Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174707
Status:
COMPLETED
Last Update Posted:
2009-12-07
First Post:
2005-09-12
Brief Title:
Study of Docetaxel in Breast Cancer Patients
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Phase III Randomized Study of Sequential Epidoxorubicin Followed By CMF CyclophosphamideMethotrexateFluorouracil Arm A Versus Sequential Epidoxorubicin Followed By Docetaxel Followed By CMF Arm B Versus Sequential Intensified Epidoxorubicin Followed By Docetaxel Followed By High-Dose Cyclophosphamide Arm C in Early Breast Cancer Patients With Positive Axillary Lymph Nodes
Status:
COMPLETED
Status Verified Date:
2009-12
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:
Primary objectives
To compare the disease free survival DFS in patients treated with the sequential epidoxorubicin cyclophosphamide methotrexate and fluorouracil CMF regimen to that in patients treated with the same treatment plus docetaxel given sequentially after epidoxorubicin
Secondary objectives
To compare the DFS in patients treated with the sequential epidoxorubicin docetaxel and CMF only patients with or 4 lymph nodes regimen to that in patients treated with sequential intensified epidoxorubicindocetaxelhigh dose HD cyclophosphamide regimen
To evaluate the overall survival in each arm
To evaluate the tolerability of a sequential intensified epidoxorubicindocetaxelHD-cyclophosphamide arm C
To compare the safety of a sequential epidoxorubicindocetaxelCMF arm B regimen versus a standard sequential epidoxorubicinCMF regimen arm A
To compare the disease free survival DFS in patients treated with the sequential epidoxorubicin cyclophosphamide methotrexate and fluorouracil CMF regimen to that in patients treated with the same treatment plus docetaxel given sequentially after epidoxorubicin
Secondary objectives
To compare the DFS in patients treated with the sequential epidoxorubicin docetaxel and CMF only patients with or 4 lymph nodes regimen to that in patients treated with sequential intensified epidoxorubicindocetaxelhigh dose HD cyclophosphamide regimen
To evaluate the overall survival in each arm
To evaluate the tolerability of a sequential intensified epidoxorubicindocetaxelHD-cyclophosphamide arm C
To compare the safety of a sequential epidoxorubicindocetaxelCMF arm B regimen versus a standard sequential epidoxorubicinCMF regimen arm A
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TAX_IT_216 | None | None | None |