Vinorelbine Plus Capecitabine Versus Docetaxel Plus Capecitabine in Anthracycline-pretreated Women With Metastatic Breast Cancer

• Conditions: Anthracycline-pretreated Metastatic Breast Cancer

• Registration Number: NCT01635465
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

Docetaxel plus Capecitabine in anthracycline-pretreated metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Vinorelbine plus Capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

Detailed Description

A randomised controlled trial of vinorelbine plus capecitabine versus docetaxel plus capecitabine in anthracycline-pretreated women with metastatic breast cancer. The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Study Timeline

• Study First Submitted: 2012-06-17
• Status Verified: 2012-07
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-09
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2015-12-22
• Study Start: 2016-11
• Primary Completion: 2016-11
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• female ≥ 18 years old ECOG 0-2

Exclusion Criteria

• brain metastasis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RECIST 1.1	-7 days

Trial Locations

Locations (1)

Tianjin Cancer Hospital; 🇨🇳 Tianjin, Tianjin, China