Exemestane With Sunitinib (SUTENT®) in Metastatic Breast Cancer

Inclusion Criteria

• •1. Must have metastatic breast cancer or locally advanced not amenable to curative therapy.
• •2. Measurable or evaluable disease are eligible.
• •3. Tumors must be Estrogen Receptor (ER)-positive and/or Progesterone Receptor (PR)-positive.
• •4. Human Epidermal Growth Factor Recepter 2 (HER2)-positive tumors are allowed but must have failed Herceptin therapy.
• •5. Postmenopausal
• •6. No more than 3 lines of chemotherapy
• •7. No more than 3 lines of hormonal therapy
• •8. Bisphosphonates may be given according to their product license
• •9. Left ventricular ejection fraction within institutional normal limits
• •10. Liver function and kidney function tests within the upper limit of normal. In patients with liver metastasis, liver function tests should be \< 5 times the upper limit of normal.
• •11. Adequate blood counts
• •12. Normal thyroid function tests.
• •13. Patients with Central Nervous System (CNS) metastatic disease are allowed if the disease is stable for more than 3 months by CT or MRI.
• •14. Adequate general health (Eastern Cooperative Oncology Group (ECOG) performance status 0-2).
• •15. Able to give informed consent and follow the procedures of the study.
• •7. ECOG performance status 3 or 4.
• •8. History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma of the skin.
• •9. History of a cerebrovascular accident, non-catheter related deep vein thrombosis, or pulmonary embolism in the last 5 years.
• •10. Major surgical procedure or significant traumatic injury within 28 days prior to study entry.
• •11. Premenopausal status.
• •12. History of receiving any investigational treatment within 28 days of study medication initiation.
• •13. Current known infection.
• •14. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).
• •15. Medical or psychiatric condition that in the opinion of the principal investigator impair their ability to participate in the study.