Randomising people with HER2‑positive metastatic breast cancer to routine brain MRI surveillance versus no routine surveillance
SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveilla
This study will test whether people with HER2‑positive metastatic breast cancer can be successfully recruited and randomized to routine brain MRI checks at 6 and 12 months versus usual care with scans only if neurological symptoms develop.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 69 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal College of Surgeons, Ireland Academic / other |
| Locations | 1 site (Beaumont) |
| Trial ID | NCT07503717 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (age ≥18) with histologically confirmed HER2‑positive metastatic breast cancer who are receiving active HER2‑directed therapy, have visceral metastatic disease, ECOG performance status 0–2, estimated life expectancy >6 months, and can safely undergo contrast MRI are the intended participants.
Not a fit: People with prior brain metastases or leptomeningeal disease, current neurological symptoms suggestive of CNS involvement, bone‑only metastatic disease, inability to have MRI or contra‑indication to contrast, or very limited life expectancy are unlikely to benefit from this surveillance approach.
Why it matters
Potential benefit: If successful, routine MRI surveillance could allow earlier detection of asymptomatic brain metastases and potentially enable earlier treatment that preserves quality of life and survival.
How similar studies have performed: Observational registry data suggest that detection of asymptomatic brain metastases may be associated with better outcomes, but prospective randomized evidence of routine CNS surveillance is currently lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beaumont
- Beaumont RCSI Cancer Centre — Beaumont, Ireland (Recruiting)
Study contacts
- Study coordinator: Carlo Palmieri, MD, PHD
- Email: cpalmi@liverpool.ac.uk
- Phone: 018093000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.