An Open Label, Randomised, Parallel Group, Multicentre Study to Compare ZOLADEX™ 10.8 mg Given Every 12 Weeks With ZOLADEX 3.6 mg Given Every 4 Weeks in Pre-menopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Number of Patients With Progression-free Survival (PFS) at 24 Weeks
研究概览
简要总结
The purpose of this study is to examine the efficacy and safety as well as the characteristics of the female hormone and study medications after administration in pre-menopausal women with estrogen receptor positive advanced breast cancer who were randomised in a 1:1 ratio to either of the two treatment groups; the ZD9393 3.6 mg depot group or ZD9393 10.8 mg depot group, both given in combination with tamoxifen tablets.
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
- 20 Years 至 130 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female ≥20 years and pre-menopausal.Pre-menopausal defined as 1) last menses within 1 year of randomisation, and 2) E2 ≥10 pg/mL and FSH ≤ 30 mIU/mL within 4 weeks of randomisation.
- •Hormone sensitivity (ER positive) of primary or secondary tumour tissue.
- •Histological/cytological confirmation of breast cancer and are candidates to receive hormonal therapy as therapy for advanced breast cancer.
排除标准
- •Patients who have received tamoxifen or other hormonal therapies as adjuvant therapy for breast cancer within 24 weeks before randomisation and/or who have received prior treatment with hormonal therapies for advanced breast cancer
- •Patients who have received LHRHa as adjuvant therapy for breast cancer within 48 weeks before randomisation
- •Patients who have relapsed during adjuvant hormonal therapy or within 48 weeks after completion of adjuvant hormonal therapy and/or
研究组 & 干预措施
1
Zoladex 10.8 mg (goserelin acetate) will be injected once every 12 weeks (± 7 days).
One oral tamoxifen 20 mg tablet also will be taken daily
干预措施: ZD9393 (Zoladex) 10.8 mg (Drug)
2
Zoladex 3.6 mg (goserelin acetate) will be injected once every 4 weeks (± 7 days). One oral tamoxifen 20 mg tablet will also be taken daily.
干预措施: ZD9393 (Zoladex) 3.6 mg (Drug)
结局指标
主要结局
Number of Patients With Progression-free Survival (PFS) at 24 Weeks
时间窗: 24 weeks after the first dosing
A patient is judged as progression-free survive at Week 24 if their PFS time is at least 24 weeks with no progression event prior to Week 24 (ie, overall visit response is complete response (CR), partial response (PR) or stable disease (SD) at a tumour assessment at least 24 weeks after randomization). Overall visit response is assessed according to the RECIST version 1.1. %PFS is the proportion of patients with PFS.
次要结局
- Number of Responders at 24 Weeks(24 weeks after the first dosing)
- Oestradiol (E2) Serum Concentrations at 24 Weeks(24 weeks after the first dosing)