Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021255
Status:
COMPLETED
Last Update Posted:
2016-11-15
First Post:
2001-07-11
Brief Title:
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Multicenter Phase III Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed By Docetaxel AC-T With Doxorubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab HerceptinAC-TH and With Docetaxel Carboplatin and Trastuzumab TCH In The Adjuvant Treatment Of Node Positive and High Risk Node Negative Patients With Operable Breast Cancer Containing The HER2 Alteration
Status:
COMPLETED
Status Verified Date:
2016-09
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 objective
Compare disease-free survival in women with human epidermal growth factor receptor 2 HER2-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin cyclophosphamide and docetaxel with or without trastuzumab Herceptin vs trastuzumab docetaxel and carboplatin
Secondary objective
Compare overall survival of participants treated with these regimens
Compare the toxic effects including cardiac of these regimens in these participants
Compare quality of life of participants treated with these regimens
Compare pathologic and molecular markers for predicting efficacy of these regimens in these participants
For substudy Compare peripheral levels of shed HER2-neu extracellular domain with fluorescence in situ hybridization in predicting outcome in participants treated with these regimens
Compare disease-free survival in women with human epidermal growth factor receptor 2 HER2-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin cyclophosphamide and docetaxel with or without trastuzumab Herceptin vs trastuzumab docetaxel and carboplatin
Secondary objective
Compare overall survival of participants treated with these regimens
Compare the toxic effects including cardiac of these regimens in these participants
Compare quality of life of participants treated with these regimens
Compare pathologic and molecular markers for predicting efficacy of these regimens in these participants
For substudy Compare peripheral levels of shed HER2-neu extracellular domain with fluorescence in situ hybridization in predicting outcome in participants treated with these regimens
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 |
|---|---|---|---|
| BCIRG 006 | None | None | None |