The primary aim of the study is to determine whether four cycles of preoperative or postoperative Taxotere given after four cycles or pre- operative Adriamycin; and cyclophosphamide will more effectively prolong disease-free survival and survival than do four cycles or preoperative AC alone. The study will also evaluate the effect of the administration of preoperative Taxotere after preoperative AC with respect to clinical and pathologic loco-regional tumor response and breast conservation. Women with palpable, operable carcinoma of the breast diagnosed by fine-needle aspiration cytology or by core needle biopsy will be stratified by age, clinical tumor size, and clinical nodal status, then randomized to one of three groups. In all three groups, tumor measurements will be obtained after each cycle of preoperative chemotherapy. Assessment of response will be performed after completion of all preoperative chemotherapy and before surgery. For patients in group II, an additional assessment of response will be performed after completion of AC chemotherapy. Patients in groups I and II who undergo lumpectomy will receive postoperative radiotherapy after their recovery from surgery. Patients in group III who undergo lumpectomy will receive postoperative radiotherapy after their recovery from the fourth cycle of postoperative Taxotere.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR005096-10A1
Application #
6265765
Study Section
Project Start
1999-07-19
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
10
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Tulane University
Department
Type
DUNS #
City
New Orleans
State
LA
Country
United States
Zip Code
70118
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