[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633519":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":138,"collaborators":10,"id":140,"slug":141,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":142,"sex":148,"minAge":149,"maxAge":10,"enrollmentInfo":150,"targetDuration":10,"studyType":153,"phases":10,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"Group 1: Cohort A",null,"Participants who received neoadjuvant therapy and achieved pathological complete response (pCR) and receive their adjuvant treatment at a designated secondary or tertiary center, administratively assigned based on their place of residence will be observed to assess the impact on quality of life (QoL) and travel burden. All treatment decisions will be made at the discretion of the treating physician and participant, reflecting routine clinical practice without any study-mandated interventions.",{"label":13,"type":10,"description":14,"interventionNames":10},"Group 2: Cohort B","Participants who received neoadjuvant therapy at a secondary center and were subsequently found to have residual invasive disease will be referred to a centralized referent tertiary institution to receive their adjuvant treatment and will be observed to assess the impact on QoL and travel burden. All treatment decisions will be made at the discretion of the treating physician and participant, reflecting routine clinical practice without any study-mandated interventions.",{"label":16,"type":10,"description":17,"interventionNames":10},"Group 1: Cohort C","Participants who received neoadjuvant therapy at their designated tertiary center, which is the institution administratively assigned based on their place of residence, and subsequently found to have residual invasive disease will continue with adjuvant treatment at the same institution, and will be observed to assess the impact on QoL and travel burden. All treatment decisions will be made at the discretion of the treating physician and participant, reflecting routine clinical practice without any study-mandated interventions.",{"label":19,"type":10,"description":20,"interventionNames":10},"Group 1: Cohort D","Participants who missed neoadjuvant therapy and underwent primary BC surgery will start adjuvant treatment at their designated secondary hospital or tertiary center, which is the institution administratively assigned based on their place of residence and will be observed to assess the impact on QoL and travel burden. All treatment decisions will be made at the discretion of the treating physician and participant, reflecting routine clinical practice without any study-mandated interventions.",[22],{"name":23,"affiliation":5,"role":24},"Clinical Trials","STUDY_DIRECTOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Reference Study ID Number: ML46477 https:\u002F\u002Fforpatients.roche.com\u002F","CONTACT","888-662-6728 (U.S. Only)","global-roche-genentech-trials@gene.com",{"name":32,"role":28,"phone":10,"phoneExt":10,"email":10},"Fastest response: use the inquiry form. No email attachments. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[34,48,58,68,78,88,98,108,118,128],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":10},"Health Centre Loznica","RECRUITING","Loznica","Bolnička 65","15300","Serbia","RS",{"type":43,"coordinates":44},"Point",[45,46],19.24267,44.53118,{"lat":46,"lon":45},{"facility":49,"status":36,"city":50,"state":51,"zip":52,"country":40,"countryCode":41,"cosmosGeoPoint":53,"geoPoint":57,"contacts":10},"General Hospital Požarevac","Požarevac","Bratstva Jedinstva 135","12000",{"type":43,"coordinates":54},[55,56],21.18782,44.62133,{"lat":56,"lon":55},{"facility":59,"status":36,"city":60,"state":61,"zip":62,"country":40,"countryCode":41,"cosmosGeoPoint":63,"geoPoint":67,"contacts":10},"Healthcare Centre Bor","Bor","Dragiše Mišovića 1","19210",{"type":43,"coordinates":64},[65,66],22.09591,44.07488,{"lat":66,"lon":65},{"facility":69,"status":36,"city":70,"state":71,"zip":72,"country":40,"countryCode":41,"cosmosGeoPoint":73,"geoPoint":77,"contacts":10},"Health Centre Kladovo","Kladovo","Dunavska 1-3","19320",{"type":43,"coordinates":74},[75,76],22.60955,44.61147,{"lat":76,"lon":75},{"facility":79,"status":36,"city":80,"state":81,"zip":82,"country":40,"countryCode":41,"cosmosGeoPoint":83,"geoPoint":87,"contacts":10},"Health