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