跳至主要内容
临床试验/NCT01635465
NCT01635465Unknown不适用

A Randomised Controlled Phase II Trial of Vinorelbine Plus Capecitabine Versus Docetaxel Plus Capecitabine in Anthracycline-pretreated Women With Metastatic Breast Cancer.

Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
RECIST 1.1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female ≥ 18 years old ECOG 0-2

排除标准

  • brain metastasis

结局指标

主要结局

RECIST 1.1

时间窗: -7 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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