[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100414047":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":37,"locations":46,"responsibleParty":101,"collaborators":104,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":20,"enrollmentInfo":117,"targetDuration":20,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":130,"overallStatus":49,"whyStopped":20,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Jewish General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Targeted Axillary Dissection","EXPERIMENTAL","Ultrasound of the axilla preoperative. Clipped biopsy proven positive node. I125 radioactive seed before surgery. Sentinel node biopsy using Tc99 +\u002F- blue dye. Targeted Axillary Node Dissection performed at surgery",[13,14],"Procedure: Targeted Axillary Dissection","Diagnostic Test: Ultrasound of the axilla",[16,21],{"type":17,"name":9,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Sentinel Node Biopsy (SNB; using Tc99 +\u002F- Blue dye) + Radioactive Seed Localisation (RSL) of clipped node using I125 seed = Targeted Axillary Dissection (TAD)",[9],null,{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":20},"DIAGNOSTIC_TEST","Ultrasound of the axilla","Prospectively recorded preoperative ultrasound of the axilla. Number of suspicious nodes recorded. Biopsy and clipping of the positive node.",[9],[27,30,34],{"name":28,"affiliation":5,"role":29},"Jean-François Boileau, MD,MSc,FRCSC","STUDY_CHAIR",{"name":31,"affiliation":32,"role":33},"Léamarie Meloche-Dumas, MD","Centre hospitalier de l'Université de Montréal (CHUM)","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":32,"role":36},"Erica Patocskai, MD","STUDY_DIRECTOR",[38,43],{"name":28,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","514-340-8222","24210","jean-francois.boileau@mcgill.ca",{"name":31,"role":39,"phone":44,"phoneExt":20,"email":45},"438-826-7489","leamarie.meloche-dumas@umontreal.ca",[47,66,87],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Hôpital Maisonneuve-Rosemont","RECRUITING","Montreal","Quebec","H1T2M4","Canada","CA",{"type":56,"coordinates":57},"Point",[58,59],-73.58781,45.50884,{"lat":59,"lon":58},[62],{"name":63,"role":39,"phone":64,"phoneExt":20,"email":65},"Lucas Sidéris, MD","514-252-0606","lucas.sideris@umontreal.ca",{"facility":67,"status":49,"city":50,"state":51,"zip":68,"country":53,"countryCode":54,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Centre hospitalier de l'Université de Montréal","H2X 3E4",{"type":56,"coordinates":70},[58,59],{"lat":59,"lon":58},[73,74,78,79,81,83,85],{"name":31,"role":39,"phone":44,"phoneExt":20,"email":45},{"name":35,"role":39,"phone":75,"phoneExt":76,"email":77},"514 890-8000","26607","erica.patocskai.med@ssss.gouv.qc.ca",{"name":31,"role":33,"phone":20,"phoneExt":20,"email":20},{"name":35,"role":80,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"name":82,"role":80,"phone":20,"phoneExt":20,"email":20},"Isabelle Trop, MPH,FRCPC",{"name":84,"role":80,"phone":20,"phoneExt":20,"email":20},"Danh Tran-Thanh, MD,MSc,FRCPC",{"name":86,"role":80,"phone":20,"phoneExt":20,"email":20},"Mona El Khoury, MD",{"facility":5,"status":49,"city":50,"state":51,"zip":88,"country":53,"countryCode":54,"cosmosGeoPoint":89,"geoPoint":91,"contacts":92},"H3T 1E2",{"type":56,"coordinates":90},[58,59],{"lat":59,"lon":58},[93,94,96,98,100],{"name":28,"role":39,"phone":40,"phoneExt":41,"email":42},{"name":95,"role":80,"phone":20,"phoneExt":20,"email":20},"Stephanie Wong, MD,MPH,FRCSC",{"name":97,"role":80,"phone":20,"phoneExt":20,"email":20},"Francesca Marie Grazia Proulx, MD",{"name":99,"role":80,"phone":20,"phoneExt":20,"email":20},"Livia Florianova, MD,MSc,FRCPC",{"name":28,"role":33,"phone":20,"phoneExt":20,"email":20},{"type":33,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Jean-Francois Boileau","MD, MSc, FRCSC, Surgical Oncologist, Associate Professor Surgery and Oncology, McGill University, Director JGH Breast Clinical Trials Group",[105],{"name":106,"class":6},"Quebec Breast Cancer Foundation","100414047","targeted-axillary-dissection-tad-in-early-stage-node-positive-breast-cancer-100414047",false,"NCT04671511","Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer","Sentinel Node Biopsy and Targeted Axillary Dissection in Node-Positive Breast Cancer Patients With Clinically Negative Axilla","TADEN","Inclusion Criteria:\n\n* Participants must be ≥ 18 years old.\n* Participants with a clinical T1 or T2 invasive ductal or lobular breast carcinoma, regardless of estrogen\u002Fprogesterone\u002Fhuman epidermal growth factor receptor 2 (HER2) receptor status.\n* Participants with clinical (on palpation) N0 and up to two suspicious lymph nodes on axillary ultrasound.\n* Participant with biopsy-proven positive axillary disease made by core needle biopsy or fine-needle aspiration.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status less than 2.\n* Participants must understand, accept, and have signed the approved consent form.\n\nExclusion Criteria:\n\n* Participant with previous ipsilateral axillary surgery, including sentinel lymph node biopsy.\n* Participants with distant metastases.\n* Participants that have had previous radiotherapy to the axillary nodes.\n* Participants who received neoadjuvant therapy.\n* If the injection of blue dye is planned, patients with hypersensitivity or allergy to isosulfan blue, patent blue, methylene blue or radiocolloid dye.\n* Participants who are unable to provide informed consent.","FEMALE","18 Years",{"count":118,"type":119},98,"ESTIMATED","INTERVENTIONAL",[122],"NA","RATIONALE: It is now standard for most breast cancer patients with 1-2 positive sentinel nodes to avoid completion node dissection when eligibility criteria from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial are met. The National Comprehensive Cancer Network (NCCN) recently proposed to extend this indication to patients that present with biopsy proven node positive disease if only 1 or 2 suspicious nodes are found on imaging, these positive nodes are not palpable clinically, and the other eligibility criteria from the Z0011 study are otherwise met. However, this recommendation is based on an expert consensus and no study has yet confirmed the optimal method to stage the axilla in this patient population.\n\nPURPOSE: Evaluate the technical success rate and accuracy of sentinel node biopsy (SNB) and the potential benefits of clipping and removing the biopsy proven node using radioactive seed localisation (RSL) (SNB+RSL = Targeted Axillary Dissection (TAD)) in patients with biopsy proven positive nodes, limited nodal disease in imaging and clinically negative axillary examination.",[125,126,127,128,129],"Breast Cancer Female","Early-stage Breast Cancer","Lymph Node Metastases","Axillary Metastases","Sentinel Lymph Node",[131,132,133,134,135],"breast cancer","targeted axillary dissection","sentinel lymph node biopsy","clinically negative axilla","metastatic axillary lymph nodes","2025-02-18",{"date":138,"type":139},"2025-02-20","ACTUAL",{"date":141,"type":139},"2021-03-30",{"date":143,"type":119},"2026-07",{"name":5,"class":6},3]