drugset / Trial / NCT00246571
Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare progression free survival for SU011248 \[sutent (sunitinib malate)\] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.
Timeline
- Start
- 2006-01
- Primary completion
- 2010-05
- Completion
- 2011-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Comparator | Capecitabine | Small molecule | 1250 mg/m2 | — |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | — |
| Comparator | Docetaxel | Small molecule | 100 mg/m2 | — |
| Comparator | Gemcitabine | Small molecule | 800 mg/m2 | — |
| Comparator | Gemcitabine | Small molecule | 1250 mg/m2 | — |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Comparator | Paclitaxel | Small molecule | 90 mg/m2 | — |
| Comparator | Paclitaxel | Small molecule | 175 mg/m2 | — |
| Comparator | Paclitaxel | Small molecule | 200 mg/m2 | — |
| Subject | Sunitinib | Small molecule | 37.5 mg | Oral |
| Subject | Sunitinib | Small molecule | 50 mg | Oral |
| Comparator | Vinorelbine | Small molecule | 25 mg/m2 | Intravenous |
| Comparator | Vinorelbine | Small molecule | 30 mg/m2 | Intravenous |
| Comparator | Vinorelbine | Small molecule | 60 mg/m2 | Intravenous |
| Comparator | Vinorelbine | Small molecule | 80 mg/m2 | Intravenous |