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.
Age ≥18 years
Male or female
Histologically or cytologically confirmed HER2-positive breast cancer
Evidence of metastatic breast cancer
Prior history of brain metastases
History or evidence of leptomeningeal carcinomatosis
Symptoms suggestive of brain metastases at screening
Bone-only metastatic disease
Parallel
Brain Magnetic Resonance Imaging (MRI) with Contrast
Diagnostic testContrast-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.
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.
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).
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.
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.
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Royal College of Surgeons, Ireland
Lead sponsor
The Clatterbridge Cancer Centre NHS Foundation Trust
Collaborator
Royal Marsden NHS Foundation Trust
Collaborator
