Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077857
Status:
COMPLETED
Last Update Posted:
2013-05-10
First Post:
2004-02-12
Brief Title:
A Study to Assess Capecitabine Xeloda in Patients With Locally Advanced or Metastatic Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Open-label Study of the Effect of Different Dosing Regimens of Xeloda in Combination With Taxotere on Disease Progression in Patients With Locally Advanced andor Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This 2 arm study compared the efficacy and safety of label dose of capecitabine Xeloda to that of a lower dose of Xeloda plus docetaxel Taxotere in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline Patients were randomized to receive either 1250 mgm2 or 825 mgm2 orally twice a day po bid on days 1-14 of each 3 week cycle in combination with Taxotere 75 mgm2 intravenous iv on day 1 of each 3 week cycle The anticipated time on study treatment was until disease progression and the target sample size was 440 individuals
Detailed Description:
None
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