[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641101":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":25,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":25,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":78,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: High-risk group","ACTIVE_COMPARATOR","Patients who undergo upfront breast-conserving surgery will be assigned to the high-risk group if any of the following high-risk factors are present:\n\n* Age younger than 40 years.\n\n  * Histology of invasive lobular carcinoma or micropapillary carcinoma.\n\n    * Multifocal disease, defined as two or more breast tumor foci.\n\n      * Tumor size greater than 3 cm.\n\n        * Lymphovascular invasion.\n\n          * Invasive carcinoma with an extensive intraductal component.\n\n            * Estrogen receptor-negative disease.\n\nPatients who receive neoadjuvant chemotherapy followed by breast-conserving surgery will be assigned to the high-risk group if any of the following high-risk factors are present:\n\n* Age younger than 40 years.\n\n  * Histology of invasive lobular carcinoma or micropapillary carcinoma.\n\n    * Multifocal breast tumor before treatment.\n\n      * Lymphovascular invasion.\n\n        * Pathologic stage ypT1-2N0.",[13],"Radiation: Whole-breast irradiation and tumor bed boost",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2: Low-risk group","Patients who undergo upfront breast-conserving surgery will be assigned to the low-risk group if they meet either of the following criteria:\n\n① Ductal carcinoma in situ (DCIS): age 40 years or older, unifocal disease on breast MRI, tumor size 3 cm or smaller, estrogen receptor-positive disease, and low-, intermediate-, or high-grade disease.\n\n② Invasive carcinoma, including invasive ductal carcinoma, mucinous carcinoma, papillary carcinoma, or tubular carcinoma: age 40 years or older, unifocal disease on breast MRI, tumor size 3 cm or smaller, grade 1 to 3 disease, no lymphovascular invasion, and estrogen receptor-positive disease.\n\nPatients who receive neoadjuvant chemotherapy followed by breast-conserving surgery will be assigned to the low-risk group if all of the following criteria are met: Age 40 years or older, unifocal disease on pretreatment breast MRI, pretreatment core needle biopsy showing invasive ductal carcinoma, and pathologic stage ypT0\u002FisN0.",[18],"Radiation: Partial-breast irradiation",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Whole-breast irradiation and tumor bed boost","Whole-breast irradiation: 36 Gy in 15 fractions; Tumor bed boost: 48 Gy in 15 fractions",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Partial-breast irradiation","Partial-breast irradiation: 40.05 Gy in 15 fractions or 26 Gy in 5 fractions",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Shu-Lian Wang, MD","CONTACT","8610-87788803","wangsl@cicams.ac.cn",[37],{"facility":38,"status":25,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Cancer Hospital, Chinese Academy of Medical Sciences","Beijing","Beijing Municipality","100021","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":34,"phoneExt":25,"email":35},"Shu-Lian Wang",{"type":54,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100641101","risk-stratified-hypofractionated-radiotherapy-after-breast-conserving-surgery-for-early-breast-cancer-100641101",false,"NCT07657442","Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer","A Prospective Study of Risk-Stratified Hypofractionated Radiotherapy After Breast-Conserving Surgery for Early Breast Cancer","Inclusion Criteria:\n\n* ECOG performance status score of 0 to 2.\n* Pathologically confirmed breast cancer, including invasive carcinoma or ductal carcinoma in situ.\n* Clinical stage cT0-2N0M0.\n* Underwent breast-conserving surgery.\n* Negative surgical margins greater than 2 mm.\n\nExclusion Criteria:\n\n* Regional lymph node metastasis.\n* Distant metastasis.\n* Bilateral breast cancer.\n* Prior thoracic radiotherapy.\n* Life expectancy of less than 5 years.\n* Lactating or pregnant women.","FEMALE","18 Years","75 Years",{"count":66,"type":67},649,"ESTIMATED","INTERVENTIONAL",[70],"NA","This prospective study is designed to evaluate the feasibility, efficacy, and safety of risk-stratified hypofractionated radiotherapy after breast-conserving surgery in patients with early breast cancer.",[73,74],"Early Stage Breast Carcinoma","Breast Cancer",[76,77],"breast cancer","radiotherapy","NOT_YET_RECRUITING","2026-06-14",{"date":81,"type":82},"2026-06-18","ACTUAL",{"date":84,"type":67},"2026-06-15",{"date":86,"type":67},"2032-12-31",{"name":5,"class":6},1]