Shanghai Yizhong Pharmaceutical Co., Ltd.

This multicenter, randomized, open, parallel positive control study compares the clinical efficacy and safety of paclitaxel polymeric micelles for injection with TPC in HER2- MBC subjects who have failed ≥2 to≤4 previous chemotherapy regimens.
Treatment Protocol: Subjects are randomized into paclitaxel polymeric micelles for injection group and the Physician's Choice (TPC) group by the proportion of 1:1. Randomization is stratified according to three factors: number of lines of previous treatment for metastatic disease (2 or 3/4 lines), receptor status (triple-negative, non-triple-negative), and visceral metastasis (yes/no).
Progression-free survival (PFS) is the main efficacy indicator in this study. Treatment Group: Subjects are given paclitaxel polymeric micelles for injection, three weeks constitutes one cycle of treatment.
Control Group: Physician's Choice Group, subjects are given Eribulin Mesilate injection; or capecitabine tablets; or gemcitabine hydrochloride for injection; or vinorelbine tartrate injection; or paclitaxel (albumin-bound). Three or four weeks constitutes one cycle of treatment.
If subject does not develop disease progression after 6 cycles of dosing, the subject continues treatment until disease progression (RECIST 1.1) or develops an intolerable toxicity, initiation of a new anti-cancer drug, withdrawal from the study, death, or loss of follow-up.
Superiority design is used in this study, progression-free survival (PFS) is the main efficacy indicator. Assuming α = 0.0249(unilateral, adjusted test level), power=80%, the median PFS of the treatment group is 6.0 months, the median PFS of the control group is 3.7 months, the enrollment period is 12 months, and the study period is 24 months. Using PASS (version 11.0) for calculation, a total of 152 subjects (76 in each group) are required to meet the statistical significance between the treatment group and the control group. In consideration of case expulsion, enlarged by 10%, a total of 168 subjects (84 in each group) are required.

主要目的：在接受过≥2 种且≤4 种既往化疗方案治疗失败的人表皮生长因子受体 2 阴性（HER2-）转移性乳腺癌（MBC）受试者中评估无进展生存期（PFS）以比较 注射用紫杉醇聚合物胶束与医生选择治疗（TPC）的临床疗效。 次要目的： 1）评价注射用紫杉醇聚合物胶束在 HER2- MBC 受试者中的客观缓解率（ORR）、 疾病控制率（DCR）、总生存期（OS）； 2）评价注射用紫杉醇聚合物胶束在 HER2- MBC 受试者中的安全性； 3）使用欧洲癌症研究与治疗组织（EORTC）生活质量问卷 3.0 版（EORTC QLQ- C30 v3.0）。

通过在开放标签、随机对照临床试验比较注射用紫杉醇胶束联合顺铂和普通紫杉醇注射液联合顺铂一线治疗晚期非小细胞肺癌的抗肿瘤疗效及安全性。