[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438725":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":49,"centralContacts":54,"locations":63,"responsibleParty":79,"collaborators":58,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":58,"enrollmentInfo":92,"targetDuration":58,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":58,"overallStatus":65,"whyStopped":58,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"AC Camargo Cancer Center","OTHER",[8,15,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1, Arm A - trastuzumab","ACTIVE_COMPARATOR","Adjuvant trastuzumab for patients with HER2 positive CTCs at baseline",[13,14],"Drug: Trastuzumab","Other: Circulating tumor cells",{"label":16,"type":17,"description":18,"interventionNames":19},"Cohort 1, Arm B - Trastuzumab + pertuzumab","EXPERIMENTAL","Adjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline",[20,13,14],"Drug: Pertuzumab",{"label":22,"type":10,"description":23,"interventionNames":24},"Cohort 2, Arm A - trastuzumab","Adjuvant trastuzumab for patients with HER2 negative\u002Fabsent CTCs at baseline",[13,14],{"label":26,"type":17,"description":27,"interventionNames":28},"Cohort 2, Arm B - Trastuzumab + pertuzumab","Adjuvant trastuzumab + pertuzumab for patients with HER2 negative\u002Fabsent CTCs at baseline",[20,13,14],[30,37,43],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Pertuzumab","Adjuvant trastuzumab + pertuzumab (arm B of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative\u002Fabsent CTCs at baseline)",[16,26],[36],"Perjeta",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Trastuzumab","Adjuvant trastuzumab (arm A of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative\u002Fabsent CTCs at baseline) Association with pertuzumab in arm B of the 2 cohorts",[9,16,22,26],[42],"Zedora",{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Circulating tumor cells","Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done.",[9,16,22,26],[48],"CTCs",[50],{"name":51,"affiliation":52,"role":53},"Marcelle G Cesca, MD","A.C. Camargo Cancer Center","PRINCIPAL_INVESTIGATOR",[55,60],{"name":51,"role":56,"phone":57,"phoneExt":58,"email":59},"CONTACT","+551121895000",null,"marcelle.cesca@accamargo.org.br",{"name":61,"role":56,"phone":57,"phoneExt":58,"email":62},"Ludmilla TD Chinen, PhD","ludmilla.chinen@accamargo.org.br",[64],{"facility":52,"status":65,"city":66,"state":58,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"RECRUITING","São Paulo","01525-001","Brazil","BR",{"type":71,"coordinates":72},"Point",[73,74],-46.63611,-23.5475,{"lat":74,"lon":73},[77,78],{"name":51,"role":56,"phone":57,"phoneExt":58,"email":59},{"name":61,"role":56,"phone":57,"phoneExt":58,"email":62},{"type":53,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":58,"oldOrganization":58},"Marcelle Goldner Cesca","Clinical Oncologist","100438725","phase-2-circulating-tumor-cells-and-treatment-de-escalation-after-neoadjuvant-therapy-for-her2-positive-breast-cancer-100438725",false,"NCT04993014","Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer","Circulating Tumor Cells and Adjuvant Treatment De-escalation After Neoadjuvant Therapy With Trastuzumab and Pertuzumab for HER2 Positive Early Breast Cancer","HER2Cell","Inclusion Criteria:\n\n* HER2 positive breast cancer (hormone receptors positive or negative)\n* Stage I to III\n* Indication for neoadjuvant therapy with chemo (any regimen) + trastuzumab + pertuzumab\n* Breast surgery after neoadjuvant therapy\n* Preserved coagnition\n* ECOG 0-3\n* For the randomization phase: pathological complete response (ypT0\u002FypTis and ypN0)\n* Agreement on participation and signature of de ICF\n\nExclusion Criteria:\n\n* Contradindication for trastuzumab or pertuzumab\n* Adjuvant chemotherapy. Hormone therapy is allowed\n* Second primary tumor \\\u003C 5 years, with an exception for treated non-melanoma skin cancer, and in situ cervical cancer","ALL","18 Years",{"count":93,"type":94},80,"ESTIMATED","INTERVENTIONAL",[97],"PHASE2","Phase II unicentric randomized trial which will include early HER2 positive breast cancer patients, candidate to neoadjuvant therapy with trastuzumab and pertuzumab. Circulating tumor cells will be collected at neoadjuvant therapy baseline.\n\nPatients with pathological complete response will be randomized in 1:1 ratio for adjuvant trastuzumab (arm A) versus trastuzumab + pertuzumab (arm B) in a two factorial design: group A, with HER2 positive CTCs and group B, with HER2 negative\u002Fabsent CTCs.",[100,101,102],"Breast Neoplasms","HER2-positive Breast Cancer","Circulating Tumor Cell","2021-07-28",{"date":105,"type":106},"2021-08-06","ACTUAL",{"date":108,"type":106},"2021-03-01",{"date":110,"type":94},"2028-04-30",{"name":5,"class":6},1]