Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127933
Status:
COMPLETED
Last Update Posted:
2011-08-10
First Post:
2005-08-05
Brief Title:
XeNA Study - A Study of Xeloda Capecitabine in Patients With Invasive Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-label Study of Xeloda Plus Taxotere on Treatment Response in Patients With HER2-neu-negative and the Addition of Herceptin for HER2-neu-positive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-07
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 single arm study stratified patients into two treatment cohorts based on HER2-neu overexpressionamplification Each cohort will be independently powered for the primary endpoint The study will evaluate the efficacy safety and impact on quality of life of treatment with oral Xeloda plus intravenous iv Taxotere docetaxel Patients with HER2-neu negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous iv Taxotere docetaxel Patients with HER2-neu positive breast cancer will receive the same chemotherapy in combination with intravenous iv Herceptin trastuzumab Patients will receive 3-weekly cycles of treatment with Xeloda 825mgm2 oral administration po twice daily bid on days 1-14 Taxotere 75mgm2 iv on day 1 HER2-neu positive patients will also receive Herceptin loading dose of 4mgkg iv followed by 2mgkg iv weekly The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 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