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