Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128310
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2005-08-08
Brief Title:
Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
Randomized Phase III Trial Comparing Vinorelbine vs Gemcitabine Plus Vinorelbine in Patients With Advanced Breast Cancer Previously Treated With Anthracyclines and Taxanes
Status:
COMPLETED
Status Verified Date:
2023-05
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:
This is a multicenter randomized prospective Phase III study in which patients with advanced breast carcinoma previously treated with anthracyclines and taxanes will be randomly assigned to receive one of two treatment options vinorelbine Arm A or gemcitabine plus vinorelbine Arm B
Detailed Description:
The investigators assume that progression-free survival mean time for patients treated with vinorelbine will be 3 months and for patients treated with gemcitabine plus vinorelbine will be 5 months That implies a reduction in risk ratio of 40 Hazard ratio 167 Assuming a bilateral alpha error of 005 and beta error of 10 and the number of events needed if 60 of patients have progressed after 1 year the number of patients needed per treatment arm is 114 Considering a 10 post-randomization drop-out the final number of patients is 252 126 per arm
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