A trial looking at camizestrant for early breast cancer (CAMBRIA-1)
Cancer type:
Status:
Phase:
This trial is looking at a new drug called camizestrant for 
that has a medium to high risk of coming back. It is comparing camizestrant with .
You pronounce camizestrant as cami-zess-trant.
This trial is for people who have had at least 2 years of hormone treatment after surgery. And whose breast cancer has:
- many receptors for the hormone oestrogen (
ER positive cancer ) and - only a small number or no receptors for
HER2 . This is HER2 negative breast cancer.
More about this trial
Surgery is the usual treatment for early breast cancer. You might also have chemotherapy or radiotherapy. In oestrogen receptor positive cancer this is usually followed by hormone treatment. This treatment blocks or lowers the amount of hormones in the body. This can slow down or stop the growth of cancer. It is sometimes called endocrine therapy. The aim of hormone treatment after surgery is to lower the risk of the cancer coming back.
Some people have a higher risk of their cancer coming back. So doctors are looking at ways to improve treatment for people in this situation. In this trial they are looking at a drug called camizestrant.
Camizestrant is a type of hormone treatment. It works by blocking oestrogen getting into the breast cancer cells. This can then stop or slow the cancer growth. Doctors think that having camizestrant long term may work better than long term standard hormone treatment. They aren’t sure so want to find out.
In this trial, some people have camizestrant and some people have standard hormone treatment.
The main aims of the trial are to find out:
- which treatment works best
- how safe camizestrant is
- what the side effects are
- more about
quality of life
Who can enter
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
You may be able to join this trial if all of the following apply. You:
- have invasive breast cancer. The cancer may have spread into nearby
lymph nodes . Your doctor checks this to see if you are suitable to take part. - have had surgery to treat your breast cancer. You may or may not have also had chemotherapy or
radiotherapy before surgery. - have cancer that has a medium to high risk of coming back after surgery
- have cancer that is
oestrogen receptor positive and HER2 negative - have had at least 2 years of hormone treatment but no more than 5 and you are still having this
- are going to continue to have hormone treatment for another 5 years
- have a sample of tissue (
biopsy ) stored that can be used to do some tests on - are fit and active but might not be able to do heavy physical work (performance status 0 or 1)
- are willing to use reliable contraception during the trial and for a time after if there is any chance you or your partner could become pregnant. Also, you must be willing not to donate sperm during the trial and for a period after.
- have satisfactory blood test results
- are at least 18 years old
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have
locally advanced breast cancer that can’t be removed with surgery, has spread to the lymph nodes in the opposite breast or has spread to distant parts of the body - have signs that your breast cancer has come back
- have inflammatory breast cancer
- have cancer that went away completely after the treatment you had before surgery
- have already had camizestrant or a similar drug, an experimental hormone treatment for ER positive breast cancer or you have had fulvestrant
- are having another cancer treatment. You can take part if you are having treatment to strengthen the bones such as
bisphosphonates or denosumab. - have had another invasive breast cancer in the past. You might be able to take part if you had ductal carcinoma in situ (
DCIS ). The team checks which breast you had the cancer in, what treatments you had and how long ago you had them. - have had another cancer that has got worse or needed treatment in the past 5 years. This is apart from successfully treated
non melanoma skin cancer , carcinoma in situ (CIS ) of the cervix or another cancer that has a low chance of coming back. - are taking part or have taken part in another clinical trial. You might be able to join if it didn’t involve an experimental drug or device. You can’t take part if you were in a similar trial such as CAMBRIA-2.
- were put into a treatment group for this trial previously but you had to withdraw from the trial for some reason. You can’t rejoin this trial.
Medical conditions
You cannot join this trial if any of these apply. You:
- have had a heart attack in the last 6 months or a significant
heart problem or a heart condition that isn’t well controlled with medication. Your doctor checks your heart before you join the trial. - have had a
stroke or mini stroke in the last 6 months - have a slow heartbeat at rest
- have high blood pressure that isn’t well controlled with medication
- have fainting episodes or low blood pressure
- can’t absorb tablets for any reason. This could be because you have had part of your bowel removed.
