RecruitingPhase 4NCT06920810

Viscum Album for TNBC on Adjuvant Pembrolizumab

Efficacy and Safety of Viscum Album in Patients With Triple-negative Breast Cancer Undergoing Immune Checkpoint Inhibitors


Sponsor

Ilsan Cha hospital

Enrollment

40 participants

Start Date

Mar 19, 2025

Study Type

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding Viscum album (mistletoe extract) to standard treatment for triple-negative breast cancer (TNBC) can improve outcomes. Participants will receive their regular chemotherapy and the immune checkpoint inhibitor pembrolizumab, plus either mistletoe extract or a placebo. **You may be eligible if...** - You are 19 or older - You have been confirmed to have triple-negative breast cancer - Your cancer is localized (not spread to other organs) - You have completed surgery and radiation, and are starting or have recently started chemotherapy with an immune checkpoint inhibitor - Your blood counts and organ function are within acceptable levels **You may NOT be eligible if...** - Your cancer has spread to other parts of the body (metastatic) - You have uncontrolled infections or autoimmune conditions - You are pregnant or breastfeeding - You have had prior systemic therapy for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGviscum 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.


Locations(1)

Ilsan Cha Hospital

Goyang-si, Gyeonggi-do, South Korea

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NCT06920810


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