Clinical trial NCT00096434 (phase 2, status: completed)
Conditions: male breast cancer, recurrent breast cancer, stage iv breast cancer
ICD codes: C50.021, C50.022, C50.029, C50.121, C50.122, C50.129, C50.621, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: sorafenib tosylate
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Eligibility criteria:

        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