SWOG 9410--DOXORUBICIN DOSE ESCALATION W/WO TAXOL FOR BREAST CANCER

本研究旨在解决以下问题： 1)多柔比星剂量的增加是否能显著改善患者的疾病- 自由和总体生存率？若然，额外得益有多少 代价是什么在剂量-反应曲线中是否有一个平台， 阿霉素？2)如果对阿霉素有剂量反应，是否观察到 在所有患者中还是仅在肿瘤过度表达erbB-2的患者中？3)并 将紫杉醇加入常规环磷酰胺组合中 和阿霉素（CA）提供更大的好处比CA单独？是否有 无论多柔比星的剂量如何，加入泰素的优势是什么？ 本研究采用析因设计，患者将首先 随机分配到三种不同剂量的阿霉素中的一种， 环磷酰胺/多柔比星组合（CA），然后重新随机分配至 接受四个周期的紫杉醇或不接受紫杉醇。

This study is designed to address the following questions determining: 1) does escalation of doxorubicin significantly improve patient disease- free and overall survival? If so, how much additional benefit is obtained and at what cost? Is there a plateau in the dose-response curve for doxorubicin? 2) if there is a dose-response to doxorubicin, is this seen in all patients or only in those whose tumors overexpress erbB-2? 3) does the addition of Taxol to a conventional combination of cyclophosphamide and doxorubicin (CA) provide greater benefit than CA alone? Is there an advantage of adding Taxol regardless of the dose of doxorubicin used? This study has a factorial design in which patients will first be randomized to one of three different doses of doxorubicin in the cyclophosphamide/doxorubicin combination (CA) and then rerandomized to receive either four cycles of Taxol or no Taxol.