Statement: Patients with aspartate aminotransferase more than 2 times the upper limit of normal are excluded from both the secondary trial but eligible for the primary trial.
Primary_evidence: Inclusion Criteria:   Signed written informed consent   Histologically confirmed primary invasive adenocarcinoma of the breast.   Clinical stage breast cancer T2-3, N0-3, M0   Negative HER-2/neu expression as determined by local hospital laboratory using Fluorescence In Situ Hybridization (FISH), or is less or equal to 1+ using Immunohistochemistry (IHC).   No prior treatment for primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy or surgery. Subjects receiving hormone replacement treatment (HRT) are eligible if this therapy is discontinued at least 2 weeks before starting study treatment. Treatment for DCIS is allowed, such as surgery, hormonal therapy and radiotherapy.   Karnofsky performance status (KPS) of 80 - 100   The ability and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.   Baseline MUGA or echocardiogram scans with LVEF of > 50%.   Normal PTT and either INR or PT < 1.5 x ULN.   Men or women 18 years of age or older.   Women of childbearing potential (WOCBP) must agree to use a medically acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drugs.   Willingness to have core biopsies and/or FNA performed before the start of study treatment and at the end of 12 week on treatment. Exclusion Criteria:   Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast-feeding.   Disease free of prior malignancy for < 5 years with the exception of DCIS, curatively treated basal carcinoma of the skin, local skin squamous cell carcinoma, or carcinoma in situ of the cervix.   Absolute neutrophils count (ANC) < 1500/mm^3   Total bilirubin > 1.5 times the upper limit of normal (ULN)   AST or ALT > 2.5 times the upper limit of normal (ULN)   Platelets < 100,000/mm^3.   Serum creatinine > 1.5 x ULN or creatinine clearance < 60 mL/min (measured or calculated by Cockcroft-Galt method)   Evidence of metastatic breast cancer following a standard tumor staging work-up   Evidence of inflammatory breast cancer.   Evidence of any grade 2 sensory or motor neuropathy.   Known human immunodeficiency viral (HIV) infection   Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy.   Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocols.
Secondary_evidence: 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