RESONATE Study: Real-world Outcomes With Ribociclib in Indian 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
- 335
- 试验地点
- 1
- 主要终点
- Real-world Progression-free Survival (rwPFS) for the Entire Patient Group
研究概览
简要总结
The aim of this study was to assess the effectiveness, safety, and tolerability of ribociclib in Indian women with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (aBC).
This study used secondary data sources, i.e., paper-based records; electronic medical records (EMRs); and other sources, such as radiology reports, pathology reports, and examination/clinician notes related to aBC, from clinics/hospitals across 18 sites in India. Aggregated data of anonymized patients treated with ribociclib plus endocrine therapy (ET) by the approved indication between June 2018 and December 2021 were collected and analyzed.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥18 years old diagnosed with HR+ and HER2- aBC who received at least one dose of ribociclib in combination with ET following the approved indication, with at least one follow-up visit after diagnosis or death due to any cause.
排除标准
- •Patients with prior/current enrollment in an interventional clinical trial for aBC/metastatic breast cancer and those who had received another cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor in any setting.
研究组 & 干预措施
Ribociclib Group
Indian women with a confirmed diagnosis of HR+, HER2- aBC who were treated with ribociclib in combination with ET.
结局指标
主要结局
Real-world Progression-free Survival (rwPFS) for the Entire Patient Group
时间窗: Up to approximately 42 months
rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause.
rwPFS by Line of Therapy for the Entire Patient Group
时间窗: Up to approximately 42 months
rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause.
Duration of Clinical Response by Type of Clinical Response and Line of Therapy for the Entire Patient Group
时间窗: Up to approximately 42 months
Clinical response categories included complete response, any response (other than complete response), no response, and any progression.
Number of Patients by Type of Clinical Response and Line of Therapy for the Entire Patient Group
时间窗: Up to approximately 42 months
Clinical response categories included complete response, any response (other than complete response), no response, and any progression.
次要结局
- rwPFS for Patients With at Least 6 Months of Follow-up(Up to approximately 42 months)
- rwPFS by Line of Therapy for Patients With at Least 6 Months of Follow-up(Up to approximately 42 months)
- Duration of Clinical Response by Type of Clinical Response and Line of Therapy for Patients With at Least 6 Months of Follow-up(Up to approximately 42 months)
- Number of Patients With Adverse Events(Up to approximately 42 months)
- Number of Adverse Events(Up to approximately 42 months)
- Number of Adverse Events by Severity(Up to approximately 42 months)
- Number of Patients who Discontinued Treatment by Reason for Discontinuation(Up to approximately 42 months)
- Number of Patients by Adverse Event That Led to Dose Discontinuation(Up to approximately 42 months)
- Number of Patients by Adverse Event That Led to Dose Interruptions(Up to approximately 42 months)
- Number of Patients by Adverse Event That Led to Dose Reduction(Up to approximately 42 months)