Assessment of Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 876
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
The purpose of this study is to assess clinical outcomes after Letrozole treatment according to the estrogen receptor expression in postmenopausal women with hormone receptor positive breast cancer.
详细描述
This study aimed at evaluating following:
-
Validity Assessment:
-
Primary End Point: To evaluate 5-year diseae free survival rate after Letrozole treatment according to the estrogen receptor expression in postmenopausal women
-
Secondary End Point: To evaluate overall survival rate(OS) and Time to distance recurrence(TTDR) after Hormonal therapy in postmenopausal women with hormone receptor positive breast cancer
-
Safety Assessment: To evaluate all adverse events including serious adverse events after Letrozole treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with estrogen receptor(+) and/or progesterone receptor(+)
- •Postmenopausal state was defined the following conditions, at least one of a, b
- •Serum FSH ≥ 30 mIU/mL and Amenorrhea ≥ 1 year for below 55 years, over than 55 years
- •Bilateral oophorectomy
- •Patients have undergone surgery of the breast cancer within 12 weeks and terminated chemotherapy after surgery within 4 weeks.
- •WHO(ECOG) performance status 0-2
- •Adequate haematological function, renal function, hepatic function.
- •No evidence of metastasis.
排除标准
- •Metachronous bilateral breast cancer.
- •Metastatic breast cancer (stage IV)
- •Other hormone therapy and Hormonal replacement therapy given within the previous 4 weeks, except for Estring, Vagifem, Estrogen Cream.
- •Patients with Child-Pugh grade C, serum creatinine>2xUNL
- •Patients with gastrectomy, small bowel resection, malabsorption syndrome and dysphagia.
结局指标
主要结局
Disease free survival
时间窗: the first 5 years after enrollment
次要结局
- Adverse effect(the first 5 years after enrollment)
- Overall Survival(the first 5 years after enrollment)
- Time to Distant Recurrence (TTDR)(the first 5 years after enrollment)