Everolimus in Treating Patients WIth Recurrent or Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed breast cancer
• * Metastatic or recurrent disease
• * Considered incurable
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Two primary breast cancers allowed
• Paraffin-embedded primary or metastatic tumor sample available
• No known brain metastases
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Sex
• Male or female
• Menopausal status
• Not specified
• Performance status
• ECOG 0-2
• Life expectancy
• Not specified
• Hematopoietic
• Absolute granulocyte count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hepatic
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Renal
• Creatinine ≤ 1.5 times ULN
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active uncontrolled infection
• No upper gastrointestinal condition or other condition that would preclude ability to take oral medication
• No other serious medical condition that would preclude study participation
• No psychiatric illness or neurologic disorder that would preclude study compliance
• No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder
• PRIOR CONCURRENT THERAPY:
• Chemotherapy
• At least 4 weeks since prior chemotherapy
• Prior adjuvant chemotherapy allowed
• No more than 1 prior chemotherapy regimen for metastatic or recurrent disease
• Endocrine therapy
• At least 5 days since prior hormonal therapy
• Radiotherapy
• At least 4 weeks since prior radiotherapy except for low-dose, limited-fraction, palliative, nonmyelosuppressive radiotherapy, defined as radiotherapy to \< 20% of functioning bone marrow
• If prior radiotherapy was to sole site of disease, must have subsequent documented disease progression at that site
• Surgery
• At least 3 weeks since prior major surgery
• Other
• Concurrent prophylactic bisphosphonates allowed, if started prior to study entry
• No concurrent potent inhibitors of cytochrome 3A4, such as erythromycin, diltiazem, or ketoconazole and similar antifungals
• No other concurrent anticancer therapy
• No other concurrent investigational agents
• No concurrent grapefruit juice