Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209092
Status:
COMPLETED
Last Update Posted:
2015-03-27
First Post:
2005-09-14
Brief Title:
Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant Dose-Dense DocetaxelCapecitabine as in Induction Therapy for Early Stage Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-03
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 study is to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast
Detailed Description:
The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast
Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome Additionally we will correlate specific molecular markers in the breast tumors before and after chemotherapy with response to treatment Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively
Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome Additionally we will correlate specific molecular markers in the breast tumors before and after chemotherapy with response to treatment Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively
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