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Open Label, Uncontrolled, Study of XRP9881 (Larotaxel) in Combination With Weekly Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)
The purpose of this study is to evaluate the anti-tumor activity of the combination of experimental drug (larotaxel) when combined with Herceptin® in patients with advanced breast cancer. Anti-tumor activity will be determined by looking at changes in tumor size on CT or MRI scans. Additional goals of this study are to look at patient safety, to determine how long the study drugs (larotaxel and Herceptin®) stay in the patient's body and what effects the study medications may have on each other, and to find out how long patients remain cancer free on this study treatment.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 6 |
| Start date | 2006-10 |
| Completion | 2008-03 |
Conditions
- Advanced Breast Cancer
- Breast Cancer
- Metastatic Breast Cancer
Interventions
- larotaxel (XRP9881)
- trastuzumab
Primary outcomes
- Tumor response measured — every 2 cycles during treatment phase
Countries
United States