[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571725":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":37,"responsibleParty":53,"collaborators":10,"id":55,"slug":10,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":10,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"European Institute of Oncology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NEOADJUVANT SETTING",null,"Neoadjuvant standard treatment for HER2+: A→Tax +T\u002FP",[13],"Drug: Neoadjuvant standard treatment for HER2+",{"label":15,"type":10,"description":16,"interventionNames":17},"ADJUVANT SETTING","Adjuvant standard treatment for HER2+ (N0): Tax + T (+\u002F-ET); Adjuvant standard treatment for HER2+ (N+): A→Tax +T\u002FP (+\u002F- ET)",[18],"Drug: Adjuvant standard treatment for HER2+",[20,24],{"type":21,"name":22,"description":9,"armGroupLabels":23,"otherNames":10},"DRUG","Neoadjuvant standard treatment for HER2+",[9],{"type":21,"name":25,"description":15,"armGroupLabels":26,"otherNames":10},"Adjuvant standard treatment for HER2+",[15],[28],{"name":29,"affiliation":30,"role":31},"Paola Zagami","Istituto Europeo di Oncologia","PRINCIPAL_INVESTIGATOR",[33],{"name":29,"role":34,"phone":35,"phoneExt":10,"email":36},"CONTACT","00390294372437","paola.zagami@ieo.it",[38],{"facility":30,"status":39,"city":40,"state":41,"zip":10,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Milan","Italy",{"type":43,"coordinates":44},"Point",[45,46],9.18951,45.46427,{"lat":46,"lon":45},[49],{"name":50,"role":34,"phone":51,"phoneExt":10,"email":52},"Carmen Criscitiello","00390294372689","carmen.criscitiello@ieo.it",{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100571725",false,"NCT06723990","Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX","Prospective Observational Monocentric Study to Evaluate the Impact of the HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2-BREAST-DX","HER2BREASTDX","Inclusion Criteria:\n\n* Patients ≥ 18 years of age;\n* Histologically confirmed HER2+ breast cancer;\n* Stage I-III breast cancer without evidence of distant metastases;\n* Being candidate to neoadjuvant\u002Fadjuvant therapy and locoregional treatment (surgery +\u002F- radiotherapy);\n* Written informed consent, signed by the patient, to study-specific procedures (the consent will consist of 2 levels: level 1 specifically for patients enrolled in the primary endpoint cohort and level 2 for all patients);\n\nExclusion Criteria:\n\n* HER2- BC;\n* Stage IV breast cancer;\n* Lack of informed consent because of patient's incapable of discernment or unwilling to participate;","ALL","18 Years",{"count":65,"type":66},60,"ESTIMATED","OBSERVATIONAL","To prospectively evaluate the impact of HER2DX on the decision-making processes of the treating physicians and especially among the routine multidisciplinary tumour board, in defining type and setting of systemic therapy administration in patients with stage I-III HER2+ BC, and the degree of clinician's confidence in the treatment recommendation.",[70],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[72],"HER2 positive breast cancer patients with stage I-III","2026-02-09",{"date":75,"type":76},"2026-02-11","ACTUAL",{"date":78,"type":76},"2024-10-24",{"date":80,"type":66},"2027-11",{"name":5,"class":6},1]