Sunitinib Malate and Exemestane in Treating Postmenopausal Women With Breast Cancer

This is an interventional treatment trial for Breast Cancer focused on measuring estrogen receptor-positive breast cancer, HER2-negative breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer Read More

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)