Real-world Effectiveness and Safety in HR+/HER2- Advanced or Metastatic BC Patients Treated With Ribociclib or Alpelisib: A European Non-interventional Retrospective Study (REASSURE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 435
- 试验地点
- 1
- 主要终点
- Real-world Progression-free Survival (rwPFS)
研究概览
简要总结
This study was a multinational and multicenter cohort study of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer (aBC/mBC) treated with ribociclib or alpelisib between the period of 01 January 2018 and 30 September 2021. Patients who were receiving active treatment for malignancies other than BC or participating in a clinical trial were excluded. This study was conducted retrospectively with secondary use of data.
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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Real-world Progression-free Survival (rwPFS)
时间窗: Up to 51 months
rwPFS was defined as the time from the index date to the date of the first documented progression or death due to any cause. If a patient did not have an event, rwPFS was censored at the date of the last adequate tumor assessment. The index date was defined as the date of the first treatment with ribociclib or alpelisib.
次要结局
- Age(Baseline)
- Number of Patients by Age Group(Baseline)
- Gender(Baseline)
- Number of Patients Categorized by Year of Index Date(Baseline)
- Number of Patients With a History of Breast Cancer(Baseline)
- Number of Patients by Comorbidity(Baseline)
- Body Mass Index (BMI)(Baseline)
- Number of Patients per BMI Category(Baseline)
- Number of Patients by Menopausal Status(Baseline)
- Number of patients per Charlson Comorbidity Index (CCI) Score Category(Baseline)
- Number of Patients Categorized by Duration of Disease Recurrence(Baseline)
- Number of Patients by Smoking Status(Baseline)
- Number of Patients Categorized by Primary Tumor Type(Baseline)
- Number of Patients Categorized by Disease Site(Baseline)
- Number of Patients With Primary Metastatic Disease(Baseline)
- Number of Patients Categorized by Number of Metastatic Sites(Baseline)
- Number of Patients Categorized by Type of Metastases(Baseline)
- Number of Patients Categorized by Time From Diagnosis to Metastasis(Baseline)
- Number of Patients With Asymptomatic Disease(Baseline)
- Number of Patients Categorized by Tumor Grade(Baseline)
- Number of Patients Categorized by Stage of Cancer(Baseline)
- Number of Patients by Eastern Cooperative Oncology Group (ECOG) Performance Score(Baseline)
- Number of Patients Categorized by Previous Types of Treatment(Baseline)
- Number of Patients Categorized by the Number of Prior Lines of Endocrine Therapy (ET)(Baseline)
- Number of Patients Resistant to ET(Baseline)
- Number of Patients Sensitive to Hormonal Therapy(Baseline)
- Number of Patients Categorized by Line of Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) Treatment Received(Baseline)
- Number of Patients Categorized by the Number of Previous Lines of Treatment(Baseline)
- Baseline Neutrophil-to-lymphocyte Ratio (NLr)(Baseline)
- Baseline Platelet-to-lymphocyte Ratio (PLr)(Baseline)
- Baseline Lymphocytes-to-monocytes Ratio (LMr)(Baseline)