[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593852":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":19,"responsibleParty":34,"collaborators":19,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":19,"enrollmentInfo":46,"targetDuration":19,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":62,"whyStopped":19,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":19},{"fullName":5,"class":6},"Gangnam Severance Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Immunochemotherapy including pembrolizumab after partial breast-irradiation","EXPERIMENTAL","First, 8Gy partial breast irradiation will be delivered in immune-cold triple-negative breast cancer (TNBC) confirmed by PD-L1 and TILs.\n\nSequentially, standard neoadjuvant chemotherapy for triple-negative breast cancer including pembrolizumab, paclitaxel, carboplatin, doxorubicin, and cyclophosphamide (KeyNote-522 regimen) will be administered, followed by surgical treatment.",[13],"Radiation: Partial breast-irradiation",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"RADIATION","Partial breast-irradiation",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Sung Gwe Ahn","M.D.,Ph.D.","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Sung Gwe Ahn, M.D.,Ph.D.","CONTACT","+82220193370","asg2004@yuhs.ac",{"name":32,"role":28,"phone":19,"phoneExt":19,"email":33},"Soong June Bae, M.D.,Ph.D.","mission815815@yuhs.ac",{"type":24,"investigatorFullName":22,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Professor","100593852","phase-2-immune-checkpoint-blockade-after-partial-breast-irradiation-by-pembrolizumab-in-early-tnbc-100593852",false,"NCT07011823","Immune-checkpoint Blockade After Partial Breast Irradiation by Pembrolizumab in Early TNBC","Phase II Trial of Immunochemotherapy and Partial Breast Irradiation in Early TNBC With Immune-cold Tumor Environment (KEY-MELT)","KEY-MELT","Inclusion Criteria:\n\n* Breast cancer patients aged 20 years or older with clinical stage IIA or higher on imaging studies\n* Patients with triple-negative breast cancer confirmed on tissue biopsy\n* Cold immune tumor environment with tumor-infiltrating lymphocytes (TILs) \\\u003C30% and PD-L1 Combined Positive Score (CPS) \\\u003C10 on immunohistochemical staining of biopsy specimens\n* Patients with no prior history of breast cancer\n* Patients with no prior history of chemotherapy or radiation therapy\n* Patients scheduled to receive partial breast irradiation\n* Patients with ECOG performance status of 0-2\n* Patients who voluntarily signed the informed consent form for study participation\n\nExclusion Criteria:\n\n* Patients with non-triple-negative breast cancer on tissue biopsy\n* Patients scheduled for surgery without neoadjuvant chemotherapy\n* Patients with TILs ≥30% or PD-L1 CPS ≥10 on immunohistochemical staining of biopsy specimens (immune-hot tumor)\n* Patients with recurrent breast cancer or de novo stage IV disease\n* Patients who have previously received chemotherapy and\u002For radiation therapy to the ipsilateral breast and chest prior to study participation\n* Patients unable to receive neoadjuvant chemotherapy and Pembrolizumab\n* Vulnerable research subjects who are unable to participate voluntarily in the study due to physical\u002Fmental disabilities","FEMALE","20 Years",{"count":47,"type":48},20,"ESTIMATED","INTERVENTIONAL",[51],"PHASE2","A single-arm, single-institution study to induce phenotypic changes in the tumor microenvironment by delivering 8Gy partial breast irradiation in immune-cold triple-negative breast cancer confirmed by PD-L1 and TILs. Additional tissue biopsy will be performed following radiation therapy. Subsequently, neoadjuvant chemotherapy including Pembrolizumab will be administered to evaluate whether pathological complete response rates are improved.",[54],"Triple-Negative Breast Neoplasm",[56,57,58,59,60,61],"Immune-cold microenvironment","Triple-negative breast cancer","Partial Breast Irradiation","Pembrolizumab","KeyNote-522","Immunochemotherapy","NOT_YET_RECRUITING","2025-06-02",{"date":65,"type":66},"2025-06-10","ACTUAL",{"date":68,"type":48},"2025-07-16",{"date":70,"type":48},"2033-07-31",{"name":5,"class":6}]