drugset / Trial / NCT00440622
Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
Phase 3
Terminated
90 enrolled
Hellenic Oncology Research Group
University Hospital of Crete · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The optimal treatment for pretreated patients with metastatic breast cancer has not been established. Gemcitabine and capecitabine are two active agents in this setting. For women with Her-2 positive breast cancer, combinations of either gemcitabine or capecitabine (Xeloda) plus Herceptin has been proved active and well tolerated.
Timeline
- Start
- 2003-04
- Primary completion
- 2008-11
- Completion
- 2008-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Subject | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |