Randomising people with HER2‑positive metastatic breast cancer to routine brain MRI surveillance versus no routine surveillance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

SURVEY‑CNS is a non‑CTIMP, randomised, parallel‑group feasibility study run in Ireland with linked centres in the UK. All participants receive a baseline contrast‑enhanced brain MRI; those with brain metastases at baseline are managed clinically and do not enter randomisation. Participants without baseline CNS disease are randomised 1:1 to scheduled surveillance MRIs at 6 and 12 months or to standard care without routine surveillance, with randomisation stratified by oestrogen receptor status and line of therapy. The study is designed to test recruitment, acceptability, and protocol delivery rather than to provide definitive effectiveness results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Beaumont RCSI Cancer Centre
  Beaumont, Ireland Recruiting

Study contacts

• Study coordinator: Carlo Palmieri, MD, PHD
• Email: cpalmi@liverpool.ac.uk
• Phone: 018093000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.