Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174655
Status:
COMPLETED
Last Update Posted:
2011-11-10
First Post:
2005-09-09
Brief Title:
BIG 0298 Docetaxel - Breast Cancer
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
An Intergroup Phase III Trial to Evaluate the Activity of Docetaxel Given Either Sequentially or in Combination With Doxorubicin Followed by CMF in Comparison to Doxorubicin Alone or in Combination With Cyclophosphamide Followed by CMF in the Adjuvant Treatment of Node-positive Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2011-11
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 Disease-Free Survival DFS of an adjuvant treatment with docetaxel given either sequentially or in combination with doxorubicin and followed by CMF to doxorubicin alone or in combination with cyclophosphamide and followed by CMF in operable breast cancer patients with positive axillary lymph nodes
Secondary objectives
To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive axillary lymph nodes
To compare DFS of an adjuvant treatment with docetaxel in combination with doxorubicin followed by CMF to doxorubicin in combination with cyclophosphamide followed by CMF in operable breast cancer patients with positive axillary lymph nodes
To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast cancer patients with positive axillary lymph nodes sequential mono-chemotherapy versus polychemotherapy
To compare overall survival of treatment arms
To compare toxicity of treatment arms
To evaluate pathologic and molecular markers for predicting efficacy
Socioeconomic data will be collected in order to be able to perform a socioeconomic analysis by country when needed
To compare Disease-Free Survival DFS of an adjuvant treatment with docetaxel given either sequentially or in combination with doxorubicin and followed by CMF to doxorubicin alone or in combination with cyclophosphamide and followed by CMF in operable breast cancer patients with positive axillary lymph nodes
Secondary objectives
To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive axillary lymph nodes
To compare DFS of an adjuvant treatment with docetaxel in combination with doxorubicin followed by CMF to doxorubicin in combination with cyclophosphamide followed by CMF in operable breast cancer patients with positive axillary lymph nodes
To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast cancer patients with positive axillary lymph nodes sequential mono-chemotherapy versus polychemotherapy
To compare overall survival of treatment arms
To compare toxicity of treatment arms
To evaluate pathologic and molecular markers for predicting efficacy
Socioeconomic data will be collected in order to be able to perform a socioeconomic analysis by country when needed
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