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

Inclusion Criteria

• •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