NCT06920810RecruitingPhase 4
Viscum Album for TNBC on Adjuvant Pembrolizumab
Efficacy and Safety of Viscum Album in Patients With Triple-negative Breast Cancer Undergoing Immune Checkpoint Inhibitors
Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 27 Mar 2025
- Start date
- 19 Mar 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Ilsan Cha hospital
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06920810
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 40
- From 19 Mar 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ilsan Cha Hospital Coordinator of this site? Confirm its status | Goyang-si | South Korea | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.