A trial looking at a new drug called AZD9833 for people with breast cancer

Cancer type:

Breast cancer
Secondary cancers

Status:

Open

Phase:

Phase 1
This trial is for people with advanced breast cancer. This means that the cancer:
  • has come back in the same place after treatment (locally recurrence)
  • has spread to other parts of the body (metastatic)
It is for people whose breast cancer cells are sensitive to the hormone oestrogen (oestrogen receptor positive or ER positive). And does not have receptors for a protein called HER2 (HER2 negative). 

More about this trial

Targeted drugs and hormone therapy are common treatments for advanced breast cancer. These treatments can work well for some time, but sometimes the cancer starts to grow again. 
 
Many breast cancers need the hormone oestrogen Open a glossary item to grow. These are called oestrogen receptor positive breast cancer. Doctors think that AZD9833 can reduce the amount of oestrogen in your body and stop breast cancer from growing. Is the first time that AZD9833 will be given to people. 
 
Everyone taking part in this trial has AZD9833 on its own, or with palbociclib. 
 
Palbociclib is a type of targeted drug called a cancer growth blocker. It stops signals that tell cancer cells to divide and grow. Palbociclib is already a possible treatment for some types of advanced breast cancer. 
 
This trial is in 4 parts:
  • Part A
  • Part B
  • Part C
  • Part D
Everyone who joins Part A and B has AZD9833 on its own. In Part A, doctors are looking for the best doses of AZD9833 that you can safely have. Once they find the best doses, Part B opens. In Part B, doctors are comparing the best doses of AZD9833 found during Part A.
 
Everyone who joins Part C and D has AZD9833 and palbociclib. In Part C, doctors are looking for the best doses of AZD9833 that you can safely have with palbociclib. Once they find the best doses, Part D opens. In Part D, doctors are comparing the best doses of AZD9833 and palbociclib found during Part C. 
 
Please note – the trial team is currently looking for people to join Part A.
 
The main aims of this trial are to:
  • find out the best doses of AZD9833 on its own and with palbociclib 
  • learn about the side effects of AZD9833

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 
 
Who can take part
You may be able to join this trial if you are a woman and all of the following apply:
  • 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 Open a glossary item, or you have taken drugs that stop the ovaries from making hormones (LH blockers Open a glossary item) for at least 4 weeks 
  • your cancer is sensitive to the hormone oestrogen (ER positive Open a glossary item) and does not have receptors for the HER2 protein (HER2 negative Open a glossary item)
  • 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 
Who can’t take part
You cannot join this trial if any of these apply. 
 
Cancer related 
You:
  • have had more than 2 types (regimens Open a glossary item) 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) Open a glossary item 
  • still have moderate or severe side effects from previous treatment, apart from hair loss
  • have cancer spread in your brain or spinal cord Open a glossary item, unless you have had treatment for it and you haven’t taken steroids in the last month
Medical conditions
You cannot join this trial if any of these apply. You:
  • 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 Open a glossary item 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  Open a glossary itemsuch 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
Other
You cannot join this trial if any of these apply. You:
  • are involved in the planning or running of this trial 
  • are sensitive to AZD9833, palbociclib or anything they contain 

Trial design

This is an international phase 1 trial. Researchers hope that up to 240 people worldwide and 35 people from the UK will agree to take part.

This trial is in 4 parts. Doctors are currently looking for people to join Part A.


Part A and B 
Doctors hope that up to 96 people will join Part A, and up to 48 people will join Part B.

Doctors will give a low dose of AZD9833 to the first few people who join Part A. If they don’t have any serious side effects, the next few people have a higher dose. And so on until doctors find the 2 best doses of AZD9833 (the best lower dose and the best higher dose). 
 
Once doctors find the 2 best doses of AZD9833, part B opens. This part of the trial is randomised. The people taking part are put into 1 of the following treatment groups by computer:
  • the best lower dose of AZD9833 
  • the best higher dose of AZD9833 
Neither you nor your doctor can choose the group you are in. 

You take AZD9833 as tablets that you swallow whole, every day. This continues for as long as the treatment is helping you and the side effects aren’t too bad. 
 
Part C and D 
Doctors hope that up to 48 people will join Part C and up to 48 people will join Part D. Everyone has AZD9833 and palbociclib. 
 
The first few people who join Part C, have a low dose of AZD9833 and palbociclib. If they don’t have any serious side effects, the next few people have a higher dose. And so on, until doctors find the 2 best doses of AZD9833 and palbociclib (the best lower dose and the best higher dose). 
 
Once doctors find the 2 best doses, Part D opens. Everyone taking part in Part D is put into 1 of the following treatment groups by computer:
  • the best lower dose of AZD9833 and palbociclib
  • the best higher dose of AZD9833 and palbociclib
Neither you nor your doctor can choose the group you are in. 

You take AZD9833 tablets and palbociclib capsules every day. This continues for as long as the treatment is helping you and the side effects aren’t too bad. 
 
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  Open a glossary itemor 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.

Hospital visits

You see a doctor and have some tests before taking part. The tests you might have include:
During treatment, you see the trial team regularly. How often you see them depends on when you join the trial. If you join Part A or Part C, you need to stay in hospital overnight on the day of your first treatment. This is so your doctor and nurses can monitor you. 
 
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 see the trial team after a month. You have blood tests, a heart trace and a physical examination. You may continue to see the trial team after a month if you still have side effects from treatment. 

Side effects

The trial team will monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the side effects before you start the treatment. 
 
AZD9833 is a new drug and there might be side effects that we don’t know about yet. Doctors think that the side effects of AZD9833 include:
  • 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 
The most common side effects of palbociclib are:

Location

Cambridge
Chelsea
Leeds
Manchester

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Richard Baird

Supported by

AstraZeneca

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15902

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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