HER2+ CNS SURVEILLANCE Study

A study of the feasibility of randomising women and men with HER2 positive metastatic breast cancer to Central Nervous System surveillance versus not.

Make 2nds Count awarded £219,560 over 3 years to the HER2+ CNS SURVEILLANCE study. This vital research will investigate MRI screening for breast cancer which has spread to the brain, before patients become symptomatic. The study is taking place across the UK and Ireland with sites opening from October 2025. 

The Co-Chief Investigators of this study are Prof Carlo Palmieri, Professor of Translational Oncology at The University of Liverpool and a Consultant in Medical Oncology at The Clatterbridge Cancer Centre NHS Foundation Trust in Liverpool and Dr Sara Meade, a Consultant Oncologist at University Hospitals Birmingham NHS Foundation Trust. The study is led by The Royal Marsden NHS Foundation Trust, sponsored by Clatterbridge Cancer Centre.

Study Background

Breast cancer cells often have too much of a protein called HER2. This protein acts like a fertiliser, making the cancer cells grow faster.

Unfortunately, studies show that HER2-positive (HER2+) secondary breast cancer is more likely to spread to the brain or spinal cord than other types of breast cancer.

Good news: We have targeted treatments for HER2+ cancer that are helping people live longer. The bad news is that because people are living longer, more and more of these HER2+ patients are now developing brain metastases (cancer spread to the brain, often called brain mets).

The Problem with Brain Metastases

Brain mets can cause serious problems that affect a person's quality of life. These include:

  • Headaches

  • Feeling sick or throwing up

  • Vision problems

  • Seizures

  • Changes in movement or motor skills

  • Changes in mood, thinking, or psychological well-being

Sometimes, brain mets can be present for a while without causing any symptoms at all.

The Need for Early Screening

Patients with HER2+ breast cancer who are at high risk of brain mets could benefit from a screening plan. This would involve using an MRI scan to check the brain for any cancer before symptoms start.

Why is this important? Research suggests that when brain mets are found before a person has symptoms, they tend to live longer than if the cancer is found after symptoms appear.

Treatment Options

Brain mets can be treated in several ways, including:

  • Surgery

  • Targeted radiation (focusing radiation only on the cancer spots)

  • Whole-brain radiation

  • A combination of these treatments

Also, some of the newer HER2-targeted drugs are able to pass into the brain and can be used to treat HER2+ brain mets directly.

Why Is This Research Needed?

Because HER2+ secondary breast cancer patients are at a higher risk of developing brain mets, and because brain mets seriously impact how long and how well a person lives, there is an urgent need to address this problem. We need research right now to test better screening plans so we can find these asymptomatic brain metastases as early as possible.

Study Aims

The HER2+ CNS SURVEILLANCE study is a research trial focused on people with HER2-positive (HER2+) secondary breast cancer who have not yet had cancer spread to their brain.

The main goal of this study is to see if it's practical to give these patients regular MRI brain scans to check for brain metastases (cancer spread).

How the Study Works

  1. Initial Scan: Everyone who joins the study will get one initial MRI scan to make sure their brain is clear of cancer right now.

  2. Groups: Patients will then be randomly put into one of two groups:

    • Surveillance Group: These patients will receive an MRI scan every six months for one year.

    • Standard Care Group: These patients will receive no regular scans unless they develop symptoms (this is what usually happens now).

  3. Feasibility Check: This is a first, smaller study designed to answer a few key questions, which we hope will lead to a larger study that will explore the benefits of regular MRI brain scanning for detecting brain metastases when no symptoms are present.

We will also gather some early information on how often brain cancer is found in patients who don't have any symptoms.

Recruitment

The study team are aiming to recruit 69 patients for the initial MRI brain scan, after which these consented patients will then be randomised to further MRI surveillance or not. The study is recruiting patients from six different cancer centres across the UK (Liverpool, Birmingham, London, Manchester, Edinburgh and Cardiff) and one in The Republic of Ireland (Dublin). Patients outside of these locations can take part if they are willing to travel. 

For more information, contact the study team by email: her2.cns.study@rmh.nhs.uk

Make 2nds Count awarded this funding after an open call and independent external review facilitated by the National Cancer Research Institute.

References

[1] Darlix et al., Impact of breast cancer molecular subtypes on the incidence, kinetics and prognosis of central nervous system metastases in a large multicentre real-life cohort. British Journal of Cancer 2019; 121:991–1000. DOI: 10.1038/s41416-019-0619-y