Brain scan surveillance for people with HER2-positive metastatic breast cancer
Tests whether people with HER2-positive metastatic breast cancer will accept routine brain MRI scans.
Plain-language title generated from the registry record
Registry title: SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveillance
Key facts
- Where
- Beaumont, IrelandSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women and men with HER2-positive breast cancer that has spread, who are on HER2-directed treatment and have no known brain metastases.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- HER2-positive breast cancer that has spread (metastatic), including spread to organs (visceral disease). ER-positive or ER-negative is allowed. Life expectancy over 6 months.
- Earlier treatment
- Must be receiving active HER2-directed systemic therapy now.
- Biomarker or test result
- HER2-positive breast cancer, confirmed on tissue or cell tests.
Main reasons for not taking part
- Past or current brain metastases, or leptomeningeal carcinomatosis
- Symptoms that suggest brain metastases at screening
- Cancer that has spread only to the bones
- Cannot have an MRI scan or cannot receive MRI contrast
- Performance status worse than ECOG 0-2, or not able to give written consent
Read by machine on 12 November 2026.
Where in Ireland
- Beaumont RCSI Cancer CentreBeaumont, IrelandContact: Prof Leonie Young, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Royal College of Surgeons, Ireland
- Trial code
- NCT07503717
- Record updated
- 31 March 2026
- Original description
SURVEY-CNS is a feasibility study evaluating whether women and men with HER2-positive metastatic breast cancer can be successfully recruited and randomised to a strategy of central nervous system (CNS) magnetic resonance imaging (MRI) surveillance versus standard of care (no routine CNS surveillance).Read full original descriptionShow less
SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveilla
SURVEY-CNS is a feasibility study evaluating whether women and men with HER2-positive metastatic breast cancer can be successfully recruited and randomised to a strategy of central nervous system (CNS) magnetic resonance imaging (MRI) surveillance versus standard of care (no routine CNS surveillance).
Patients with HER2-positive metastatic breast cancer have a high risk of developing brain metastases. Brain metastases can cause significant symptoms, including headache, nausea, seizures, visual disturbance, motor dysfunction, and cognitive or psychological changes. Although new HER2-directed therapies have improved systemic disease control, CNS progression remains common and is associated with reduced quality of life and survival.
Currently, routine brain imaging is not recommended in asymptomatic patients. Brain imaging is typically performed only when neurological symptoms develop. Observational data suggest that patients diagnosed with asymptomatic brain metastases may have better outcomes than those diagnosed after symptoms occur. However, it is not known whether a surveillance strategy is feasible or acceptable to patients.
All participants in this study will undergo a baseline contrast-enhanced brain MRI. Patients without evidence of CNS metastases on the baseline scan will be randomised (1:1) to either:
CNS surveillance with repeat brain MRI at 6 and 12 months, or No routine surveillance imaging (standard of care), with imaging only if clinically indicated.
The primary objective is to determine whether more than 30% of eligible patients approached agree to undergo screening and randomisation. The study will approach up to 193 patients and will be considered feasible if 69 patients consent to screening with intent to randomise.
Secondary objectives include:
Determining the proportion of patients with previously undetected (occult) CNS metastases at baseline; Determining the incidence of occult CNS metastases during surveillance; Recording symptomatic CNS presentations; Describing management of CNS metastases, including surgery or radiotherapy. Participants will be followed for 14 months from baseline.
Inclusion: Age ≥18 years; Male or female; Histologically or cytologically confirmed HER2-positive breast cancer; Evidence of metastatic breast cancer; Estrogen receptor (ER) positive or negative disease permitted; Presence of visceral metastatic disease; Receiving active HER2-directed systemic therapy; Eastern Cooperative Oncology Group (ECOG) performance status 0-2; Estimated life expectancy greater than 6 months; Ability to provide written informed consent; Willing and able to comply with study procedures and follow-up.
Exclusion: Prior history of brain metastases; Bone-only metastatic disease; Known hypersensitivity or contraindication to MRI contrast agents that cannot - be managed per local standard of care; Significant medical condition or laboratory abnormality that, in the opinion of - the investigator, makes participation inappropriate Inability to provide informed consent; History or evidence of leptomeningeal carcinomatosis; Symptoms suggestive of brain metastases at screening; Inability to undergo MRI scanning; Deemed unsuitable for participation by the principal investigator due to clinical, mobility, or social circumstances.