A new national research study, led by researchers at The Clatterbridge Cancer Centre NHS Foundation Trust in Liverpool and University Hospitals Birmingham, has opened to investigate whether magnetic resonance imaging (MRI) screening should become standard practice for detecting breast cancer that has spread to the brain.
The trial, known as the HER2+ CNS SURVEILLANCE study, focuses on people with HER2-positive (HER2+) secondary breast cancer – a type of breast cancer that has spread beyond the breast to other parts of the body and in which the cancer cells have too much of a protein called HER2 on their surface. This protein drives the cancer cells to grow and divide faster than normal, making this subtype more aggressive.
Patients with HER2-positive breast cancer are at an increased risk of developing brain metastases (cancer spread to the brain), which can have a significant impact on survival and quality of life.
Research shows that detecting brain metastases before symptoms appear can improve outcomes for these patients. The main goal of the study is therefore to see whether regular MRI brain scans are a practical way to detect metastases earlier, allowing doctors to intervene sooner and potentially improve survival.
£219, 560 has been awarded to fund the study over three years by the charity Make 2nds Count, a UK-wide patient and family focused charity dedicated to giving hope to women and men living with secondary (metastatic) breast cancer.
Rachel Hines, 47, from Ormskirk in Lancashire, was the first patient in the UK to sign up to the study. She was first diagnosed with HER2+ breast cancer in June 2024 and found out just a few weeks later that it had already spread to her liver and her bones. Rachel said:
The lump in my breast was relatively small at 3cm and my lymph nodes were clear so it was quite a shock to find out that my disease had already spread so significantly throughout my body without major symptoms. I knew about the enormity of brain mets which is why I signed up for this study. To be honest, I didn’t take the decision lightly but, if something is found, it’s got to be better to know and have it treated earlier.
I wouldn’t want my husband or children to come home one day and find me on the floor – or to be driving my kids somewhere and have an accident – because something had happened due to brain metastases I didn’t know about. This study has got to be a positive step forward for people with HER2+ breast cancer and it’s good to be part of something that could help people in future.
Professor Carlo Palmieri, Consultant Medical Oncologist at The Clatterbridge Cancer Centre, an academic at the University of Liverpool, and Co-chief Investigator of the study, said:
This study is the first of its kind in the UK in breast cancer. For reasons we don't quite understand, HER2-positive breast cancer, when it's spread, can commonly spread to the brain. This can result in significant problems such as headaches, weakness or fits but it is not usually diagnosed until symptoms develop.
Given that there is an unanswered question about whether we should look for disease in the brain before it causes symptoms, we've established a study called HER2-CNS Surveillance. The aim is to show whether it is feasible to get men and women with advanced HER2-positive breast cancer to enter into a study where they are randomised to screening versus no screening of the brain.
Dr Sarah Thomas, Head of Research & Education at Make 2nds Count, said:
As Chair of the Research Committee, I’m proud that we were able to support this vital study through our grant funding programme. HER2+ secondary breast cancer patients face a particularly high risk of brain metastases, and this research has the potential to make a real difference in how we detect and manage these to maintain quality of life.
About the study
The study team aims to recruit 69 patients with HER2+ secondary breast cancer who have not yet developed brain metastases. This initial feasibility study will help determine the practicality of the research, and if recruitment is successful, the team plans to expand it into a larger study involving more patients.
Those taking part will have an initial MRI brain scan, and if no cancer is detected, they will be randomly assigned to receive either ongoing MRI surveillance (a scan both six and twelve months later) or standard care (no scans).
Recruitment is taking place at six cancer centres across the UK, including Liverpool, Birmingham, London, Manchester, Edinburgh, and Cardiff, and one centre in Dublin, Ireland. Patients outside these locations are also welcome to take part if they are able to travel.
If you are living with HER2+ secondary breast cancer without brain metastases and would like to take part, please speak to your oncologist.
Prof Palmieri explains the study in this short video
