A Phase III, Multicenter, Randomized, Open-Label Study to Assess the Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Observe the proportion of subjects whose E2 levels remain at postmenopausal levels between 4 and 48 weeks after treatment, to assess the Efficacy of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subject.
研究概览
简要总结
The study is to assess the safety, efficacy and pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
详细描述
This is a multicenter, randomized, open-Label , non-inferiority phase III study . All premenopausal women breast cancer subjects were randomly allocated to either the study group or control group in a 1:1 ratio. Furthermore, all subjects received tamoxifen citrate treatment throughout the entire duration of the study. The efficacy of maintaining serum E2 levels ≤30 pg/mL at 4-48 weeks post-treatment will be assessed in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal female subjects aged 18 to 55 years old.
- •Histological or cytological confirmation of HR+，HER2- premenopausal breast cancer.
- •Subjects have any breast cancer surgery before informing, and no clinical residual local regional lesions were found after the surgery.
- •Life expectancy is not less than 12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate function of major organs.
排除标准
- •History of evidence of distant metastatic lesions;
- •Subjects have the history of new adjuvant or adjuvant endocrine treatment for breast cancer ( Excluding subjects receiving tamoxifen citrate tablets treatment for less than 12 weeks before informing).
- •Active hepatitis B, hepatitis C or HIV in screening.
研究组 & 干预措施
Leuprolide Injectable Emulsion
100 subjects were injected Leuprolide Injectable Emulsion 42mg every 24 weeks for 48 weeks.
干预措施: T Leuprolide Injectable Emulsion (Drug)
Leuprorelin Acetate Microspheres for Injection
100 subjects were injected Leuprorelin Acetate Microspheres for Injection 11.25mg every 12 weeks for 48 weeks.
干预措施: Leuprorelin Acetate Microspheres for Injection (Drug)
结局指标
主要结局
Observe the proportion of subjects whose E2 levels remain at postmenopausal levels between 4 and 48 weeks after treatment, to assess the Efficacy of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subject.
时间窗: 48 weeks
次要结局
- Pharmacokinetic Parameter(AUC)(48 weeks)
- Pharmacokinetic Parameter(Cmax)(48 weeks)
- Observe the concentration of LH, FSH, E2 after treatment.(48 weeks)