Safety and Immunological Response Rate Study of THERATOPE® Vaccine in Metastatic Breast Cancer Patients

Exclusion Criteria

• •Pregnant or lactating
• •Known brain metastasis
• •Bone marrow involvement as the only site of metastasis
• •First line chemotherapy for Stage IV disease
• •Past or current cancer other than breast cancer, except for curatively treated basal cell cancer or in situ cancer of the cervix with no evidence of disease
• •Autoimmune disease, e. g., type I juvenile onset diabetes mellitus, antibody positive rheumatoid arthritis, Grave's disease, lupus, Crohn's disease, IBD, Hashimoto's thyroiditis
• •Known intercurrent infections (including HBV or HCV) or immunosuppression \[human immunodeficiency virus (HIV) or other conditions\] or clinical evidence of these conditions
• •Other significant active infection
• •Pleural effusions and/or ascites requiring paracentesis every 2 weeks or more frequently
• •Splenectomy
• •Concurrent treatment with chemotherapeutic agents other than low-dose cyclophosphamide used in this study
• •Treatment with interferons (IFNs), cytokines, systemic steroids or other biologicals within 4 weeks prior to enrolment
• •Receipt of another investigational drug within 30 days of enrolment
• •Known allergy to shellfish
• •Known allergy to soy beans or soy products
• •Known hypersensitivity to polysorbate 80
• •Known hypersensitivity to the study drugs
• •Legal incapacity or limited legal capacity