Viscum Album for TNBC on Adjuvant Pembrolizumab

NCT06920810 | Recruiting Phase 4 DMC

• 1 other identifier: ICICC-CT-24-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Breast Cancer; Triple Negative Breast Cancer

Keywords

triple negative breast cancer; adjuvant chemotherapy; pembrolizumab; mistletoe

Outcome Measures

Primary Outcomes (1)

• cytokine panel

  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)

  week 1, week 4, week 7, week 19

Secondary Outcomes (3)

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30

  week 1, week 4, week 7, week 19

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast 23

  week 1, week 4, week 7, week 19

• MD Anderson Symptom Inventory - core

  week 1, week 4, week 7, week 19

Study Arms (2)

Viscum album group

EXPERIMENTAL

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

Drug: viscum album

Wait-list control group

NO INTERVENTION

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.

Interventions

viscum album DRUG

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.

Viscum album group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Ilsan Cha hospital: lead

Study Sites (1)

Ilsan Cha Hospital

Goyang-si, Gyeonggi-do, 082-10414, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jee Young Lee, MD(KMD), PhD

CONTACT

082-31-782-3113; happiade@chamc.co.kr

Myung Han Hyun

CONTACT

082-31-782-3113; myunghanmd1@chamc.co.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: viscum album group added on adjuvant pembrolizumab and adjuvant pembrolizumab monotherapy group

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 10, 2025
• Study Start: March 19, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)