Clinical Adoption, Treatment Patterns and Tolerability of Adjuvant Ribociclib in the Real-World Practice of HR+/HER2- Early Breast Cancer (CATTALYST)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Cohort B and Subcohort B1: Proportion of Patients by Year of ET Initiation, Prior to Ribociclib Initiation
研究概览
简要总结
The aim of this study is to assess the clinical adoption, treatment patterns, and safety of adjuvant ribociclib use in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (eBC) patients. This is a multi-country study using secondary real-world data sources.
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
- •Evidence of diagnosis of eBC during the identification period.
- •Aged ≥18 years at index diagnosis date. The index diagnosis date is the date of first diagnosis of eBC.
- •Anatomic stage I-III breast cancer (BC) per American Joint Committee on Cancer (AJCC), 8th Edition at index diagnosis date.
- •Evidence of HR+ during the study period:
- •have tested positive for estrogen receptor (ER+), or
- •have tested positive for progesterone receptor (PR+), or
- •have tested positive for both.
- •Tested negative for HER2 (HER2-) during the study period.
- •Evidence of surgical resection of the primary breast tumor at any time.
- •Received endocrine therapy (ET) in the adjuvant setting after index diagnosis date.
排除标准
- •Evidence of another secondary malignancy at any time prior to index diagnosis date.
- •Evidence of other primary cancer (except for skin cancer) at any time prior to index diagnosis date.
- •Patients who participate in an interventional clinical trial at any time prior to or during the study period.
- •Patients with severely incomplete or inconsistent data, precluding validity of results.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Cohort B and Subcohort B1: Proportion of Patients by Year of ET Initiation, Prior to Ribociclib Initiation
时间窗: Up to 40 months
Cohort B and Subcohort B1: Duration of ET by Type, Prior to Ribociclib Initiation
时间窗: Up to 40 months
Cohort B and Subcohort B1: Duration of Other Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) Treatment by Type, Prior to Ribociclib Initiation
时间窗: Up to 40 months
Cohort B and Subcohort B1: Duration Between Surgery and Ribociclib Initiation
时间窗: Up to 40 months
Cohort B and Subcohort B1: Proportion of Patients by Type of Surgery Prior to Ribociclib Initiation
时间窗: Up to 40 months
Cohort B and Subcohort B1: Proportion of Patients by Type of BC Treatment Prior to Ribociclib Initiation
时间窗: Up to 40 months
Cohort B and Subcohort B1: Duration of Neoadjuvant and Adjuvant Therapy by Type, Prior to Ribociclib Initiation
时间窗: Up to 40 months
Cohort B and Subcohort B1: Proportion of Patients by Baseline Demographics and Clinical Characteristics
时间窗: Baseline
Baseline characteristics (subject to data availability) include: * Age group * Sex * Race/Ethnicity * Geographic region * Insurance type * Menopausal status * Body mass index (BMI) category * Alcohol use * Year of initial BC diagnosis * Tumor stage and grade * Clinical pathological node and tumor stage * Multiple breast primary diagnoses (yes/no) * Eastern Cooperative Oncology Group (ECOG) performance status * Estrogen and progesterone receptor status * HER2 immunohistochemistry (IHC) test results (0, 1+, 2+, 3+) * HER2 Fluorescence In Situ Hybridization (FISH) test (positive, negative) * Ki-67 category (positive, negative) * Genomic risk score * Hepatic dysfunction (yes/no) * Renal dysfunction (yes/no) * Cardiovascular disease (yes/no) * Gastrointestinal (GI) dysfunction (yes/no)
Cohort B and Subcohort B1: Proportion of Patients by Demographics and Clinical Characteristics at Index Treatment Date
时间窗: Baseline
The index treatment date is the date of adjuvant ribociclib treatment initiation. Demographics and clinical characteristics (subject to data availability) include: * Age group * Insurance type * Menopausal status * BMI category * ECOG performance status
Cohort B and Subcohort B1: Charlson Comorbidity Index (CCI)
时间窗: Baseline
CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be categorized as low (0-1) and high (≥2).
Cohort B and Subcohort B1: AST Levels at Index Diagnosis Date and Index Treatment Date
时间窗: Baseline
Index diagnosis date is the date of first diagnosis of eBC. Index treatment date is the date of adjuvant ribociclib initiation.
Cohort B and Subcohort B1: ALT Levels at Index Diagnosis Date and Index Treatment Date
时间窗: Baseline
Index diagnosis date is the date of first diagnosis of eBC. Index treatment date is the date of adjuvant ribociclib initiation.
Cohort B and Subcohort B1: Total Bilirubin Level at Index Diagnosis Date and Index Treatment Date
时间窗: Baseline
Index diagnosis date is the date of first diagnosis of eBC. Index treatment date is the date of adjuvant ribociclib initiation.
Cohort B and Subcohort B1: QTc Interval at Index Diagnosis Date and Index Treatment Date
时间窗: Baseline
Index diagnosis date is the date of first diagnosis of eBC. Index treatment date is the date of adjuvant ribociclib initiation.
Cohort B and Subcohort B1: Neutrophil Count at Index Diagnosis Date and Index Treatment Date
时间窗: Baseline
Index diagnosis date is the date of first diagnosis of eBC. Index treatment date is the date of adjuvant ribociclib initiation.
