RecruitingOBSERVATIONAL

Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer

This study aims to discover why some women with HER2-positive breast cancer develop cancer in their brain. While treatments for HER2-positive breast cancer have greatly improved, cancer spreading to the brain remains a significant concern, affecting many patients and impacting their quality of life. Currently, doctors don't routinely check for brain cancer unless symptoms appear. However, newer medicines are showing real promise in treating brain recurrences. This study hopes to find specific factors that put some patients at a higher risk. This would help doctors identify those at risk earlier, allowing for closer monitoring and more tailored treatment plans, potentially improving their care and outcomes.

At a glance

Status

Recruiting

Sponsor

Center Eugene Marquis

Enrolment target

120

Start

06 Jun 2024

Estimated completion

06 Jun 2031

HER2-positive Breast Cancer

What is this study about?

Imagine doctors could tell which patients with a specific type of breast cancer — called HER2-positive breast cancer — are most likely to have the cancer spread to their brain. That's exactly what this study is trying to figure out. HER2-positive breast cancer used to be very difficult to treat, but over the last 20 years, new medicines have made a huge difference. However, even with these advances, cancer can sometimes spread to the brain, which can cause new problems and affect how people feel.

Bizarrely, doctors don't currently recommend routine brain scans for all patients unless there are symptoms. This is because, traditionally, brain recurrences were very hard to treat effectively. But things are changing! New anti-HER2 medicines are now showing real promise in shrinking these brain tumours. This means finding them early could make a big difference for patients' treatment options and quality of life.

Currently, we don't have good ways to predict who is at highest risk of brain recurrence. This study aims to look closely at different factors in breast cancer to see if any of them can act as a warning sign. If successful, this research could lead to more personalised care, where patients identified as high-risk could get more frequent checks for brain tumours and potentially start treatment earlier, giving them the best possible chance.

Key takeaways

This study investigates why HER2-positive breast cancer sometimes spreads to the brain.
It aims to find specific characteristics that predict a higher risk of brain recurrence.
Better prediction could lead to earlier detection and more personalised care for patients.
New medicines are improving treatment options for brain recurrences.
The study focuses on analysing pre-treatment biopsy samples.

Who may be eligible?

To join this study, you need to be a woman aged 18 or older. You must have been diagnosed with HER2-positive breast cancer, which has been confirmed by special tests. Your treatment plan should already include chemotherapy before surgery, and tiny clips placed in your tumour. You also need to agree to take part by signing a consent form.

You cannot join if you are pregnant or breastfeeding. Also, if you have had a serious bleed that needed strong pain relief when you had your first biopsy, or if you have certain blood clotting problems, you won't be able to take part. Finally, if you are in prison or under certain types of guardianship, or if you don't have social security coverage, you cannot be included in this study.

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?
Are you female?
Have you been diagnosed with HER2-positive breast cancer?
Is your treatment plan including chemotherapy before surgery?
Are you not pregnant or breastfeeding?
Have you signed the consent form?

Answer every question to see your result.

What does participation involve?

The detailed description of what taking part involves is not provided in your summary. Typically, a pre-treatment biopsy would mean that a small sample of your cancer tissue is taken before you start your main treatment. This sample would then be analysed by the researchers for the aims of this study. There is no mention of additional visits, medication, or follow-up specific to this study, suggesting the focus is on analysing existing biopsy tissue and patient information. The total duration of your participation would depend on how long the researchers need to collect and analyse the data from your biopsy and medical records.

Potential risks and benefits

Participating in this study might offer the benefit of contributing to new knowledge that could help future patients with HER2-positive breast cancer by identifying those at higher risk of brain recurrence. As the study seems to focus on analysing pre-treatment biopsy tissue, the direct risks to you may be minimal beyond those associated with your standard diagnostic biopsy. However, any medical procedure carries some risks, and it's important to understand these fully. You are always free to withdraw from the study at any time without affecting your standard medical care.

Locations (1)

Centre de lutte contre le cancer Eugène Marquis
Verified postcode
Rennes, France· Recruiting

Common questions

What is HER2-positive breast cancer?

It's a type of breast cancer that has a lot of a protein called HER2, which helps cancer cells grow quickly.

What does 'brain recurrence' mean?

It means the breast cancer has spread and grown in the brain after initial treatment.

Will this study change my breast cancer treatment?

This study aims to understand risk factors, not directly change your current treatment, but findings could help future patient care.

Is a brain scan part of this study?

The information provided doesn't suggest that extra brain scans are part of this study for you.

Who is funding this research?

The funding source is not mentioned in the provided study details.

How to find out more

Valérie JOLAINE, Dr

v.jolaine@rennes.unicancer.fr (0)299253036 Official trial record

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