A Randomized, Open Label, Multi-Centre Study to Compare the Efficacy and Tolerability of Fulvestrant 500mg With Exemestane for Postmenopausal Advanced Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
A Randomized, Open label, Parallel-group, Multi-center study. Eligible patients will be randomized in a 1:1 ratio to receive fulvestrant 500 mg or Exemestane 25mg.
详细描述
To compare the efficacy and tolerability of Fulvestrant 500 mg with Exemestane 25 mg as first line endocrine therapy in postmenopausal women with oestrogen receptor positive HER2 negative advanced breast cancer who have relapsed on or after adjuvant non-aromatase inhibitor therapy
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent document on file;
- •Age over 60 years;
- •Age < 60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol level in the postmenopausal range;
- •Patients with metastatic or locally advanced disease not amenable to therapy with Curative intent
- •ER + and/or PgR +;
- •Duration of adjuvant non-aromatase inhibitors treatment should be at least 2 years or more;
- •WHO performance status 0, 1 or 2;
- •Patients with life expectancy of more than 3 months.
排除标准
- •Presence of life-threatening metastatic visceral disease;
- •Previous systemic chemotherapy for advanced breast cancer;
- •Received systemic endocrine therapy for advanced disease;
- •Extensive radiation therapy within the last 4 weeks ;
- •Platelets < 100*109 / L,Total bilirubin no less than 1.5ULRR, ALT or AST no less than 2.5ULRR if no demonstrable liver metastases or no less than 5ULRR in presence of liver metastases;
- •Severe renal impairment, bleeding diathesis, long-term anticoagulant therapy;
- •History of hypersensitivity to active or inactive excipients of fulvestrant, Exemestane and/or castor oil.
研究组 & 干预措施
Fulvestrant
Fulvestrant 500 mg
干预措施: Fulvestrant 500 mg (Drug)
Exemestane
Exemestane 25mg
干预措施: Exemestane 25 mg (Drug)
结局指标
主要结局
PFS
时间窗: 3 years
To compare the efficacy of Fulvestrant 500 mg with the patients treated with Exemestane 25mg as first line setting in terms of progression-free survival.
次要结局
- ORR(3 years)
研究者
Binghe Xu
Head of the medical department
Chinese Academy of Medical Sciences