Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase Ⅳ Randomized Clinical Trial of Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: 5-FU（intravenous infusion）+epirubicin+cyclophosphamide
* Drug: 5-FU（intravenous bolus）+epirubicin+cyclophosphamide
* Drug: epirubicin+cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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: Absolute neutrophil count (ANC) ≥ 1500/mm3 Platelets ≥ 100,000/ mm3 Hemoglobin ≥ 10 g/dL Adequate hepatic and renal function with: Serum bilirubin ≤ 1.5×UNL Alkaline phosphatase and alanine aminotransferase (ALT) ≤ 2.5 x ULN. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group B(CEF)<br> | Drug: 5-FU（intravenous bolus）+epirubicin+cyclophosphamide<br>* 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.<br>* Other names: CEF;|
| Experimental: Group A(CEFci)<br> | Drug: 5-FU（intravenous infusion）+epirubicin+cyclophosphamide<br>* 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<br>* Other names: CEFci;|
| Active Comparator: Group C(EC)<br> | Drug: epirubicin+cyclophosphamide<br>* 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.<br>* Other names: EC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | up to four weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at the last day of every chemotherapy cycle | 
| Number of patients undergoing breast conserving surgery |  | up to a week after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Breast Cancer