drugset / Trial / NCT00121836
A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was until disease progression or unacceptable toxicity. The target sample size was \<100 individuals.
Timeline
- Start
- 2005-06
- Primary completion
- 2008-12
- Completion
- 2008-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg | Intravenous |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |