BEAT-Breast: Trial of DE-iPTV in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy.
This study, called BEAT-Breast, is for people in the UK whose breast cancer has spread to their brain (brain metastases) and who cannot have another type of targeted radiotherapy. It's testing a new approach to radiotherapy called DE-iPTV. The main goals are to find out if this new radiotherapy can be given effectively, how it affects patients' quality of life, how well it controls the cancer in the brain, and if it reduces the need for other medicines like steroids. Participants will receive five doses of this new radiotherapy. They will also answer questions about their quality of life and track their medication use regularly for about 12 weeks. Doctors will check their progress with MRI scans at different times over 24 weeks. The study hopes to find a better treatment option for brain metastases that also helps patients feel better.
At a glance
What is this study about?
When breast cancer spreads to the brain, it's called brain metastases. This can be a very challenging condition. Doctors often treat this with surgery, targeted radiotherapy (called stereotactic radiosurgery or SRS), or whole brain radiotherapy (WBRT). However, not everyone can have surgery or SRS, so WBRT is often the usual treatment in these cases.
This study is looking at a new, modern way to give radiotherapy called "Dose Escalated internal PTV" (DE-iPTV). This special type of radiotherapy aims to deliver a higher dose of radiation directly to the cancer in the brain, while carefully reducing the amount of radiation that reaches the healthy parts of the brain. The idea is that by targeting the cancer more precisely and protecting the healthy brain tissue, patients might have fewer side effects and a better quality of life.
The main goal of this study is to see if this new DE-iPTV radiotherapy can be delivered safely and effectively. The researchers also want to understand how it affects important things like a patient's overall quality of life, how well it controls the cancer in the brain, and if it might help reduce the need for certain medications, like steroids. They are specifically focusing on patients who would normally receive WBRT because other treatments aren't suitable for them.
Key takeaways
- Tests a new radiotherapy (DE-iPTV) for breast cancer that has spread to the brain.
- Aims to protect healthy brain tissue while hitting the cancer harder.
- Looks at how the new treatment affects your quality of life and cancer control.
- For UK patients unable to have certain other targeted therapies.
- Involves 5 radiotherapy doses, weekly questionnaires, and MRI scans.
Who may be eligible?
This study is for adults over 16 living in the UK with breast cancer that has spread to their brain. To join, your doctors must feel that whole brain radiotherapy (WBRT) would currently be the best treatment for you outside of this study. You should also be well enough to take part and able to answer questions about your health and feelings, either over the phone or by post.
You cannot take part if you have certain types of brain cancer spread, such as cancer affecting the lining of the brain, or if you have too many small cancer spots (more than 15). If you've had radiotherapy to your whole brain before, or if you are pregnant or breastfeeding, you won't be able to join. You'll also need to be able to have an MRI scan and have a life expectancy of at least three months.
- Are you over 16 and live in the UK?
- Do you have breast cancer that has spread to your brain?
- Has your doctor said that whole brain radiotherapy (WBRT) would be your usual treatment option?
- Are you able to have an MRI scan?
- Have you NOT had whole or partial brain radiotherapy before?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive five doses of the new DE-iPTV radiotherapy. This will happen over a short period. Throughout your participation, you will be asked to complete weekly questionnaires, either by phone or post, to check your quality of life. You'll also need to keep a diary of any steroid medications you're taking for up to 12 weeks after you start.
You will have regular check-ups at the clinic. These will include up-to-date MRI scans of your brain, which will happen at 8, 12, and 24 weeks after you join the study. You will also fill out more detailed quality of life questionnaires at the start, and again at weeks 8, 12, and 24. The total study follow-up period involves these assessments and scans over 24 weeks.
Potential risks and benefits
Locations (1)
- Imperial College LondonLondon, United Kingdom
Common questions
What is 'brain metastases'?
This means that breast cancer cells have spread from the original tumour in your breast to your brain.
What is DE-iPTV radiotherapy?
It's a new, modern way to give radiation treatment that aims to deliver a stronger dose directly to the cancer in your brain, while trying to protect the healthy parts of your brain.
Why is this study important?
It's important because it's looking for a potentially better and kinder treatment for breast cancer that has spread to the brain, especially for people who can't have other targeted treatments.
Will I have to pay to take part?
No, you will not have to pay for the treatment or assessments included in this study, as it's part of a UK clinical trial.
What is 'quality of life' in this study?
It refers to how you feel and how your daily life is affected by your health and treatment. The study will ask questions about this to see if the new treatment helps.
How to find out more
Lillie Pakzad-Shahabi, BSc MSc
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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