Breast Neoplasms Clinical Trial
Official title:
Safety Issue and Efficacy Study of Combining Mix Vaccine and Standard Therapy in the Treatment of Breast Carcinoma Patient
The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV). Enrolled patients will receive standard treatment according to National Comprehensive Cancer Network (NCCN) guide line with or without combining MV injection. The efficacy and side effect will be compared between the two groups.
In the study, after evaluation of the general and physical status, eligible patients will be
enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients
will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN)
guide line (control group) and in experimental arm, patients will be receiving simultaneous
standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease
progression.
Blood sample will be obtained at baseline and every week before MV injection for the
assessment of clinical hematology, biochemistry measurements and immunology index (including
immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity
throughout the study. Side effect, progression free survival, immunology index and general
status will be recorded.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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