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).