[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100385060":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":34,"locations":39,"responsibleParty":55,"collaborators":24,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":24,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"N.N. Petrov National Medical Research Center of Oncology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TNBC group","EXPERIMENTAL","A group with TNBC in neoadjuvant therapy will receive 4 cycles of neoadjuvant polychemotherapy according to the AC regimen (doxorubicin 60 mg \u002F m2, cyclophosphamide 600 mg \u002F m2) once every 21 days, then 12 cycles of neoadjuvant polychemotherapy according to the paclitaxel 60-100 mg \u002F m² scheme in 1 day + carboplatin AUC 2 1 p in 7 days. VAB with SLNB and radiation therapy on the remaining breast tissue with cCR and pCR patients. Patients with residual breast cancer undergo standart surgery procedure.",[13],"Procedure: Vacuum-assisted biopsy",{"label":15,"type":10,"description":16,"interventionNames":17},"HER2-positive breast cancer group","ER + - \u002F HER2 + will receive 4 cycles of neoadjuvant polychemotherapy according to the AC regimen (doxorubicin 60 mg \u002F m2, cyclophosphamide 600 mg \u002F m2) once every 21 days, then docetaxel 75-100 mg \u002F m² on the 1st day + trastuzumab 6 mg \u002F kg (loading dose of 8 mg \u002F kg) on the 1st day + pertuzumab 420 mg (loading dose of 840 mg) on the 1st day; 4 cycles, 1 time in 21 days and surgical treatment. In adjuvant therapy, a group of patients with HER2-positive breast cancer will receive trastuzumab for up to one year and hormone therapy with an antiestrogen (tamoxifen) or aromatase inhibitors in ER + \u002F HER2 + tumors. VAB with SLNB and radiation therapy on the remaining breast tissue with cCR and pCR patients. Patients with residual breast cancer undergo standart surgery procedure.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Vacuum-assisted biopsy","The vacuum-assisted (7-10G), minimal invasive biopsy (VAB), either guided by ultrasound, after neoadjuvant systemic treatment on patients with clinical complete response on primary breast cancer management we recommend to take at least 12 biopsies with 7-10G needle sizes with sentinel lymph node biopsy.",[15,9],null,[26,30],{"name":27,"affiliation":28,"role":29},"Petr Krivorotko, MD,PhD","N.N. Petrov Research Institute of Oncology","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":32,"role":33},"Vladimir Semiglazov, Professor","N.N.Petrov Research Institute of Oncology","STUDY_DIRECTOR",[35],{"name":27,"role":36,"phone":37,"phoneExt":24,"email":38},"CONTACT","+79219597722","dr.krivorotko@mail.ru",[40],{"facility":41,"status":42,"city":43,"state":24,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Petr Krivorotko","RECRUITING","Saint Petersburg","197758","Russia","RU",{"type":48,"coordinates":49},"Point",[50,51],30.31413,59.93863,{"lat":51,"lon":50},[54],{"name":27,"role":36,"phone":37,"phoneExt":24,"email":38},{"type":56,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100385060","refusal-of-breast-surgery-in-patients-with-breast-cancer-with-a-clinical-complete-response-ccr-after-neoadjuvant-systemic-therapy-and-a-confirmed-pathological-complete-response-pcr-using-vacuum-assisted-biopsy-vab-and-sentinel-lymph-node-biopsy-slnb-100385060",false,"NCT04293796","Refusal of Breast Surgery in Patients With Breast Cancer With a Clinical Complete Response (cCR) After Neoadjuvant Systemic Therapy and a Confirmed Pathological Complete Response (pCR) Using Vacuum-assisted Biopsy (VAB) and Sentinel Lymph Node Biopsy (SLNB)","VAB","Inclusion Criteria:\n\nTriple negative breast cancer \u002F HER2-positive breast cancer (ER \u002F PR +\u002F-)\n\n* age\\> 18 years.\n* morphologically confirmed diagnosis of breast cancer, IIA-IIIA stage\n* ECOG score 0-1.\n* life expectancy of more than 3 months.\n* the consent of patients to use reliable methods of contraception throughout the study\n* adequate liver and bone marrow function\n* the absence of contraindications to surgical intervention (including anesthetic risk is taken into account).\n\nExclusion Criteria:\n\n* Inconsistency with inclusion criteria.\n* Conducting earlier any systemic therapy for breast cancer.\n* stage 4 cancer\n* carrier mutations of the BRCA1 \u002F 2 gene\n* severe uncontrolled concomitant chronic diseases or acute diseases\n* the presence of a second malignant tumor\n* pregnancy or lactation\n* acute conditions and complications, which, according to the doctor, interfere with treatment","FEMALE","18 Years","70 Years",{"count":68,"type":69},60,"ESTIMATED","INTERVENTIONAL",[72],"NA","The main goal of the study is to abandon breast surgery in patients with breast cancer with a clinical complete response (cCR) after neoadjuvant systemic therapy and confirmed pCR using Vacuum-assisted biopsy (VAB) and sentinel lymph node biopsy (SLNB).\n\nEvidence of the high diagnostic accuracy (sensitivity and specificity) of vacuum aspiration biopsy in determining pCR in patients with clinical complete response after neoadjuvant systemic therapy will allow abandoning breast surgery in favor of radiation therapy alone, improving the quality of life of these patients.",[75],"Refusal of Breast Surgery in Patients With Breast Cancer With a cCR After NST and a Confirmed Pathological Complete Response (pCR) Using VAB and SLNB","2022-06-14",{"date":78,"type":79},"2022-06-15","ACTUAL",{"date":81,"type":79},"2019-10-08",{"date":83,"type":69},"2028-12-10",{"name":5,"class":6},1]