Vaccination Of High Risk Breast Cancer Patients With Heptavalent Antigen - Keyhole Limpet Hemocyanin Conjugate Plus The Immunological Adjuvant QS21

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of breast cancer at high risk for recurrence, defined by one of the
following:

- Stage IV that is free of all known disease after eradication by surgery,
radiotherapy, or chemotherapy

- May or may not have elevated CA 15-3 or CEA levels

- Stage I, II, or III previously treated with adjuvant chemotherapy and clinically
free of identifiable disease, but have rising CA 15-3 or CEA levels

- Rising CA 15-3 and CEA defined as a prior normal level increased on 2
consecutive occasions at least 2 weeks apart

- For patients with a significant history of smoking who have a
chronically elevated CEA (less than 15), CEA must be increased at
least 1.5 times the uppermost chronic value on 2 consecutive occasions
at least 2 weeks apart

- Stage III and completed adjuvant therapy no more than 24 months ago

- Recurrence in the ipsilateral axilla after lumpectomy and/or axillary dissection
or modified radical mastectomy

- Recurrence in the ipsilateral breast after lumpectomy and/or axillary dissection

- Stage II with at least 4 positive axillary nodes and completed adjuvant therapy
no more than 24 months ago

- Stage IV that is stable on hormonal therapy

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Male or female

Menopausal status:

- Not specified

Performance status:

- Karnofsky 80-100%

Life expectancy:

- Not specified

Hematopoietic:

- Lymphocyte count at least 500/mm^3

- WBC at least 3,000/mm^3

Hepatic:

- AST no greater than 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 1.5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No clinically significant New York Heart Association class III or IV cardiac disease

Other:

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior seafood allergy

- No known prior immunodeficiency or autoimmune disease

- No other active cancer except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 6 weeks since prior immunotherapy

- No prior vaccine with any of the antigens in this study

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy

- No concurrent chemotherapy

Endocrine therapy:

- See Disease Characteristics

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- At least 4 weeks since prior surgery

- Concurrent surgery for local recurrence allowed if patient remains disease free