Viscum Album for TNBC on Adjuvant Pembrolizumab

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

Inclusion Criteria:

1. Adults aged 19 years or older
2. Histologically confirmed diagnosis of triple-negative breast cancer
3. ECOG Performance Status of 0 or 1
4. 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
5. 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)
6. Able to understand the study information and voluntarily provide written informed consent

Exclusion Criteria:

1. Presence of distant metastasis
2. Uncontrolled pleural effusion, ascites, or pericardial effusion
3. Other non-cancer comorbidities (e.g., dementia, cerebrovascular disease, end-stage renal disease) that are expected to significantly impair physical function
4. Pregnant or breastfeeding women
5. Estimated life expectancy of less than 3 months, making adequate follow-up unlikely
6. Any other medical condition that may interfere with study results or any situation in which, in the investigator's judgment, participation is not appropriate

Conditions3

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