[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586855":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":34,"responsibleParty":55,"collaborators":18,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Ilsan Cha hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Viscum album group","EXPERIMENTAL","Viscum album Active Ingredient: Viscum album Formulation: a colorless ampoule; the solution is colorless to pale yellow and clear.\n\nManufacturer: LB Abnoba Co., Ltd. Dosage and Administration: Administered subcutaneously three times per week, with dose escalation",[13],"Drug: viscum album",{"label":15,"type":16,"description":17,"interventionNames":18},"Wait-list control group","NO_INTERVENTION","Participants assigned to the waitlist control group will receive pembrolizumab monotherapy as part of their standard adjuvant chemotherapy regimen without additional investigational intervention for the first 18 weeks of the study. On week 19, Participants will begin Viscum album administration for four weeks, as the same schedule with the Viscum album group.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","viscum album","Active Ingredient: Viscum album Excipients: Ascorbic acid, disodium phosphate dihydrate, monosodium phosphate monohydrate Formulation: Injectable solution contained in a colorless ampoule; the solution is colorless to pale yellow and clear.\n\nManufacturer: LB Abnoba Co., Ltd. Dosage and Administration: Administered subcutaneously three times per week, with dose escalation according to the following protocol.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Jee Young Lee, MD(KMD), PhD","CONTACT","082-31-782-3113","happiade@chamc.co.kr",{"name":32,"role":28,"phone":29,"phoneExt":18,"email":33},"Myung Han Hyun","myunghanmd1@chamc.co.kr",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":18,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Ilsan Cha Hospital","RECRUITING","Goyang-si","Gyeonggi-do","082-10414","South Korea",{"type":43,"coordinates":44},"Point",[45,46],126.835,37.65639,{"lat":46,"lon":45},[49,50,52],{"name":32,"role":28,"phone":29,"phoneExt":18,"email":33},{"name":51,"role":28,"phone":29,"phoneExt":18,"email":30},"Jee Young Lee",{"name":53,"role":54,"phone":18,"phoneExt":18,"email":18},"Myung Han Hyun, MD, PhD","PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":32,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Assistant professor","100586855","phase-4-viscum-album-for-tnbc-on-adjuvant-pembrolizumab-100586855",false,"NCT06920810","Viscum Album for TNBC on Adjuvant Pembrolizumab","Efficacy and Safety of Viscum Album in Patients With Triple-negative Breast Cancer Undergoing Immune Checkpoint Inhibitors","TNBNOBA","Inclusion Criteria:\n\n1. Adults aged 19 years or older\n2. Histologically confirmed diagnosis of triple-negative breast cancer\n3. ECOG Performance Status of 0 or 1\n4. Completed surgery and radiotherapy for localized disease, and either (a) requires adjuvant chemotherapy including immune checkpoint inhibitors, or (b) has initiated such therapy within 3 cycles\n5. Laboratory values meeting the following criteria:\n\n   Absolute Neutrophil Count (ANC) ≥ 1,500\u002FμL Platelet count (PLT) ≥ 100,000\u002FμL Hemoglobin (Hb) ≥ 9.0 g\u002FdL Albumin ≥ 3.0 g\u002FdL Acceptable levels of creatinine, total bilirubin, AST, and ALT ≤ 3 × upper limit of normal (ULN)\n6. Able to understand the study information and voluntarily provide written informed consent\n\nExclusion Criteria:\n\n1. Presence of distant metastasis\n2. Uncontrolled pleural effusion, ascites, or pericardial effusion\n3. Other non-cancer comorbidities (e.g., dementia, cerebrovascular disease, end-stage renal disease) that are expected to significantly impair physical function\n4. Pregnant or breastfeeding women\n5. Estimated life expectancy of less than 3 months, making adequate follow-up unlikely\n6. Any other medical condition that may interfere with study results or any situation in which, in the investigator's judgment, participation is not appropriate","ALL","19 Years",{"count":68,"type":69},40,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","The goal of this clinical trial is to evaluate the efficacy and safety of Viscum album extract when used in combination with pembrolizumab as adjuvant chemotherapy in adult patients (aged 19 and older) who have been diagnosed with malignant neoplasm of unilateral breast and have completed surgery.\n\nThe main questions it aims to answer are:\n\nDoes the addition of Viscum album improve clinical outcomes when combined with pembrolizumab as adjuvant chemotherapy? Is Viscum album safe and tolerable for use in this patient population?",[75,76],"Breast Cancer","Triple Negative Breast Cancer",[78,79,80,81],"triple negative breast cancer","adjuvant chemotherapy","pembrolizumab","mistletoe","2025-04-02",{"date":84,"type":85},"2025-04-10","ACTUAL",{"date":87,"type":85},"2025-03-19",{"date":89,"type":69},"2028-12-31",{"name":5,"class":6},1]