drugset / Trial / NCT00251095
Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-09
- Primary completion
- 2007-09
- Completion
- 2007-09
Outcome
Outcome not reported
Stopped: “Failed primary endpoint”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Comparator | Paclitaxel | Small molecule | 100 mg/m2 | — |