Breast Cancer
Conditions
Keywords
Primary Breast Cancer
Brief summary
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.
Interventions
DRUG5-FU（intravenous infusion）+epirubicin+cyclophosphamide
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
DRUG5-FU（intravenous bolus）+epirubicin+cyclophosphamide
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.
Sponsors
Tao OUYANG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female patients, age ≦ 65 years old * Histologically or cytologically confirmed primary breast cancer by core biopsy * Disease stage appropriate for neoadjuvant chemotherapy (T2～T3，N0～2，M0) * No previous treatment for breast cancer * No history of other malignancies * No currently uncontrolled diseased (e.g., ongoing cardiac dysrhythmias, unstable diabetes) or active infection * 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 without 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. 3. Serum creatinine ≤ 1.7 mg/dl * 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 or active infection * Hepatic or renal dysfunction as detailed above * Geographical, social, or psychological problems that would compromise study compliance * Known or suspected hypersensitivity to cyclophosphamide, epirubicin and fluorouracil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete response （PCR） | up to four weeks after surgery | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Ⅲ° and Ⅳ° Adverse Events According to NCI-CTC | at the last day of every chemotherapy cycle | 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. |
| Number of patients undergoing breast conserving surgery | up to a week after operation | — |
Countries
China
Outcome results
None listed