Using mistletoe extract with pembrolizumab for treating triple negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Extended-interval versus standard-interval immunotherapy for advanced triple-negative breast cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.