Safety and Efficacy Study of Mix Vaccine in Breast Carcinoma Patient

Study Overview
=================
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.

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

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Biological: MV
* Other: standard treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Patients diagnosed with breast carcinoma based on histology 2.Evaluable lesions on imaging study 3.Without known immunodeficiency 4.Age >18 and <80 years ago Exclusion Criteria: 1.Patients is unable or unwilling to sign informed consent 2.Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication 3.Positive HIV and/or RPR (rapid plasma reagin) 4.Female patient who is pregnant or breast feeding 5.Patients, based on the opinion pf the investigator, should not be enrolled into this study 6.Prior anti-cancer vaccine or biological immunotherapy 7.Allergic to any known ingredient of the MV compound

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>Patients in this group will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line | Other: standard treatment<br>* Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.<br>|
| Experimental: MV+control<br>Patients in this group will be receiving both standard therapy according to NCCN guide line and simultaneous injection of mix vaccine (MV). | Biological: MV<br>* MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), typhoid, Staphylococcus aureus, paratyphoid A and B. Accessories include microbial A, lecithin, Twain-80, span 20 and soy-bean oil for injection. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable.<br>Other: standard treatment<br>* Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety as measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria |  | 1 month | 
| immunology index | including lymphocyte sub-type number and function, and cytokines | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mix vaccine, breast neoplasms, immunotherapy