Viscum Album for TNBC on Adjuvant Pembrolizumab
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorIlsan Cha hospital
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- viscum album
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov