Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at a new drug called AZD9833 for people with breast cancer (Serena 1)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
- has come back in the same place after treatment (locally recurrence)
- has spread to other parts of the body (metastatic)
More about this trial
Palbociclib, everolimus, abemaciclib and capivasertib are all types of targeted drugs. They are called cancer growth blockers. They block signals that cancer cells use to divide and grow.
Palbociclib, everolimus and abemaciclib are usual treatments for some types of advanced breast cancer.
Please note: currently doctors are only looking for people to join the parts of the trial looking at AZD9833, everolimus and capivasertib. This is part E, I and J.
The main aims of this trial are to:
- find out the best doses of AZD9833 on its own and with palbociclib, everolimus, abemaciclib or capivasertib
- learn about the side effects of AZD9833
Who can enter
- you have adenocarcinoma of the breast (breast cancer) that has spread to other parts of the body or has come back in the same place after treatment
- you are post menopausal, or you have taken drugs that stop the ovaries from making hormones (LH blockers) for at least 4 weeks
- your cancer is sensitive to the hormone oestrogen (ER positive) and does not have receptors for the HER2 protein (HER2 negative)
- doctors think that you can’t have treatment to try to cure your cancer
- your cancer got worse (progressed) during or after treatment that reached your whole body (systemic)
- you are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1) and this hasn’t changed during the last 2 weeks
- you have satisfactory blood test results
- your heart is working well
- you can swallow and absorb tablets
- you are at least 18 years old
- you are willing to use reliable contraception during treatment and for at least a month afterwards, if there is any chance that you could become pregnant
- have had more than 2 types (regimens) of chemotherapy for advanced breast cancer
- have had chemotherapy, an experimental drug or any other cancer drug in the last 2 weeks
- have had radiotherapy to help with symptoms in the last week (4 weeks if it was radiotherapy to a large part of your body, including the bone marrow)
- still have moderate or severe side effects from previous treatment, apart from hair loss
- have cancer spread in your brain or spinal cord, unless you have had treatment for it and you haven’t taken steroids in the last month
- take drugs or herbal supplements that affect certain enzymes called CYP3A and CYP2B, or that affect your heart (your doctor can tell you more about this)
- are going to have, or have had a major operation in the last month
- have heart problems such as hypertension that isn’t controlled, angina that isn’t stable, or you have had a heart attack in the last 6 months
- have a high risk of bleeding
- have problems with your digestive system such as sickness that isn’t controlled
- have an infection and need to have antibiotics
- have hepatitis B or hepatitis C
- have HIV
- have any other serious medical condition that the trial team think could affect you taking part
- are involved in the planning or running of this trial
- are sensitive to AZD9833, palbociclib, everolimus, abemaciclib or anything they contain
This is an international phase 1 trial. Researchers hope that up to 340 people worldwide and 35 people from the UK will agree to take part.
There are 10 parts to this trial. The following parts are open to recruitment:
- part E
- part I and J
The following parts are closed to recruitment:
- parts A, B, C and D
- part F, G and H
In Part E you have AZD9833 and everolimus. You have both treatments as tablets that you take in the morning, with or without food.
First you take one dose of everolimus alone. After 7 days, you start taking AZD9833 and everolimus tablets every day. This continues for as long as the treatment is helping you and the side effects aren’t too bad.
Part I and J
You have AZD9833 and capivasertib. Researchers hope that around 24 people will join part I and J.
The first few people have a,low dose of AZD9833 and capivasertib. If they don’t have any serious side effects, the next few people have a higher dose. This continues until doctors find the best dose of AZD9833 and capivasertib.
You take AZD9833 tablets every day. Capivasertib come as tablets that you take twice a day, for 4 days. You then have a break of 3 days and then start taking capivasertib in the same way.
Tissue and blood sample
The trial team ask you for a tissue sample of your cancer. This can be from when you had a biopsy or surgery to remove the cancer (archival tumour sample).
They may also ask you to give up to 3 new tissue samples (fresh tumour biopsies). You have them:
- before the start of treatment
- during treatment
- if your cancer gets worse
You don’t have to agree to give new tissue samples if you don’t want to. You can still take part in this trial.
You also have extra blood tests as part of this trial. Where possible, you have them at the same time as your routine blood tests. Doctors want to:
- look for different substances (markers) that can help to tell how well treatment might work
- find out what happens to AZD9833 in your body
You have the extra blood tests at set times during this trial.
- a physical examination
- heart trace (ECG)
- an ultrasound scan of your heart (ECHO)
- blood tests
- urine tests
- CT scan or MRI scan
- bone scan
- an eye examination
- a test of your heart called a
holter test(if you are in Part H)
During treatment, you see the trial team regularly. How often you see them depends on when you join the trial.
You have regular tests during treatment. The tests you have include blood tests, physical examinations, and heart traces.
You also have a CT scan or MRI scan every 8 weeks, for six months. You then have a CT scan or MRI scan every 3 months. This continues for as long as the treatment is helping you and the side effects aren’t too bad.
When you finish treatment, you might see the trial team after one week, 2 weeks and a month. You have blood tests, a heart trace and a physical examination. You may continue to see the trial team afterwards if you still have side effects from treatment.
- high blood pressure and changes to the way your heart works
- a build up of fat in the cells of your liver and lungs which may cause difficulty breathing, tummy (abdominal) pain, and yellow colouring of your skin and whites of your eyes
- shaking (tremor), agitation and fits (seizures)
- changes in the size and the lining of your ovaries and womb
- changes to your eyesight such as seeing shadows
We have information about the side effects of:
How to join a clinical trial
Dr Richard Baird