[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"triple-negative-breast-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:triple-negative-breast-neoplasm":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"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":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Triple-Negative Breast Neoplasm",[29,30,31,32,33,34],"Immune-cold microenvironment","Triple-negative breast cancer","Partial Breast Irradiation","Pembrolizumab","KeyNote-522","Immunochemotherapy","NOT_YET_RECRUITING","2025-06-02",{"date":38,"type":39},"2025-06-10","ACTUAL",{"date":41,"type":21},"2025-07-16",{"date":43,"type":21},"2033-07-31",{"name":45,"class":46},"Gangnam Severance Hospital","OTHER"]