- can’t swallow the trial medication
- have hormone treatment for birth control or hormone replacement therapy (
HRT ) - have had major surgery or a significant injury in the 2 weeks before starting trial treatment
- take medication that affects substances in the body called
CYP enzymes in the 2 weeks before starting trial treatment. Your doctor can tell you more about this. - have any medical condition or a mental health condition that could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- are allergic to camizestrant, similar drugs or anything they contain
- are pregnant or breastfeeding
Trial design
This phase 3 trial is taking place worldwide. The team need 4,300 people to take part including 96 from the UK.
It is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor will be able to decide which group you are in.
There are 2 treatment groups. You have 1 of the following:
- camizestrant
- standard treatment
Camizestrant
Camizestrant is a tablet. You take it once a day, every day. You have treatment for 5 years. You might take it for longer if your doctor thinks it is helping you. They will talk to you about this if they think it is suitable.
You stop treatment if your cancer comes back. Your doctor will then talk to you about other treatment options.
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 (called an ).
Luteinising hormone blockers stop the ovaries and testes from working. This stops them producing the sex hormones, testosterone in men and oestrogen in women. These hormones can help the cancer to grow.
You have LHRHa as an injection under the skin or an injection into a muscle. You start it before starting camizestrant or on the first day you have it. You have the LHRHa every 4 weeks or every 12 weeks. You continue while you are having treatment.
If you are already on a LHRHa you might need to change to another one. Your doctor will tell you if this is the case.
Standard treatment
You have 1 of the following hormone treatments:
You have these hormone treatments as tablets. You take them once a day, every day. You have treatment for 5 years. You might take it for longer if your doctor thinks it is helping you. They will talk to you about this if they think it is suitable.
Your doctor will talk to you about having a LHRHa if they think you need it.
You stop treatment if your cancer comes back. Your doctor will then talk to you about other treatment options.
Samples for research
The researchers ask to look at a previous tissue sample () that was taken. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
They plan to use the samples to:
- look at
genes to understand more about breast cancer - look for substances called
biomarkers to help work out why treatment might work for some people and not for others - see what happens to camizestrant in the body
You can say no to the team looking at your genes. It won’t affect you taking part in the rest of the trial.
The team might also ask to take a sample of breast cancer tissue if the cancer comes back.
Quality of life
The trial team ask everyone to fill out some questionnaires:
- before you start treatment
- at set times during and after treatment
You fill in the quality of life questionnaires on an . This is either on your own device or a device that the trial team provide. They will show you how to do this. The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.
Diary
The team might ask you to record when you take your treatment. This is on an electronic diary. You fill this in on your own device or a device that the trial team provide. They will show you how to do this.
Hospital visits
You see the doctor for a and have some tests before you can take part. These include:
- blood tests
- a heart trace (
ECG ) - an eye test
- a mammogram or an MRI scan of the breast if you have not had one in the last 9 months
- a CT scan and a bone scan or a PET-CT scan
During treatment you see the doctor regularly. This is for blood tests and to see how you are. You also have regular eye tests if you are having camizestrant.
The first few hospital visits may take about 6 hours. After that each visit takes about 2 to 3 hours. There is a chance you might be at the hospital for longer than this.
Trial scans
You have a mammogram or breast MRI once a year. You may also have some of the scans repeated that you had when you joined the trial. This is only if your doctor thinks that they are necessary.
Follow up visits
When you stop treatment, you see the trial team one month later for a check up.
The team then check how you are getting on at:
- 4 months
- 7 months and then
- every 6 months for 5 years and then
- once a year for at least 10 years
You might see your trial team at a routine hospital appointment or they may call you or look at your medical notes.
Side effects
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 so there may be side effects we don’t know about yet. The team say the side effects they know about so far are manageable. The common side effects we know about so far include:
- slowing down of your heartbeat and changes to how your heart works. In most people, this does not cause symptoms. You should contact the trial doctor immediately if you have a fast or uneven heartbeat, feel lightheaded, dizzy, short of breath, faint or have chest pain.
- changes to eyesight that include trailing lights, flashing lights on the edge of the vision or after images. In most people, these effects are only last for a short time.
The trial doctor will talk to you about all the possible side effects of treatment. You’ll have a chance to ask them any questions you may have.
Location
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.
Chief Investigator
Professor Ram Venkitaraman
Supported by
AstraZeneca
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
