Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Ruth O'Regan, MD
Winship Cancer Institute of Emory University
United States: Institutional Review Board
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|Grady Memorial Hospital||Atlanta, Georgia 30335|
|Emory Crawford Long Hospital||Atlanta, Georgia 30308|