NCT00912639

A Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients With Taxane-Pretreated Recurrent Breast Cancer

A Clinical Trial of Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) in Patients With Taxane-Pretreated Recurrent Breast Cancer

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Korean Breast Cancer Study Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the response rate in patients with taxane-pretreated recurrent breast cancer receiving paclitaxel loaded polymeric micelle (Genexol-PM).

Detailed description

Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This single arm, multicenter phase IV study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of Genexol-PM in patients with Taxane-pretreated recurrence breast cancer.

Conditions

• Recurrent Breast Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel loaded Polymeric micelle	Genexol-PM at a dose of 300mg/m2 was diluted in 500 ml of 5% dextrose solution or normal saline and infused i.v. for 3 h on day 1.Treatment was repeated every 3 weeks until either disease progression or intolerance. A minimum of 6 cycles was recommended.

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-05-01
• Completion: 2011-05-01
• First posted: 2009-06-03
• Last updated: 2009-06-16

Locations

1 site across 1 country: South Korea