Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer
Conditions
Metastatic Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Gemcitabine,Capecitabine Type: Drug
Name: Gemcitabine, Carboplatin Type: Drug
Overall Status
Recruiting
Summary
Gemcitabine plus carboplatin in recurrent or metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. gemcitabine in combination with capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.
Detailed Description
A multicenter randomized phase Ⅲ clinical trial of gemcitabine in combination with capecitabine versus gemcitabine plus carboplatin as first-line treatment in triple-negative recurrent or 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Female

- 18-70 years old

- ECOG 0-1

- Expected lifetime more than 12 weeks

Exclusion Criteria:

- Pregnancy

- Brain Metastasis,

- Severe Infection
Location
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China
Status: Recruiting
Contact: Zhongsheng Tong, Master - +86 18622221181 - 18622221181@163.com
Start Date
December 2013
Completion Date
December 2015
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Source
Tianjin Medical University Cancer Institute and Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page