drugset / Trial / NCT01609127
Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is being conducted to compare the efficacy and safety of tesetaxel administered once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive weeks in a 28-day cycle, and capecitabine administered twice daily for 14 consecutive days in a 21-day cycle.
Timeline
- Start
- 2012-05
- Primary completion
- 2013-09
- Completion
- 2014-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Subject | Tesetaxel | Small molecule | 15 mg/m2 | Oral |
| Subject | Tesetaxel | Small molecule | 27 mg/m2 | Oral |