Erlotinib and Everolimus in Treating Patients With Metastatic Breast Cancer

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the breast
Evaluable metastatic disease (no need for measurable disease)

Must have had anthracycline therapy in the adjuvant setting or failed anthracycline treatment in the metastatic setting

Total cumulative dose of lifetime exposure of doxorubicin not greater than 360 mg/m^2 or epirubicin not greater than 640 mg/m^2

Must have failed previous taxane (paclitaxel or docetaxel) therapy, defined as:

Taxane use in the adjuvant setting with metastatic relapse within 12 months of therapy
Progression on taxane therapy in the metastatic setting
Discontinuation of taxane therapy in the metastatic setting secondary to lack of resolution of ≥ grade 2 toxicity

No symptomatic brain metastases

Patients with a history of brain metastases are eligible provided they are clinically stable and not taking steroids or therapeutic anticonvulsants that are CYP3A4 modifiers
Patients with asymptomatic brain metastasis are eligible provided they are not on prophylactic anticonvulsants that are CYP3A4 modifiers
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Inclusion criteria

Menopausal status not specified
ECOG performance status 0-1
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
SGOT and SGPT ≤ 2.5 times ULN
Albumin > 30 g/L
Creatinine ≤ 1.5 upper limit of normal
INR normal provided the patient is not on warfarin therapy
Not pregnant or nursing
Negative pregnancy test for premenopausal patients
Fertile patients must use effective barrier method contraception during and for 3 months after completion of study treatment
Patients must be disease-free of prior invasive cancers for > 5 years with the exception of basal cell or squamous cell cancer of the skin or cervical carcinoma in situ

Exclusion criteria

Serious or non-healing active wound, ulcer, or bone fracture
Known human immunodeficiency virus positivity

Uncontrolled intercurrent illness including, but not limited to, any of the following

Ongoing or active infection requiring parenteral antibiotics
Impairment of lung function (COPD, lung conditions requiring oxygen therapy)
Symptomatic congestive heart failure (New York Heart Association class III or IV heart disease)
Unstable angina pectoris or myocardial infarction within the past 6 months
Uncontrolled hypertension (i.e., systolic blood pressure > 180 mm Hg or diastolic blood pressure > 100 mm Hg, found on two consecutive measurements separated by a 1-week period despite adequate medical support)
Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment)
Uncontrolled diabetes
Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary

PRIOR CONCURRENT THERAPY:

Inclusion criteria

See Disease Characteristics
Prior trastuzumab (Herceptin®) in the first-line treatment of metastatic breast cancer is required for patients who have HER2/neu overexpressing tumors
More than 6 months since prior cardiac angioplasty or stenting

Use of endocrine therapy (i.e., aromatase inhibitors, fulvestrant, tamoxifen or ovarian ablation) in the first-line treatment of metastatic breast cancer is required for patients who have estrogen receptor and or progesterone receptor expressing tumors

Concurrent endocrine therapy is not allowed

Patients may receive concurrent radiotherapy to painful bone metastases or areas of impending bone fracture as long as radiotherapy is initiated prior to study entry

Patients who have received prior radiotherapy must have recovered from toxicity induced by this treatment
More than 3 weeks since prior chemotherapy, biological or hormonal therapy while on protocol therapy.
No other concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy

Exclusion criteria

More than 3 prior chemotherapy treatments in the metastatic setting

This restriction does not include endocrine therapies or single agent biologic therapies (i.e., trastuzumab [Herceptin®])
Use of steroids or immunosuppressants
Use of CYP3A4 modifiers
Concurrent therapy with trastuzumab (Herceptin®)
Use of growth support factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], recombinant erythropoietin) during the phase I portion of the study
Other concurrent investigational agents