NCT00251095

Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer

A Multicenter Phase 3, Randomized Comparison of the Safety and Efficacy of Weekly TOCOSOL(R) Paclitaxel vs. Weekly Paclitaxel Injection in the Treatment of Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 821 (actual)
• Sponsor: Achieve Life Sciences · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the objective response rates of patients randomized to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every week to patients with metastatic breast cancer. The study hypothesis is that the objective response rate with TOCOSOL Paclitaxel given every week is non-inferior to that observed with Taxol given every week.

Detailed description

Female patients with first or second line metastatic breast cancer will be randomized to receive either weekly TOCOSOL Paclitaxel or weekly Taxol (paclitaxel injection). Patients will undergo radiographic imaging of their disease to assess response to therapy. The primary endpoint of this study is a comparison of the objective response rates observed in patients receiving TOCOSOL Paclitaxel, to those receiving Taxol. Time-to-disease progression and overall survival will also be compared. The toxicities of the two treatment regimens will be compared.

Conditions

• Breast Neoplasm

Interventions

Type	Name	Description
DRUG	Taxol
DRUG	TOCOSOL Paclitaxel	100 mg/m2/week

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2005-11-09
• Last updated: 2009-06-04

Locations

14 sites across 1 country: United States