Clinical trial · Interventional
Viscum Album for TNBC on Adjuvant Pembrolizumab
Efficacy and Safety of Viscum Album in Patients With Triple-negative Breast Cancer Undergoing Immune Checkpoint Inhibitors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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?
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| viscum album | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Viscum album group
- description
- Viscum album Active Ingredient: Viscum album Formulation: 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
- interventionNames
- Drug: viscum album
- type
- NO_INTERVENTION
- label
- Wait-list control group
- description
- 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.
Primary outcomes (1)
- measure
- cytokine panel
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults aged 19 years or older 2. Histologically confirmed diagnosis of triple-negative breast cancer 3. ECOG Performance Status of 0 or 1 4. 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 5. 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) 6. Able to understand the study information and voluntarily provide written informed consent Exclusion Criteria: 1. Presence of distant metastasis 2. Uncontrolled pleural effusion, ascites, or pericardial effusion 3. Other non-cancer comorbidities (e.g., dementia, cerebrovascular disease, end-stage renal disease) that are expected to significantly impair physical function 4. Pregnant or breastfeeding women 5. Estimated life expectancy of less than 3 months, making adequate follow-up unlikely 6. Any other medical condition that may interfere with study results or any situation in which, in the investigator's judgment, participation is not appropriate
References
Publications (1)
- DERIVEDLee JY, Ko EJ, Lee SH, Hong SE, Hyun MH. Efficacy and Safety of Viscum album L. in Patients With Triple-Negative Breast Cancer Receiving Immune Checkpoint Inhibitors: A Protocol for an Open-Label Randomized Clinical Trial. Integr Cancer Ther. 2026 Jan-Dec;25:15347354261483616. doi: 10.1177/15347354261483616. Epub 2026 Aug 27. PMID 42657864