
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called AZD5363 alongside paclitaxel for breast cancer that has spread into surrounding tissue or to another part of the body.
Doctors often use a chemotherapy drug called paclitaxel (Taxol) to treat breast cancer that has spread. But researchers are looking for ways to improve treatment. In this trial, they are looking at a drug called AZD5363.
AZD5363 is a type of biological therapy. It stops signals that cancer cells use to divide and grow and may make the cancer cells more sensitive to paclitaxel, making the drug work better.
The trial is in 2 parts. The 1st part of the trial is open to all women who are about to have paclitaxel for breast cancer. The aims of this part of the trial are to
The aim of the 2nd part of the trial is to see how much AZD5363 improves the effect of paclitaxel in women who have breast cancer that has . This is called oestrogen receptor positive breast cancer.
You may be able to join this trial if all of the following apply. You
As well as the above, to join the 2nd part of the trial the following must also apply
You cannot join this trial if any of these apply. You
As well as the above, you can’t join the 1st part of the trial if you have had either of the following
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 , you must have finished the treatment at least a year ago.
This is a phase 1/2 trial. The researchers need 140 women to join.
The 1st part of the trial will recruit about 40 women. Everybody joining this part of the trial has AZD5363 and paclitaxel.
You have paclitaxel through a drip into a vein once a week for 3 weeks out of 4. It takes about an hour each time. AZD5363 comes in capsules or tablets that you swallow twice a day.
There are 2 different ways of taking AZD5363. Some women will take it on 2 days a week for 3 weeks out of 4. Some women will take it on 4 days a week for 3 weeks out of 4. During the 1st part of the trial, the researchers will work out which is the best treatment plan.
The researchers also want to find the highest safe dose of AZD5363 that you can have with paclitaxel. For each treatment plan, the first few women taking part will have a low dose of AZD5363 alongside a standard dose of paclitaxel. If they don’t have any serious side effects, the next few patients will have a higher dose of AZD5363. And so on, until they find the best dose to give in each treatment plan. This is called a dose escalation study.
The 2nd part of the trial will recruit about 100 women. This part is randomised. The women 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.
Half the women taking part have AZD5363 and paclitaxel. The other half have a dummy drug () and paclitaxel.
The trial team will tell you whether to take the tablets on 2 days a week or on 4 days a week.
If you join the 2nd part of the trial, the researchers will ask you to fill out a questionnaire before you start treatment, every 3 months during treatment and after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
Whichever part of the trial you join, as long as you don’t have bad side effects, you can carry on having AZD5363 (or the dummy drug) for as long as it helps you. The length of time you can have paclitaxel is usually limited to 6 months.
You will see the trial team and have some tests before you start treatment. The tests include
You go to hospital 4 times in the first week of treatment, twice in each of the next 7 weeks and then on 2 days in every 4th week after that.
You have regular blood tests and more ECGs. You have a heart scan after a month of treatment and then every 3 months after that. You have a CT or MRI scan every 3 months.
If you join the first part of the trial and you agree, the trial team will take 4 of your eyebrow hairs on 3 separate occasions. This is to look for substances called biomarkers that doctors can measure to help them see how well the treatment is working.
The trial team will also ask you to have 2 more during the trial. You don’t have to agree to this if you don’t want to. You can still take part in the trial.
When you finish having treatment, you see the trial team again 4 weeks later.
As AZD5363 is a new drug, there may be side effects we don’t know about yet. In trials so far, the most common side effects have included
AZD5363 can also cause changes
The trial team will monitor you closely for any side effects during the trial.
The most common side effects of paclitaxel include
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Nicholas Turner
AstraZeneca
Experimental Cancer Medicine Centre (ECMC)
Freephone 0808 800 4040
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”