Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT00156312
Status:
COMPLETED
Last Update Posted:
2012-02-07
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Tumor Factors in Breast Cancer Treated With Docetaxel and Capecitabine
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
Study Overview
Official Title:
Evaluation of Thymidine Phosphorylase and Other Predictive/Prognostic Factors in Primary Breast Cancer Treated With Docetaxel and Capecitabine (DC)
Status:
COMPLETED
Status Verified Date:
2012-02
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 study is to determine whether the combination of the drugs docetaxel and capecitabine is effective in treating breast cancer patients.
Detailed Description:
Some chemotherapy drugs are thought to work in synergy, meaning they work better in combination, rather than singly because one drug may cause changes in the tumor that will make the other drug more effective. The drugs docetaxel and capecitabine may work in synergy, based on laboratory studies in tumors. These laboratory studies show that docetaxel increases the levels of a critical enzyme, called thymidine phosphorylase (TP), which is necessary to activate the capecitabine. This study will use this promising chemotherapy combination in patients with breast cancer. Before, during, and after chemotherapy, the participants' breast tumors will be examined to see if TP increases, as predicted by the laboratory studies. The study will also look at other factors in tumors and blood that may be able to predict how effective the chemotherapy will be for each individual, so that in the future we may better select the best chemotherapy for an individual's cancer.
Study Oversight
Has Oversight DMC:
True
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?: