Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00493870
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
2007-06-27
Brief Title:
TAC Versus TC for Adjuvant Breast Cancer
Sponsor:
US Oncology Research
Organization:
US Oncology Research
Study Overview
Official Title:
Phase III Trial of TC Versus TAC in HER2-Negative Early Stage Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2023-02
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:
The purpose of this research study is to find out what effects good and bad TC or TAC has on early stage HER2- breast cancer
Detailed Description:
Both TAC docetaxel doxorubicin and cyclophosphamide and TC docetaxel and cyclophosphamide are established adjuvant chemotherapy regimens for early stage breast cancer TAC however due to the inclusion of the anthracycline doxorubicin carries a high risk of hematologic and cardiotoxic adverse effects Substantial evidence supports the concept that early stage HER2-negative breast cancers will benefit similarly from anthracycline-based adjuvant and non-anthracycline-based chemotherapy
Further approximately 0 to 9 of HER2-negative breast cancers have alterations in the TOP2A gene which may predict for benefit from anthracycline-based chemotherapy
We hypothesize that 6 cycles of TC versus 6 cycles of TAC will have similar efficacy in the treatment of early stage HER2-negative breast cancer and that TC will have less toxicity If this hypothesis were upheld and the anthracycline doxorubicin could be eliminated from the regimen while obtaining similar efficacy in this population of patients it would not only be an important advance in the understanding of the biology of cancer but it would also be of significant clinical benefit to women with breast cancer
Further approximately 0 to 9 of HER2-negative breast cancers have alterations in the TOP2A gene which may predict for benefit from anthracycline-based chemotherapy
We hypothesize that 6 cycles of TC versus 6 cycles of TAC will have similar efficacy in the treatment of early stage HER2-negative breast cancer and that TC will have less toxicity If this hypothesis were upheld and the anthracycline doxorubicin could be eliminated from the regimen while obtaining similar efficacy in this population of patients it would not only be an important advance in the understanding of the biology of cancer but it would also be of significant clinical benefit to women with breast cancer
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 |
|---|---|---|---|
| 11271 | OTHER | Sanofi-Aventis | None |