This is a phase IV, prospective, single-center, open-label, randomized, controlled study. Eligible patients are randomly assigned into three groups. The investigators propose to evaluate and compare the efficacy and safety of different neoadjuvant chemotherapies in women with primary breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
501
5-FU 200mg/m2 per day from day 1 to day 28 (Continuous intravenous infusion); epirubicin 65mg/m2 per day on day 1 and day 8 and cyclophosphamide 500mg/m2 per day on day 1 and day 8 ; every 28 days as a cycle. Total four cycles is needed
5-FU 500mg/m2 per day on day 1 and day 8(intravenous bolus); epirubicin 65mg /m2 per day on day 1 and day 8 and cyclophosphamide 500mg/m2 per day on day 1 and day 8 ; every 28 days as a cycle. Total four cycles is needed.
epirubicin 65mg/m2 per day on day 1 and day 8 and cyclophosphamide 500mg/m2 per day on day 1 and day 8 ; every 28 days as a cycle. Total four cycles is needed.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Pathologic complete response (PCR)
pathological evaluation by Miller \& Payne Grading System. Pathological complete response (pCR) was defined as no histological evidence of invasive tumor cells in the breast. The presence of DCIS alone was considered as pCR (G5). Residual cancer consisting of scattered tumor cells, not directly measurable, was reported as near pCR (G4)
Time frame: up to four weeks after surgery
Number of Participants with Ⅲ° and Ⅳ° Adverse Events According to NCI-CTC
All adverse events that occur after the initiation of the treatment will be handled with utmost attention, and carefully documented. Investigator will identify the adverse events according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0, the Common Terminology Criteria for Adverse Events.Development of a severe side effect will be an indication for drop-outs.
Time frame: at the last day of every chemotherapy cycle
Number of patients undergoing breast conserving surgery
Time frame: up to a week after operation
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