Statement: Participants of the primary trial must be older than 18, have histologically confirmed stage 3 or above breast cancer, ECOG<2 and a life expectancy exceeding 6 months.
Primary_evidence: Inclusion Criteria:   Histologically confirmed Stage IV breast cancer   Prior banked malignant effusion or significant malignant effusion for tumor harvest or surgically-accessible tumor nodule of at least 2cm in greatest diameter by physical exam, magnetic resonance imaging (MRI) or computed tomography (CT) scan   Must have received at least one prior regimen of chemotherapy for metastatic disease   Patients with HER2 positive tumors must have received at least one prior trastuzumab-based therapy in the metastatic setting, and may not receive trastuzumab therapy and vaccine treatment concurrently   Patients may receive concurrent bisphosphonate therapy and/or erythropoetin therapy at any point while on study   ECOG performance status 0 or 1   Estimated life expectancy of greater than or equal to 6 months   18 years of age or older   Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy   Adequate recovery from drug-related toxicities from prior systemic therapies   Adequate recovery from recent surgery and radiation therapy   Greater than 6 months since bone marrow or peripheral blood stem cell transplant Exclusion Criteria:   Urgent need for cytotoxic chemotherapy, radiotherapy, or surgery in the next 60 days   Uncontrolled active infection or illness   Psychiatric illness/social situation that would limit study compliance   Pregnant or nursing mothers   Evidence of HIV infection   Previous participation in an adenovirus-based trial   Concurrent invasive malignancy