Evaluation of Tumor Factors in Breast Cancer Treated With Docetaxel and Capecitabine
The purpose of this study is to determine whether the combination of the drugs docetaxel and capecitabine is effective in treating breast cancer patients.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Evaluation of Thymidine Phosphorylase and Other Predictive/Prognostic Factors in Primary Breast Cancer Treated With Docetaxel and Capecitabine (DC)|
- specific key measurements [ Time Frame: refer to protocol ] [ Designated as safety issue: No ]
|Study Start Date:||July 2003|
|Study Completion Date:||February 2007|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
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.
|United States, Michigan|
|University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Anne Schott, M.D.||University of Michigan|