drugset / Trial / NCT01423695
Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer
Phase 2
Completed
121 enrolled
WiSP Wissenschaftlicher Service Pharma GmbH
Bristol-Myers Squibb · collabRoche Pharma AG · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. The present trial examines the efficacy and safety of weekly paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.
Timeline
- Start
- 2001-02
- Primary completion
- 2009-12
- Completion
- 2009-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |