HER-2 Protein Vaccine in Treating Women With Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed adenocarcinoma of the breast, meeting criteria for 1 of the following:
• * Metastatic disease currently in complete or partial response or stable disease
• * Have been receiving a stable endocrine therapy regimen (e.g., aromatase inhibitor, tamoxifen, fulvestrant, or gonadotropin-releasing hormone agonist) for at least 30 days OR status post oophorectomy
• * Completed a course of local and adjuvant systemic therapy for high-risk stage II or III disease (i.e., anticipated 5-year relative survival is no greater than 50%) meeting any of the following staging criteria:
• * Stage IIB with involvement of at least 4 nodes
• * Stage IIIA (T3 disease with involvement of at least 4 nodes)
• * Any stage IIIB or IIIC disease
• * Stage IV with no evidence of disease (e.g., prior resection of local chest wall recurrence with no evidence of disease elsewhere)
• 1+, 2+, or 3+ HER2/neu expression by immunohistochemistry
• Treatment with trastuzumab (Herceptin®) not clinically indicated
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Sex
• Female
• Menopausal status
• Not specified
• Performance status
• ECOG 0-1
• Life expectancy
• At least 6 months
• Hematopoietic
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 10 g/dL
• Absolute neutrophil count at least 1,500/mm\^3
• Hepatic
• ALT or AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN for patients with liver metastases)
• Bilirubin no greater than 2 mg/dL (unless due to Gilbert's disease)
• Renal
• Creatinine no greater than 2 mg/dL
• Cardiovascular
• No history of significant cardiovascular disease
• No myocardial infarction within the past 6 months
• No poorly controlled cardiac arrhythmia
• No New York Heart Association class III or IV heart disease
• LVEF at least 50% by MUGA
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other malignancy except basal cell skin cancer or adequately treated carcinoma in situ of the cervix
• No concurrent severe autoimmune disease
• No other clinically significant or serious medical disease that would preclude study participation or compromise patient safety or the results of this study
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• More than 4 months since prior trastuzumab
• No prior anticancer vaccine therapy
• No concurrent trastuzumab
• No concurrent immunomodulators (e.g., thalidomide or interferons/interleukins)
• Chemotherapy
• More than 4 weeks since prior chemotherapy
• No concurrent low-dose methotrexate or cyclophosphamide
• No concurrent cytotoxic chemotherapy
• Endocrine therapy
• See Disease Characteristics
• No concurrent corticosteroids
• * Topical or inhaled steroids are allowed
• No changes to current endocrine therapy regimen (e.g., discontinuation or addition of an agent)
• Radiotherapy
• More than 3 months since prior radiotherapy involving more than 25% of the bone marrow
• No concurrent radiotherapy
• Surgery
• See Disease Characteristics
• No prior bilateral breast procedures
• Other
• More than 4 weeks since prior immunosuppressive therapy
• More than 30 days since prior investigational agents or clinical trial participation
• No other concurrent experimental or investigational agents
• No concurrent cyclosporine
• No concurrent immunosuppressive agents