Phase 2b Study of Taxol Plus Sorafenib or Placebo in Patients With Advanced Breast Cancer

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the breast * Locally recurrent or metastatic disease * Locally recurrent disease not amenable to resection with curative intent * Measurable or evaluable disease * No HER-2 overexpression (defined as positive for gene amplification by FISH or 3+ overexpression by IHC) * No unknown HER-2 status * No active brain metastases * Patients with neurological symptoms and known brain metastases treated with definitive therapy must undergo contrast CT scan or brain MRI to exclude active brain metastasis * Previously treated brain metastases allowed provided at least 3 months since prior definitive therapy (including steroids) AND no evidence of disease * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Male or female * Menopausal status not specified * ECOG performance status 0-1 * Not pregnant or nursing for ≥ 2 weeks after completion of study therapy * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 2 weeks after completion of study therapy * Hemoglobin ≥ 9.0 g/dL * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) * ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement) * INR ≤ 1.5 and aPTT within normal limits * Anticoagulation therapy (e.g., warfarin or heparin) allowed * Stable INR required for patients on warfarin * Creatinine ≤ 1.5 times the ULN * Able to swallow and retain oral medication * More than 4 weeks since prior significant traumatic injury * No evidence or history of bleeding diathesis or coagulopathy * No serious nonhealing wound, ulcer, or bone fracture * No substance abuse or medical, psychological, or social condition that would interfere with study participation or evaluation of study results * No pre-existing peripheral neuropathy ≥ grade 2 * No clinically significant cardiac disease, including any of the following: * New York Heart Association class II-IV congestive heart failure * Unstable angina (i.e., angina symptoms at rest) or new-onset angina within the past 3 months * Myocardial infarction within the past 6 months * No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * No uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 90 mm Hg despite optimal medical management) * No thrombolic, embolic, venous, or arterial events such as a cerebrovascular accident, including transient ischemic attacks within the past 6 months * No pulmonary hemorrhage or bleeding event \> grade 2 within the past 4 weeks * No other hemorrhage or bleeding event ≥ grade 3 within the past 4 weeks * No active clinically serious infection \> grade 2 * No known HIV infection or chronic hepatitis B or C * No other prior or concurrent cancer except carcinoma in situ of the cervix, treated basal cell skin cancer, superficial bladder tumors (e.g., Ta and Tis), or any cancer curatively treated for \> 5 years * No known or suspected allergy to sorafenib tosylate or hypersensitivity to paclitaxel or drugs using the vehicle Cremophor PRIOR CONCURRENT THERAPY: * More than 12 months since prior adjuvant or neoadjuvant taxane therapy * At least 3 weeks since other prior adjuvant chemotherapy * At least 3 weeks since prior hormonal therapy for locally recurrent or metastatic disease * No prior chemotherapy for locally recurrent or metastatic breast cancer * More than 4 weeks since prior major surgery or open biopsy * At least 3 weeks since prior radiotherapy * Previously irradiated area must not be the only site of disease * More than 30 days or 5 half-lives, whichever is longer, since prior investigational drug * No prior or concurrent bevacizumab or any other licensed or investigational drugs that target VEGF or VEGF-receptor * More than 3 weeks since prior and no concurrent Hypericum perforatum (St. John's wort ) or rifampin (rifampicin) * No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital) * No concurrent irinotecan hydrochloride or doxorubicin hydrochloride * No other concurrent anticancer therapy (i.e., chemotherapy, radiotherapy, surgery, immunotherapy, biologic therapy, or tumor embolization) * No concurrent nonconventional therapies (e.g., herbal) * No concurrent palliative radiotherapy