[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595832":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":57,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":10,"eligibilityCriteria":64,"healthyVolunteers":61,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immediate One-Stage Prepectoral Prosthetic Breast Reconstruction Cohort",null,"Patients undergoing nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) with immediate prepectoral prosthetic breast reconstruction are eligible for inclusion, regardless of mesh use (with or without mesh). Approaches including open, endoscopic, or robotic techniques are acceptable, provided that adjuvant radiotherapy is administered after permanent implant placement.",[13],"Procedure: Breast Reconstruction Surgery",{"label":15,"type":10,"description":16,"interventionNames":17},"Delayed-Immediate Two-Stage Expander\u002FImplant Breast Reconstruction Cohort","Patients undergoing nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) with two-stage expander\u002Fimplant breast reconstruction are eligible, provided that: Expander placement may be either prepectoral or subpectoral, Mesh use is optional (with or without acellular dermal matrix), Radiotherapy is administered with the expander in situ, Permanent implant exchange is performed ≥6 months after completing radiotherapy, The implant exchange procedure permits any approach (open, endoscopic, or robotic) and any plane\u002Fmesh configuration (prepectoral\u002Fsubpectoral, with\u002Fwithout mesh).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Breast Reconstruction Surgery","Breast Reconstruction Surgery (either immediate one-stage prepectoral implant reconstruction or two-stage expander\u002Fimplant reconstruction) with postoperative adjuvant radiotherapy",[15,9],[25],"radiation",[27],{"name":28,"affiliation":5,"role":29},"xiuchun chen","STUDY_DIRECTOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"xiuchun Chen","CONTACT","18603719919","cxc701024@163.com",{"name":37,"role":33,"phone":38,"phoneExt":10,"email":39},"minhao Lv","13838392355","lvminhao2004628@163.com",[41],{"facility":42,"status":43,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Henan cacer hospital","RECRUITING","Henan","450008","China","CN",{"type":49,"coordinates":50},"Point",[51,52],112.13664,33.81876,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":10,"phoneExt":10,"email":10},"Chen chun",{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100595832","efficacy-and-safety-of-prepectoral-prosthesis-immediate-one-stage-breast-reconstruction-versus-two-stage-expanderprosthesis-reconstruction-in-postoperative-adjuvant-radiotherapy-breast-cancer-patients-a-prospective-single-center-cohort-study-100595832",false,"NCT07037576","Efficacy and Safety of Prepectoral Prosthesis Immediate One-Stage Breast Reconstruction Versus Two-Stage Expander\u002FProsthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients: A Prospective, Single-Center, Cohort Study","Inclusion Criteria:\n\n1. women aged 18 to 70；\n2. Newly diagnosed breast cancer patients showing no evidence of distant metastasis on clinical examination and diagnostic workup；\n3. adjuvant radiotherapy is required;\n4. Patients scheduled to undergo nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) with immediate prepectoral implant-based reconstruction (via open, endoscopic, or robotic approach) require adjuvant radiotherapy AFTER permanent implant placement; OR Patients scheduled for NSM\u002FSSM with two-stage tissue expander\u002Fimplant reconstruction (with expander placement in either submuscular or prepectoral plane) receive radiotherapy WITH the tissue expander in situ, followed by exchange for permanent implant ≥6 months post-radiotherapy (expander position: submuscular\u002Fprepectoral acceptable; surgical approach: open\u002Fendoscopic\u002Frobotic acceptable);\n5. Patients are eligible regardless of whether mesh is used in the reconstruction surgery;\n6. Patients with severe breast ptosis are eligible;\n7. During the study observation period, lipofilling is permitted on the affected breast and symmetrization procedures on the contralateral breast in both cohorts;\n8. ECOG performance status 0-1;\n9. Patients receiving neoadjuvant chemotherapy (NACT) are eligible;\n10. Bilateral breast reconstruction is permitted;\n11. No smoking history OR smoking cessation ≥4 weeks prior to enrollment;\n12. Investigator-confirmed protocol compliance capability;\n13. Concurrent participation in other interventional\u002Fnon-interventional trials is allowed if deemed non-interfering by the investigator;\n14. Voluntarily participate and sign the informed consent form after comprehensive understanding.\n\nExclusion Criteria:\n\n1. Stage IV (metastatic) breast cancer;\n2. No prior radiotherapy post-mastectomy;\n3. History of ipsilateral chest wall\u002Faxillary radiation therapy;\n4. Immunodeficiency, poorly controlled diabetes (HbA1c \\>7%), or active tobacco use;\n5. Inflammatory breast cancer (cT4d);\n6. Autologous-based breast reconstruction or delayed reconstruction;\n7. Severe cardiopulmonary\u002Fhepatic\u002Frenal comorbidities contraindicating surgery\u002Fradiotherapy (ASA class ≥III);\n8. Psychiatric disorders precluding independent BREAST-Q completion;\n9. Pregnancy or lactation;\n10. Documented history of protocol non-adherence;\n11. Life-limiting comorbidities interfering with treatment OR investigator-determined ineligibility.","FEMALE","18 Years","70 Years",{"count":69,"type":70},104,"ESTIMATED","OBSERVATIONAL","Prospective Evaluation of the Efficacy and Safety of Prepectoral Immediate One-Stage Prosthetic Breast Reconstruction Versus Two-Stage Expander\u002FProsthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients",[74],"Breast Cancer Patients",[76,77,78],"Breast cancer","Breast reconstruction surgery","Radiotherapy","2025-06-17",{"date":81,"type":82},"2025-06-25","ACTUAL",{"date":84,"type":82},"2025-05-20",{"date":86,"type":70},"2028-03-30",{"name":5,"class":6},1]