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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B(CEF) | Experimental |
| |
| Group A(CEFci) | Experimental |
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| Group C(EC) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-FU(intravenous infusion)+epirubicin+cyclophosphamide | Drug | 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 |
| 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 |
| 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. |
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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:
Adequate hepatic and renal function with:
Knowledge of the investigational nature of the study and Ability to give informed consent
Ability and willingness to comply with study procedures
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tao Ouyang, Doctor | Beijing Cancer Hospital Breast Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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| 5-FU(intravenous bolus)+epirubicin+cyclophosphamide | Drug | 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. |
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| epirubicin+cyclophosphamide | Drug | 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. |
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| at the last day of every chemotherapy cycle |
| Number of patients undergoing breast conserving surgery | up to a week after operation |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C098534 | EC regimen |
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