Real-World, Retrospective Study of Treatment Patterns, Tolerability and Effectiveness of CDK4/6 Inhibition in HR+, HER2-negative Metastatic Breast Cancer, With a Focus on Patients 65 Years and Older, and Patients Who Self-identify as African American
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 945
- 试验地点
- 1
- 主要终点
- Number of Patients Who Initiated 1L Ribociclib Treatment for HR+/HER2- mBC, by Demographic and Clinical Characteristics Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
研究概览
简要总结
The aim of this study was to assess real-world treatment patterns and tolerability of ribociclib among patient populations historically underrepresented in clinical trials - specifically older adults and Black/African American patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC).
The study was conducted using data from a nationwide database derived from electronic health record (EHR) data collected from oncology practices across the United States. The study population was drawn from community and academic oncology practices within the health research network.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Included in Flatiron's mBC Enhanced Data Model (EDM):
- •Had an International Classification of Diseases (ICD) diagnosis of breast cancer (ICD, 9th revision, clinical modification [ICD-9-CM] 174.x or 175.x or ICD, 10th revision, clinical modification [ICD-10-CM] C50x)
- •At least two documented clinical visits, on different days, occurring on or after January 1, 2011
- •Included in probabilistic sample of patients queued for review via abstraction
- •Had pathology consistent with breast cancer
- •Had evidence of stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2011, including patients diagnosed as stage IV at initial diagnosis, or diagnosed with earlier stage disease who then developed metastatic disease
- •Initiated treatment with first-line (1L) ribociclib (in combination with endocrine therapy [ET]) in the metastatic setting on or after January 1, 2018, and at least 6 months prior to the study data cutoff date (October 31, 2024) to ensure adequate time to observe dose modifications and treatment discontinuations
- •Had evidence of HR+/HER2- test result prior to or up to 30 days after initiation of 1L ribociclib
- •Had 1L ribociclib on or before April 30, 2024, to allow for at least 6 months of potential follow-up time prior to the data cutoff date of October 31, 2024
排除标准
- •Use of any CDK4/6 inhibitor therapy in combination with tamoxifen
- •Use of any CDK4/6 inhibitor in the pre-metastatic setting
研究组 & 干预措施
Adults Aged 65 and Older
HR+/HER2- mBC cancer patients aged 65 years or older who initiated 1L ribociclib plus ET on or after January 01, 2018.
Black or African American Adults
HR+/HER2- mBC cancer patients aged 65 years or older who self-identify as Black/African American and initiated 1L ribociclib plus ET on or after January 01, 2018.
Adults Aged 75 and Older
HR+/HER2- mBC cancer patients aged 75 years or older who initiated 1L ribociclib plus ET on or after January 01, 2018.
结局指标
主要结局
Number of Patients Who Initiated 1L Ribociclib Treatment for HR+/HER2- mBC, by Demographic and Clinical Characteristics Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
时间窗: Baseline
Demographics and clinical characteristics included race/ethnicity, practice type, geographic region, insurance type, socioeconomic status (SES) quintile, stage at initial diagnosis, menopausal status at 1L start, sites of metastasis, endocrine sensitivity status, year of 1L initiation, and prior chemotherapy exposure.
Age at 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
时间窗: Baseline
Body Mass Index (BMI) at 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
时间窗: Baseline
Number of Patients by Eastern Cooperative Oncology Group (ECOG) Performance Status Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older,
时间窗: Baseline
ECOG performance status is a scale used to measure a patient's level of functioning in terms of self-care, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased).
Duration Between Metastatic Diagnosis and 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
时间窗: Baseline
Number of Patients by Initial and Subsequent Dosing Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
时间窗: Up to approximately 6 years, 10 months
Number of Patients With Dose Modifications Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
时间窗: Up to approximately 6 years, 10 months
Dose modifications defined as a dose being held, increased, or decreased.
Number of Patients by Reasons for Dose Modifications Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
时间窗: Up to approximately 6 years, 10 months
Dose modifications defined as a dose being held, increased, or decreased.
Number of Patients Who Discontinued Treatment Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
时间窗: Up to approximately 6 years, 10 months
Number of Patients by Reason for Treatment Discontinuation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
时间窗: Up to approximately 6 years, 10 months
次要结局
- BMI at 1L Ribociclib Initiation Among Black/African American Patients(Baseline)
- Number of Patients by Reason for Treatment Discontinuation Among Black/African American Patients(Up to approximately 6 years, 10 months)
- Number of Patients Who Initiated 1L Ribociclib Treatment for HR+/HER2- mBC, by Demographic and Clinical Characteristics Among Black/African American Patients(Baseline)
- Age at 1L Ribociclib Initiation Among Black/African American Patients(Baseline)
- Number of Patients by ECOG Performance Status Among Black/African American Patients(Baseline)
- Duration Between Metastatic Diagnosis and 1L Ribociclib Initiation Among Black/African American Patients(Baseline)
- Number of Patients by Initial and Subsequent Dosing Among Black/African American Patients(Up to approximately 6 years, 10 months)
- Number of Patients With Dose Modifications Among Black/African American Patients(Up to approximately 6 years, 10 months)
- Number of Patients by Reasons for Dose Modifications Among Black/African American Patients(Up to approximately 6 years, 10 months)
- Number of Patients Who Discontinued Treatment Among Black/African American Patients(Up to approximately 6 years, 10 months)