近几年来，乳癌药物治疗进展十分迅速，各种新药层出不穷。本文对德国Bayer公司于2005年1月开始进行并于2011年11月结束的54例晚II期乳癌患者的临床试验数据进行分析。对数据的分析过程中，采用了Weibull分布拟合方法以及Kaplan-Meier法估计了病人病情的无进展生存时间的中位数及置信区间。得到了抗肿瘤新药Sorafenib对于病人病情的疗效方面的情况，但由于试验样本来源仅限于欧美地区，且本次试验未设立对照组，尚无法判断该药是否对全球范围内的乳癌病人均有较好的效果。随后对拟合结果进行了检验，并通过似然估计得到了Weibull分布的具体参数，进而采用了W方检验以及Anderson-Darling检验方法对得到的估计进行检验并获得了很好的结果。最后本文总结了本次试验中的不足与难点，并对今后的研究工作提出了建议，指明了研究的发展方向。

In recent years, the breast cancer drug treatment progressed very rapidly, new drugs launched frequently. In this paper, I focused on a phase II multi-center uncontrolled trial of BAY 43-9006 in subjects with metastatic breast cancer which is began in January 2005 and the end of November 2011. In this paper, I used several fitting methods and Kaplan-Meier method to obtain the estimations of the median and CIs of a time-to-event variable in Weibull distribution. After that, I realized the situation of those subjects. But limited by the trial, I was not convinced whether BAY 43-9006 was effective to those patients all around the world. To test the result I got, I utilized W-squared and Anderson-Darling method and the testing result was pretty good. At the end of this paper, I summarized the deficiencies and difficulties in this research. Also, I made recommendations and pointed out the direction for further research.