Autologous Vaccination With Lethally Irradiated, Autologous Breast Cancer Cells Engineered to Secrete GM-CSF in Women With Operable Breast Cancer

Inclusion Criteria:

* Histologically or cytologically confirmed invasive breast cancer, pre-operative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging
* Cohort 1: At least 2cm of residual disease in sum of diameters by clinical or radiographic findings following their preoperative chemotherapy
* Cohort 2: Patients who have not received preoperative chemotherapy must have at least 4cm of disease in the largest diameter by clinical or radiographic findings
* Prior therapy for Cohort 1 only: Must have completed preoperative (neoadjuvant) chemotherapy with either a standard regimen (containing an anthracycline and/or a taxane) or on a clinical trial
* HER2 positive tumors must have received at least one prior trastuzumab-based therapy, and may not receive concurrent trastuzumab therapy and vaccination
* Must initiate hormonal therapy (if indicated), including ovarian suppression, at least 4 weeks prior to initiation of vaccinations
* Must have completed definitive resection of primary tumor with adequated excision of gross disease. Surgery should have occured more than 28 days but within 12 weeks prior to enrollment
* May receive concurrent hormonal therapy, such as tamoxifen, ovarian suppression, and aromatase inhibitors
* Must have had prior banked tumor of sufficient cellular yield for vaccination
* ECOG Performance Status 0 or 1
* 18 years of age or older
* Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy
* Adequate recovery from recent surgery and radiation therapy

Exclusion Criteria:

* Uncontrolled active infection or illness
* Other medical or psychiatric illness or social situation that would limit study compliance
* Pregnancy or nursing mothers
* Evidence of HIV infection
* Previous participation in an adenovirus-based trial
* Concurrent invasive malignancies