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

这项研究旨在解决以下决定问题： 1)阿霉素的升级是否显著改善了患者的疾病- 自由而全面的生存？如果是，将获得多少额外的好处 那么代价是什么呢？在剂量-反应曲线中是否存在一个平台期 阿霉素？2)如果阿霉素有剂量反应，会出现这种情况吗？ 在所有患者中，还是仅在肿瘤过度表达erbB-2的患者中 紫杉醇在环磷酰胺常规组合中的加成 和阿霉素(CA)提供了比单独CA更大的好处？有没有 添加紫杉醇的好处是不考虑阿霉素的剂量？ 这项研究采用析因设计，患者将首先 随机分成三种不同剂量的阿霉素 环磷酰胺/阿霉素联合(CA)，然后重新随机到 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.