Status:
RECRUITING
Viscum Album for TNBC on Adjuvant Pembrolizumab
Lead Sponsor:
Ilsan Cha hospital
Conditions:
Breast Cancer
Triple Negative Breast Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE4
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...
Detailed 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...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
March 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06920810
Start Date
March 19 2025
End Date
December 31 2028
Last Update
April 10 2025
Active Locations (1)
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1
Ilsan Cha Hospital
Goyang-si, Gyeonggi-do, South Korea, 082-10414