[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474788":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":20,"locations":31,"responsibleParty":48,"collaborators":7,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":7,"enrollmentInfo":60,"targetDuration":7,"studyType":63,"phases":7,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":34,"whyStopped":7,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Kliniken Essen-Mitte","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"PROCEDURE","Targeted axilllary dissection (TAD) followed by axillary lymph node dissection (ALND)","Intraoperative excision of TAD lymph nodes followed by ALND in the same surgical session or secondary surgical intervention",[14,18],{"name":15,"affiliation":16,"role":17},"Sherko Kuemmel, Prof. Dr.","Breast Unit, Kliniken Essen-Mitte, Essen, Germany","STUDY_CHAIR",{"name":19,"affiliation":16,"role":17},"Mattea Reinisch, Dr.",[21,27],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Oliver Halfmann","CONTACT","+49201174","33048","O.Halfmann@kem-med.com",{"name":28,"role":23,"phone":24,"phoneExt":29,"email":30},"Dorothea Schindowski","33005","D.Schindowski@kem-med.com",[32],{"facility":33,"status":34,"city":35,"state":7,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Kliniken Essen-Mitte (KEM)","RECRUITING","Essen","45136","Germany","DE",{"type":40,"coordinates":41},"Point",[42,43],7.01228,51.45657,{"lat":43,"lon":42},[46],{"name":22,"role":23,"phone":47,"phoneExt":25,"email":26},"+49 201 174",{"type":49,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100474788","tad-in-primary-breast-cancer-with-initially--3-suspicious-lymph-nodes-100474788",false,"NCT05462457","TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes","Prospective, Multicentric Registry Study Evaluating the False-negative Rate of Targeted Axillary Dissection (TAD) in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes Under Neoadjuvant Systemic Therapy (SenTa 2)","SenTa2","Inclusion Criteria:\n\n* signed informed consent form\n* female\u002Fmale patient aged ≥ 18 years\n* clinical (c) tumor stage T1-4c, bilateral breast cancer and multifocal tumor allowed\n* invasive breast cancer confirmed by core biopsy\n* clinically node positive (cN+) (by means of axillary ultrasound or other imaging methods) with ≥ 3 clinically suspicious lymph nodes\n* biopsy-proven axillary lymph node involvement\n* marking (e.g. with a clip, magnetic seed, carbon suspension) of the clinically suspicious lymph node(s) before the start of NST\n* without distant metastases\n* indication for NST including chemotherapy\n* TAD + ALND planned\n* at least 7 lymph nodes (TAD + ALND) planned for histological analysis\n\nExclusion Criteria:\n\n* cN0 or cN+ with ≤ 2 clinically suspicious lymph nodes\n* patients without indication for NST or NST \\\u003C 12 weeks\n* NST without chemotherapy\n* adjuvant\u002F neoadjuvant therapy already started prior to inclusion in the study\n* patients for whom only ALND is planned\n* ycN+ (by means of axillary ultrasound or other imaging methods)\n* recurrent breast cancer\n* larger surgery of the breast (starting from quadrant resection) or the axilla prior to the study\n* previous radiotherapy of the breast or axilla\n* inflammatory breast cancer\n* extramammary breast cancer\n* pregnant women\n* not able to undergo surgery\n* inability to understand the purpose of the clinical study or to comply with study conditions","ALL","18 Years",{"count":61,"type":62},150,"ESTIMATED","OBSERVATIONAL","Due to high pathological complete remission (pCR) rates in both breast and lymph nodes (ypT0\u002FTis, ypN0) following neoadjuvant systemic therapy (NST) in many patients with initially clinically node-positive (cN+) breast cancer, the standard treatment of the axilla has changed from axillary lymph node dissection (ALND), which is associated with high morbidity, to less invasive, surgical approaches. In several studies, targeted axillary dissection (TAD) has presented with false-negative rates (FNRs) less than 5%, however, in patients with high initial lymph node involvement (≥ 3 clinically suspicious lymph nodes) TAD has not been thoroughly investigated.\n\nThe present prospective registry study aims to evaluate the FNR of TAD in patients with ≥ 3 initially suspicious lymph nodes and clinically node-negative status (ycN0) after NST in comparison to ALND.",[66,67],"Breast Cancer","Node-positive Breast Cancer",[69,70,71],"Targeted axillary dissection","TAD","False-negative rate","2023-02-13",{"date":74,"type":75},"2023-02-15","ACTUAL",{"date":77,"type":75},"2022-03-07",{"date":79,"type":62},"2032-03",{"name":5,"class":6},1]