Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201435
Status:
COMPLETED
Last Update Posted:
2008-05-20
First Post:
2005-09-12
Brief Title:
Weekly Taxol Plus Xeloda vs Taxotere q3wk Plus Xeloda in the Treatment of Metastatic BC
Sponsor:
Norwegian Breast Cancer Group
Organization:
Norwegian Breast Cancer Group
Study Overview
Official Title:
Weekly Taxol Plus Xeloda Versus Taxotere Every Three Weeks Plus Xeloda in the Treatment of Metastatic Breast Cancer A Phase IIIII 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 IIIII 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:
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NMA 03-07568 | None | None | None |
| REK 378-04-03133 | None | None | None |