[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650482":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":45,"collaborators":12,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":12,"enrollmentInfo":57,"targetDuration":12,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":12,"overallStatus":33,"whyStopped":12,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"The Clatterbridge Cancer Centre NHS Foundation Trust","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"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.",[18],"Diagnostic Test: Intervention for Arm 2: Brain MRI Surveillance",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DIAGNOSTIC_TEST","Intervention for Arm 2: Brain MRI Surveillance","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",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Carlo Palmieri","CONTACT","0151 556 5000","c.palmieri@nhs.net",[32],{"facility":5,"status":33,"city":34,"state":12,"zip":12,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Liverpool","United Kingdom","UK",{"type":38,"coordinates":39},"Point",[40,41],-2.97794,53.41058,{"lat":41,"lon":40},[44],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},{"type":46,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100650482","her2-cns-surveillance-100650482",false,"NCT07748598","HER2+ CNS Surveillance","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","HER2+ CNS","Inclusion Criteria Age 16 years or older. Male or female. Histologically or cytologically confirmed HER2-positive breast cancer with evidence of metastatic breast cancer.\n\nEstrogen 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.\n\nExclusion 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.\n\nInability to provide informed consent.","ALL","16 Years",{"count":58,"type":59},69,"ESTIMATED","INTERVENTIONAL",[62],"NA","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\u002For 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.",[65,66,67],"Her 2 Positive Breast Cancer","Cancer","CNS","2026-08-04",{"date":70,"type":71},"2026-08-05","ACTUAL",{"date":73,"type":71},"2025-10-03",{"date":75,"type":59},"2027-12-31",{"name":5,"class":6},1]