
“I had treatment last year and I want to give something back.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is trying to find out if denosumab can stop or delay breast cancer spreading to the bones. It is for women who have early breast cancer and their doctors think there is a high risk of it coming back or spreading to their bones.
Doctors treat early breast cancer with surgery, radiotherapy, hormone therapy, chemotherapy or biological therapy. Most women begin treatment with surgery to remove their cancer. But they often have one or more other treatments to lower the chance of the cancer coming back in the breast, or spreading elsewhere in the body. This is called adjuvant therapy.
In this trial, researchers are looking at a drug called denosumab as adjuvant therapy. It is a type of biological therapy called a monoclonal antibody. Denosumab may help to stop breast cancer spreading to the bones.
The aims of the study are to
You can enter this trial if you
You cannot enter this trial if you
The trial will recruit about 4,500 people in a number of countries around the world. It is a randomised trial. The people taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither you nor your doctor will know which group you are in either. This is called a double blind trial.
Everybody taking part in the study will take vitamin D and calcium supplements every day. Your doctor will prescribe these for you free of charge.
If you have already had surgery to remove your cancer, the researchers will get a sample of the cancer tissue removed. They will study this, along with blood samples, to learn more about how characteristics of your tumour or certain genes may affect the way breast cancer grows and how people respond to denosumab.
The researchers will use some of your blood and cancer tissue samples to look for biomarkers. These are substances in the body that doctors can measure to help them tell how a disease is developing or how a treatment is working. They hope that in the future, biomarkers may help them to work out who is most likely to benefit from denosumab.
If results from this trial show that denosumab helps to stop cancer spreading to the bones, any woman still having treatment will be able to have denosumab for the remainder of their 5 years of treatment. If the results show that denosumab does not help, then all women will stop taking study treatment. In that case, your doctor will talk to you about other possible treatment options that are available.
You will see a doctor and have some tests before you start treatment. The tests include
You will go to the hospital every 3 or 4 weeks for the first 6 months and then every 3 months for the next 4 and a half years. You will have blood tests and an injection under the skin each time. These visits will last about 1 to 2 hours. Every 6 months, you will have an examination of your mouth to check that your mouth and jaw are healthy. And every 3 months, the trial team will ask you to give a urine sample.
Every year during the trial treatment you will have a
After you finish treatment, the trial team will see you at the hospital one more time, and you have more tests and scans. This visit will take 2 to 3 hours. For the next 6 months after this visit the trial team will contact you by phone or see you at the hospital once a month. These phone calls should take no more than about 15 minutes.
After 6 months, you will have another blood test at the hospital. After this, a member of the trial team will contact you every 3 or 6 months to see how you are doing. You may also have bone scans and CT or MRI scans once a year.
As denosumab is still quite a new drug, there may be some side effects we don’t know about yet. From earlier trials, we know the possible side effects include
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Robert Coleman
Amgen
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
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.”