| Exclusion Criteria: | 1) Patients whose tumors express ER, PR or HER2/neu gene amplification.
2) Patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer
3) Patients with an organ allograft or other history of immune compromise
4) Prior exposure to mTOR inhibitors
5) Hypersensitivity to rapamycin or other similar compounds
6) Prior treatment with any investigational drug within the preceding 4 weeks
7) Chronic treatment with systemic steroids or another immunosuppressive agent
8) A known history of HIV seropositivity
9) Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
10) Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin defined as 1 mg a day).
11) Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration)
12) Patients with a pre-existing peripheral neuropathy > grade 1
13) Patients taking medications metabolized by the CYP3A4 subfamily will not be included in this study. |