[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640407":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":55,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":26,"enrollmentInfo":66,"targetDuration":26,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"N.N. Petrov National Medical Research Center of Oncology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 2:breast resection without sentinel lymph node biopsy, radiotherapy to the breast area and SLN","EXPERIMENTAL","1. Prior to the surgical phase of treatment, all patients undergo SPECT-CT of the breasts with 99mTc-Technetril and SPECT-CT of the sentinel lymph nodes with Tc99m-colloid. A sectoral resection of the breast is performed according to the standard technique, with subsequent histological examination of the excised tissue. Surgical staging using sentinel lymph node biopsy is not performed.\n2. In the next phase, 4-12 weeks after surgery, 3D conformal radiotherapy is administered to the remaining breast tissue, including the region of the sentinel lymph nodes as identified by the preoperative SPECT-CT of the sentinel lymph nodes with Tc99m-colloid. Radiation planning is carried out according to ESTRO protocols, modified in accordance with the atlas of the sentinel lymph nodes.\n3. Based on the postoperative histological findings, adjuvant systemic therapy is prescribed to the patient in accordance with current clinical guidelines.",[13],"Procedure: breast resection",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 1: Breast resection with biopsy of the sentinel lymph node, radiotherapy","ACTIVE_COMPARATOR","1. Prior to surgical treatment all patients undergo breast SPECT-CT using 99mTc-Technetril and SPECT-CT of the SLN using Tc99m-colloid. The patient then undergoes a sectoral resection of the breast with a sentinel lymph node biopsy, followed by histological analysis of the excised tissue.\n2. In the next stage, 3D conformal RT is administered to the remaining breast tissue 4 to 12 weeks after the surgical treatment. In patients who have undergone SLNB, only the remaining breast tissue is irradiated, without irradiation of the axillary region, provided that the postoperative histological examination shows no evidence of sentinel lymph node involvement. If metastatic involvement of the SLN is detected, additional RT of the axillary region is performed. Radiation planning is carried out in accordance with ESTRO protocols.\n3. Based on the postoperative histological findings, the patient is prescribed adjuvant systemic therapy in accordance with current clinical guidelines.",[19],"Procedure: Breast resection with sentinel lymph node biopsy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","breast resection","breast resection without sentinel lymph node biopsy, radiotherapy to the breast area and sentinel lymph nodes",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Breast resection with sentinel lymph node biopsy","Breast resection with sentinel lymph node biopsy, radiotherapy to the breast and axilla according to current treatment standards",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Petr Krivorotko, Degree","CONTACT","+79219597722","dr.krivorotko@mail.ru",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Arina Gorina","+79185374992","dr.arina_olegovna@mail.ru",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":26},"RECRUITING","Saint Petersburg","Russian Federation","197758","Russia","RU",{"type":50,"coordinates":51},"Point",[52,53],30.31413,59.93863,{"lat":53,"lon":52},{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100640407","refusal-of-sentinel-lymph-node-biopsy-in-patients-with-luminal-a-subtype-early-breast-cancer-100640407",false,"NCT07579286","Refusal of Sentinel Lymph Node Biopsy in Patients With Luminal A Subtype Early Breast Cancer","LumiNOde","Inclusion Criteria:\n\n1. HER2-negative breast cancer (ER +\u002F PR +), Ki67 \\\u003C= 30%, G1-2\n2. age\\> 59 years.\n3. morphologically confirmed diagnosis of breast cancer, IA-IIA stage\n4. ECOG score 0-2.\n5. the absence of contraindications to surgical intervention (including anesthetic risk is taken into account).\n6. patient is able to provide informed consent and sign approved consent forms to participate in the study.\n7. patients after surgical treatment in the scope of breast resection with sentinel lymph node biopsy (SLNB, group 1) or without axillary surgery (without SLNB, group 2).\n8. N0 status of axillary lymph nodes according to ultrasound and SPECT-CT of the breast with 99mTc-Technetril.\n\nExclusion Criteria:\n\n1. Inconsistency with inclusion criteria.\n2. stage T2-4, N1 or M1 cancer\n3. severe uncontrolled concomitant chronic diseases or acute diseases\n4. previous\u002Fconcurrent malignancy or history of radiation therapy to the chest wall region\n5. any condition that is a contraindication to radiation therapy\n\n5\\. pregnancy","FEMALE","60 Years",{"count":67,"type":68},100,"ESTIMATED","INTERVENTIONAL",[71],"NA","Sentinel lymph node biopsy (SLNB) is the standard of axillary lymph node surgical staging in patients with early breast cancer.\n\nThe main goal of the study is to abandon axillary surgery in patients over 59 years old with early, luminal A, clinical lymph node negative breast cancer.",[74],"Early Breast Cancer",[76,77,78,79,80,81],"early breast cancer","radiotherapy","refusal of Sentinel Lymph Node Biopsy","SLNB","breast surgery","Mammolymphoscintigraphy","2026-05-06",{"date":84,"type":85},"2026-05-12","ACTUAL",{"date":87,"type":85},"2023-07-27",{"date":89,"type":68},"2027-05-25",{"name":5,"class":6},1]