Safety and Immune Response to a Mammaglobin-A DNA Vaccine In Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy

Inclusion Criteria: A patient will be eligible for inclusion in this study only if ALL of the following criteria apply: * Newly diagnosed histologically confirmed invasive breast cancer. * Clinical T2-T4c, any N, M0 invasive ER+ (Allred Score of 6-8) and HER2- (0 or 1+ by IHC or FISH negative for amplification) breast cancer by AJCC 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node. Patients with T1c tumors are eligible if they are considered candidates for neoadjuvant endocrine therapy or chemotherapy * At least 1 measurable lesion. * Candidate for neoadjuvant endocrine therapy or chemotherapy. * At least 18 years of age. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2. * Adequate organ and marrow function no more than 28 days prior to the start of neoadjuvant endocrine therapy or chemotherapy as defined below: * WBC ≥3,000/μL * absolute neutrophil count ≥1,500/μL * platelets ≥100,000/μL * total bilirubin ≤institutional upper limit of normal * AST/ALT ≤2.5 X institutional upper limit of normal * creatinine ≤ institutional upper limit of normal OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine above IULN * Postmenopausal or premenopausal. NOTE: Postmenopausal women, verified by: (1) bilateral surgical oophorectomy, or (2) no spontaneous menses ≥ 1 year or (3) no menses for \<1 year with FSH and estradiol levels in postmenopausal range, according to i…