drugset / Trial / NCT00687440
A Study to Determine the Activity of Caelyx With Trastuzumab and Docetaxel in the Treatment of Metastatic Breast Cancer (Study P03679)
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate, in a first stage, the safety (incidence of cardiac toxicity) of Caelyx in combination with Trastuzumab and Docetaxel; and in a second stage, the tumor response rate of this regimen. This study will be conducted in approximately 30 centers. A total of approximately 70 to 95 subjects will be enrolled.
Timeline
- Start
- 2005-07-15
- Primary completion
- 2008-10-24
- Completion
- 2008-10-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Pegylated liposomal doxorubicin | Unknown | 30 mg/m2 | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |