Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129922
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2005-08-10
Brief Title:
Fluorouracil Epirubicin and Cyclophosphamide Alone or Followed by Paclitaxel for Early Breast Cancer
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
Phase III Study to Compare 6 Courses of FEC Fluorouracil Epirubicin and Cyclophosphamide vs 4 Courses of FEC Followed by 8 Weekly Paclitaxel Administrations as Adjuvant Treatment for Node Positive Operable BC Patients
Status:
COMPLETED
Status Verified Date:
2023-03
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:
The efficacy of adjuvant chemotherapy is limited in patients with a high risk of recurrence
Also for axillary positive node patients optimum chemotherapy regimens are still under discussion Some previous studies suggest that in the subset of node-positive patients treatments based on sequential administration of anthracyclines and taxanes are more efficient Paclitaxel dose-dense weekly administration renders an improved therapeutic index activitytoxicity
The study is designed to compare 6 courses of FEC scheme 60090600 a combination of proven efficacy in node positive breast cancer patients versus 4 FEC courses followed by 8 weekly paclitaxel administrations 100mgm2
The study hypothesis is that 5-year disease-free survival in the control arm will be 60 The investigators expect to increase this by 8 with the experimental treatment With an alpha error of 005 80 power and a post-randomization estimated drop-out rate of 10 1250 patients are needed 625 per arm
Also for axillary positive node patients optimum chemotherapy regimens are still under discussion Some previous studies suggest that in the subset of node-positive patients treatments based on sequential administration of anthracyclines and taxanes are more efficient Paclitaxel dose-dense weekly administration renders an improved therapeutic index activitytoxicity
The study is designed to compare 6 courses of FEC scheme 60090600 a combination of proven efficacy in node positive breast cancer patients versus 4 FEC courses followed by 8 weekly paclitaxel administrations 100mgm2
The study hypothesis is that 5-year disease-free survival in the control arm will be 60 The investigators expect to increase this by 8 with the experimental treatment With an alpha error of 005 80 power and a post-randomization estimated drop-out rate of 10 1250 patients are needed 625 per arm
Detailed Description:
The primary endpoint of study-5-year disease-free survival DFS will be assessed by Kaplan Meier analysis Secondary endpoints included overall survival and analysis of the prognostic and predictive value of clinical and molecular markers Associations and interactions will be assessed with a multivariable Cox proportional hazards model for DFS for the following covariates age menopausal status tumor size lymph node status type of chemotherapy tumor size positive lymph nodes HER2 status and hormone receptor status All statistical tests will be two-sided
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