A Prospective Non-interventional Study to Evaluate Clinical Outcomes of Ribociclib Combined With Endocrine Therapy in Elderly Patients With HR+HER2 - Advanced Breast Cancer in Routine Clinical Practice in Russian Federation
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- HR+HER2- Advanced Breast Cancer
- 发起方
- Novartis Pharmaceuticals
- 入组人数
- 329
- 试验地点
- 20
- 主要终点
- change of QoL (RAND SF-36)
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
This is а prospective, non-interventional, primary data collection study to evaluate the effectiveness, safety and quality of life in older patients (≥65 years) with HR+HER2- advanced breast cancer receiving ribociclib with ET in the first or second line in the real-life settings in Russia.
详细描述
In this study, an index event is a start of ribociclib+ET treatment. Post-index follow-up period is 24 months or until treatment discontinuation. The recruitment period is planned for 12 months. The interim analyses will be performed after enrollment is complete, and further one year later. Patients will visit the sites in accordance with routine clinical practice. It is assumed according to the clinical practice that visits will be conducted every 3-4 months. Patients will undergo standard procedures and tests according to clinical guidelines and physician's judgement.
研究者
入排标准
入选标准
- •Age ≥ 65 years at the moment of ribociclib+ET initiation
- •Female/Male gender
- •Confirmed diagnosis of locally advanced/metastatic not eligible for curative surgery HR+HER2- BC for whom the treating physician took the decision to initiate treatment with ribociclib+IA/FUL in the first or in the second line of the treatment
- •Patient who initiated treatment with ribociclib+IA/FUL no longer than 4 weeks (28 days) prior to written informed consent for this study
- •Provision of written informed consent.
排除标准
- •Patients with a life expectancy of less than 3 months per the investigator's judgment
- •Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study)
- •Patients on active treatment for malignancies other than aBC within 3 years before BC diagnosis
- •Patients with active cardiac disease, or history of cardiac dysfunction, including prolonged QT interval corrected using Fridericia's formula (QTcF \> 450 msec).
结局指标
主要结局
change of QoL (RAND SF-36)
时间窗: from baseline to the level at 12 months
The primary endpoint of the study is the change of QoL during treatment with ribociclib+ET from baseline to the level at 12 months (RAND SF-36) across all age's subgroups (ages 65 to 74 years; middle-old, 75 to 84 years; and oldest-old, ≥85 years) and depend on treatment lines (first-line (1L) or in second-line (2L) settings)
次要结局
- Time to treatment failure (TTF)(up to two years)
- Progression free survival rate (PFS)(up to two years)
- Median progression free survival(up tp two years)
- Overall survival rate (OS)(up to two years)
- Clinical benefit rate (CBR)(up to two years)
- Proportions (%) of patients and reasons of permanent discontinuation of ribociclib(up to two years)
- Objective response rate (ORR)(up to two years)
- Proportions (%) of patients and reasons of dose adjustment on ribocicli(up to two years)
- Adverse events (AEs) frequency and severity(up to two years)
- Quality of life (RAND SF-36, questionnaire of patient's satisfaction)(up to two years)