Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy

Inclusion Criteria

• •Female patients, age ≦65 years
• •Biopsy proven lymph node positive, estrogen receptor- positive primary breast cancer
• •Must have completed a 4-cycle neo-adjuvant chemotherapy with a standard regimen(containing anthracycline or paclitaxel)
• •Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision
• •Postoperative residual positive lymph nodes or G1/G2/G3 of Miller \& Payne Grading System
• •Adequate recovery from recent surgery
• •No history of other malignancies
• •No currently uncontrolled diseased or active infection
• •Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential
• •Adequate cardiovascular function reserve with a myocardial infarction within the past six month
• •Adequate hematologic function with:
• •1. Absolute neutrophil count (ANC) ≥1500/mm3
• •2. Platelets ≥100,000/ mm3
• •3. Hemoglobin ≥10 g/dL
• •Adequate hepatic and renal function with:
• •1. Serum bilirubin ≤1.5×UNL
• •2. Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is acceptable in the setting of hepatic metastasis)
• •3. BUN between 1.7 and 8.3 mmol/L
• •4. Cr between 40 and 110 umol/L
• •Knowledge of the investigational nature of the study and Ability to give informed consent
• •Ability and willingness to comply with study procedures.