A Phase 2 interventional study of XRP9881 in Breast Cancer, sponsored by Sanofi. Completed at 15 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-05-01.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
The purpose of this clinical trial is to determine if the investigational drug is able to reduce/shrink advanced breast cancer tumors in patients who no longer benefit from anthracyclines, taxanes and capecitabine.
All patients in this trial will receive the investigational (chemotherapy) drug at an optimal dose as determined by previous clinical trials. The investigational drug is given through a vein once every three weeks. This drug prevents tumor cells from dividing, so they may stop growing or die.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 168 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
In order to be eligible for this trial you must:
Exclusion Criteria:
Objective response rate as assessed by Response Evaluation Criteria in Solid Tumors
Progression free survival, overall survival, composite event of CR, PR and stable disease > or = to 12 weeks
Time to tumor response and duration of response.
Safety analyses based on incidence, severity, chronicity and cumulative nature of TEAEs.
This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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Sanofi