NSABP B-26:Women with metastatic stage IV or locally advanced stage IIB breast cancer will be eligible for this study. Patients will be randomized to receive Taxol either as a 3 hour or as a 24 hour continuous infusion. Rhu GCSF will be administered subcutaneously from day 3 of every cycle only in patients receiving Taxol as a 24 hour infusion. The Taxol infusion will be repeated every 3 weeks until the occurrence of protocol defined progressive disease, protocol defined relapse, or toxicity requiring treatment discontinuation. The primary endpoint for this study is response to Taxol therapy. It is estimated that approximately 520 patients will need to be randomized nationally in order to detect a 15% difference between groups with a power of 90%. 5-10 patients will be enrolled locally.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR005096-10A1
Application #
6122118
Study Section
Project Start
Project End
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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