NSABP26--BREAST CANCER COMPARING EFFECT OF 3 HOUR V 24 HOUR INFUSION OF TAXOL

NSABP B-26：转移性IV期或局部晚期II期B的女性 乳腺癌患者将有资格参加本研究。 患者将 随机接受紫杉醇治疗3小时或24小时 持续输液 rhu GCSF将从 仅在接受泰素24小时治疗的患者中，每个周期的第3天 输液 泰素输注将每3周重复一次，直至 发生方案定义的疾病进展，方案定义 复发或需要停止治疗的毒性。 主 本研究的终点是对紫杉醇治疗的反应。 据估计 大约有520名患者需要在全国范围内进行随机化， 以90%的功效检测组间15%的差异。 5-10将在当地招募患者。

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.