RecruitingNAINTERVENTIONAL

MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer

This study aims to discover how often breast cancer, specifically a type called HER2-positive or 'triple-negative' advanced breast cancer (stages IIb or III), has spread to the brain without causing any noticeable symptoms. Researchers will use special brain MRI scans and blood tests that look for tiny bits of cancer DNA. They also want to understand patients' feelings about having these types of screening tests. By understanding this, doctors hope to learn more about this aggressive cancer and improve how it's detected and treated in the future. Participants will have a brain scan, give a blood sample, and answer a short questionnaire.

At a glance

Status

Recruiting

Phase

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

100

Start

29 Nov 2023

Estimated completion

01 Jun 2028

Breast Cancer

What is this study about?

This research study is looking into a specific type of breast cancer that's either HER2-positive or 'triple-negative' and has reached an advanced stage (IIb or III). These types of breast cancer can sometimes spread to other parts of the body, including the brain. What doctors want to find out is how often this spread to the brain happens even when a person doesn't have any symptoms like headaches or dizziness.

To do this, the study will use special scans of the brain called MRIs, which are very good at finding small changes. They will also collect a blood sample from participants to look for tiny pieces of cancer material floating in the blood. Another important part of this study is understanding how people feel about having these tests. Do they find them worrying, or are they comfortable with the idea of possibly finding something early?

The results of this study will help doctors better understand how often breast cancer spreads to the brain without symptoms and who might be most at risk. This knowledge could eventually lead to better ways of checking for and treating this type of cancer in the future, ultimately improving care for patients.

Key takeaways

This study investigates advanced HER2-positive or 'triple-negative' breast cancer.
It aims to find out how often this cancer spreads to the brain without symptoms.
Participants will have a brain MRI scan and a blood test.
The study also explores how patients feel about these screening tests.
Findings could help improve future breast cancer detection and care.
Participation involves no new medication and is for research purposes only.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with a specific type of breast cancer. This includes breast cancer that is either HER2-positive or 'triple-negative' and has been classified as stage IIb or III. It's okay if you've had other cancers in the past, as long as they wouldn't affect the study's results or your safety.

There are a few reasons why someone might not be able to join. You can't participate if your kidneys aren't working well enough (specifically, if your creatinine clearance is below 30 mL/min), or if you are pregnant, as the safety of the MRI dye for pregnant women is unknown. Also, if you already have symptoms that suggest the cancer might have spread to your brain and your doctor is already planning a brain scan for that reason, then this study might not 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.

Are you 18 years old or older?
Do you have HER2-positive or 'triple-negative' breast cancer?
Is your breast cancer stage IIb or III?
Do your kidneys generally work well?
Are you not currently pregnant?
Do you not currently have brain-related symptoms that would already lead to a brain scan?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will need to undergo a brain scan using a type of imaging called an MRI. This scan will use a special dye to help doctors see things clearly. You will also be asked to provide one blood sample. After your brain scan, you will complete a short questionnaire called the 'Testing Morbidities Index' to share your feelings about the tests you've just had. These procedures will all take place within 18 months of your initial breast cancer diagnosis. They can happen either before or after you've completed any initial treatments for your breast cancer. The total duration of your active participation will involve these few steps, and there won't be any further long-term follow-up required as part of this specific study.

Potential risks and benefits

Potential benefits of participating include getting a detailed scan of your brain which might detect any spread of cancer early, even before symptoms appear. This information could be useful for your care team. Your participation also helps researchers learn more about breast cancer, which could improve care for future patients. Potential risks are generally low; the MRI scan involves a contrast dye which some people might react to (though this is uncommon), and the blood test is a standard procedure with minor risks like bruising. There are no known risks for the brain scan itself. Remember, participation is completely voluntary, and you are free to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Sunnybrook Health Science Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What does 'triple-negative' or 'HER2-positive' breast cancer mean?

These are specific types of breast cancer that doctors identify by looking at cancer cells under a microscope. They behave differently and often need different treatments.

Why are you looking for cancer in the brain if I don't have symptoms?

Sometimes cancer can spread to the brain without causing any noticeable symptoms. Finding it early helps doctors understand its behaviour and could potentially lead to better management.

Is the MRI scan safe?

MRI scans are generally safe. A special dye is used, and while rare, some people might have an allergic reaction to it. You will be monitored closely.

Will I get my test results?

The study aims to gather information for research purposes. Any findings from your scans that require medical attention will be shared with your doctor.

How long will it take to participate?

Your involvement will include a brain scan, providing a blood sample, and filling out a short questionnaire. These activities will be completed within a single visits, all within 18 months of your original diagnosis.

How to find out more

Katarzyna Jerzak, MD, M.Sc

katarzyna.jerzak@sunnybrook.ca 416-480-6100 Official trial record

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