to about 120 people in the UK. The researchers will look at 3 different doses of AZD5363.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
The trial is in 2 parts. Part 1 has now closed.
People who joined the 1st part were put into 1 of 2 groups
- AZD5363 capsules
- Dummy capsules (
People joining the 2nd part will be put into 1 of 2 groups.
- A lower dose of AZD5363 than the dose tested in the 1st part of the trial
- An even lower dose of AZD5363
People in part 1 had AZD5363 or the dummy drug as capsules, people in part 2 will have AZD5363 as tablets.
You take up to 6 tablets twice a day for 4½ days. You should take them about the same time each day. You mustn’t eat or drink anything apart from water for 2 hours before taking the tablets for an hour afterwards.
To see how the tablets affect your body, the trial team will take samples of your blood and urine before and after you have the trial treatment. They will also look at samples of your cancer.
To look at your cancer before treatment, the trial team may be able to use some of the tissue removed when you had a biopsy to diagnose breast cancer. If this isn’t available, they will ask you to have another biopsy under
After you’ve had the tablets, the researchers need to get another sample of your cancer. If you are having surgery to remove your cancer, the trial team should be able to get a sample of tissue during your operation. But if you are having chemotherapy before surgery, they will ask you to have another biopsy before you start chemotherapy.
The first visit to the trial team is to see if are able to take part. This visit will last about an hour and a half and they will ask you not to eat or drink anything except water for 8 hours beforehand. They will take a blood sample and a urine sample. You can then have something to eat and drink.
The trial team will examine you and measure your height, weight and blood pressure. They will do 3 heart traces (
If you need to have an extra biopsy, you have another hospital visit before starting treatment. This lasts about an hour.
You go to hospital on the day you start the trial treatment. This visit lasts about 7 hours and you mustn’t eat or drink anything except water for 8 hours beforehand.
Before you have the first dose of AZD5363, the trial team will take a blood sample and a urine sample.
You have another blood test 2 hours after taking the tablets. After this, you can have something to eat and drink.
The trial team will take another blood sample after 4 hours. And you can have another blood test 6 hours after taking the tablets, but it is up to you if you want to give this sample.
After 4½ days of taking the tablets, you go back to hospital to see the trial team. You mustn’t eat or drink anything except water for 8 hours before this visit. The trial team will take more blood and urine samples. If you are going to have surgery, they will do 3 more ECGs.
The trial team will see you at the hospital or contact you by phone about 4 weeks later.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor J F R Robertson
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Tayside Clinical Trials Unit (TCTU)
University of Nottingham
This is Cancer Research UK trial number CRUKE/12/054.