EICHORCondition: Breast Cancer · HER2-Positive Metastatic Breast Cancer · Sponsor: Royal College of Surgeons, Ireland
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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 pri…
This description comes directly from the study's public registry record.
Carlo Palmieri, MD, PHD · 018093000 · cpalmi@liverpool.ac.uk
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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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Beaumont RCSI Cancer Centre | Beaumont, Ireland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07503717