Viewing Study NCT00415285



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Last Modification Date: 2024-10-26 @ 9:29 AM
Study NCT ID: NCT00415285
Status: UNKNOWN
Last Update Posted: 2007-02-13
First Post: 2006-12-20

Brief Title: Docetaxel Followed by Capecitabine Versus Concomitant DocetaxelCapecitabine for Early Stage Breast Cancer
Sponsor: Georgia Center for Oncology Research Education
Organization: Georgia Center for Oncology Research Education

Study Overview

Official Title: Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant DocetaxelCapecitabine as in Induction Therapy for Early Stage Breast Cancer
Status: UNKNOWN
Status Verified Date: 2007-02
Last Known Status: RECRUITING
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 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
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

Approximately 100 patients will participate at Emory Winship Cancer Institute and Emory Crawford W Long Hospital and Grady Health System in Atlanta Georgia

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