Viscum Album for TNBC on Adjuvant Pembrolizumab

Recruiting now · Phase 4

Conditions studied: Breast Cancer, Triple Negative Breast Cancer

In brief

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?

Key facts

Study ID

NCT06920810

Run by

Ilsan Cha hospital

People needed

40

Starts

2025-03-19

Expected to finish

2028-12-31

Last updated by the study team

2025-04-10

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ilsan Cha Hospital — Goyang-si, Gyeonggi-do, South Korea (enrolling)

Full record on ClinicalTrials.gov

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