Actively Recruiting
SURVEY-CNS: Feasibility Study of CNS MRI Surveillance Versus No Surveillance in Women and Men With HER2-Positive Metastatic Breast Cancer
Led by Royal College of Surgeons, Ireland · Updated on 2026-03-31
69
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
R
Royal College of Surgeons, Ireland
Lead Sponsor
T
The Clatterbridge Cancer Centre NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
HER2-positive metastatic breast cancer has a high risk of spreading to the brain, which can cause serious symptoms like headaches, seizures, and cognitive changes. Although treatments targeting HER2 have improved control of cancer outside the brain, brain involvement remains a major concern. This study evaluates whether it is possible and acceptable to recruit patients and randomly assign them to routine brain MRI surveillance or standard care without routine brain imaging. Participants will receive a baseline contrast-enhanced brain MRI. Those without brain metastases on this scan will be randomly assigned to one of two groups: one undergoes brain MRI surveillance at 6 and 12 months, and the other receives no routine brain imaging unless symptoms develop. If brain metastases are found at any time, treatment follows standard clinical practice. The study will follow participants for 14 months from the baseline scan. During the study, participants will be monitored for the development of brain metastases, symptoms related to brain involvement, treatments directed at brain metastases like surgery or radiotherapy, changes in systemic cancer therapy, and survival. Researchers will assess how many eligible patients agree to participate and be randomized. This information will help decide if a larger trial on brain surveillance in this patient group is feasible.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Male or female
- Confirmed HER2-positive breast cancer
- Evidence of metastatic breast cancer
- Estrogen receptor positive or negative
- Presence of visceral metastatic disease
- Receiving active HER2-directed systemic therapy
- ECOG performance status of 0 to 2
- Estimated life expectancy over 6 months
- Able to provide written informed consent
- Willing and able to comply with study procedures and follow-up
You will not qualify if you...
- Prior history of brain metastases
- History or evidence of leptomeningeal carcinomatosis
- Symptoms suggesting brain metastases at screening
- Bone-only metastatic disease
- Unable to undergo MRI scanning
- Known hypersensitivity or contraindication to MRI contrast agents not manageable
- Significant medical condition or lab abnormality deemed inappropriate for participation
- Unable to provide informed consent
- Deemed unsuitable by investigator due to clinical, mobility, or social reasons
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for baseline brain MRI and eligibility assessment
Duration - 12 months
Participants without CNS metastases are randomized to undergo structured brain MRI surveillance at 6 months and 12 months after baseline to detect asymptomatic CNS metastases.
Brain MRI at 6 months and 12 months after baseline
Duration - 14 months from baseline
Participants are followed for 14 months from baseline for development of CNS metastases, symptomatic CNS disease, CNS-directed therapies, changes in systemic anti-cancer therapy, and survival status.
Ongoing follow-up assessments over 14 months
Trial Site Locations
Total: 1 location
1
Beaumont RCSI Cancer Centre
Beaumont, Ireland
Actively Recruiting
Research Team
C
Carlo Palmieri, MD, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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