Phase IIa Study of Metastatic Breast Cancer
The test article is extracted from many natural herbals, in which most or their components
have been shown to have anti-tumor activity. A study in 2004 showed the test article could
have strong immunomodulatory effect on the antigen-stimulated proliferation response (PR) of
peripheral blood mononuclear cells (PBMC) and T-cells from recurrent aphthous ulcerations
(RAU) patients and suggested that it might be a potential immunoceutical agent for treatment
of RAU. Subsequent study in 2005 also suggested the test article as a potential
immunoceutical agent for treatment of RAU because the result showed it could modulate the
antigen-stimulated cytokine production by T-cells isolated from RAU patients. Another study
in 2005 showed the test article also had a broad-range tumor killing function and provided a
molecular basis underlying therapeutic activity. It was also suggested in this study will
could be a potential and promising cancer therapeutic or preventive agent.
The aim of this current study is to explore the safety and efficacy of the investigational
product with 20 ml, 3 times per day (daily dose: 60 ml) for a total of 24 weeks in the
patients with metastatic breast cancer refractory to conventional treatment modalities.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
6 months measure
King-Jen Chang, M.D.,Ph.D.
National Taiwan University Hospital
Taiwan: Department of Health