Open-Label, Phase II Trial of Immunological Response Rate, Safety, and Tolerability of THERATOPE® Vaccine in Subjects With Metastatic Breast Cancer Undergoing Treatment With Aromatase Inhibitors or Faslodex®
Inclusion Criteria
Inclusion Criteria
- Histopathologically confirmed breast cancer
- Documented Stage IV disease
- Estrogen and/or progesterone-receptor positive
- Stable disease on aromatase inhibitor or Faslodex® treatment begun at least 12 weeks
prior to enrolment
- Performance status, ECOG = 0 or 1
- Life expectancy > 12 weeks
- History of freedom from progression for at least 6 months following surgery with a
curative intent or for at least 6 months during adjuvant chemotherapy, adjuvant
radiotherapy or adjuvant hormonal therapy such as tamoxifen/toremifene treatment
- No radiotherapy or major surgery within 4 weeks prior to enrolment
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