Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081796
Status:
COMPLETED
Last Update Posted:
2008-08-21
First Post:
2004-04-20
Brief Title:
Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Open-Label Phase III Study of RPR109881 IV Every 3 Weeks Versus Capecitabine Xeloda Tablets Twice Daily for 2 Weeks in 3-Week Cycles in Patients With Metastatic Breast Cancer Progressing After Taxanes and Anthracycline Therapy
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical trial is to determine if RPR109881 is a better treatment than capecitabine Xeloda for advanced breast cancer in patients that no longer benefit from docetaxel andor paclitaxel
Detailed Description:
All patients in this trial will receive either the investigational drug or capecitabine a chemotherapy drug that is already approved to treat your disease These drugs prevent tumor cells from dividing so they may stop growing or die The investigational drug in this clinical trial is a chemotherapy drug given through the vein once every three weeks Patients who receive capecitabine will receive this drug by mouth for 14 days every 21 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| XRP9881B-3001 | None | None | None |