Her 2 Positive Breast CancerHER2+ CNSNCT07748598
HER2+ CNS Surveillance
A study testing Intervention for Arm 2: Brain MRI Surveillance in people with Her 2 Positive Breast Cancer and Cancer, run by The Clatterbridge Cancer Centre NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A multi-centre, randomised study, to determine the feasibility of recruiting men and women with metastatic HER2 positive breast cancer to a study with a baseline MRI scan followed by randomising to surveillance by two further six-monthly MRI scans versus no further surveillance of the brain. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Her 2 Positive Breast Cancer, Cancer, CNS
- What is being tested?
- Intervention for Arm 2: Brain MRI Surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Oct 2025to 31 Dec 2027
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria Age 16 years or older. Male or female. Histologically or cytologically confirmed HER2-positive breast cancer with evidence of metastatic breast cancer.
Estrogen receptor (ER) positive or negative disease. Visceral disease present. Receiving active HER2-directed therapy. ECOG Performance Status 0-2. Life expectancy greater than 6 months. Written informed consent and ability to comply with study procedures and follow-up.
Exclusion Criteria History of brain metastases. History or evidence of leptomeningeal carcinomatosis. Symptoms suggestive of brain metastases. Inability to tolerate or undergo MRI scans. Bone-only metastatic disease. Significant medical condition or laboratory finding that would make study participation undesirable.
Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool
Carlo Palmieri, 0151 556 5000, c.palmieri@nhs.net
About this study
Official title: HER2-CNS SURVEILLANCE: A Study of the Feasibility of Randomising Women and Men With HER2 Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus no Surveillance
A multi-centre, randomised study, to determine the feasibility of recruiting men and women with metastatic HER2 positive breast cancer to a study with a baseline MRI scan followed by randomising to surveillance by two further six-monthly MRI scans versus no further surveillance of the brain. Qualitative research (focus groups and/or interviews) and monitoring of approach and consent with SEAR framework will be embedded within the trial to achieve the primary endpoint and explore challenges with study implementation and delivery.
Read the detailed description
Patients with metastatic breast cancer who are HER2+ (i.e. their cancer cells show an abnormally high level of HER2 proteins when tested) are at high risk of cancer spreading to the brain and central nervous system (CNS). The current standard of care is to monitor patients for symptoms indicative of such cancer spread. The motivation of the researchers is to investigate if surveillance through MRI scans of the brain with standard MRI contrast agents would allow detection of asymptomatic spread to the brain and CNS, and then earlier management of such spread.
Metastatic lesions in the brain and CNS can be treated or managed, including by neurosurgery, stereotactic radiosurgery (radiotherapy highly focussed on the observed volume of lesions) or other radiotherapy treatment plans.
The investigators are interested in surveillance plans of either a single MRI scan, or repeated MRI scans every 6 months for a year. The purpose of this research protocol is to look at the feasibility of running trials into the diagnostic value of such brain MRI scans. In order to assess the feasibility of such trials the primary research endpoint will be the proportion of patients agreeing to register to a study with baseline MRI and then randomisation to further MRIs or not. The proportion that agree and the feedback from patients about the reasons to participate or not will feed into the design and planning of future research protocols. There will be an embedded qualitative sub-study with interviews and/or focus groups discussing recruiting to and running such studies with patients and staff. The investigators also plan to collect data on diagnosis, management and clinical outcomes (given as secondary endpoints in the protocol) that will allow the outcomes for the patients on this study to be included in combined analyses with those of future studies.
- Conditions
- Her 2 Positive Breast Cancer, Cancer, CNS
- Being tested
- Intervention for Arm 2: Brain MRI Surveillance
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention for Arm 2: Brain MRI SurveillanceDiagnostic test
Contrast-enhanced magnetic resonance imaging (MRI) of the brain performed at baseline and, for participants assigned to the surveillance arm, repeated at 6 and 12 months to detect asymptomatic CNS metastases
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: No Further Surveillance Brain MRI (Control) | No intervention | Participants undergo a baseline contrast-enhanced MRI of the brain. Participants with no evidence of CNS metastases on the baseline MRI are randomized to receive no further protocol-mandated surveillance brain MRI and continue standard clinical care. Management of any subsequently identified CNS disease is according to local standard practice. |
| Arm 2: Surveillance Brain MRI | Experimental | Participants undergo a baseline contrast-enhanced MRI of the brain. Participants with no evidence of CNS metastases on the baseline MRI are randomized to a surveillance strategy involving additional contrast-enhanced brain MRI scans at 6 and 12 months. If CNS metastases are detected or symptoms develop before a scheduled scan, subsequent management is according to local standard practice. Contrast-enhanced magnetic resonance imaging (MRI) of the brain performed at baseline and, for participants assigned to the surveillance arm, repeated at 6 and 12 months to detect asymptomatic CNS metastases. Receives: Diagnostic Test: Intervention for Arm 2: Brain MRI Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible participants agreeing to undergo screening and randomisation to surveillance versus no surveillance brain MRI.
Feasibility of recruitment, measured as the proportion of approached eligible patients who consent to participate in a study involving baseline brain MRI and randomisation to CNS surveillance versus no surveillance.
