Viscum Album for TNBC on Adjuvant Pembrolizumab

Launched by ILSAN CHA HOSPITAL · Apr 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for adults with triple-negative breast cancer (TNBC) who have already had surgery. The researchers want to see if adding a natural extract called Viscum album to an existing cancer treatment called pembrolizumab can help improve outcomes for patients. Pembrolizumab is a type of immunotherapy that helps the body fight cancer. The trial will check if this combination is safe and if it makes the treatment more effective.

To be eligible for this trial, participants need to be at least 19 years old, have been diagnosed with TNBC, and have completed their surgery. They should also have certain acceptable lab test results and be able to give their consent to participate. However, individuals with distant cancer spread, certain medical conditions that could affect their treatment, or who are pregnant or breastfeeding cannot join. If you participate, you can expect close monitoring and support throughout the study as researchers gather important information about how these treatments work together.

Gender

ALL

Eligibility criteria

• 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