Bendamustine and Erlotinib in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed breast cancer meeting 1 of the following criteria:
• * Unresectable stage IIIB or IIIC disease
• * Stage IV disease
• Must be negative for all of the following:
• * Estrogen receptor (\< 10%)
• * Progesterone receptor (\<10%)
• * HER-2 (negative FISH, IHC 0 - 1+, or IHC +2 with negative FISH)
• Measurable or evaluable disease
• No symptomatic or progressive CNS (central nervous system) metastases
• * Previously treated CNS metastases allowed provided all of the following criteria are met:
• * At least 8 weeks since prior radiation to brain or CNS metastases
• * No concurrent steroids
• * No leptomeningeal disease
• PATIENT CHARACTERISTICS:
• Menopausal status not specified
• ECOG (Eastern Cooperative Oncology Group) performance status 0-2
• Life expectancy ≥ 6 months
• WBC \> 1,500/mm³
• Platelet count \> 100,000/mm³
• Creatinine clearance \> 40 mL/min
• Normal electrolytes (i.e., Na, K, and Ca normal; minor deviations are allowed if they do not impact on patient safety in the clinical judgment of the treating physician)
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN in the presence of documented liver metastases)
• Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver or bone metastases)
• Not pregnant or nursing
• Fertile patients must use effective barrier contraception
• No uncontrolled intercurrent illness
• No active infection requiring systemic therapy
• Able to swallow oral medications and with no medical problems or prior surgeries that may interfere with the absorption of oral medications including the following:
• * Uncontrolled nausea, vomiting, or diarrhea
• * Lack of the physical integrity of the upper gastrointestinal tract
• * Malabsorption syndrome
• No known hypersensitivity to bendamustine hydrochloride, mannitol, or erlotinib hydrochloride
• No prior malignancy in the past 5 years except for adequately treated basal cell or squamous cell skin carcinoma, or adequately treated stage I-II cancer for which the patient is in complete remission
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Prior adjuvant or neoadjuvant chemotherapy and 1 prior chemotherapy regimen in the metastatic setting allowed provided recovered from all acute toxicities
• No prior bendamustine hydrochloride or EGFR-directed therapy
• No other concurrent antineoplastic treatments, including radiotherapy, chemotherapy, biological therapy, hormonal therapy, immunotherapy, gene therapy, and surgery
• * Intravenous bisphosphonates allowed
• No concurrent antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents