Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430001
Status:
UNKNOWN
Last Update Posted:
2008-05-09
First Post:
2007-01-30
Brief Title:
Vinorelbine Plus Trastuzumab vs Docetaxel Plus Trastuzumab as 1 Line Treatment for HER2 Positive Metastatic Breast Cancer
Sponsor:
Danish Breast Cancer Cooperative Group
Organization:
Danish Breast Cancer Cooperative Group
Study Overview
Official Title:
A Randomised Phase III Study of Trastuzumab-Docetaxel vs Trastuzumab-Vinorelbine as 1 Line Therapy for Patients With Metastatic HER2 Positive Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2008-05
Last Known Status:
RECRUITING
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:
In an open-label randomised phase III-trial patients with metastatic HER2-positive breast cancer naive to chemotherapy with normal organ function and WHO performance status 3 are randomised to receive either docetaxel 100 mgm2 iv plus trastuzumab 6 mgkg 8 mgkg loading dose q 3 weeks or vinorelbine 30 or 35 mgm2 days 18 plus trastuzumab 6 mgkg 8 mgkg loading dose q 3 weeks Primary endpoint is time to progression Secondary endpoints include overall survival time to treatment failure response rate duration of response and toxicity The study hypothesis is that docetaxel is more efficient than vinorelbine but also more toxic
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