[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599440":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":58,"collaborators":24,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":24,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":24,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HFRT group","EXPERIMENTAL","43.5 Gy in 15 fractions (2.9 Gy\u002Ffraction, 3 weeks)",[13],"Radiation: hypofractionated radiotherapy",{"label":15,"type":6,"description":16,"interventionNames":17},"CFRT group","50 Gy in 25 fractions, 2 Gy\u002Ffraction, 5 weeks",[18],"Radiation: conventional fractionated radiotherapy",[20,25],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"RADIATION","hypofractionated radiotherapy",[9],null,{"type":21,"name":26,"description":16,"armGroupLabels":27,"otherNames":24},"conventional fractionated radiotherapy",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Xuran Zhao, MD","CONTACT","86-13661135602","923791362@qq.com",{"name":35,"role":31,"phone":36,"phoneExt":24,"email":37},"Yirui Zhai, MD","86-18610168510","januarywind@163.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Department of Radiation Oncology, National Cancer Center\u002FNational Clinical Research Center for Cancer\u002FCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College","RECRUITING","Beijing","Province","10000","China","CN",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},[54],{"name":55,"role":31,"phone":56,"phoneExt":24,"email":57},"Shulian Wang, MD","8810-87787659","wangsl@cicams.ac.cn",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Shulian Wang,MD","Professor of radiation oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences","100599440","phase-3-hypofractionated-vs-conventional-rt-after-prosthetic-breast-reconstruction-100599440",false,"NCT07084519","Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction","Randomized Controlled Trial of Postmastectomy Hypofractionated Radiotherapy Versus Conventional Fractionated Radiotherapy in Breast Cancer Patients Undergoing Prosthetic Breast Reconstruction","Inclusion Criteria:\n\n* Female, aged 18-75 years\n* Karnofsky Performance Status ≥60\n* Histopathologically confirmed invasive breast adenocarcinoma\n* Total mastectomy \\[with or without nipple-areolar complex preservation\\] + axillary dissection\u002Fsentinel lymph node biopsy + implant\u002Fexpander placement R0 resection with negative margins\n* pT3 or N2-3 disease; or pT1-2N1\n* No distant metastasis\n* Completed standard neoadjuvant\u002Fadjuvant chemotherapy cycles\n* ≤8 weeks post-chemotherapy or ≤12 weeks post-surgery if no chemotherapy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Prior radiotherapy to chest wall or nodal regions\n* Pregnancy or lactation\n* T4 stage disease\n* Autologous breast reconstruction of the irradiated breast\n* Pre-radiotherapy local\u002Fregional\u002Fdistant metastasis\n* Grade ≥3 implant-related adverse events irreversible before radiotherapy\n* Bilateral breast cancer requiring bilateral radiotherapy\n* Concurrent\u002Fsecondary malignancy with disease-free interval \\\u003C5 years \\[except non-melanoma skin cancer, papillary\u002Ffollicular thyroid cancer, or cervical carcinoma in situ\\]\n* Active collagen vascular disease, e.g., SLE, scleroderma\n* Uncontrolled comorbidities: acute cardiovascular disease, substance abuse, or psychiatric disorders","FEMALE","18 Years","75 Years",{"count":73,"type":74},506,"ESTIMATED","INTERVENTIONAL",[77],"PHASE3","This study investigates the safety and efficacy of hypofractionated radiotherapy (HFRT) versus conventional fractionated radiotherapy (CFRT) in breast cancer patients undergoing total mastectomy with prosthetic reconstruction.\n\nStudy Design Population: Patients with high-risk breast cancer after mastectomy and immediate implant reconstruction.\n\nIntervention:\n\nHFRT Arm: 43.5 Gy in 15 fractions (2.9 Gy\u002Ffraction, 3 weeks). Control Arm: CFRT (50 Gy in 25 fractions, 2 Gy\u002Ffraction, 5 weeks). Endpoints Primary: Reconstruction failure rate (e.g., implant removal, capsular contracture)",[80,81,82],"Breast Cancer","Breast Reconstruction","Radiation Oncology",[84,85,22],"breast cancer","prosthetic breast reconstruction","2026-06-17",{"date":88,"type":89},"2026-06-22","ACTUAL",{"date":91,"type":89},"2026-03-27",{"date":93,"type":74},"2030-12-31",{"name":5,"class":6},1]