Breast CancerSURVEY-CNSNCT07503717
SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveillance
A study testing Brain Magnetic Resonance Imaging (MRI) with Contrast in people with Breast Cancer and HER2-Positive Metastatic Breast Cancer, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, HER2-Positive Metastatic Breast Cancer
- What is being tested?
- Brain Magnetic Resonance Imaging (MRI) with Contrast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jun 2025to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Beaumont RCSI Cancer Centre
Beaumont
Prof Leonie Young, PhD, lyoung@rcsi.com
About this study
Official title: SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveilla
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Brain Magnetic Resonance Imaging (MRI) with Contrast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Magnetic Resonance Imaging (MRI) with ContrastDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Brain Magnetic Resonance Imaging (MRI) with Contrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through recruitment completion, an average of 24 months.
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 14 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Jun 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- The Clatterbridge Cancer Centre NHS Foundation Trust, Royal Marsden NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503717
- Sponsor's protocol ID
- 25-46
- Acronym
- SURVEY-CNS
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveilla
- ClinicalTrials.gov ID
- NCT07503717
- Acronym / sponsor ID
- SURVEY-CNS / 25-46
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- The Clatterbridge Cancer Centre NHS Foundation Trust, Royal Marsden NHS Foundation Trust
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CNS Surveillance | Experimental | Diagnostic Test: Brain Magnetic Resonance Imaging (MRI) with ContrastParticipants 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. |
| No Routine CNS Surveillance (Standard of Care) | Active comparator | Diagnostic Test: Brain Magnetic Resonance Imaging (MRI) with ContrastParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Magnetic Resonance Imaging (MRI) with ContrastContrast-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. | Diagnostic test | CNS Surveillance, No Routine CNS Surveillance (Standard of Care) |
Primary outcome
Proportion of Eligible Patients Consenting to Screening and Randomisation
Time frame: Through recruitment completion, an average of 24 months.
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.
5 secondary outcomes
Proportion of Patients With Occult CNS Metastases at Baseline MRI
Time frame: At baseline (prior to randomisation)
Proportion of Patients With Radiologically Detected CNS Metastases During Surveillance
Time frame: Up to 12 months after randomisation
Proportion of Patients Developing Symptomatic CNS Disease
Time frame: Up to 14 months after baseline
Description of Initial Local Treatment for CNS Metastases
Time frame: Up to 14 months after baseline
Systemic Anti-Cancer Therapy (SACT) Modification Following CNS Diagnosis
Time frame: Up to 14 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Magnetic Resonance Imaging (MRI) with Contrast in people with Breast Cancer and HER2-Positive Metastatic Breast Cancer, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlo Palmieri, MD, PHD (018093000, cpalmi@liverpool.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Eligible Patients Consenting to Screening and Randomisation (time frame: Through recruitment completion, an average of 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.