Actively Recruiting
Viscum Album for TNBC on Adjuvant Pembrolizumab
Led by Ilsan Cha hospital · Updated on 2025-04-10
40
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Viscum Album for TNBC on Adjuvant Pembrolizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 require adjuvant chemotherapy including immune checkpoint inhibitors or have started such therapy within 3 cycles
- Laboratory values meeting criteria: Absolute Neutrophil Count ≥ 1,500/µL, Platelet count ≥ 100,000/µL, Hemoglobin ≥ 9.0 g/dL, Albumin ≥ 3.0 g/dL, creatinine, total bilirubin, AST, and ALT ≤ 3 times upper limit of normal
- Able to understand study information and provide written informed consent
You will not qualify if you...
- Presence of distant metastasis
- Uncontrolled pleural effusion, ascites, or pericardial effusion
- Non-cancer comorbidities significantly impairing physical function (e.g., dementia, cerebrovascular disease, end-stage renal disease)
- Pregnant or breastfeeding women
- Estimated life expectancy less than 3 months
- Any medical condition or situation judged by investigator to interfere with study results or participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ilsan Cha Hospital
Goyang-si, Gyeonggi-do, South Korea, 082-10414
Actively Recruiting
Research Team
J
Jee Young Lee, MD(KMD), PhD
CONTACT
M
Myung Han Hyun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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