Statement: Patients with tumors overexpressing HER-2 are eligible for the secondary trial, but not for the primary trial.
Primary_evidence: DISEASE CHARACTERISTICS:   Histologically confirmed adenocarcinoma of the breast   Does not overexpress HER-2/neu, defined as FISH negative or 0, 1+, or 2+ by IHC   Stage IV disease   Must not be eligible for therapy of known curative potential for metastatic breast cancer   Measurable or evaluable disease   Stable CNS disease allowed provided that it's adequately treated and not under active treatment   Hormone receptor status not specified   PATIENT CHARACTERISTICS:   Menopausal status not specified   ECOG performance status 0-1   ANC > 1,000/mm^3   Platelets > 100,000/mm^3   Serum bilirubin < 2.0 mg/dL (unless due to Gilbert syndrome)   AST and ALT < 2 times upper limit of normal (ULN)   Alkaline phosphatase < 5 times ULN   Serum creatinine < 2.0 mg/dL   Ejection fraction normal by MUGA OR  50% by echocardiogram   Not pregnant or nursing   Fertile patients must use effective contraception   HIV negative   Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids allowed   No prior or concurrent autoimmune disease requiring management with systemic immunosuppression, including any of the following:   Inflammatory bowel disease   Systemic vasculitis   Scleroderma   Psoriasis   Multiple sclerosis   Hemolytic anemia or immune-mediated thrombocytopenia   Rheumatoid arthritis   Systemic lupus erythematosus   Sjogren syndrome   Sarcoidosis   Other rheumatologic disease   No other malignancies within the past 5 years, except carcinoma in situ of the cervix, superficial nonmelanoma skin cancer, superficial bladder cancer, or tamoxifen-related endometrial cancer that has been adequately treated   No active major medical or psychosocial problems that could be complicated by study participation   No symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest   No uncontrolled medical problems   No evidence of active acute or chronic infection   No known severe hypersensitivity to trastuzumab, except mild to moderate infusion reactions that are easily managed and do not recur   No allergy to corn   PRIOR CONCURRENT THERAPY:   See Disease Characteristics   More than 28 days since prior and no other concurrent chemotherapy, radiation therapy, or biologic therapy (except trastuzumab)   Concurrent endocrine therapy and supportive therapy with bisphosphonates allowed   More than 28 days since prior and no other concurrent participation in an investigational new drug trial   More than 28 days since prior and no other concurrent systemic oral steroids   Topical, ocular, and nasal steroids allowed   No prior vaccination with the allogeneic GM-CSF-secreting breast tumor vaccine
Secondary_evidence: Inclusion Criteria:   Female patients with histologically confirmed adenocarcinoma of the breast or inflammatory breast cancer   Clinical stage T 1-4, N 0-3, M0   FISH+ HER2 gene amplified breast cancer   18 years or older   Normal cardiac function   Performance status 0-2   Cannot have received any prior chemotherapy for this disease or cannot have received chemotherapy for any other cancer in the past 5 years.   Previous diagnosis of noninvasive breast cancer is OK.   Must have adequate bone marrow, renal and liver function.   Pregnant or lactating females not allowed.   Preexisting peripheral neuropathy must be equal to or less than grade 1   Must have archived tumor tissue for tissue testing. Exclusion Criteria:   You cannot be in this study if you any of the following:   History of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure   Any heart attack, stroke or TIAs within the last 6 months or serious arrhythmias needing medication; no bleeding diathesis or coagulopathy.   No prior investigational drug within the last 30 days   No prior trastuzumab or bevacizumab therapy   There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons.