
“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is for people with breast cancer that has come back in the area where it was first found, or that has spread elsewhere in the body.
It is open to men and women whose breast cancer cells have:
Also, they have not had any hormone therapy for their advanced breast cancer.
Some breast cancers have hormone receptors. A receptor allows a hormone to bind to a cell. Oestrogen and progesterone are sex hormones that are made naturally in the body. But they can stimulate some breast cancers to grow by triggering particular proteins (receptors) in the cancer cells.
Cancers that have these hormone receptors are called hormone receptor positive. If you have a hormone receptor positive cancer you usually have treatment with a hormone therapy.
Hormone therapies slow the growth of your cancer by stopping hormones from reaching cancer cells.
If your breast cancer cells have a lot of a protein called human epidermal growth factor (HER2) then a drug called trastuzumab (Herceptin) can be used. It attaches to the HER2 protein and stops the cells growing and dividing. But Herceptin won't work if you are HER2 negative. So doctors want to find other treatments for people in this situation.
In this study everyone has
Letrozole is a standard treatment for people with hormone receptor positive breast cancer.
Ribociclib blocks certain proteins, called cycline dependent kinase. Cells need these proteins to divide. They might also control the ability of breast cancer to grow.
Men and pre menopausal women in this study also have a drug called goserelin or leuprorelin. These drugs are a type of hormone therapy. It stops the production of the hormone oestrogen and so lowers the amount of oestrogen in the body.
Doctors want to learn more about how safe it is to have ribociclib alongside letrozole and whether this is a useful treatment for advanced breast cancer.
The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
You may be able to join this study if all of the following apply.
You cannot join this study if any of these apply.
Cancer related
Medical conditions
Other
This is a phase 3 international trial. Researchers need around 3000 people from several different countries to join the study. They hope at least 100 people in the UK will take part.
Ribociclib and letrozole are both tablets. You take:
Men and pre menopausal women have goserelin or leuprorelin as an injection. You have this as an injection just under the skin (a subcutaneous injection), usually into your tummy. You go to hospital once a month to have this. A nurse will give you the injection.
Each 28 day period is a cycle of treatment. When 1 cycle finishes, you start the next cycle. You have treatment for up to 2 years, as long as it is helping you and the side effects aren’t too bad.
You must avoid eating the following for 7 days before starting and during all of your treatment:
You must also avoid drinking the juice of any of the above.
Quality of life
Women are asked to complete some questionnaires:
The questionnaires ask about any side effects you’ve had and how you have been feeling. This is called a quality of life study.
You see the doctors and have some tests before you start treatment. The tests include:
During the time you take the study drugs you need to go to the hospital for a check up:
For the first 6 months you have regular blood tests and ECGs during your check ups. You then only have these if your doctor thinks it is necessary.
If you are having goserelin or leuprorelin, you go to hospital once a month for your injections.
You have a CT or MRI scan every 3 months.
When you stop treatment you see the study team within 1 week and again one month later. You have most of the same tests you had before starting the study.
The study team will monitor you during the time you have treatment and you are given a phone number to call if you are worried about anything.
The most common side effects of ribociclib include:
Your nurse will explain all the possible side effects to you in more details. You have a contact number to ring in case you have any questions or concerns.
We have information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Alistair Ring
Novartis
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."