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RecruitingNAINTERVENTIONAL

HER2+ CNS Surveillance

This study is for people with advanced breast cancer that is HER2-positive, meaning their cancer cells have a lot of a protein called HER2. These patients are at higher risk of the cancer spreading to the brain. Currently, doctors usually wait for symptoms to appear before checking the brain. This research wants to find out if offering regular brain MRI scans could help doctors find any spread to the brain earlier, even before symptoms show up. The main goal is to see how many people would be willing to take part in such a study. We'll also ask for their opinions to help design better studies in the future. This study isn't about treating cancer, but about how we look for it spreading to the brain.

At a glance

Status
Recruiting
Phase
NA
Sponsor
The Clatterbridge Cancer Centre NHS Foundation Trust
Enrolment target
69
Start
03 Oct 2025
Estimated completion
31 Dec 2027

What is this study about?

This study is about a type of breast cancer called HER2-positive. If you have this type of cancer and it has spread to other parts of your body (doctors call this metastatic cancer), there's a higher chance it could also spread to your brain. Currently, doctors usually monitor patients for signs or symptoms that might suggest the cancer has reached the brain.

The researchers want to explore if regular scans of the brain, called MRI scans, could help find any cancer spread to the brain earlier, before symptoms even start. If spread is found early, it might be possible to manage it sooner. This study isn't looking at new treatments, but rather how we might keep an eye on things. They want to see if it's practical to carry out studies like this in the future.

The main aim of *this specific study* is to understand if people with HER2-positive breast cancer would be willing to join a study that includes brain MRI scans. Some people would have an initial scan and then two more over a year, while others would just have the initial scan. The study will also gather feedback from patients about their experiences and thoughts on taking part, which will help researchers design better studies in the future.

Key takeaways

  • This study is for people with advanced HER2-positive breast cancer.
  • It explores whether regular brain MRI scans can find cancer spread earlier.
  • The main goal is to see if patients are willing to take part in such screening studies.
  • Participation involves at least one brain MRI scan; some will have more.
  • Your feedback is important to help design future research.
  • This study does not involve new cancer treatments.

Who may be eligible?

To be able to join this study, you need to be at least 16 years old. You must have HER2-positive breast cancer that has spread to other parts of your body, and you should be receiving treatment for your HER2-positive cancer right now. You also need to be generally well enough to take part and have a life expectancy of more than six months. Importantly, you must be able to understand and sign a consent form, agreeing to all the study procedures.

There are some reasons why you wouldn't be able to join. For example, if you've already had breast cancer spread to your brain, or if you have symptoms that suggest it might have spread there. Also, if you can't have MRI scans for any reason, or if your cancer has only spread to your bones (and nowhere else), this study wouldn't be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 16 years old or older?
  2. Do you have HER2-positive breast cancer that has spread?
  3. Are you currently receiving treatment for your HER2-positive cancer?
  4. Have you *not* had cancer spread to your brain before?
  5. Are you able to have MRI scans?
  6. Are you generally well and able to follow study instructions?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have an MRI scan of your brain. After this, you'll be randomly assigned to one of two groups, like flipping a coin. One group will have two more MRI scans of the brain over the next year (one at six months and another at 12 months). The other group won't have any further brain scans as part of the study, though your regular doctor may still recommend them if needed.

During the study, you might also be asked to take part in interviews or group discussions. This is to gather your thoughts and experiences about the study, which will help researchers understand what works well and what challenges there might be. The total duration of active participation for those having extra scans would be about one year.

Potential risks and benefits

A potential benefit of joining is that if you are in the group having extra scans, any spread of cancer to the brain might be found earlier, even before symptoms appear. This could lead to earlier management. However, there's no guarantee this will improve your overall outcome, as this study is mainly looking at whether these scans are practical to do. Risks might include the usual risks associated with MRI scans, such as reactions to the dye used for the scan. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • The Clatterbridge Cancer Centre NHS Foundation Trust
    Verified postcode
    Liverpool, United Kingdom· Recruiting

Common questions

What does HER2-positive mean?

It means your breast cancer cells have a lot of a specific protein called HER2 on their surface. This can make the cancer grow and spread faster.

What is an MRI scan?

An MRI (Magnetic Resonance Imaging) scan uses strong magnets and radio waves to create detailed pictures of the inside of your body, in this case, your brain.

Will I get treatment for my cancer in this study?

No, this study is not testing new treatments. It's about how we look for cancer spread to the brain. You will continue to receive your usual cancer treatment.

Why is it important to find cancer spread to the brain early?

Finding cancer spread early might allow doctors to manage it sooner, potentially preventing or reducing severe symptoms. However, this study aims to see if that's truly beneficial.

What if I decide I don't want to continue with the study?

You are completely free to leave the study at any point, and your decision will not affect your ongoing medical care.

How to find out more

Carlo Palmieri

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "HER2+ CNS Surveillance…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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