Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant, Dose-Dense 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
to treatment. Expression of these molecular markets may be used in the future to predict
the likelihood of response to chemotherapy given post-operatively.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A(Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles)or Arm B(Docetaxel Plus Capecitabine for 8 Cycles)in Patients With Early Stage Breast Cancer.
Pathologic complete response (pCR): Absence of invasive breast cancer in the breast. Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignanat disease)+partial response(PR-reduction by atleast 30%) Stable disease(SD):No decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions. Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.
Ruth Regan, MD
Emory University Winship Cancer Institute
United States: Institutional Review Board
|Grady Memorial Hospital||Atlanta, Georgia 30335|
|John B. Amos Cancer Center||Columbus, Georgia 31904|
|Emory Crawford Long Hospital||Atlanta, Georgia 30308|
|Emory University Winship Cancer Institute||Atlanta, Georgia 30322|
|Suburban Hematology-Oncology Associates, Pc||Lawrenceville, Georgia 30046|
|Augusta Oncology Associates, PC 1348 Walton Way, Ste. 4300||Augusta, Georgia 30901|
|Augusta Oncology Associates, PC 3696 Wheeler Road||Augusta, Georgia 30909|
|WellStar Health System-Northwest Georgia Oncology Center, PC||Austell, Georgia 30106|
|WellStar Health System-Georgia Cancer Specialists||Austell, Georgia 30106|
|South Atlanta Hematology-Oncology Group||East Point, Georgia 30344|
|Central Georgia Cancer Care, PC||Macon, Georgia 31201|