drugset / Trial / NCT03887130
Study of Oral Vinorelbine Plus Capecitabine Versus Taxane-gemcitabine Combinations as 1st Line Chemotherapy in Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this international open-label randomized phase II trial is to evaluate the efficacy and safety of an all-oral combination and two all-intravenous combinations as first-line therapy for HER2-negative mBC patients.
Timeline
- Start
- 2007-03-27
- Primary completion
- 2013-04-18
- Completion
- 2013-04-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Subject | Vinorelbine | Small molecule | 80 mg/m2 | Oral |