Viscum Album for TNBC on Adjuvant Pembrolizumab
Efficacy and Safety of Viscum Album in Patients With Triple-negative Breast Cancer Undergoing Immune Checkpoint Inhibitors
Ilsan Cha hospital
40 participants
Mar 19, 2025
INTERVENTIONAL
Conditions
Summary
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. The main questions it aims to answer are: Does 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?
Eligibility
Inclusion Criteria7
- Adults aged 19 years or older
- Histologically confirmed diagnosis of triple-negative breast cancer
- ECOG Performance Status of 0 or 1
- 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
- Laboratory values meeting the following criteria:
- Absolute Neutrophil Count (ANC) ≥ 1,500/μL Platelet count (PLT) ≥ 100,000/μL Hemoglobin (Hb) ≥ 9.0 g/dL Albumin ≥ 3.0 g/dL Acceptable levels of creatinine, total bilirubin, AST, and ALT ≤ 3 × upper limit of normal (ULN)
- Able to understand the study information and voluntarily provide written informed consent
Exclusion Criteria6
- Presence of distant metastasis
- Uncontrolled pleural effusion, ascites, or pericardial effusion
- Other non-cancer comorbidities (e.g., dementia, cerebrovascular disease, end-stage renal disease) that are expected to significantly impair physical function
- Pregnant or breastfeeding women
- Estimated life expectancy of less than 3 months, making adequate follow-up unlikely
- Any other medical condition that may interfere with study results or any situation in which, in the investigator's judgment, participation is not appropriate
Interventions
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. Manufacturer: LB Abnoba Co., Ltd. Dosage and Administration: Administered subcutaneously three times per week, with dose escalation according to the following protocol.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06920810