Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-30 @ 1:21 PM
Study NCT ID:
NCT00127933
Status:
COMPLETED
Last Update Posted:
2011-08-10
First Post:
2005-08-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
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 overexpression/amplification. 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 (825mg/m2 oral administration \[po\] twice daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: