Using mistletoe extract with pembrolizumab for treating triple negative breast cancer
Efficacy and Safety of Viscum Album in Patients With Triple-negative Breast Cancer Undergoing Immune Checkpoint Inhibitors
This study is testing if adding mistletoe extract to pembrolizumab can help adults with triple negative breast cancer feel better after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Ilsan Cha hospital Academic / other |
| Drugs / interventions | chemotherapy, pembrolizumab |
| Locations | 1 site (Goyang-si, Gyeonggi-do) |
| Trial ID | NCT06920810 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of Viscum album extract when combined with pembrolizumab as adjuvant chemotherapy in adults diagnosed with triple negative breast cancer who have completed surgery. The study aims to recruit 40 participants aged 19 and older, assessing whether the addition of Viscum album improves clinical outcomes and is safe for this patient population. Participants will receive Viscum album alongside pembrolizumab for 18 weeks, while a control group will undergo assessments without intervention for the same period. The trial will compare outcomes between the treatment and control groups to determine the effectiveness of the combination therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with histologically confirmed triple negative breast cancer who have completed surgery and require adjuvant chemotherapy.
Not a fit: Patients with distant metastasis or significant non-cancer comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes for patients with triple negative breast cancer.
How similar studies have performed: While the use of Viscum album in cancer treatment is explored, this specific combination with pembrolizumab is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Goyang-si, Gyeonggi-do
- Ilsan Cha Hospital — Goyang-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Study coordinator: Jee Young Lee, MD(KMD), PhD
- Email: happiade@chamc.co.kr
- Phone: 082-31-782-3113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.