NCT06920810 Viscum Album for TNBC on Adjuvant Pembrolizumab
| NCT ID | NCT06920810 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ilsan Cha hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-03-19 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2025-03-19 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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?
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06920810 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06920810 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06920810 currently recruiting?
Yes, NCT06920810 is actively recruiting participants. Contact the research team at happiade@chamc.co.kr for enrollment information.
Where is the NCT06920810 trial being conducted?
This trial is being conducted at Goyang-si, South Korea.
Who is sponsoring the NCT06920810 clinical trial?
NCT06920810 is sponsored by Ilsan Cha hospital. The trial plans to enroll 40 participants.
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