NCT01072318Unknown4 期
Evaluate Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Have Completed 5 Years of Toremifene
Korean Breast Cancer Study Group1 个研究点 分布在 1 个国家目标入组 495 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 495
- 试验地点
- 1
- 主要终点
- Disease free survival rate
研究概览
简要总结
The purpose of this study is to assess Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene
详细描述
- Primary purpose To evaluate disease free survival rate (DFS) after taking 36 months with Letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of Toremifene
- Secondary purpose
- To evaluate follows after taking 36 months with Letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of Toremifene.
- Disease Free Survival rate(DFS)-12 months, 24 months
- Distant disease free survival rate(DDFS), Overall Survival(OS)
- 12 months, 24 months, 36 months c. safety
- Change of lipid profiles
- Mortality and morbidity due to Cardiovascular disease
- Incidence of Fracture
- Change of Bone density
- Common toxic effect
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients have undergone surgery of the breast cancer and proven histologically to be invasive breast cancer.
- •Removed the breast cancer histologically or cytologically
- •No evidence of breast cancer in controlateral breast
- •No evidence of metastasis
- •Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene in 30 months
- •Postmenopausal state was defined the following conditions, at least one of a, b
- •Serum FSH ≥ 30 mIU/mL
- •Amenorrhea ≥ 1 year
- •Estrogen receptor(+) or Progesterone receptor(+)
- •No Evidence of Recurrence
排除标准
- •Patient with hormone receptor negative
- •Patients with malignancies
- •Patients with other aromatase inhibitor and chemotherapy
- •Patients with Other hormone therapy and Hormonal replacement therapy
- •Patients with Hormone replacement therapy during taking Toremifene
- •Estimated life expectancy of <12 months
- •WBC<3,000/mm3 or Platelet count<100,000/mm3
- •AST and/or ALT ≥2xUNL
- •Alkaline phosphatase ≥2xUNL
研究组 & 干预措施
Letrozole, DFS
Experimental
Efficacy evaluation of extended letrozole after 5 year fareston use
干预措施: Letrozole (Drug)
结局指标
主要结局
Disease free survival rate
时间窗: 3 years
次要结局
- Overall survival rate(12, 24, 36 months)
- Distant disease free survival rate(12 months, 24 months, 36 months)
- Disease free survival rate(12 months, 24 months)
- Toxicity was assessed by NCI-CTC version 3.0(36 months)
研究者
研究点 (1)
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