drugset / Trial / NCT00270569
An Effective and Compliance Regimen of Paclitaxel Plus Cisplatin to Treat Metastatic Breast Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary endpoint of this phase II trial is the objective response rate of the stage I (low-dose) regimen. The secondary endpoints include treatment-related toxicity, the change in quality of life, progression free survival and overall survival. Simon's optimal two-stage design will be used to determine the patient number.
Timeline
- Start
- 2005-10
- Primary completion
- 2007-02
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 40 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |