Tests mistletoe extract with pembrolizumab after breast cancer surgery
Tests mistletoe extract with pembrolizumab in adults with triple-negative breast cancer.
Plain-language title generated from the registry record
Registry title: Viscum Album for TNBC on Adjuvant Pembrolizumab
Key facts
- Where
- Goyang-si, South KoreaSee the site
- Phase
- Phase 4
Where in South Korea
- Ilsan Cha HospitalGoyang-si, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ilsan Cha hospital
- Trial code
- NCT06920810
- Record updated
- 10 April 2025
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of Viscum Album in Patients With Triple-negative Breast Cancer Undergoing Immune Checkpoint Inhibitors
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?
Inclusion: 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.
Exclusion: Other non-cancer comorbidities (e.g., dementia, cerebrovascular disease, end-stage renal disease) that are expected to significantly impair physical function; Any other medical condition that may interfere with study results or any situation in which, in the investigator's judgment, participation is not appropriate; Presence of distant metastasis; Uncontrolled pleural effusion, ascites, or pericardial effusion; Pregnant or breastfeeding women; Estimated life expectancy of less than 3 months, making adequate follow-up unlikely.