RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. GM-CSF may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether giving docetaxel together with vaccine therapy is more effective than docetaxel alone in treating breast cancer.

PURPOSE: This randomized phase II trial is studying giving docetaxel with or without vaccine therapy to see how well it works compared to docetaxel alone in treating patients with metastatic breast cancer.

OBJECTIVES:

Primary

• Compare the progression-free survival of patients with metastatic breast cancer treated with docetaxel with vs without vaccinia-CEA-MUC-1-TRICOM vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim (GM-CSF).

Secondary

• Compare the overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, controlled, pilot study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive vaccinia-CEA-MUC-1-TRICOM vaccine subcutaneously (SC) once and sargramostim (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel IV over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
• Arm II: Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-CEA-MUC-1-TRICOM vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and GM-CSF as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.

After completion of study treatment, patients are followed annually for 15 years.

PROJECTED ACCRUAL: A total of 48 patients (24 per treatment arm) will be accrued for this study within 3 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast
• Metastatic disease
• CEA- or MUC-1-positive disease
• Primary tumor or metastatic lesion must express CEA or MUC-1 (≥ 20% of cells) by immunohistochemical techniques
• Radiographic evidence of measurable disease
• HLA-A2 phenotype known
• At least 12 patients in each treatment arm must be HLA-A2 positive
• HER2/neu status known
• Must have progressive or recurrent disease after prior trastuzumab (Herceptin®) therapy if disease is HER2/neu-positive by fluorescence in situ hybridization or immunohistochemistry (3+)
• No clinically active brain metastases
• Hormone receptor status:
• Estrogen-receptor (ER) status known
• Must have failed prior primary hormonal therapy if tumor is ER-positive

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Male or female

Menopausal Status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• At least 4 months

Hematopoietic

• Granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Lymphocyte count ≥ 500/mm^3
• Hemoglobin ≥ 8 g/dL

Hepatic

• Bilirubin normal
• Meets 1 of the following criteria:
• SGOT and SGPT < 1.5 times upper limit of normal (ULN)
• SGOT and SGPT ≤ 2 times ULN AND alkaline phosphatase < 2.5 times ULN
• Hepatitis B and C negative
• No other chronic hepatitis infection

Renal

• Creatinine normal OR
• Creatinine clearance ≥ 60 mL/min*
• Proteinuria < 1,000 mg by 24-hour urine collection* NOTE: *Unless due to nonrenal causes

Cardiovascular

• No New York Heart Association class II-IV cardiac disease
• No clinically significant cardiomyopathy requiring treatment

Gastrointestinal

• No inflammatory bowel disease
• No Crohn''''s disease
• No ulcerative colitis
• No active diverticulitis

Immunologic

• HIV negative
• No history of allergy or untoward reaction to prior vaccinia virus vaccination
• No history of allergy or hypersensitivity reaction to eggs or egg products
• No active autoimmune disease requiring treatment OR history of autoimmune disease that may be stimulated by vaccine therapy
• No altered immune function, including any of the following conditions:
• History of or active immunodeficiency
• History of or active eczema or other eczematoid skin disorders
• Acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 4 months after completion of study treatment
• Endocrine disease, including thyroid disease, adrenal disease, and vitiligo, that is controlled by replacement therapy allowed
• No active seizures within the past year
• No close household contact (i.e., shares housing or has close physical contact) with the following individuals for ≥ 2 weeks after vaccinia vaccination:
• Individuals with a history of or active eczema or other eczematoid skin disorders
• Individuals with other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) until condition resolves
• Pregnant or nursing women
• Children 3 years of age and under
• Immunodeficient or immunosuppressed individuals (by disease or therapy), including HIV-positive individuals
• No other serious medical illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics
• No prior vaccinia-CEA-MUC-1-TRICOM or fowlpox-CEA-MUC-1-TRICOM vaccines
• No other concurrent anticancer immunotherapy

Chemotherapy

• At least 12 months since prior adjuvant docetaxel
• No prior docetaxel for metastatic disease
• At least 3-4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or carboplatin)
• No more than 3 prior chemotherapy regimens for metastatic breast cancer
• No other concurrent anticancer chemotherapy

Endocrine therapy

• See Disease Characteristics
• Prior hormonal therapy allowed
• No concurrent systemic steroids except physiologic doses for systemic steroid replacement OR local (topical, nasal, or inhaled) steroid use
• No concurrent steroid eye drops
• No concurrent anticancer hormonal therapy

Radiotherapy

• No concurrent anticancer radiotherapy

Surgery

• No prior splenectomy
• No concurrent major surgery

Other

• Recovered from all prior therapy
• No other concurrent anticancer therapy