Cohort B and Subcohort B1: Duration Between Initial Diagnosis and Ribociclib Initiation
时间窗: Up to 40 months
Cohort B and Subcohort B1: Duration Between Initial Diagnosis and Surgery
时间窗: Up to 40 months
次要结局
- Cohort B and Subcohort B1: Number of Prior Ribociclib Dose Interruptions per Patient Prior to Ribociclib Discontinuation(Up to 40 months)
- Cohort B and Subcohort B1: Number of Prior Ribociclib Dose Reductions per Patient Prior to Ribociclib Discontinuation(Up to 40 months)
- Cohort B and Subcohort B1: Proportion of Patients by Clinical Monitoring Practices Before and After DDI Occurrence(Up to 40 months)
- Cohort B and Subcohort B1: Proportion of Patients Who Switch to an Alternative CDK4/6i(Up to 40 months)
- Cohort B and Subcohort B1: Proportion of Patients Who Receive Concomitant Systemic and Local Oncology Therapies(Up to 40 months)
- Cohort A: Proportion of Patients by Year of ET Initiation(Up to 58 months)
- Cohort A: Duration of ET by Type(Up to 58 months)
- Cohort A: Duration of Other CDK4/6i Treatment by Type(Up to 58 months)
- Cohort A: Proportion of Patients by Type of Concomitant Medication Received(Up to 58 months)
- Cohort B and Subcohort B1: Duration of Subsequent Systemic and Local Oncology Therapies Administered After Ribociclib Initiation, by Type of Therapy(Up to 40 months)
- Cohort B and Subcohort B1: Time Between Discontinuation of Ribociclib and Start of Subsequent Systemic and Local Oncology Therapies, by Type of Therapy(Up to 40 months)
- Cohort B and Subcohort B1: Initial Dose of Ribociclib(Baseline)
- Cohort B and Subcohort B1: Proportion of Patients Who Receive Subsequent Systemic and Local Oncology Therapies Administered After Ribociclib Initiation(Up to 40 months)
- Cohort B and Subcohort B1: Proportion of Patients Who Undergo Ribociclib Dose Reduction(Up to 40 months)
- Cohort B and Subcohort B1: Number of Prior Ribociclib Dose Interruptions per Patient Prior to Ribociclib Dose Reduction(Up to 40 months)
- Cohort B and Subcohort B1: Proportion of Patients Who Experience Ribociclib Dose Interruption(Up to 40 months)
- Cohort B and Subcohort B1: Time to First Ribociclib Dose Interruption(Up to 40 months)
- Cohort B and Subcohort B1: Proportion of Patients by Reason for Ribociclib Dose Interruption(Up to 40 months)
- Cohort B and Subcohort B1: Number of Prior Ribociclib Dose Reductions per Patient Prior to Ribociclib Dose Interruption(Up to 40 months)
- Cohort B and Subcohort B1: Time to First Ribociclib Dose Reduction(Up to 40 months)
- Cohort B and Subcohort B1: Proportion of Patients by Reason for Ribociclib Dose Reduction(Up to 40 months)
- Cohort B and Subcohort B1: Proportion of Patients Who Discontinue Ribociclib Treatment(Up to 40 months)
- Cohort B and Subcohort B1: Time-to-Discontinuation (TTD) of Ribociclib Treatment(Up to 40 months)
- Cohort B and Subcohort B1: Proportion of Patients by Reason for Ribociclib Discontinuation(Up to 40 months)
- Cohort A: Proportion of Patients by Baseline Demographics and Clinical Characteristics(Baseline)
- Cohort A: CCI(Baseline)
- Cohort A: Duration Between Initial Diagnosis and Surgery(Up to 58 months)
- Cohort A: Proportion of Patients by Type of Surgery(Up to 58 months)
- Cohort A: Proportion of Patients by Type of BC Treatment Received(Up to 58 months)
- Cohort A: Duration of Neoadjuvant and Adjuvant Therapy by Type(Up to 58 months)
- Cohort B and Subcohort B1: Persistence of Ribociclib Treatment(Up to 40 months)
- Cohort B and Subcohort B1: Number of Clinical Visits and/or Laboratory Assessments for Ribociclib Monitoring(Up to 40 months)
- Cohort B and Subcohort B1: Cumulative Exposure to Ribociclib(Up to 40 months)
- Subcohort B1: Incidence of Adverse Events (AEs) of Interest(Up to 6 months)
- Subcohort B1: Proportion of Patients Requiring Changes to the Ribociclib Regimen Following AE Occurrence(Up to 6 months)
- Cohort B and Subcohort B1: Proportion of Patients With Potential DDIs Who Experience AEs(Up to 40 months)
- Subcohort B1: Proportion of Patients by the Sequalae of AEs(Up to 6 months)
- Cohort B and Subcohort B1: Proportion of Patients Undergoing Drug-drug Interaction (DDI) Assessment Upon Ribociclib Initiation(Up to 40 months)
- Cohort B and Subcohort B1: Proportion of Patients With Actual DDIs(Up to 40 months)
- Cohort B and Subcohort B1: Number of DDIs per Patient(Up to 40 months)
- Cohort A: Proportion of Patients With Potential DDIs(Up to 58 months)
- Cohort B and Subcohort B1: Proportion of Patients With Potential DDIs(Up to 40 months)
- Cohort B and Subcohort B1: Among Patients With Clinically Consequential DDIs, Number of Patients by Demographics and Clinical Characteristics(Up to 40 months)
- Cohort B and Subcohort B1: Among Patients With Clinically Consequential DDIs, Number of Patients by BC Treatment Prior to Ribociclib(Up to 40 months)
- Cohort B and Subcohort B1: Frequency of Ribociclib Treatment Modifications Related to DDIs(Up to 40 months)