Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121992
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2005-07-18
Brief Title:
Docetaxel Doxorubicin A Cyclophosphamide C TAC vs 5-Fluorouracil A C 5FAC Breast Cancer Adjuvant Treatment
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
Phase III Randomized Comparing Docetaxel Doxorubicin and Cyclophosphamide TAC vs 5-Fluorouracil Doxorubicin and Cyclophosphamide FAC as Adjuvant Treatment of High Risk Operable Breast Cancer Patients With Negative Axillary Lymph Nodes
Status:
COMPLETED
Status Verified Date:
2023-04
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 prospective non-blinded randomized phase III trial Patients will be post-surgically stratified at inclusion first according to the participating institution then according to menopausal status and will be randomly assigned to receive either
TAC Docetaxel 75 mgm2 as a 1 hour intravenous iv infusion on day 1 every 3 weeks q3w in combination with doxorubicin 50 mgm2 as an iv bolus and cyclophosphamide 500 mgm2 as an iv bolus on day 1 every 3 weeks
FAC 5-fluorouracil 500 mgm2 as an iv bolus on day 1 every 3 weeks in combination with doxorubicin 50 mgm2 as an iv bolus and cyclophosphamide 500 mgm2 as an iv bolus on day 1 every 3 weeks
TAC Docetaxel 75 mgm2 as a 1 hour intravenous iv infusion on day 1 every 3 weeks q3w in combination with doxorubicin 50 mgm2 as an iv bolus and cyclophosphamide 500 mgm2 as an iv bolus on day 1 every 3 weeks
FAC 5-fluorouracil 500 mgm2 as an iv bolus on day 1 every 3 weeks in combination with doxorubicin 50 mgm2 as an iv bolus and cyclophosphamide 500 mgm2 as an iv bolus on day 1 every 3 weeks
Detailed Description:
Primary objective
To compare disease-free survival DFS after treatment with docetaxel in combination with doxorubicin and cyclophosphamide TAC to 5-Fluorouracil in combination with doxorubicin and cyclophosphamide FAC as adjuvant treatment of high risk operable breast cancer patients with negative axillary lymph nodes
Secondary objectives
To compare overall survival OS between the 2 above mentioned arms
To compare toxicity and quality of life between the 2 above mentioned arms
To evaluate pathologic markers for predicting efficacy hormonal receptors and human epidermal growth factor receptor 2 HER2 protein expression
To compare disease-free survival DFS after treatment with docetaxel in combination with doxorubicin and cyclophosphamide TAC to 5-Fluorouracil in combination with doxorubicin and cyclophosphamide FAC as adjuvant treatment of high risk operable breast cancer patients with negative axillary lymph nodes
Secondary objectives
To compare overall survival OS between the 2 above mentioned arms
To compare toxicity and quality of life between the 2 above mentioned arms
To evaluate pathologic markers for predicting efficacy hormonal receptors and human epidermal growth factor receptor 2 HER2 protein expression
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 |
|---|---|---|---|
| TAXES1301 | OTHER | RHÔNE-POULENC RORER SA RPR | None |