Sorafenib in Treating Patients With Metastatic Breast Cancer

Inclusion Criteria: Histologically or cytologically confirmed breast cancer Clinical evidence of metastatic disease Measurable disease HER2-positive or -negative disease If HER2 gene amplified or strongly positive for HER2 by immunohistochemistry, patient must have had prior treatment containing trastuzumab (Herceptin®) unless contraindicated Previously treated with anthracycline- and/or taxane-containing regimen in the neoadjuvant, adjuvant, or metastatic setting Candidate for first- or second-line chemotherapy for metastatic disease Core block or tumor slides of the primary or metastatic tumor available No known brain metastases Hormone receptor status: Not specified Male or female Performance status - ECOG 0-1 At least 3 months WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.5 g/dL No evidence of bleeding diathesis Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST ≤ 3 times ULN Alkaline phosphatase ≤ 3 times ULN PT normal PTT normal INR normal Creatinine ≤ 1.5 times ULN Calcium normal No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No uncontrolled hypertension No gastrointestinal tract disease that would preclude taking oral medication No active peptic ulcer disease Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other study agents No ongoing or active infection No psychiatric illness or social situation that would preclude study participation No other uncontrolled illness See Disease Characteristics More than 4 weeks since prior immunotherapy No concurrent anticancer immunotherapy No concurrent bevacizumab See Disease Characteristics More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No more than 1 prior chemotherapy regimen for metastatic disease No concurrent anticancer chemotherapy Prior hormonal therapy in the neoadjuvant, adjuvant, or metastatic setting is allowed No concurrent anticancer hormonal therapy No prior radiotherapy to ≥ 25% of the bone marrow More than 4 weeks since prior radiotherapy More than 4 weeks since prior major surgery No prior surgical procedure that would affect gastrointestinal absorption No other concurrent drugs that target vascular endothelial growth factor (VEGF) or VEGF receptors No concurrent antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anticancer therapy No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following: Phenytoin Carbamazepine Phenobarbital No concurrent rifampin No concurrent Hypericum perforatum (St. John's wort) No concurrent therapeutic anticoagulation Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for venous or arterial devices is allowed