[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603372":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":25,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":25,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":37,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Shanghai Proton and Heavy Ion Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"moderate hypofractionated proton radiotherapy","ACTIVE_COMPARATOR","Whole Breast Irradiation, at 40 Gy(RBE) in 15 fractions, tumor bed SIB to 48Gy(RBE)",[13],"Radiation: moderate hypofractionated proton radiotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"ultra-hypofractionated proton radiotherapy","EXPERIMENTAL","Whole breast radiotherapy, 26 Gy(RBE) in 5 fractions，tumor bed boost with 10Gy(RBE) in 2 fractions.",[19],"Radiation: ultra-hypofractionated proton radiotherapy",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","moderate hypofractionated proton radiotherapy: Whole Breast Irradiation, at 40 Gy(RBE) in 15 fractions, tumor bed SIB to 48Gy(RBE)",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Ultra-hypofractionated proton radiotherapy:Whole breast radiotherapy, 26 Gy(RBE) in 5 fractions，tumor bed boost with 10Gy(RBE) in 2 fractions.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Ping Li","CONTACT","+86 02138296666","ping.li@sphic.org.cn",[36],{"facility":5,"status":37,"city":38,"state":25,"zip":25,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Shanghai","China","CN",{"type":42,"coordinates":43},"Point",[44,45],121.45806,31.22222,{"lat":45,"lon":44},[48],{"name":49,"role":32,"phone":50,"phoneExt":25,"email":34},"Ping Li, M.D.","+86 021-38296538",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Qing Zhang,MD","Principal Investigator","100603372","ultra-hypofractionated-vs-moderately-hypofractionated-proton-therapy-for-early-breast-cancer-after-lumpectomy-100603372",false,"NCT07135661","Ultra-Hypofractionated vs. Moderately Hypofractionated Proton Therapy for Early Breast Cancer After Lumpectomy","A Prospective Phase II Randomized Controlled Trial Comparing Ultra-Hypofractionated and Moderately Hypofractionated Proton Radiotherapy Following Breast-Conserving Surgery in Early-Stage Breast Cancer（UPH-BC）","UPH-BC","Inclusion Criteria:\n\n1. Age ≥ 40 years\n2. Pathologically (cytologically or histologically) confirmed unilateral primary invasive breast carcinoma\n3. Breast conserving surgery + sentinel lymph node biopsy\u002Faxillary lymph node dissection, pathological stage pT1-2N0M0，negative margins (≥ 2 mm)\n4. No distant metastasis confirmed by CT, MRI, bone scan, and PET\u002FCT\n5. No prior radiation therapy to the ipsilateral chest or breast\n6. ECOG 0 \\~ 2 or KPS ≥ 70\n\nExclusion Criteria:\n\n1. Without pathology diagnosis\n2. Positive margins or close margins (\\\u003C 2mm)\n3. Lymph nodes or distant metastasis\n4. Bilateral breast cancer or patients with a history of contralateral breast cancer\n5. Prior radiation therapy to the ipsilateral chest or breast\n6. Pregnancy (confirmed by serum or urine β-HCG test) or lactation","FEMALE","40 Years",{"count":66,"type":67},312,"ESTIMATED","INTERVENTIONAL",[70],"NA","Breast-conserving surgery (BCS) followed by whole-breast irradiation (WBI) remains the standard therapeutic approach for early-stage breast cancer. Long-term follow-up data from the FAST trial (10-year analysis) demonstrated that the 28.5 Gy\u002F5-fraction regimen exhibited comparable adverse effects to the conventional 50 Gy\u002F25-fraction regimen, with no statistically significant differences in photographic cosmetic assessments at 2 and 5 years post-treatment. The FAST-Forward trial demonstrated comparable 5-year ipsilateral breast tumor recurrence rates (IBTR) and incidence of radiation-related toxicities between ultra-hypofractionated whole-breast irradiation (UH-WBI; 26 Gy in 5 fractions over 1 week) and moderately hypofractionated whole-breast irradiation (MH-WBI; 40 Gy in 15 fractions over 3 weeks). Additionally, no statistically significant difference in cosmetic outcomes was observed between the two regimens at the 2-year follow-up.\n\nProton radiotherapy enables precise dose delivery to tumor targets while minimizing radiation exposure to surrounding normal tissues, thereby reducing treatment-related toxicities. However, current clinical protocols predominantly employ conventional fractionation for proton therapy, with a paucity of robust evidence evaluating the efficacy and safety of ultra-hypofractionated proton radiotherapy in breast cancer patients. This prospective randomized controlled trial aims to establish high-level scientific evidence for the clinical application of ultra-hypofractionated proton radiotherapy following BCS, ensuring non-inferiority in oncologic control, toxicity profiles, and cosmetic preservation compared to standard regimens.",[73,74],"Breast Cancer","Proton Therapy",[76,77,73,74],"Ultra-Hypofractionated Irradiation","Moderately Hypofractionated Irradiation","2025-08-14",{"date":80,"type":81},"2025-08-22","ACTUAL",{"date":83,"type":81},"2024-10-10",{"date":85,"type":67},"2029-10-31",{"name":5,"class":6},1]