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A Dose-escalating, Multicenter, Single Arm, Open-Label Study of XRP9881 in Combination With Capecitabine (Xeloda), in Metastatic Breast Cancer Patients With Disease Progressing After Anthracycline and Taxane Therapy
The goal of this phase I-II clinical research study is to find the highest safe dose of XRP9881 and capecitabine that can be given in combination in the treatment of metastatic breast cancer in patients who have been previously treated by taxanes and anthracyclines. The safety and effectiveness of this combination will also be studied. Patients participating in the study will be asked to give additional blood samples to look at the level of study drugs in the blood.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 34 |
| Start date | 2006-08 |
| Completion | 2009-03 |
Conditions
- Breast Cancer
- Cancer
Interventions
- larotaxel
- capecitabine
Primary outcomes
- Safety, tolerability, and maximum tolerated dose (MTD) of XRP9881 when given in combination with capecitabine — study period
Countries
United States, France