SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveillance
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Potwierdzony nowotwór piersi z dodatnim markerem HER2
- •Rak rozprzestrzeniony na inne części ciała
- •Aktualnie otrzymując leczenie skierowane na HER2
- •Dobry stan ogólny zdolności do codziennych czynności (0-2 w skali ECOG)
- •Spodziewana długość życia ponad 6 miesięcy
- •Zdolność do podpisania świadomej zgody
- •Gotowość do udziału w procedurach badania i wizytach kontrolnych
✗ Disqualifies
- •Historia przerzutów do mózgu
- •Przerzuty w oponach mózgowo-rdzeniowych
- •Objawy sugerujące przerzuty do mózgu
- •Przerzuty tylko w kościach
- •Niemożliwość wykonania badania MRI
- •Uczulenie na środki kontrastowe do MRI, które nie można kontrolować
- •Poważne schorzenia lub nieprawidłowości laboratoryjne uniemożliwiające udział
- •Uznanie przez badającego za niestosownego do uczestnictwa
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- March 31, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Beaumont RCSI Cancer Centre
Beaumont, Ireland
Trial contact
Carlo Palmieri, MD, PHD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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