Regimens Comparison for Breast Cancers of Positive Lymph Nodes

Phase 3

• Conditions: Breast Cancer
• Interventions: Drug: Epirubicin, CTX, Paclitaxel; Drug: Epirubicin, Paclitaxel

• Registration Number: NCT01134523
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

To compare the efficacy and safety of EC-T and ET regimen as adjuvant treatment of breast cancer patients with positive lymph nodes

Detailed Description

EC-T regimen: epirubicin 90mg/m2 day1, CTX 600mg/m2, day 1, 21 days per cycle \*4cycle. followed by paclitaxel 175mg/m2,d1,21days per cycle, 4 cycle.

ET regimen: epirubicin 75mg/m2 day1,paclitaxel 175mg/m2,d2,21days per cycle, 6 cycle

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-01
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-14
• Last Update Posted: 2013-03-15
• Primary Completion: 2018-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• patients with breast cancer after breast cancer surgery with positive lymph nodes age 18-70 years old

Exclusion Criteria

• with other malignance disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: EC-T regimen	Epirubicin, CTX, Paclitaxel	-
Group B: ET regimen	Epirubicin, Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
PFS	5 years after all the recuiment

Secondary Outcome Measures

Name	Time	Method
OS	5 years after all the adjuvent treatments
Safety	5 years after all the recruiment	Assessing for Hematology and Non-hematology toxicities, including all SAEs.

Trial Locations

Locations (1)

Cancer Institute & Hospital. Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China