Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy
The purpose of this phase Ⅲ, multi-center, prospective, open-label, randomized,controlled
 study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can
 increase distant disease free survival(DDFS) in operable patients 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.

 Exclusion Criteria:

 -  Known or suspected distant metastases

 -  Concurrent malignancy or history of other malignancy

 -  Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months,
 arrhythmia, unstable diabetes, hypercalcemia) or active infection

 -  Geographical, social, or psychological problems that would compromise study compliance

 -  Known or suspected hypersensitivity to anthracycline or paclitaxel