Statement: Patients with AIDS are eligible for both the secondary trial and the primary trial.
Primary_evidence: 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
Secondary_evidence: Inclusion Criteria:   Histologically or cytologically confirmed invasive breast cancer, with stage IV disease   Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as greater than or equal to 20mm with conventional techniques or as greater than or equal to 10mm with spiral CT scan.   Primary tumor or metastasis must overexpress HER2   Patient must have received 1-2 prior chemotherapeutic regiments for metastatic breast cancer and must have been off treatment for at least three weeks.   Patient must have received and progressed on at least 1 prior trastuzumab-containing regimen, but not more than 2, in the metastatic setting.   Patients may have received prior radiation therapy   Patients may have received hormonal therapy in the adjuvant or metastatic setting   18 years of age or older   Life expectancy of greater than 6 months   Normal organ and marrow function as defined in the protocol   Left ventricular ejection fraction (LVEF) greater than or equal to the institutional lower limit of normal Exclusion Criteria:   Treatment with any investigational drug within 4 weeks   Long-term treatment, over 3 months, with a systemic steroid or another immunosuppressive agent   Other malignancies within the past 3 years, except for adequately treated carcinoma of teh cervix or basal-or squamous-cell carcinoma of the skin   Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001   An active, bleeding diathesis or an oral anti-vitamin K medication   Prior treatment with an mTOR inhibitor   History of non-compliance with medical regimens   Unwillingness or inability to comply with the protocol   Major surgery within 2 weeks before study entry   Patients with active brain metastases or leptomeningeal carcinomatosis   Patients who have experienced grade 1 or grade 2 hypersensitivity reactions to prior trastuzumab therapy are eligible ONLY IF these reactions did not prevent further administration   Severe and/or uncontrolled intercurrent medical condition, psychiatric illness or a social situation that could limit their ability to comply with the study requirements.   Pregnant or breast-feeding women   HIV positive patients   Known hypersensitivity to RAD001 (everolimus) or other rapamycins