| Exclusion Criteria: | 1) Patients enrolled in the Phase I portion of the trial may have received prior docetaxel in the adjuvant or metastatic setting. Patients enrolled in the Phase II portion of the trial will not be considered eligible if they have received prior docetaxel as treatment for metastatic breast cancer. For the purposes of this protocol, patients who develop systemic metastasis <6 months from adjuvant docetaxel will be considered to have had treatment with docetaxel for metastatic breast cancer and will be ineligible for protocol participation.
2) Patients with a history of thromboembolism within the prior 6 months or active thrombophlebitis
3) For the phase I portion of the study, patients with grade > 2 neuropathy, for the phase II portion of the trial, patients with > or = grade 2 neuropathy.
4) For the phase I portion of the trial, patients with treated brain metastasis that are stable for 3 months will be eligible for protocol participation; however, patients with brain metastasis will be excluded from the phase II portion of the trial.
5) Patients with an uncontrolled infection
6) Patients with a known history of HIV seropositivity
7) Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except patients receiving 1 mg of warfarin to prevent central venous catheter thrombosis)
8) Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration)
9) Patients with 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 who received any other investigational drugs within the preceding 30 days
11) Patients who have received mitomycin C or nitrosourea
12) Patients receiving anti-neoplastic therapy less than 14 days prior to entry onto this study or who have not recovered from the toxic effects of such therapy
13) Patients who received radiation therapy within 3 weeks prior to entry on this study or who have not recovered from the toxic effects of such therapy.
14) Patients who had surgery within 2 weeks prior to entry on this study or who have not recovered from the side effects of such therapy
15) Patients with a history of noncompliance to medical regimens
16) Patients unwilling to or unable to comply with the protocol
17) Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A4 or patients taking lithium chloride |