HER-2 Protein Vaccine in Treating Women With Breast Cancer

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