NCT00913016Unknown不适用
Assessment of Quality of Life, Bone Density and Safety in Postmenopausal Breast Cancer Patients With Letrozole (Femara) as an Early Adjuvant Treatment
Korean Breast Cancer Study Group1 个研究点 分布在 1 个国家目标入组 897 人开始时间: 2007年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 897
- 试验地点
- 1
- 主要终点
- overall QoL(Quality of Life) using Trial outcome index(TOI) of FACT-B questionnaire.
研究概览
简要总结
To compare the overall QoL (Quality of Life) using Trial Outcome index (TOI) of FACT-B questionnaire for 3 years from baseline.
详细描述
- TOI is the sum of the scores from the physical and functional well-being and the breast cancer subscales.
- To assess incidence of adverse events (including cardiovascular, cerebrovascular, and endocrine, musculoskeletal) in Korean postmenopausal breast cancer patients in early adjuvant setting.
- To assess the effect of letrozole (Femara) on BMD in early adjuvant setting.
- To assess the effect of letrozole (Femara) on total cholesterol in early adjuvant setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 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 breast cancer with postmenopausal women older than 45 years. Postmenopausal state was defined the following conditions, at least one of a, b, c.
- •serum FSH ≥ 30 mIU/mL
- •amenorrhea ≥ 1 year
- •oophorectomy
- •patients with estrogen receptor(+) and/or progesterone receptor(+)
- •WHO(ECOG) performance status 0-2
- •Adequate haematological function, renal function, hepatologic function.
- •No evidence of metastasis.
排除标准
- •patient with hormone receptor negative.
- •Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell / squamous cell carcinoma of the skin.
- •Other hormone therapy given within the previous 4 weeks.
- •Patients with other aromatase inhibitor and chemotherapy
- •Uncontrolled infection, medically uncontrollable heart disease
- •Other serious medical illness or prior malignancies
- •Patients with BMD T-score ≤-2.5
- •Patients who were treated with bisphosphonate
- •Patients with postmenopausal state induced chemotherapy
- •Estimated life expectancy of <12 months
结局指标
主要结局
overall QoL(Quality of Life) using Trial outcome index(TOI) of FACT-B questionnaire.
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (1)
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