Sorafenib and Paclitaxel in Treating Patients With Metastatic Breast Cancer

DISEASE CHARACTERISTICS:

Inclusion criteria:

* Histologically\* confirmed breast cancer

  * Stage IV (metastatic) disease

    * Radiographic evidence of metastases NOTE: \*Histological confirmation of the actual metastasis is not required.
* Measurable disease by RECIST criteria defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (i.e., physical examination, CT scan, MRI, or x-ray) or ≥ 10 mm by spiral CT scan

  * No prior radiotherapy unless growth has been documented following radiotherapy
* Primary tumor or metastatic tumor HER2-negative, defined as the following:

  * Immunohistochemistry of 0 or 1+ OR the equivalent, if an automated quantitative assay is used
  * HER2 fluorescent in situ hybridization (FISH) assay negative as defined by a HER2:chromosome 17 centromeric probe ratio \< 1.8 (or \< 2.2 if immunohistochemistry is less than 3+ or equivalent) OR equivalent values for negative FISH assays that do not normalize to chromosome 17
* Hormone-receptor positive (estrogen receptor-\[ER\] or progesterone receptor \[PgR\]-positive) disease or hormone receptor-negative (ER- or PgR-negative) disease
* Tumor block from initial breast cancer primary or a biopsy of a metastatic site must be available for correlative studies
* Brain metastases allowed provided the patient is stable after completion of treatment (i.e., surgery and/or radiotherapy), asymptomatic, and off steroids with 2 consecutive stable brain scans at least 4 weeks after radiotherapy

Exclusion criteria:

* Bone-only or other nonmeasurable-only disease
* Newly diagnosed brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

* ECOG performance status 0-1
* Life expectancy \> 6 months
* Menopausal status not specified
* WBC ≥ 3,000/mcL
* Absolute neutrophil count ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Total bilirubin \< 1.5 times upper limit of normal (ULN)
* AST and ALT transaminases ≤ 2.5 times ULN (\< 5 times ULN if liver involvement)
* Creatinine \< 1.5 times ULN OR creatinine clearance \> 60 mL/min
* INR \< 1.5 OR PT/PTT normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception prior to and during (women and men) and for at least 3 months after (men) study therapy
* Able to swallow and absorb oral medications

Exclusion criteria:

* Active or uncontrolled medical illness (e.g., active infection \> CTCAE grade 2), including any of the following:

  * HIV or chronic hepatitis B or C
  * Uncontrolled diabetes
  * NYHA class II-IV uncompensated congestive heart failure
  * Unstable angina (anginal symptoms at rest)
  * New onset angina (i.e., began within the past 3 months)
  * Coronary artery disease
* Myocardial infarction within the past 6 months
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis or coagulopathy
* Pulmonary hemorrhage/bleeding event \> CTCAE grade 2 within 4 weeks of first dose of study drug
* Any other hemorrhage/bleeding event \> CTCAE grade 3 within 4 weeks of first study drug
* Thrombotic or embolic events (i.e., cerebrovascular accident), including transient ischemic attacks within the past 6 months
* Hypertension that cannot be controlled with medication to ≤ 150/90 mm Hg
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib tosylate
* Prior invasive cancer other than breast cancer except nonmelanoma skin cancer
* Chronic nonhealing wound or ulcer

PRIOR CONCURRENT THERAPY:

* No more than 1 prior chemotherapy regimen for metastatic breast cancer (MBC)
* At least 3 weeks since prior hormonal therapy for MBC or adjuvant or neoadjuvant chemotherapy

  * More than 1 year since adjuvant paclitaxel
* At least 4 weeks since major thoracic, abdominal, or pelvic surgery and recovered
* At least 3 weeks since prior and no concurrent investigational drugs
* Concurrent bisphosphonates allowed
* Concurrent anticoagulation agents (i.e., warfarin or heparin) allowed
* No anticipated need for or concurrent radiotherapy
* No concurrent Hypericum perforatum (St. John wort) or rifampin (rifampicin)
* No other concurrent anti-neoplastic drugs