Real World Treatment Patterns and Outcomes in HR+, HER2- Metastatic Breast Cancer Patients Treated With CDK 4/6 Inhibition in the First Line (1L) Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Number and Percentage of 1L Ribociclib Patients With ESR1 Mutation any Time During Study
研究概览
简要总结
The aim of this study was to evaluate patient profiles, treatment patterns, and outcomes of hormone receptor positive (HR+)/human epidermal growth factor receptor-2 negative (HER2-) metastatic breast cancer (mBC) patients treated with a 1L cyclin dependent kinase 4/6 inhibitor (CDK4/6i) in the real-world setting.
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
- •A diagnosis of mBC based on at least two diagnoses of breast cancer (International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM] code C50.xxx) along with a diagnosis of secondary malignant neoplasm (ICD-10-CM codes C77.xxx - C80.xxx except C79.8 or C79.81, reporting of a metastatic site by curation), in the period prior to or on the index date.
- •Patients with HR+/HER2- status.
- •Use of either ribociclib, palbociclib, or abemaciclib in 1L treatment for mBC.
- •Continuous care at the contributing practices. Patients with a minimum of two visits up to and including the index date.
排除标准
- •Use of any prior CDK4/6i before the index date.
- •Prior 1L treatment, other than CDK4/6i, in mBC including treatment with endocrine therapy (ET) either with tamoxifen, aromatase inhibitors (AI; anastrozole, exemestane, or letrozole) or fulvestrant. For it to be considered 1L in mBC, the diagnosis of mBC must have preceded treatment initiation, or was indicated so in unstructured data.
- •Diagnosis of cancer other than breast cancer and/or mBC on or prior to the index.
- •Evidence of participation in a clinical trial at any time during the study observation period.
研究组 & 干预措施
CDK4/6i Cohort
Adult HR+/HER2- mBC patients treated with 1L ribociclib, palbociclib, or abemaciclib.
结局指标
主要结局
Number and Percentage of 1L Ribociclib Patients With ESR1 Mutation any Time During Study
时间窗: Up to approximately 7 years and 6 months
Among 1L Ribociclib Patients, Age at mBC Diagnosis
时间窗: Baseline
Among 1L Ribociclib Patients, Age at Initial BC Diagnosis
时间窗: Baseline
Interval Between mBC Diagnosis and 1L Ribociclib Initiation
时间窗: Baseline
Number and Percentage of 1L Ribociclib Patients With ESR1 Mutation at Baseline
时间窗: Baseline
Number and Percentage of 1L Ribociclib Patients by Clinical Characteristic Category
时间窗: Baseline
Clinical characteristics included: * Menopausal status * Eastern Cooperative Oncology Group (ECOG) performance status * Stage at initial breast cancer (BC) diagnosis * Comorbidities * QT prolongation diagnosis (yes/no) * Sites of metastasis
Among 1L Ribociclib Patients, Body Mass Index (BMI)
时间窗: Baseline
Follow-up Time From 1L Ribociclib Treatment Initiation
时间窗: Up to approximately 7 years and 6 months
Among 1L Ribociclib Patients, Number of Metastatic Sites per Patient at Baseline
时间窗: Baseline
Among 1L Ribociclib Patients, Number of Metastatic Sites per Patient any Time During Study
时间窗: Up to approximately 7 years and 6 months
Number and Percentage of 1L Ribociclib Patients by Sites of Metastasis During Follow-up
时间窗: Up to approximately 7 years and 6 months
Number and Percentage of 1L Ribociclib Patients by Type of Medical Procedures Received
时间窗: Baseline
Among 1L Ribociclib Patients, Hemoglobin Level
时间窗: Baseline
Among 1L Ribociclib Patients, Hematocrit Level
时间窗: Baseline
Among 1L Ribociclib Patients, White Blood Cell Count
时间窗: Baseline
Among 1L Ribociclib Patients, Platelet Count
时间窗: Baseline
Number and Percentage of 1L Ribociclib Patients With Neutropenia
时间窗: Baseline
Among 1L Ribociclib Patients, Serum Creatinine Level
时间窗: Baseline
Among 1L Ribociclib Patients, Aspartate Aminotransferase (AST) Level
时间窗: Baseline
Among 1L Ribociclib Patients, Red Blood Cell (RBC) Count
时间窗: Baseline
Among 1L Ribociclib Patients, Alanine Aminotransferase (ALT) Level
时间窗: Baseline
Among 1L Ribociclib Patients, Alkaline Phosphatase (ALP) Level
时间窗: Baseline
Among 1L Ribociclib Patients, Bilirubin Level
时间窗: Baseline
Number and Percentage of 1L Ribociclib Patients by Type of Other Medications in 1L Treatment
时间窗: Baseline
Interval Between Treatment Initiation and Ribociclib Initiation
时间窗: Baseline
Number and Percentage of Patients by Type of Treatment Received per Line of Treatment
时间窗: Up to approximately 7 years and 6 months
Number and Percentage of Patients Treated With 1L Ribociclib by Demographic Category
时间窗: Baseline
Demographics included: * Age group * Sex * Race * Ethnicity * Geographical region * Payer type * Year of 1L treatment initiation * De novo or recurrent mBC
Age at 1L Ribociclib Treatment Initiation
时间窗: Baseline
次要结局
- Number and Percentage of 1L Ribociclib Patients by Type of First Dose Adjustment(Up to approximately 7 years and 6 months)
- Among 1L Ribociclib Patients, Number of Total Dose Adjustments(Up to approximately 7 years and 6 months)
- Number and Percentage of 1L Ribociclib Patients by Starting Dose of Ribociclib(Baseline)
- Relative Dose Intensity (RDI) of Ribociclib(Up to approximately 7 years and 6 months)
- Ribociclib Dose at First Dose Adjustment(Up to approximately 7 years and 6 months)
- Among 1L Ribociclib Patients, Time to First Dose Adjustment(Up to approximately 7 years and 6 months)
- Number and Percentage of Patients by Ribociclib Dosage Received per Dose Adjustment(Up to approximately 7 years and 6 months)