A Randomised in Practice Evaluation of the Influence of Patient's Understanding of Her Disease and Therapy on Persistence and Compliance to Adjuvant Therapy for Post-menopausal Hormone Sensitive Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 4,923
- 主要终点
- Compliance rate and persistence rate
研究概览
简要总结
Approximately 60 specialised clinics and 420 office based gynaecologists or oncologists will participate in this in practice evaluation program (NIS). The clinic and approximately 7 office based physicians will collaborate within their breast centre networks to conduct this program. A breast centre network should be able to recruit in this program approximately 80 patients (approximately 40 patients per year). It is planned to enroll approximately 4674 patients in this NIS (2337 patients per arm). The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer scheduled for upfront adjuvant endocrine treatment with anastrozole according to the current standard medical procedures.
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
- •Histological/cytological confirmed primary diagnosis of early breast cancer
- •Postmenopausal
- •Hormone receptor positive
排除标准
- •Patients with severe renal function disorders
- •Patients with moderate or severe disorders of hepatic function
- •Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen
研究组 & 干预措施
1
Standard routine care for breast cancer
干预措施: Anastrozole (Drug)
2
Standard + Intervention arm: standard routine care for breast cancer and additional information material via post
干预措施: Anastrozole (Drug)
结局指标
主要结局
Compliance rate and persistence rate
时间窗: until discontinuation of treatment
次要结局
- Time of disease free survival(date of recurrence or progression of the tumor minus date of primary breast cancer surgery + 1)
- Demographics and other baseline characteristics as well as information regarding concomitant medication, quality of life(until treatment discontinuation)
- The percentage number of patients with disease free survival(after 12 months)
- Time to treatment discontinuation(date of last intake of anastrozole minus date of first prescription of anastrozole + 1)