An Observational, Retrospective, Multicenter, National Study of the Effectiveness of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors in First-line Treatment of Brazilian Patients With HR+/HER2- Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Proportion of patients alive and progression-free from disease at 1 year
研究概览
简要总结
Observational, longitudinal (retrospective cohort), multicenter, national study aiming to evaluate the proportion of women with HR+/HER2- advanced breast cancer treated with ribociclib plus non-steroidal aromatase inhibitors who were alive and without disease progression at 1 year.
详细描述
The study was conducted in 11 Brazilian sites specialized in the treatment of this condition. The study data were collected from the review of medical records by the Investigator (or designated).
The sites must have had adequate medical records to ensure robust medical record review. Therefore, a feasibility assessment was carried out at potential site prior to the study implementation to assess the adequacy of medical records and the data routinely available.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ribociclib in combination with non-steroidal aromatase inhibitors
Included patients who received doses (600 mg, 400 mg, and 200 mg) at 6 months and 1 year
干预措施: Ribociclib (Drug)
结局指标
主要结局
Proportion of patients alive and progression-free from disease at 1 year
时间窗: 1 year post-treatment
The purpose was to evaluate the effectiveness of first-line ribociclib in combination with non-steroidal aromatase inhibitors in a Brazilian female population diagnosed with HR+/HER2- locally advanced or metastatic BC. Effectiveness was measured by the proportion of patients alive and free of disease progression at 1 year.
次要结局
- Pattern of the treatment of AE of interest at 12 months(12 months post-treatment)
- Frequency of dose interruption and cause, per patient, at 1 year(1 year post-treatment)
- Adverse Event frequency and classification of the severity degree(throughout the study, approximately 1 year)
- Pattern of the treatment of AE of interest at 6 months(6 months post-treatment)
- Proportion of patients alive and progression-free from disease at 6 months(6 months post-treatment)
- Proportion of patients who had disease progression at 6 months(6 months post-treatment)
- Proportion of patients who had disease progression at 1 year(1 year post-treatment)
- Proportion of patients who died at 6 months(6 months post-treatment)
- Proportion of patients who died at 1 year(1 year post-treatment)
- Proportion and cause of patients who reduced a treatment dose at 6 months(6 months post-treatment)
- Proportion and cause of patients who reduced a treatment dose at 1 year(1 year post-treatment)