Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-01 @ 5:32 PM
Study NCT ID:
NCT00201435
Status:
COMPLETED
Last Update Posted:
2008-05-20
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weekly Taxol Plus Xeloda® vs Taxotere q3wk Plus Xeloda® in the Treatment of Metastatic BC
Sponsor:
Norwegian Breast Cancer Group
Organization:
Study Overview
Official Title:
Weekly Taxol® Plus Xeloda® Versus Taxotere® Every Three Weeks Plus Xeloda® in the Treatment of Metastatic Breast Cancer A Phase II/III Study
Status:
COMPLETED
Status Verified Date:
2008-05
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:
We want to compare Taxol given weekly with Taxotere given every 3 week both in comination with Xeloda. We are going to compare time to treatment failure and quality of life.
Detailed Description:
Open labeled randomized multicentre phase II/III trial. It is intended to include patients who are not usually included into clinical trials because they are not having disease with measurable lesions. In breast cancer the bulk of patients with metastatic disease is presenting with bone metastases which is difficult to evaluate with respect to response. In this study it is one of the main objectives to include this kind of everyday patients that we see in the clinic.
Because of this we will be using TTF as the primary endpoint. Skeletal events requiring radiotherapy or major changes in pain medications are defined as treatment failures causing stop in treatment even in the absence of radiological findings.
A: weekly Taxol® plus Xeloda® on days 1-14 q 3w B: Taxotere® q 3w plus Xeloda® on days 1-14 q 3w
Patients are randomized equally between the two arms.
Concomitant therapy: Simultaneous use of bisphosphonates is allowed, if this treatment has been initiated at least four weeks before study entry.
Because of this we will be using TTF as the primary endpoint. Skeletal events requiring radiotherapy or major changes in pain medications are defined as treatment failures causing stop in treatment even in the absence of radiological findings.
A: weekly Taxol® plus Xeloda® on days 1-14 q 3w B: Taxotere® q 3w plus Xeloda® on days 1-14 q 3w
Patients are randomized equally between the two arms.
Concomitant therapy: Simultaneous use of bisphosphonates is allowed, if this treatment has been initiated at least four weeks before study entry.
Study Oversight
Has Oversight DMC:
False
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?: