[Translation] An international multicenter, open-label Phase II/III clinical trial evaluating the efficacy and safety of Liporaxel versus Taxol as first-line treatment for patients with recurrent or metastatic HER2-negative breast cancer
Ⅱ期: 主要目的:通过客观缓解率评估紫杉醇口服溶液的抗肿瘤作用。 次要目的: 评估下列各项: 无进展生存期 总生存期 至治疗失败的时间 疾病控制率 生存质量 安全性 Ⅲ期: 主要目的:比较试验组和对照组的无进展生存期; 次要目的:比较试验组和对照组的客观缓解率、总生存期、至治疗失败的时间、疾病控制率、生存质量和安全性。
[Translation] Phase II: Primary purpose: To evaluate the anti-tumor effect of paclitaxel oral solution by objective response rate. Secondary purpose: To evaluate the following: Progression-free survival Overall survival Time to treatment failure Disease control rate Quality of life Safety Phase III: Primary purpose: To compare the progression-free survival between the experimental group and the control group; Secondary purpose: To compare the objective response rate, overall survival, time to treatment failure, disease control rate, quality of life and safety between the experimental group and the control group.