Phase II Study of Irinotecan/Capecitabine in Patients With Antracycline/Taxane Pretreated MBC

Inclusion Criteria: * Histologic or cytologic diagnosis of breast cancer Stage IV or recurrent. * Previous chemotherapy with anthracyclines and taxane in adjuvant setting * Previous hormonal therapy in adjuvant and metastatic setting is allowed * Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease. * No other forms of cancer therapy, such as radiation, immunotherapy for at least 3 weeks before the enrollment in study. * Performance status of 0, 1, 2 on the ECOG criteria. * Clinically measurable disease, defined as uni-dimensionally measurable lesions with clearly defined margins on x-ray, CT scan, MRI or physical examination. Lesions serving as measurable disease must be at least 1 cm, as defined by x-ray, CT scan, MRI, or physical examination. * Estimated life expectancy of at least 12 weeks. * Patient compliance that allow adequate follow-up. * Adequate hematologic (WBC count ³ 3,000/mm3, platelet count ³ 100,000/mm3), hepatic (bilirubin level £ 1.5 mg/dL), and renal (creatinine concentration £ 1.5 mg/dL) function. * Informed consent from patient or patient's relative. * Males or females at least 18 years of age. * If female: childbearing women should use non-hormonal contraceptive method Exclusion Criteria: * MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia. * Serious concomitant infection. * Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).