An Observational, Multicenter Study on the Safety and Efficacy of Femara(Letrozole) as an Extended Adjuvant Treatment in Breast Cancer Patients Who Completed Adjuvant Tamoxifen or Toremifen Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- To identify unknown adverse reactions, especially serious adverse reactions
研究概览
简要总结
Title of study: An observational, multicenter study on the safety and efficacy of Femara® (Letrozole) as an extended adjuvant treatment in breast cancer patients who completed adjuvant Tamoxifen or Toremifen treatment
Objectives:
The major objective of the study is to assess safety and efficacy of Femara® in women who had undergone resection of a primary breast cancer and subsequently received prior adjuvant tamoxifen or toremifen therapy for 5 years in real-life condition.
The study aims at the following objectives:
- To identify unknown adverse reactions, especially serious adverse reactions
- To evaluate incidence and descriptions of adverse reactions under the routine drug use
- To identify factors that may affect the safety of Femara®
- To identify factors that may affect the efficacy of Femara®
Methodology: This will be an open-label, multi-center, single-arm, observational phase IV study.
Number of centers & patients: Approximately 610 (planned No. of patients for total study period) patients from 4 centers will be enrolled in this study.
Population: Postmenopausal early breast cancer patients who have finished adjuvant treatment with Tamoxifen or Toremifen for 5 years after curative surgery as "indications" described in local product labeling.
Investigational drug: Femara® will be administered orally as described in "dose & administration" of local product labeling up to 3 years.
Study duration: FPFV May. 2006, LPFV Dec. 2011. Study drug will be administered for up to 3 years with renewal of contract on yearly basis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent form
- •Postmenopausal patients who had had a histologically or cytologically confirmed breast cancer removed at the time of diagnosis with no evidence of metastases and who had completed over 5 years of adjuvant therapy with tamoxifen or toremifen before entering the study
- •Age ≥50 years with cessation of menses and Age <50 years Postmenopausal status defined by one of the following:
- •FSH level > 30-40 IU/L
- •cessation of menses over the past 1 year
- •are/become amenorrheic due to either chemotherapy or LHRH, are/become amenorrheic due to surgical ovarian ablation
- •The tumor was to be ER and/or PgR-positive or the receptor status could have been unknown
- •No evidence of recurrence of the disease at entry
- •Patient must be accessible for follow-up
排除标准
- •Those patients known to have had receptor-negative primary tumors
- •Any concurrent malignancy
- •Patients who previously received hormone replacement therapy (HRT) during 5 years of adjuvant therapy with tamoxifen or toremifen
- •Patients who are currently receiving other aromatase inhibitors, or chemotherapy
- •Patients who have serious cardiovascular or hepatic disease with significantly abnormal daily function and/or laboratory results
- •Life expectancy < 12 months
结局指标
主要结局
To identify unknown adverse reactions, especially serious adverse reactions
时间窗: for 3 years
次要结局
未报告次要终点