Real-World Treatment Pattern and Clinical Outcome With Influential Factors of HR+/HER2-aBC 1L Patients in China

Official title

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

Overview

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.

Detailed description

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

Primary outcome measures

• Distribution of first-line treatment regimens [Time frame: Up to 39 months]
• Proportion of patients with treatment changes [Time frame: Up to 39 months]
• Time to treatment initiation, time to discontinuation, and time to next line therapy [Time frame: Up to 39 months]
• Proportion of patients by initial CDK4 6 inhibitor dose [Time frame: Up to 39 months]
• Proportion of patients with dose modifications of CDK4/6 inhibitor therapy [Time frame: Up to 39 months]
• Time to first dose modification of CDK4/6 inhibitor therapy [Time frame: Up to 39 months]

Secondary outcome measures (5)

• rwPFS of 1L treatment patterns [Time frame: Up to 39 months]
• rwPFS of HR+/HER2- ABC patients [Time frame: Up to 39 months]
• rwPFS of HR+/HER2- ABC patients receiving ribociclib-based 1L treatment regimens [Time frame: Up to 39 months]
• Number of subjects with AESIs [Time frame: Up to 39 months]
• Baseline demographics [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

(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: 1. 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; 2. 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Novartis Investigative SIte — Bingjie

Identifiers

NCT: NCT07476170 · CLEE011ACN01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