Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 40
- 主要终点
- To record the choice, in clinical practice, of adjuvant hormone therapy.
研究概览
简要总结
This will be a prospective, multicenter, observational study. The primary objective is to record the choice, in clinical practice, of adjuvant hormone therapy (tamoxifen, tamoxifen + LhRh, aromatase inhibitors + LhRh) in premenopausal patients with estrogen-receptor positive breast cancer.
The secondary objective is to correlate adjuvant hormone therapy choices with biological characteristics of the tumor (T size, lymph node status, grade, receptor level, Ki67, HER2 status) and patient characteristics (age, prior chemotherapy treatment).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal patients candidate to start adjuvant hormone therapy after breast cancer surgery
- •Age >18 years
- •No previous hormonal treatment
- •Written informed consent
排除标准
- •1- Patient's inability to provide written informed consent 2 - Stage IV disease
结局指标
主要结局
To record the choice, in clinical practice, of adjuvant hormone therapy.
时间窗: 21 months
Patients will be divided in groups according to type of adjuvant hormone therapy received: 1. tamoxifen 2. tamoxifen + LhRh 3. aromatase inhibitor + LhRh Differences between groups will be evaluated with Chi-square test and Mann-Whitney test.
次要结局
未报告次要终点