Statement: Patients with prior chemotherapy for the treatment of stage 4 cancer are not eligible for either the primary trial or the secondary trial.
Primary_evidence: Inclusion Criteria:   Histologically confirmed breast cancer with evidence of metastatic disease   HER2 3+ or FISH (fluorescent in situ hybridization)+   Age  18 years   No prior trastuzumab, except as given in the adjuvant or neoadjuvant setting.   No prior chemotherapy in the metastatic setting. Exclusion Criteria:   CNS (central nervous system) metastases   Prior radiation therapy within the last 4 weeks   Pregnant (positive pregnancy test) or lactating women   Major surgical procedure, open biopsy, non-healing wounds, or significant traumatic injury within 28 days prior to starting study or anticipation of need for major surgical procedure during the study   Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to start of study.
Secondary_evidence: DISEASE CHARACTERISTICS:   Histologically confirmed invasive breast cancer meeting the following criteria:   Primary tumor  3 cm by mammography, ultrasound, or palpation AND/OR palpable axillary lymph nodes > 1 cm   Survivin- and/or carcinoembryonic antigen-positive by IHC   Tumor must be localized by exam or ultrasound to allow tumor injection   No stage IV or metastatic disease   HER2/neu-negative tumor by IHC   If 2+ or in the indeterminate range, further testing of HER2/neu overexpression by fluorescent in situ hybridization (FISH) is required   Hormone receptor status known   PATIENT CHARACTERISTICS:   Female   Pre-, peri-, or postmenopausal   ECOG performance status 0-1   Not pregnant or nursing   Negative pregnancy test   Fertile patients must use effective contraception during and for up to 6 months following completion of study therapy   ANC  1,500/mm³   Platelet count  100,000/mm³   Alkaline phosphatase  1.5 times upper limit of normal (ULN)   Total bilirubin  1.5 times ULN   AST and ALT  1.5 times ULN   Creatinine < 1.5 times ULN   No active serious infections   No prior malignancy except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinoma, or other cancer from which the patient has been disease free for 5 years   No comorbidity or condition that would interfere with study assessments and procedures or preclude study participation   PRIOR CONCURRENT THERAPY:   No prior chemotherapy or radiotherapy