Spots Global Cancer Trial Database for Safety and Efficacy Study of Mix Vaccine in Breast Carcinoma Patient

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Trial Identification

Brief Title: Safety and Efficacy Study of Mix Vaccine in Breast Carcinoma Patient

Official Title: Safety Issue and Efficacy Study of Combining Mix Vaccine and Standard Therapy in the Treatment of Breast Carcinoma Patient

Study ID: NCT02338804

Conditions

Breast Neoplasms

Interventions

standard treatment

Study Description

Brief Summary: 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.

Detailed Description: 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.