
“I had treatment last year and I want to give something back.”
This trial is looking at camizestrant (AZD9833) with a for breast cancer. It is for people with breast cancer that has come back in the same area or spread to another part of the body.
It is open to people with breast cancer who are doing well on their current treatment and their cancer has:
Doctors can treat ER positive and HER 2 negative breast cancer with an combined with a targeted drug.
Letrozole and anastrozole are aromatase inhibitors. They work by lowering the amount of oestrogen in the body. ER positive breast cancer needs oestrogen to grow. Lowering the amount of oestrogen can slow or stop the cancer growth.
Abemaciclib , palbociclib and ribociclib are targeted drugs called cancer growth blockers. They work by blocking substances that cancer cells need to grow.
In this trial researchers are looking at a treatment called camizestrant (AZD9833). It works by blocking oestrogen getting into the breast cancer cell. This then can stop or slow the cancer growth.
This trial has 2 steps.
In the first step you have the . Your doctor decides which one. This can be either letrozole or anastrozole with abemaciclib, palbociclib or ribociclib.
During this step you give regular blood samples. The team use these samples to look for a change () in the ESR1
. They do this by looking for small pieces of the cancer DNA in the blood (
).
This gene change can happen while you are having treatment. If one of your blood samples show you have a change in ESR1 the team might invite you to take part in step 2, the treament stage.
In the treatment stage you have either:
The aims of this trial are to find out:
The following bullet points are a summary of 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
There are 2 steps in this trial.
Step 1
You may be able to join step 1 if all of the following apply. You:
Treatment stage (Step 2)
You may be able to join the treatment stage if all of the above apply and:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply.
You can’t join the treatment stage if any of the following also apply. You:
Medical conditions
You cannot join step 1 of this trial if any of these apply. You:
You can’t join the treatment stage if any of the following also apply. You:
Other
You can’t join the trial if any of the following also apply. You are:
This is an international phase 3 trial. There are 2 steps to this trial.
For step 1 the team need 3,050 people to take part with about 107 people from the UK.
For the treatment stage (step 2) the team need 300 people to take part with 16 people from the UK.
Step 1
In step 1 everyone takes letrozole or anastrozole with either abemaciclib, palbociclib or ribociclib. You give a blood sample every 8 to 12 weeks.
The team use the blood samples to look for the gene change () in ESR1. They do this by looking for small pieces of the cancer DNA (
) in the blood.
If one of your blood samples show the ESR1 gene change you might be invited to take part in the treatment stage of the trial.
You continue giving blood samples and being a part of step 1 until:
Researchers use the blood samples to:
Treatment stage
In this stage the team are looking at whether swapping letrozole and anastrozole with camizestrant works better. You continue to have the targeted drug, that is palbociclib, abemaciclib or ribociclib.
This is a randomised double blinded trial. A computer puts you into 1 of 2 treatment groups. Neither you nor your doctor can choose which group you are in. And neither you nor your doctor will know which group you are in.
Your doctor will be able to find out which group you are in if it is necessary to do so.
The groups are:
Camizestrant is a tablet. You take it once a day every day.
Letrozole is a tablet. You take it once a day every day.
Anastrozole is a tablet. You take it once a day every day.
Abemaciclib is a tablet. You take it once a day every day.
Palbociclib is a tablet. You take it once a day every day for 3 weeks. Then for the next week you don’t take palbociclib. You continue having palbociclib like this.
Ribociclib is a tablet. You take it once a day every day for 3 weeks. Then for the next week you don't take ribociclib. You continue having ribociclib like this.
The dummy drugs are tablets. You take them once a day every day.
You continue with treatment as long as it is helping and the side effects aren’t too bad.
Luteinising hormone blockers (LHRH)
Women who haven’t gone through the menopause and men who haven’t had their testicles removed by surgery will need to have a luteinising hormone blocker.
LHRHs stops the ovaries and testes from working. This stops them producing the sex hormones, testosterone in men and oestrogen and progesterone in women. These hormones can help the cancer to grow.
You have LHRH as an injection under the skin or an injection into a muscle. You start LHRH before starting treatment. And then you have it every 4 weeks. You continue while you are having treatment.
If you are already on LHRH you might need to change to another one. Your doctor will tell you if this is the case.
Samples for research
The team take several blood samples during the trial. How many depends on how long you are in the trial and what treatment you have.
In step 2 the team ask for a piece of tissue from a previous sample of tissue (). They also ask for a biopsy during treatment and when your cancer starts to grow again.
Some of these samples you must agree to and some you don’t have to. The doctor or a member of the trial team will tell you which ones they are.
Quality of life
In step 2 you fill in several forms:
The questions ask about:
These are quality of life questionnaires.
You see the doctor for tests before taking part in each step.
Step 1
In step 1 the tests include:
You continue to be a part of step 1 and having bloods taken every 8 to 12 weeks until:
Treatment stage
Before taking part in the treatment stage you have the following tests:
While having treatment as part of step 2 you see the doctor regularly. This is for blood tests and to see how you are.
You see the doctor when you finish treatment and a month later to see how you are. The trial team may contact you up to every 8 weeks until your cancer gets worse.
You have a CT scan or MRI scan every:
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
Camizestrant is a new drug and there might be side effects we don’t know about yet. The side effects we do know about are:
We have information on:
Your doctor will talk to you about the side effects of the treatments before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Richard Baird
AstraZeneca
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I had treatment last year and I want to give something back.”