Sunitinib Malate and Exemestane in Treating Postmenopausal Women With Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed invasive breast carcinoma meeting the following criteria:
• •* Estrogen receptor-positive ≥ 50% or Allred score \> 6
• •* HER-2 negative defined as IHC \< 2+ and negative FISH/CISH
• •* Primary tumor measuring ≥ 3 cm if there is no node involvement
• •* Any T if N1 or N2 disease
• •* No inflammatory breast cancer (T4d)
• •* No metastatic disease
• •Measurable disease by mammography and/or ultrasound and MRI (if available)
• •PATIENT CHARACTERISTICS:
• •Postmenopausal
• •* Prior bilateral oophorectomy
• •* ≥ 60 years of age
• •* \< 60 years of age AND have experienced amenorrhea for ≥ 12 months in the absence of chemotherapy, tamoxifen, or toremifene OR have undergone ovarian suppression and follicle-stimulating hormone and estradiol levels in the postmenopausal range
• •ECOG performance status 0-1
• •ANC ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hemoglobin ≥ 10 g/dL
• •Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
• •Bilirubin normal
• •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• •Alkaline phosphatase ≤ 2.5 times ULN
• •Albumin \> 2.5. g/dL
• •No known HIV infection
• •Adequate left ventricular ejection fraction (LVEF) at baseline defined as LVEF not below normal range by echocardiogram or MUGA
• •No evidence of prior uncontrolled hypertension
• •* Patients with controlled hypertension (systolic \< 150 mm Hg and/or diastolic \< 90 mm Hg) by antihypertensive therapies allowed
• •No prior uncontrolled or symptomatic angina, myocardial infarction, congestive heart failure, clinically significant arrhythmias, or prolongation of the QTc interval
• •No hemorrhagic or thrombotic events, including transient ischemic attack, pulmonary embolism, or deep-vein thrombosis, within the past 12 months
• •No gross hemorrhage within the past 6 months (e.g., gastrointestinal bleeding, hemoptysis, or hematuria)
• •No history or evidence of an inherited bleeding diathesis or coagulopathy at risk of bleeding
• •None of the following:
• •* Unable to swallow oral medications
• •* Active inflammatory bowel disease
• •* Partial or complete bowel obstruction
• •* Chronic diarrhea
• •No history of another malignancy within the past 5 years except for cured non-melanoma skin cancer or successfully treated carcinoma in situ of the cervix
• •No psychiatric disease or social situations that would limit compliance with study requirements or patient unwilling or unable to comply with protocol for the duration of study
• •No unstable or severe intercurrent medical condition that, in the opinion of the investigator, might interfere with the achievement of study objectives
• •No known immediate or delayed hypersensitive reaction or idiosyncrasy to drugs chemically related to exemestane or sunitinib malate or their excipients
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •No prior or other concurrent chemotherapy, radiotherapy, immunotherapy, biologic therapy, or hormonal therapy for primary invasive breast cancer
• •No concurrent anticoagulant therapy except for low-dose anticoagulants (i.e., low molecular weight heparin or aspirin) for the prevention of deep-vein thrombosis
• •No chronic therapy with corticosteroids, except for steroids administered by inhalation
• •More than 4 weeks since prior major surgery and ≥ 7 days since prior minor surgery
• •No prior or other concurrent investigational anticancer agent
• •No concurrent participation in another clinical trial
• •No concurrent drugs with potential proarrhythmic activity
• •No concurrent known CYP3A4 inhibitors (i.e., grapefruit, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, clarithromycin, diltiazem, nefazodone, voriconazole, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, delavirdine)
• •No concurrent known CYP3A4 or CYP1A2 inducers (i.e., carbamazepine, dexamethasone, felbamate, omeprazole, efavirenz, tipranavir, phenobarbital, phenytoin, primidone, rifabutin, rifampicin, St. John's wort)