Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer
NCT01199432 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 501
Last updated 2015-06-10
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.
Conditions
Interventions
- DRUG
-
5-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
- DRUG
-
5-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.
- DRUG
-
epirubicin+cyclophosphamide
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 & Collaborators
-
Tao OUYANG
lead OTHER
Principal Investigators
-
Tao Ouyang, Doctor · Beijing Cancer Hospital Breast Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-10-31
- Primary Completion
- 2014-07-31
- Completion
- 2014-12-31
Countries
- China
Study Locations
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