SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveillance

NCT07503717 | Recruiting DMC

• 1 other identifier: 25-46
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; HER2-Positive Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Through recruitment completion, an average of 24 months.

Secondary Outcomes (5)

• Proportion of Patients With Occult CNS Metastases at Baseline MRI

  At baseline (prior to randomisation)

• Proportion of Patients With Radiologically Detected CNS Metastases During Surveillance

  Up to 12 months after randomisation

• Proportion of Patients Developing Symptomatic CNS Disease

  Up to 14 months after baseline

• Description of Initial Local Treatment for CNS Metastases

  Up to 14 months after baseline

• Systemic Anti-Cancer Therapy (SACT) Modification Following CNS Diagnosis

  Up to 14 months after baseline

Study Arms (2)

CNS Surveillance

EXPERIMENTAL

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

No Routine CNS Surveillance (Standard of Care)

ACTIVE COMPARATOR

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

Interventions

Brain Magnetic Resonance Imaging (MRI) with Contrast DIAGNOSTIC_TEST

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.

CNS Surveillance; No Routine CNS Surveillance (Standard of Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior history of brain metastases
• History or evidence of leptomeningeal carcinomatosis
• Symptoms suggestive of brain metastases at screening
• Bone-only metastatic disease
• Inability to undergo MRI scanning
• 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
• Deemed unsuitable for participation by the principal investigator due to clinical, mobility, or social circumstances

Sponsors & Collaborators

• The Clatterbridge Cancer Centre NHS Foundation Trust: collaborator
• Royal Marsden NHS Foundation Trust: collaborator
• Royal College of Surgeons, Ireland: lead

Study Sites (1)

Beaumont RCSI Cancer Centre

Beaumont, Ireland

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Carlo Palmieri, MD, PHD

CONTACT

018093000; cpalmi@liverpool.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is a diagnostic surveillance feasibility study. Neither participants nor investigators are blinded to allocation.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants without CNS metastases on baseline MRI will be randomized 1:1 to surveillance MRI versus no routine surveillance. All registered participants undergo a baseline contrast-enhanced brain MRI. Participants with no radiologic evidence of CNS metastases are randomized (1:1) to: Surveillance arm: brain MRI at 6 and 12 months Standard-of-care arm: no routine surveillance imaging Randomization is stratified by: Estrogen receptor (ER) status (positive vs negative) Line of therapy (first-line vs second or later) Participants are followed for 14 months from baseline.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: March 31, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-02

Locations

IE (1)