Phase I/II Study of Weekly Abraxane and RAD001 in Women With Locally Adv. or Metastatic Breast Ca

DISEASE CHARACTERISTICS:

Histologically confirmed breast cancer

Locally recurrent or metastatic disease
Not amenable to surgery or radiotherapy
HER2/neu-negative disease

Has ≥ 1 measurable lesion, as defined by RECIST criteria

No non-measurable lesions (e.g., pleural effusion or ascites) other than bone metastases

Bone metastases as the sole site of disease allowed provided there are ≥ 2 lytic bone lesions by x-ray, CT scan, or MRI
Lesions irradiated in the advanced setting are not considered sites of measurable disease unless clear tumor progression has been documented in these lesions since the completion of radiotherapy
No bilateral diffuse lymphangitis carcinomatosa of the lung (> 50% of lung involvement) or evidence of liver metastases estimated as involving > one third of the liver by sonogram and/or CT scan
No unstable CNS metastases
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Menopausal status not specified
ECOG performance status 0-2
Life expectancy ≥ 3 months
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin > 9 g/dL
Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN in patients with liver metastases)
INR < 1.5 times ULN
Serum creatinine ≤ 1.5 mg/dL
Fasting serum cholesterol ≤ 300 mg/dL (or 7.75 mmol/L) (levels outside this threshold allowed provided statin therapy is initiated)
Fasting triglycerides ≤ 2.5 times ULN (levels outside this threshold allowed provided statin therapy is initiated)
Not pregnant or nursing
Negative pregnancy test

Fertile patients must use effective contraception

Oral, implantable, or injectable contraceptives are not considered effective contraception
No ascites or encephalopathy due to liver disease
No neuropathy ≥ grade 2

No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of everolimus, including any of the following:

Ulcerative disease
Uncontrolled nausea, vomiting, or diarrhea
Malabsorption syndrome
No active, bleeding diathesis
No known HIV seropositivity
No known hypersensitivity to everolimus or sirolimus (rapamycin), paclitaxel albumin-stabilized nanoparticle formulation, or lactose
No history of noncompliance to medical regimens

No severe and/or uncontrolled medical condition or other condition that could affect study participation, including any of the following:

Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within the past 6 months, or serious uncontrolled cardiac arrhythmia
Severely impaired lung function
Active (acute or chronic) or uncontrolled infections or disorders
Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by study treatment
Liver disease (e.g., cirrhosis, chronic active hepatitis, or chronic persistent hepatitis)
No other malignancies within the past 5 years, except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Prior systemic endocrine therapy for advanced breast cancer allowed

No prior chemotherapy for advanced breast cancer

Prior adjuvant chemotherapy allowed
No prior small bowel resection
More than 5 days since prior strong CYP3A inhibitors or inducers (e.g., rifabutin, rifampin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, or telithromycin)
More than 30 days since prior radiotherapy and recovered (alopecia allowed)
Prior localized radiotherapy for analgesic purposes allowed provided radiotherapy has been completed and the patient's condition is stabilized
No prior radiotherapy to ≥ 25% of the bone marrow
More than 30 days since prior investigational drugs
More than 1 week since prior and no concurrent immunization with attenuated live vaccines
No concurrent oral anti-vitamin K medication, except low-dose coumadin

No concurrent systemic steroids or other immunosuppressive agents as chronic therapy

Topical applications, inhaled sprays, eye drops, or local injections allowed
A short duration (< 2 weeks) of systemic corticosteroids allowed
No concurrent hormone replacement therapy, topical estrogens (including any intra-vaginal preparations), megestrol acetate, or selective estrogen-receptor modulators (e.g., raloxifene)
No other concurrent investigational or anticancer agents
Concurrent antiangiogenic agents allowed
Concurrent bisphosphonates allowed