
“I had treatment last year and I want to give something back.”
This trial is for women who have changes to the gene but do not have cancer. It is looking at a new way to try and prevent breast cancer.
People who have a very strong family history of certain cancers may have a faulty gene in their family that increases the risk of cancer.
Everyone has BRCA1 and BRCA2 genes. BRCA stands for BReast CAncer gene. They are important genes that stop the cells in our body from growing and dividing out of control. Doctors call these tumour suppressor genes.
A fault (or mutation) in the BRCA1 or BRCA2 gene means that the cells can grow out of control. This can lead to cancer developing.
Faulty BRCA1 and BRCA2 genes are rare. Only around 1 in every 400 people have a faulty BRCA1 or BRCA2 gene.
Both men and women can have a faulty BRCA1 or BRCA2 gene. People who inherit faulty versions of these genes have an increased risk of developing different types of cancers. These include:
There are treatments that can reduce the risk of developing breast or ovarian cancer in women with a change in the BRCA1 gene. These are:
Researchers would like to reduce the risk of cancer developing in women with this increased cancer risk.
Denosumab is a type of targeted therapy called a .
In healthy bones, specialised cells constantly break down and replace old tissue. These specialised bone cells are:
Denosumab works by targeting a protein called RANKL which controls the activity of osteoclasts. This stops bone cells being broken down and strengthens the bone. Doctors use it for managing bone health in people with and without cancer. They would now like to find out if denosumab could help to prevent cancer.
The aims of the 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
You may be able to join this trial if all of the following apply:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is an international phase 3 trial. The researchers need around 2,918 people to take part including 80 from the UK.
It is a randomised double blind trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. Nor will you or your doctor know which treatment you have. During the trial your doctor will be able to find out what treatment you are having, if necessary. There are 2 treatment groups.
Group 1 – you have denosumab.
Group 2 – you have a dummy drug (placebo).
You have denosumab or the dummy drug as an injection under the skin. You have your injection every 6 months for 5 years.
Follow up
After finishing the five years of treatment, your trial doctor will continue to keep in contact for a further 5 years. This is called follow up. You will be in the trial for up to 10 years.
Blood samples for research
The team ask to take some extra blood samples. Where possible, you have these at the same time as any routine blood tests.
They plan to use the samples to help research into preventing, diagnosing and treating cancer in the future,
You don’t have to give these samples if you don’t want to. You can still take part in the trial.
Quality of life study
The trial team are interested in how the trial drug affects your every day life.
You will be asked to complete 4 questionnaires at each of the following times:
It takes about 10 minutes to fill them all out. You don’t have to do the questionnaires. If you say no, you can still take part in the study.
You see the doctor and have tests before you can take part. These include:
You go to the hospital once every 6 months to see the team and have your injection. You have your injection as an outpatient and each visit takes around an hour.
You also have some tests and scans while having treatment. They include:
The trial team monitor you during treatment and afterwards. Tell your doctor or nurse if any side effects are bad or not getting better.
The most common side effects of denosumab are:
We have more information on the side effects of denosumab.
Calcium and vitamin D Supplements.
Your doctor might recommend that you to take calcium and vitamin D supplements while taking part in the trial. These supplements generally do not cause side effects. Your doctor will talk to you about the benefits and risks of taking these supplements.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Gareth Evans
Amgen
Manchester University Hospital NHS Foundation Trust
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.”