Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286819
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2006-02-03
Brief Title:
Dose Density FU 75 and FU 90 as Adjuvant Therapy for Early Breast Cancer
Sponsor:
Central European Cooperative Oncology Group
Organization:
Central European Cooperative Oncology Group
Study Overview
Official Title:
Randomized Phase II Study of Dose-Dense Fluorouracil Plus Epirubicin 75 Plus Cyclophosphamide FEC75 and Fluorouracil Plus Epirubicin 90 Plus Cyclophosphamide FEC90 as Adjuvant Therapy for Early Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-05
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 an open -label randomized phase II study of dose-dense FluorouracilEpirubicinCyclophosphamide FEC administered with Epirubicin of 75mgm2 FEC75 and Epirubicin 90mgm2 FEC90 in untreated patients with early breast cancer
Detailed Description:
Arm A the FEC75 regimen will be given at the following doses
Fluorouracil 500mgm2 by iv bolus or infusion Epirubicin 75mgm2 by 30 minutes iv infusion and Cyclophosphamide 500mgm2 by iv bolus or infusion All three drugs will be administered intravenously on Day 1 of each 14-day cycles
Arm B the FEC90 regimen will be given at the following doses
Fluorouracil 500mgm2 by iv bolus or infusionEpirubicin 90mgm2 by 30 minutes iv infusion and Cyclophosphamide 500mgm2 by iv bolus or infusion
All three drugs will be administered intravenously on Day 1 of each 14-day cycles
Pegfilgrastim fixed dose of 6mg as a single subcutaneous injection will be given in both arms on Day 2 of each cycle
Six cycles of adjuvant chemotherapy will be administered in both arms A B
Fluorouracil 500mgm2 by iv bolus or infusion Epirubicin 75mgm2 by 30 minutes iv infusion and Cyclophosphamide 500mgm2 by iv bolus or infusion All three drugs will be administered intravenously on Day 1 of each 14-day cycles
Arm B the FEC90 regimen will be given at the following doses
Fluorouracil 500mgm2 by iv bolus or infusionEpirubicin 90mgm2 by 30 minutes iv infusion and Cyclophosphamide 500mgm2 by iv bolus or infusion
All three drugs will be administered intravenously on Day 1 of each 14-day cycles
Pegfilgrastim fixed dose of 6mg as a single subcutaneous injection will be given in both arms on Day 2 of each cycle
Six cycles of adjuvant chemotherapy will be administered in both arms A B
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