Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089479
Status:
COMPLETED
Last Update Posted:
2012-12-21
First Post:
2004-08-05
Brief Title:
A Study of Xeloda Capecitabine in Women With High-Risk Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Open-label Study of the Effect of Adjuvant Therapy With Adriamycin Plus Cytoxan Followed by Taxotere or Taxotere Plus Xeloda on Overall Survival in Female Patients With High-risk Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-12
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 will compare the efficacy and safety of Taxotere Xeloda versus Taxotere alone following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer Following 4 cycles of Adriamycin and Cytoxan patients will be randomized to receive either 1Taxotere 75mgm2 iv on day 1 and Xeloda 825mgm2 po bid on days 1-14 of each 3 week cycle or 2 Taxotere 100mgm2 iv alone on day 1 of each 3 week cycle The anticipated time on study treatment is until disease progression and the target sample size is 500 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