Sunitinib in Treating Patients With Newly Diagnosed Stage II or Stage III Breast Cancer That Can Be Removed by Surgery

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed breast cancer
• * Newly diagnosed disease
• * Stage II-IIIA (T1c, T2, or T3) disease
• * Unifocal disease
• * Resectable disease
• Tumor must be suitable for multiple biopsies and imaging
• No prior breast cancer
• Hormone receptor status not specified
• PATIENT CHARACTERISTICS:
• Male or female
• Menopausal status not specified
• ECOG performance status 0-1
• Absolute granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine normal
• Calcium ≤ 3 mmol/L
• Bilirubin normal
• ALT and AST ≤ 2.5 times upper limit of normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other malignancies except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
• No QTc prolongation (defined as a QTc interval ≥ 500 msec) or other significant ECG abnormalities
• No history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
• No prior or concurrent NYHA class II-IV cardiovascular disease
• No inadequately controlled hypertension (systolic BP ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
• No myocardial infarction, cardiac arrhythmia, stable or unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within the past 12 months
• No pulmonary embolism within the past 12 months
• No cerebrovascular accident or transient ischemic attack within the past 12 months
• No serious illness or medical condition that would preclude study compliance including, but not limited to, the following:
• * History of significant neurologic or psychiatric disorder
• * Active uncontrolled infection
• * Serious or nonhealing wound, ulcer, or bone fracture
• No medical condition that could interfere with oral medication intake (e.g., frequent vomiting, malabsorption)
• No history of allergic reactions attributed to compounds with similar chemical composition to sunitinib malate
• No preexisting hypothyroidism unless patient is euthyroid on medication
• PRIOR CONCURRENT THERAPY:
• At least 7 days since prior and no concurrent CYP3A4 inhibitors, including the following:
• * Azole antifungals (ketoconazole, miconazole)
• * Verapamil
• * Clarithromycin
• * HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir)
• * Erythromycin
• * Delavirdine
• * Diltiazem
• At least 12 days since prior and no concurrent CYP3A4 inducers, including the following:
• * Rifampin
• * Phenytoin
• * Rifabutin
• * Hypericum perforatum (St. John's wort)
• * Carbamazepine
• * Efavirenz
• * Pentobarbital
• * Tipranavir
• * Phenobarbital
• No prior protein tyrosine kinase inhibitor
• No prior antiangiogenic agent
• No prior hormonal therapy, radiotherapy, chemotherapy, surgery, investigational therapy, or other therapy for breast cancer
• At least 12 days since prior and no concurrent cyclooxygenase-2 inhibitors (e.g., etoricoxib, valdecoxib, celecoxib, dual cyclooxygenase/lipid oxidation, and lumiracoxib)
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent agents with proarrhythmic potential (e.g., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, and flecainide)
• No other concurrent treatment for breast cancer
• No concurrent coumadin-derivative anticoagulants (e.g., warfarin)
• * Anticoagulants at ≤ 2 mg/day for prophylaxis of thrombosis allowed
• * Low molecular weight heparin allowed provided INR ≤ 1.5