[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656637":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":25,"interventions":29,"overallOfficials":25,"centralContacts":32,"locations":25,"responsibleParty":38,"collaborators":25,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":25,"eligibilityCriteria":47,"healthyVolunteers":44,"sex":48,"minAge":25,"maxAge":25,"enrollmentInfo":49,"targetDuration":25,"studyType":52,"phases":25,"briefSummary":53,"conditions":54,"keywords":25,"overallStatus":56,"whyStopped":25,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":25},{"fullName":5,"class":6},"Samsung Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"primary purpose","Evaluate pathologic complete response, pCR,ypT0N0","until 2027.12.31",[14],{"measure":15,"description":16,"timeFrame":12},"Outcome Measure","Analysis of overall survival (OS), in real-world practice of neoadjuvant therapy including pembrolizumab in patients with triple-negative breast cancer (TNBC)",[18,22],{"measure":19,"description":20,"timeFrame":21},"Other Outcome Measure","Analysis of event-free survival in real-world practice of neoadjuvant therapy including pembrolizumab in patients with triple-negative breast cancer (TNBC)","Until 2027.12.31",{"measure":19,"description":23,"timeFrame":12},"Analysis of adverse events, etc., in real-world practice of neoadjuvant therapy including pembrolizumab in patients with triple-negative breast cancer (TNBC)",{"allocation":25,"interventionModel":25,"interventionModelDescription":25,"primaryPurpose":25,"observationalModel":6,"timePerspective":26,"maskingInfo":25},null,"RETROSPECTIVE","There is a need for research analyzing treatment response, long-term clinical outcomes, and the patterns of short- and long-term immune-related adverse events in TNBC patients who have received neoadjuvant chemotherapy including pembrolizumab in a real-world clinical setting. This study aims to provide real-world evidence by comprehensively analyzing pathological response, recurrence patterns, survival outcomes, and treatment-related adverse events in TNBC patients who received pembrolizumab-based neoadjuvant chemotherapy in actual clinical practice. These findings are expected to provide important evidence for validating clinical trial results in real-world clinical settings and optimizing future treatment strategies for TNBC patients.","about 2000 population with TNBC",[30],{"type":6,"name":31,"description":31,"armGroupLabels":25,"otherNames":25},"Medical record use research",[33],{"name":34,"role":35,"phone":36,"phoneExt":25,"email":37},"Yeon hee Park, MD,phD","CONTACT","82-10-9933-1780","yoenh.park@samsung.com",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Yeon Hee Park","Clinical Professor","100656637","real-world-treatment-outcomes-and-safety-of-neoadjuvant-pembrolizumab-containing-therapy-in-patients-with-triple-negative-breast-cancer-korean-nationwide-multicenter-study-pembro-real-world-100656637",false,"NCT07828652","Real-world Treatment Outcomes and Safety of Neoadjuvant Pembrolizumab-containing Therapy in Patients With Triple-negative Breast Cancer: Korean Nationwide Multicenter Study (Pembro-Real World)","Inclusion Criteria:\n\n* Age of 19 years or older at the start of treatment\n\n  * Patients diagnosed with triple-negative breast cancer (TNBC) pathologically\n\n    * Patients diagnosed with clinical stage II or III ④ Patients who started neoadjuvant chemotherapy including pembrolizumab, paclitaxel, carboplatin, doxorubicin, and cyclophosphamide as preoperative neoadjuvant chemotherapy after July 2022\n\nExclusion Criteria:\n\n* History of other invasive malignancies, either concurrently or in the past (except for cancers where at least 5 years have passed since completion of treatment and there has been no recurrence) ② Patients diagnosed with clinical stage II or III who have a history of previous diagnosis and treatment for invasive breast cancer and have experienced local recurrence\n\n  * Patients who have not started pembrolizumab treatment concurrently with chemotherapy ④ Cases where assessment of pathological response is impossible due to the absence of surgery","ALL",{"count":50,"type":51},2000,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to evaluate the treatment outcomes and safety of neoadjuvant therapy including pembrolizumab in real-world practice for patients with triple-negative breast cancer (TNBC) in a multi-center study in Korea. In particular, we aim to evaluate the treatment efficacy focusing on the pathologic complete response (pCR) and analyze the association with recurrence rates and survival indicators.",[55],"TNBC - Triple-Negative Breast Cancer","NOT_YET_RECRUITING","2026-09-15",{"date":59,"type":60},"2026-09-18","ACTUAL",{"date":62,"type":51},"2026-09-14",{"date":64,"type":51},"2027-12-31",{"name":40,"class":6}]