An interventional study of Brain Magnetic Resonance Imaging (MRI) with Contrast in Breast Cancer and HER2-Positive Metastatic Breast Cancer, sponsored by Royal College of Surgeons, Ireland. Recruiting at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Royal College of Surgeons, Ireland · Not applicable, Interventional, and Screening
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.
HER2-positive metastatic breast cancer is associated with a high cumulative incidence of central nervous system metastases. Advances in systemic HER2-targeted therapies have improved extracranial disease control and overall survival; however, CNS progression remains a major cause of morbidity and mortality.
Current standard practice does not include routine CNS surveillance imaging in asymptomatic patients. Brain imaging is typically performed only following the onset of neurological symptoms. Observational registry data suggest that detection of asymptomatic brain metastases may be associated with improved survival compared with symptomatic presentation. Whether a structured surveillance approach is feasible and acceptable to patients has not been prospectively evaluated.
SURVEY-CNS is a non-CTIMP, randomised, parallel-group feasibility study conducted in Ireland in collaboration with UK centres running a parallel study under the same protocol.
All registered participants will undergo a baseline contrast-enhanced MRI of the brain. Participants with radiologically evident CNS metastases at baseline will not proceed to randomisation and will be managed according to standard clinical practice. Participants without CNS metastases will be randomised in a 1:1 ratio to:
Surveillance arm: Brain MRI at 6 months and 12 months Standard-of-care arm: No routine surveillance imaging
Randomisation will be stratified by:
Oestrogen receptor (ER) status (positive vs negative) Line of metastatic therapy (first line vs second or later)
Participants will be followed for 14 months from baseline for:
Development of radiologically detected CNS metastases Development of symptomatic CNS disease CNS-directed local therapy (surgery, stereotactic radiosurgery, whole brain radiotherapy) Changes in systemic anti-cancer therapy Survival status
The primary endpoint is feasibility, defined as the proportion of eligible patients who consent to screening and randomisation. A single-stage A'Hern design will be used. The study will halt when either 69 patients have consented or 193 patients have been approached.
Recruitment pathways will be evaluated using a structured screening log and the SEAR (Screened, Eligible, Approached, Randomised) framework to identify barriers to participation and inform planning of a future definitive trial.
This study is designed to determine whether a larger efficacy trial of CNS surveillance in HER2-positive metastatic breast cancer is practicable.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 69 is close to the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Royal College of Surgeons, Ireland is the lead sponsor of 93 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants undergo a baseline contrast-enhanced brain MRI. Those without radiologic evidence of CNS metastases are randomized to receive structured CNS surveillance consisting of repeat brain MRI at 6 months and 12 months after baseline. If CNS metastases are detected at any time, management is according to standard clinical practice.
Diagnostic Test: Brain Magnetic Resonance Imaging (MRI) with Contrast
Participants undergo a baseline contrast-enhanced brain MRI. Those without radiologic evidence of CNS metastases are randomized to no routine surveillance imaging. Subsequent brain imaging is performed only if clinically indicated based on symptoms or clinician judgment. Management of any detected CNS metastases follows standard clinical practice.
Diagnostic Test: Brain Magnetic Resonance Imaging (MRI) with Contrast
Contrast-enhanced MRI of the brain performed according to local institutional standards. In the surveillance arm, MRI is performed at baseline, 6 months, and 12 months. In the standard-of-care arm, MRI is performed at baseline only, with additional imaging if clinically indicated.
Proportion of Eligible Patients Consenting to Screening and Randomisation
The proportion of eligible patients approached who provide written informed consent to undergo baseline contrast-enhanced brain MRI with intent to proceed to randomisation (if no CNS metastases are detected). Feasibility will be determined using a single-stage design, with success defined as more than 30% of approached eligible patients consenting to participate.
Time frame: Through recruitment completion, an average of 24 months.
Proportion of Patients With Occult CNS Metastases at Baseline MRI
The proportion of registered participants in whom previously undiagnosed (asymptomatic) CNS metastases are detected on the baseline contrast-enhanced brain MRI prior to randomisation.
Time frame: At baseline (prior to randomisation)
Proportion of Patients With Radiologically Detected CNS Metastases During Surveillance
Among randomised participants, the proportion who develop previously undiagnosed CNS metastases detected on scheduled surveillance MRI (surveillance arm) or clinically indicated imaging (standard-of-care arm).
Time frame: Up to 12 months after randomisation
Proportion of Patients Developing Symptomatic CNS Disease
The proportion of participants who develop neurological symptoms attributable to CNS metastases, including headache, nausea/vomiting, seizure, visual disturbance, motor dysfunction, coordination impairment, cognitive change, or psychological disturbance.
Time frame: Up to 14 months after baseline
Description of Initial Local Treatment for CNS Metastases
Among participants diagnosed with CNS metastases, the proportion receiving surgery, stereotactic radiosurgery (SRS), or whole brain radiotherapy (WBRT) as initial CNS-directed local therapy.
Time frame: Up to 14 months after baseline
Systemic Anti-Cancer Therapy (SACT) Modification Following CNS Diagnosis
The proportion of participants requiring initiation, cessation, or modification of systemic anti-cancer therapy following diagnosis of CNS metastases.
Time frame: Up to 14 months after baseline
Plan to share: Undecided
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Royal College of Surgeons, Ireland