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.
Showing the most recent 10 out of 211 publications