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Clinical Trials in South Korea / NCT06920810
Recruiting Phase 4

Viscum Album for TNBC on Adjuvant Pembrolizumab

NCT06920810 · tracked via the Priya Life Science South Korea tracker
Sponsor
Ilsan Cha hospital
Phase
Phase 4
Started
2025-03-19
Last updated
2025-04-10

Condition(s) studied

Breast CancerTriple Negative Breast Cancer

Investigational drug(s) / intervention(s)

viscum album

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. Manufacturer: LB Abnoba Co., Ltd. Dosage and Administration: Administered subcutaneously three times per week, with dose escalation according to the following protocol.

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • cytokine panel — week 1, week 4, week 7, week 19
    the result of immune-related cytokine panel kit (CCL2, CCL3, CCL4, CD40 Ligand, CXCL10, GM-CSF, Granzyme B, IFN-α, IFN-γ, IL-1α, IL-1β, IL-1ra, IL-2, IL-4, IL-6, IL-8, IL-9, IL-10, IL-12 p70, IL-13, IL-15, IL-17, IL-33, PD-L1, TNF-α)

Trial sites (1)

FacilityCityRegionStatus
Ilsan Cha Hospital Goyang-si Gyeonggi-do Recruiting

More Ilsan Cha hospital trials in South Korea

Pharmacopuncture for Aromatase Inhibitor Induced Arthralgia (AIA) Recruiting
Hemodynamic Effects of Remimazolam vs Propofol During Robot-assisted Gynecologic Surgery Starting soon
An Observational Study on Postoperative Symptoms After Thyroidectomy (POS-T) Recruiting
Nasal Steam Therapy for Post-extubation Respiratory Events Recruiting

Other trials for the same condition

The OPBC-07/microNAC Study Active, not recruiting
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Recruiting
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63) Recruiting
Pharmacopuncture for Aromatase Inhibitor Induced Arthralgia (AIA) Recruiting
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06920810 on ClinicalTrials.gov ↗ ← All trials in South Korea