Retrospective Analysis of Real-World Outcomes of Ribociclib in First-Line Treatment for Metastatic HR+/HER2- Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Number Patients by Demographic Category
研究概览
简要总结
The main aim of this study was to describe the profile of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC) patients who received first-line (1L) current treatment options with ribociclib in the United States (US) clinical practice.
This study used administrative claims data. De-identified patient-level data of adult patients with HR+/HER2- mBC who initiated 1L treatment with a cyclin dependant kinase 4/6 inhibitor (CDK4/6i) i.e., ribociclib from the Komodo Health Solutions Research Database (KRD; data from 1 January 2016 to 30 June 2023) was used. Data included medical and pharmacy claims for insured patients, which had already been collected (i.e., 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
Number Patients by Demographic Category
时间窗: Baseline
Demographics included: * Age (≥ 65 years, ≥ 75 years) * Gender * Race * Index year (year of the first paid pharmacy claim for ribociclib)
Number of Patients by Clinical Characteristic Category
时间窗: Baseline
Clinical characteristic categories included: * Menopausal status * Comorbidity * Metastatic site * Eastern Cooperative Oncology Group (ECOG) performance score less than 2 ECOG performance score measures a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased).
Clinical Characteristic: National Cancer Institute (NCI) Comorbidity Index Score
时间窗: Baseline
The NCI comorbidity index is a tool used to measure the risk of non-cancer deaths for cancer patients based on the presence and severity of other health conditions. It includes 14 conditions identified using administrative data diagnosis and procedure codes. The index excludes solid tumors, leukemias, and lymphomas as comorbid conditions. Each condition is assigned a score based on how serious it is and patient scores are summed to give a final overall score. A high score indicates a higher burden of comorbid conditions and possible higher risk of death.
Clinical Characteristic: Number of Metastatic Sites
时间窗: Baseline
Treatment Characteristic: Number of Patients by Type of Treatment Received While on 1L mBC Treatment
时间窗: Up to approximately 3 years and 4 months
Treatments included: * Endocrine therapy partner (AI, Fulvestrant, or AI and Fulvestrant) * Gonadotropin-releasing hormone (GNRH) * Cytochrome P450, family 3, subfamily A (CYP3A) inhibitors and inducers * P-inhibitors and inducers * Medications potentially associated with an increased risk of torsade de pointes
Treatment Characteristic: Time from mBC diagnosis to 1L Initiation
时间窗: Baseline
Treatment Characteristic: Duration of Follow-up From 1L Initiation
时间窗: Up to approximately 3 years and 4 months
Treatment Characteristic: Duration of 1L mBC Treatment
时间窗: Up to approximately 3 years and 4 months
次要结局
- Number of Patients by Tolerability-related Medical Events Experienced While on 1L Treatment With Ribociclib(Up to approximately 3 years and 4 months)
- Number of Patients by Cardiovascular-related Medical Events Experienced While on 1L Treatment With Ribociclib(Up to approximately 3 years and 4 months)