“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 of AZD5363 with paclitaxel for advanced breast cancer (BEECH)
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.
More about this trial
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
- Find the highest safe dose of AZD5363 that you can have alongside paclitaxel
- Learn more about the side effects and what happens to the drug in your body
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
Who can enter
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
radiotherapywith 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
menopauseand 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
- 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
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
nitrosoureasor 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
diabetesor 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
anthracyclinesor 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
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 (
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
- Physical examination
- Blood tests
- Urine test
- Heart trace (
- Heart scan (
echocardiogram) or MUGA scan
- CT scan
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
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
- Changes to your blood sugar level
- Tiredness (fatigue)
- Skin rash
- Feeling or being sick
- Shortness of breath
AZD5363 can also cause changes
- In your blood pressure and the strength of your heart beat
- To your liver
- To the levels of certain
hormonesin your body
The trial team will monitor you closely for any side effects during the trial.
The most common side effects of paclitaxel include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- An allergic reaction to the drug which may cause skin rash and itching, a high temperature (fever), shivering, dizziness, a headache or breathlessness
- Numbness and tingling in your hands and feet (peripheral neuropathy)
- Feeling or being sick
- Sore mouth
- Hair loss
- Pain or aching in your joints or muscles
- Rash or itchy skin
- Taste changes
- Pain along the vein where you have the drip
How to join a clinical trial
Dr Nicholas Turner
Experimental Cancer Medicine Centre (ECMC)