Centre ''Sveti Luka'' Smederevo","Smederevo","Knez Mihailova 51","11300",{"type":43,"coordinates":84},[85,86],20.92763,44.66436,{"lat":86,"lon":85},{"facility":89,"status":36,"city":90,"state":91,"zip":92,"country":40,"countryCode":41,"cosmosGeoPoint":93,"geoPoint":97,"contacts":10},"General Hospital Pančevo","Pančevo","Miloša Trebinjca 11","26000",{"type":43,"coordinates":94},[95,96],20.64167,44.87177,{"lat":96,"lon":95},{"facility":99,"status":36,"city":100,"state":101,"zip":102,"country":40,"countryCode":41,"cosmosGeoPoint":103,"geoPoint":107,"contacts":10},"Institute for Onocology and Radiology of Serbia","Belgrade","Pasterova 14","11000",{"type":43,"coordinates":104},[105,106],20.46513,44.80401,{"lat":106,"lon":105},{"facility":109,"status":36,"city":110,"state":111,"zip":112,"country":40,"countryCode":41,"cosmosGeoPoint":113,"geoPoint":117,"contacts":10},"General Hospital \"Dr Laza K. Lazarevic\" Sabac","Šabac","Popa Karana 2-4","15000",{"type":43,"coordinates":114},[115,116],19.69,44.74667,{"lat":116,"lon":115},{"facility":119,"status":36,"city":120,"state":121,"zip":122,"country":40,"countryCode":41,"cosmosGeoPoint":123,"geoPoint":127,"contacts":10},"Health Centre Valjevo","Valjevo","Sinđelićeva 62","14000",{"type":43,"coordinates":124},[125,126],19.89821,44.27513,{"lat":126,"lon":125},{"facility":129,"status":36,"city":130,"state":131,"zip":132,"country":40,"countryCode":41,"cosmosGeoPoint":133,"geoPoint":137,"contacts":10},"General Hospital ''Stefan Visoki'' Smederevska Palanka","Smederevska Palanka","Vuka Karadžića 147","11420",{"type":43,"coordinates":134},[135,136],20.95885,44.36548,{"lat":136,"lon":135},{"type":139,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100633519","a-study-to-assess-treatment-patterns-and-treatment-adherence-in-early-her2-positive-breast-cancer-participants-after-treatment-decentralization-100633519",false,"NCT07527741","A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization","Real-World Research of Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer in Serbia After Treatment Decentralization (Close2HER)","Close2HER","Inclusion Criteria:\n\n* Diagnosis of stage II and III HER2+ eBC according to European Society For Medical Oncology (ESMO) guidelines\n* Underwent curative-intent surgical resection for BC\n* Histologically documented HER2-positive BC (determined per American Society of Clinical Oncology \\[ASCO\\]\u002FCollege of American Pathologists \\[CAP\\] guidelines) before or after surgery\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition that, in the investigator's opinion, would compromise the participant's ability to provide informed consent or to complete study-related questionnaires\n* Receipt of prior neoadjuvant or adjuvant therapy for HER2+ BC at a center other than the 10 participating study sites (Bor, Kladovo, Institute for oncology and Radiology of Serbia (IORS), Loznica, Pančevo, Požarevac, Smederevo, Smederevska Palanka, Šabac, Valjevo)\n* Participants administratively belonging to the following secondary centers: Bor, Kladovo, Loznica, Pančevo, Požarevac, Smederevo, Smederevska Palanka, Šabac, or Valjevo, who initiated neoadjuvant therapy at IORS instead of their local secondary center","FEMALE","18 Years",{"count":151,"type":152},100,"ESTIMATED","OBSERVATIONAL","The main purpose of this study is to evaluate the impact of a decentralized treatment model on treatment adherence in participants with early-stage human epidermal growth factor receptor 2- positive (HER2+) breast cancer (BC).\n\nThis study has 2 groups: Group 1: Consistent Travel Burden (Cohorts A, C, and D), will include participants whose adjuvant therapy location does not increase their travel requirements, and Group 2: Increased Travel Burden (Cohort B), will include participants who must travel from a secondary center to a tertiary center to receive their adjuvant therapy.",[156],"Early-stage HER2+ Breast Cancer",[158,159,160,161],"Decentralization","Anti-HER2 therapy","Real-world data","Early-stage HER2+ BC","2026-06-04",{"date":164,"type":165},"2026-06-08","ACTUAL",{"date":167,"type":165},"2026-02-23",{"date":169,"type":152},"2028-05-31",{"name":5,"class":6},10]