NCT02207361

Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin in Metastatic Breast Cancer

A Randomized Prospective Clinical Trial of Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin as First-Line Treatment in Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Paclitaxel plus Epirubicin in metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Paclitaxel in Combination with Carboplatin is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

Detailed description

A Randomized Prospective Clinical Trial of Paclitaxel in Combination with Carboplatin Versus Paclitaxel plus Epirubicin as First-Line Treatment in 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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel, Carboplatin	Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.
DRUG	Paclitaxel, Epirubicin	Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-11-01
• Completion: 2016-12-01
• First posted: 2014-08-04
• Last updated: 2015-12-22

Locations

1 site across 1 country: China