Measured: Up to 24 months (from first participant approach until recruitment completion, defined as 69 participants consented or 193 participants approached, whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start3 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Her 2 Positive 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 are randomized 1:1 into two different groups. Group 1: No further surveillance brain MRI (standard care). Group 2: Surveillance brain MRI at 6 and 12 months. Participants remain in their assigned group throughout the study and do not switch interventions
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Clatterbridge Cancer Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748598
- Sponsor's protocol ID
- C1566
- Other IDs
- 341272
- Acronym
- HER2+ CNS
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 5 Aug 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HER2-CNS SURVEILLANCE: A Study of the Feasibility of Randomising Women and Men With HER2 Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus no Surveillance
- ClinicalTrials.gov ID
- NCT07748598
- Acronym / sponsor ID
- HER2+ CNS / C1566
- Conditions
- Her 2 Positive Breast Cancer, Cancer, CNS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- The Clatterbridge Cancer Centre NHS Foundation TrustUniversity, hospital or other
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Aug 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.
A multi-centre, randomised study, to determine the feasibility of recruiting men and women with metastatic HER2 positive breast cancer to a study with a baseline MRI scan followed by randomising to surveillance by two further six-monthly MRI scans versus no further surveillance of the brain. Qualitative research (focus groups and/or interviews) and monitoring of approach and consent with SEAR framework will be embedded within the trial to achieve the primary endpoint and explore challenges with study implementation and delivery.
Detailed description
Patients with metastatic breast cancer who are HER2+ (i.e. their cancer cells show an abnormally high level of HER2 proteins when tested) are at high risk of cancer spreading to the brain and central nervous system (CNS). The current standard of care is to monitor patients for symptoms indicative of such cancer spread. The motivation of the researchers is to investigate if surveillance through MRI scans of the brain with standard MRI contrast agents would allow detection of asymptomatic spread to the brain and CNS, and then earlier management of such spread.
Metastatic lesions in the brain and CNS can be treated or managed, including by neurosurgery, stereotactic radiosurgery (radiotherapy highly focussed on the observed volume of lesions) or other radiotherapy treatment plans.
The investigators are interested in surveillance plans of either a single MRI scan, or repeated MRI scans every 6 months for a year. The purpose of this research protocol is to look at the feasibility of running trials into the diagnostic value of such brain MRI scans. In order to assess the feasibility of such trials the primary research endpoint will be the proportion of patients agreeing to register to a study with baseline MRI and then randomisation to further MRIs or not. The proportion that agree and the feedback from patients about the reasons to participate or not will feed into the design and planning of future research protocols. There will be an embedded qualitative sub-study with interviews and/or focus groups discussing recruiting to and running such studies with patients and staff. The investigators also plan to collect data on diagnosis, management and clinical outcomes (given as secondary endpoints in the protocol) that will allow the outcomes for the patients on this study to be included in combined analyses with those of future studies.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 into two different groups. Group 1: No further surveillance brain MRI (standard care). Group 2: Surveillance brain MRI at 6 and 12 months. Participants remain in their assigned group throughout the study and do not switch interventions
| Arm | Type | Receives |
|---|---|---|
| Arm 1: No Further Surveillance Brain MRI (Control) | No intervention | –Participants undergo a baseline contrast-enhanced MRI of the brain. Participants with no evidence of CNS metastases on the baseline MRI are randomized to receive no further protocol-mandated surveillance brain MRI and continue standard clinical care. Management of any subsequently identified CNS disease is according to local standard practice. |
| Arm 2: Surveillance Brain MRI | Experimental | Diagnostic Test: Intervention for Arm 2: Brain MRI SurveillanceParticipants undergo a baseline contrast-enhanced MRI of the brain. Participants with no evidence of CNS metastases on the baseline MRI are randomized to a surveillance strategy involving additional contrast-enhanced brain MRI scans at 6 and 12 months. If CNS metastases are detected or symptoms develop before a scheduled scan, subsequent management is according to local standard practice. Contrast-enhanced magnetic resonance imaging (MRI) of the brain performed at baseline and, for participants assigned to the surveillance arm, repeated at 6 and 12 months to detect asymptomatic CNS metastases. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Intervention for Arm 2: Brain MRI SurveillanceContrast-enhanced magnetic resonance imaging (MRI) of the brain performed at baseline and, for participants assigned to the surveillance arm, repeated at 6 and 12 months to detect asymptomatic CNS metastases | Diagnostic test | Arm 2: Surveillance Brain MRI |
Primary outcome
Proportion of eligible participants agreeing to undergo screening and randomisation to surveillance versus no surveillance brain MRI.
Time frame: Up to 24 months (from first participant approach until recruitment completion, defined as 69 participants consented or 193 participants approached, whichever occurs first)
Feasibility of recruitment, measured as the proportion of approached eligible patients who consent to participate in a study involving baseline brain MRI and randomisation to CNS surveillance versus no surveillance.
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 5 Aug 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 Intervention for Arm 2: Brain MRI Surveillance in people with Her 2 Positive Breast Cancer and Cancer, run by The Clatterbridge Cancer Centre NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Aug 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 United Kingdom. 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 (0151 556 5000, c.palmieri@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible participants agreeing to undergo screening and randomisation to surveillance versus no surveillance brain MRI. (time frame: Up to 24 months (from first participant approach until recruitment completion, defined as 69 participants consented or 193 participants approached, whichever occurs first)). 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 5 Aug 2026.