[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570385":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":13,"interventions":13,"overallOfficials":19,"centralContacts":24,"locations":33,"responsibleParty":49,"collaborators":13,"id":51,"slug":13,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":13,"enrollmentInfo":60,"targetDuration":13,"studyType":63,"phases":13,"briefSummary":64,"conditions":65,"keywords":13,"overallStatus":35,"whyStopped":13,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"European Institute of Oncology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"circulating tumor DNA (ctDNA) in advanced\u002Fmetastatic breast cancer with low levels of HER2 expression (HER2 low)","evaluate the mutations present in breast cancer of patients with advanced\u002Fmetastatic disease e HER2-low defined with 1+ or 2+ expression levels by IHC (immunohistochemistry) technique and gene not amplified by ISH test (in situ hybridization)","12 months",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","Prospective single-center feasibility study of 30 patients with carcinoma breast with low levels of HER2 expression, defined as 1+ or 2+ expression levels by the IHC technique (immunohistochemistry) and the gene not amplified by the ISH test (in situ hybridization)","advanced\u002Fmetastatic breast cancer with low levels of HER2 expression (HER2 low)",[20],{"name":21,"affiliation":22,"role":23},"Nicola Fusco, MD","Istituto Europeo di Oncologia","PRINCIPAL_INVESTIGATOR",[25,29],{"name":21,"role":26,"phone":27,"phoneExt":13,"email":28},"CONTACT","00390294372079","nicola.fusco@ieo.it",{"name":30,"role":26,"phone":31,"phoneExt":13,"email":32},"francesca lombardi, biologist","00390257489425","francesca.lombardi@ieo.it",[34],{"facility":5,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Milan","MI","20141","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],9.18951,45.46427,{"lat":45,"lon":44},[48],{"name":21,"role":26,"phone":27,"phoneExt":13,"email":28},{"type":50,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100570385",false,"NCT06706557","Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced\u002FMetastatic Breast Cancer","A Pilot Study on the Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced\u002FMetastatic Breast Cancer","LEGO","Inclusion Criteria\n\n* Participants diagnosed with HER2-low breast cancer, defined as IHC score 1+ or 2+ and not amplified at in situ hybridization (ISH) test as confirmed by local laboratory testing.\n* Participants should be at advanced or metastatic setting prior to treatment.\n* Written informed consent (Accordo di Partecipazione alla Ricerca Scientifica) and specific informed consent to the study must be signed and dated by the patient and the doctor prior to inclusion.\n* Patients must be accessible for follow-up.","FEMALE","18 Years",{"count":61,"type":62},30,"ESTIMATED","OBSERVATIONAL","A Pilot study on circulating tumor DNA (ctDNA) in advanced\u002Fmetastatic breast cancer with low levels of HER2 expression (HER2 low)",[66],"Advanced Metastatic Breast Cancer","2026-03-23",{"date":69,"type":70},"2026-03-24","ACTUAL",{"date":72,"type":70},"2024-01-11",{"date":74,"type":62},"2030-12-31",{"name":5,"class":6},1]