Gene Expression Profiles in Predicting Chemotherapy Response in Breast Cancer

Inclusion Criteria

• •Female, age \> 18 years.
• •Histologic or cytologic diagnosis of breast carcinoma.
• •Stage II to IV breast cancer with measurable primary breast tumor, defined as palpable tumor with both diameters 2.0cm or greater as measured by caliper.
• •Patients must not have received prior chemotherapy or hormonal therapy for the treatment of breast cancer.
• •Karnofsky performance status of 70 or higher.
• •Estimated life expectancy of at least 12 weeks.
• •Adequate organ function including the following:
• •\- Bone marrow: White blood cells (WBC) \>= 3.5 x 109/L Absolute neutrophil (segmented and bands) count (ANC) \>= 1.5 x 109/L Platelets \>= 100 x 109/L Haemoglobin \>= 9g/dL
• •\- Hepatic: Bilirubin \<= 1.5 x upper limit of normal (ULN), ALT or AST \<= 2.5x ULN, (or \<=5 X with liver metastases) Alkaline phosphatase \<= 2.5x ULN.
• •\- Renal: creatinine \<= 1.5x ULN
• •* Cardiac:
• •* Adequate cardiac function
• •Signed informed consent from patient or legal representative.
• •Patients with reproductive potential must use an approved contraceptive method if appropriate (eg, intrauterine device, birth control pills, or barrier device) during and for three months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.