NCT01199432

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 501 (estimated)
• Sponsor: Tao OUYANG · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-07-01
• Completion: 2014-12-01
• First posted: 2010-09-13
• Last updated: 2015-06-10

Locations

1 site across 1 country: China