Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Carcinoma

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Other Dietary Supplements

Herbal and Botanical

Vaccines

Immunomodulating Agents

Lecithin

Soy Bean

Patients in this group will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line

Patients in this group will be receiving both standard therapy according to NCCN guide line and simultaneous injection of mix vaccine (MV).

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.

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.

standard treatment

Kecheng Xu, MD

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.

Safety and Efficacy Study of Mix Vaccine in Breast Carcinoma Patient

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

including lymphocyte sub-type number and function, and cytokines

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy Study of Mix Vaccine in Breast Carcinoma Patient	NCT02338804	Breast Neoplasm...	MV standard treatm...	18 Years - 80 Years	Fuda Cancer Hospital, Guangzhou
Safety and Efficacy Study of Mix Vaccine in Breast Carcinoma Patient	NCT02338804	Breast Neoplasm...	MV standard treatm...	18 Years - 80 Years	Fuda Cancer Hospital, Guangzhou
Safety and Efficacy Study of Mix Vaccine in Breast Carcinoma Patient	NCT02338804	Breast Neoplasm...	MV standard treatm...	18 Years - 80 Years	Fuda Cancer Hospital, Guangzhou

Spots Global Cancer Trial Database for mix vaccine, breast neoplasms, immunotherapy