Metastatic Breast Cancer Clinical Trial
Official title:
Phase IIa Study of Metastatic Breast Cancer
The purpose of this study is to obtain evidence from test article with efficacy in Metastatic Breast Cancer patients. The average of all changes from baseline to post-treatment evaluations in global health/quality of life (QoL) subscale assessed by self-administered European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30).
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
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