Real-World Treatment Pattern and Clinical Outcome With Influential Factors of HR+/HER2-aBC 1L Patients in China: A Retrospective Analysis Based on a Database
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 14,000
- 主要终点
- Distribution of first-line treatment regimens
研究概览
简要总结
This study aims to fill the current gap in data regarding HR+/HER2- ABC 1L treatment patterns and outcomes in the real-world setting in China, especially in the context of the widespread application of CDK4/6is and the lack of sufficient evidence for ribociclib as a most recently marketed drug in the real-world setting.
详细描述
This study is a longitudinal, non-interventional, retrospective, and observational study based on secondary real-world data in the National Anti-Tumor Drug Surveillance System (NATDSS) database. The study will not involve any active intervention, randomization, or control group.
All analyses will be conducted using Electronic Health Record (EHR) routinely collected in clinical practice and additional secondary 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with HR+/HER2- ABC:
- •HR+ is defined as ER+ or PR+, and HER2+ is defined as immunohistochemistry 3+, or 2+ with positive in situ hybridization (amplification). Advanced or metastatic breast cancer is defined as having a documented inoperable clinical or pathological stage IIIB, IIIC, or IV, or the records indicating distant metastasis.
- •Initiation of 1L anti-cancer treatment between Jan. 1, 2024 and Jan. 1, 2027; Defined as having records of systemic anti-cancer treatment in disease course records or order records within 90 days after the initial diagnosis of ABC, and receiving the first dose between Jan. 1, 2024 and Jan. 1, 2027, as recorded in the NATDSS database.
- •Aged 18 years or older at the time of receiving the 1L treatment; Definition: The initiation date (index date) of 1L treatment is defined as the initiation date of systemic anti-cancer treatment for HR+/HER2- ABC first recorded in the database. Age will be preferentially calculated based on the date of birth (or year of birth) and the initiation date of 1L treatment in the database. If the birth information is not included in the database but shown in an "Age" field in the medical visit/hospitalization record associated with 1L treatment, this age field will be used as the basis for age.
- •At least 3 months of follow-up records after the initiation of 1L treatment. Defined as having at least one outpatient or inpatient medical visit record in the NATDSS at least 3 months after the index date.
排除标准
- •(1) Patients with any other concomitant invasive malignancies Defined as patients meeting any of the following conditions based on their diagnosis records in the cancer registry/medical database used for the study:
- •Within 5 years before the diagnosis of HR+/HER2- ABC, there is a diagnosis record of invasive malignancy other than breast cancer in the database (based on the International Classification of Diseases [ICD] diagnosis code or cancer registry code), and the diagnosis is not carcinoma in situ or benign/borderline tumor;
- •On the day of, or within 3 months after, the diagnosis of HR+/HER2- ABC, there is a new diagnosis record of invasive malignancy at another site (also based on the ICD diagnosis code or cancer registry code) indicating a concomitant active malignancy.
结局指标
主要结局
Distribution of first-line treatment regimens
时间窗: Up to 39 months
Proportion of patients receiving each first line treatment category and specific regimen
Proportion of patients with treatment changes
时间窗: Up to 39 months
Proportion of patients who discontinue or switch first line treatment
Time to treatment initiation, time to discontinuation, and time to next line therapy
时间窗: Up to 39 months
Time to treatment initiation (TTI), time to discontinuation (TTD), and time to next-line therapy (TTNT)
Proportion of patients by initial CDK4 6 inhibitor dose
时间窗: Up to 39 months
Proportion of patients treated with a CDK4 6 inhibitor, stratified by initial dose level
Proportion of patients with dose modifications of CDK4/6 inhibitor therapy
时间窗: Up to 39 months
Proportion of patients treated with CDK4/6 inhibitor who experience any dose modification (including dose reduction and interruption)
Time to first dose modification of CDK4/6 inhibitor therapy
时间窗: Up to 39 months
Time from initiation of CDK4/6 inhibitor therapy to the first dose modification, including dose reduction or interruption
次要结局
- Baseline demographics(Baseline)
- rwPFS of 1L treatment patterns(Up to 39 months)
- rwPFS of HR+/HER2- ABC patients(Up to 39 months)
- rwPFS of HR+/HER2- ABC patients receiving ribociclib-based 1L treatment regimens(Up to 39 months)
- Number of subjects with AESIs(Up to 39 months)