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

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

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.

Study Overview

• Status: Recruiting
• Conditions: HR+/HER2- Advanced or Metastatic Breast Cancer

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

• Study Type: Observational
• Enrollment (Estimated): 14000

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• China
  • Beijing Municipality
    • Bingjie, Beijing Municipality, China, 100021
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

HR+/HER2- ABC adult patients (aged 18 years or older) with 1L treatment being initiated between Jan. 1, 2024 and Jan. 1, 2027, and have at least 3 months of follow-up records after the initiation of 1L treatment.

Description

Inclusion Criteria:

1. 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.

2. 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.
3. 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.
4. 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of first-line treatment regimens	Proportion of patients receiving each first line treatment category and specific regimen	Up to 39 months
Proportion of patients with treatment changes	Proportion of patients who discontinue or switch first line treatment	Up to 39 months
Time to treatment initiation, time to discontinuation, and time to next line therapy	Time to treatment initiation (TTI), time to discontinuation (TTD), and time to next-line therapy (TTNT)	Up to 39 months
Proportion of patients by initial CDK4 6 inhibitor dose	Proportion of patients treated with a CDK4 6 inhibitor, stratified by initial dose level	Up to 39 months
Proportion of patients with dose modifications of CDK4/6 inhibitor therapy	Proportion of patients treated with CDK4/6 inhibitor who experience any dose modification (including dose reduction and interruption)	Up to 39 months
Time to first dose modification of CDK4/6 inhibitor therapy	Time from initiation of CDK4/6 inhibitor therapy to the first dose modification, including dose reduction or interruption	Up to 39 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rwPFS of 1L treatment patterns	rwPFS is defined as the duration from the initiation date of 1L treatment to documented disease progression or death from any cause. If a patient has not experienced disease progression or death, the last confirmed survival time will be used as the censoring time to calculate the rwPFS censoring duration	Up to 39 months
rwPFS of HR+/HER2- ABC patients	rwPFS of HR+/HER2- ABC patients adhering or not adhering to the highest level of first-line treatment recommendation in the guidelines in the real-world setting based on the NATDSS database	Up to 39 months
rwPFS of HR+/HER2- ABC patients receiving ribociclib-based 1L treatment regimens	rwPFS of HR+/HER2- ABC patients receiving ribociclib-based 1L treatment regimens in the real-world setting based on the NATDSS database	Up to 39 months
Number of subjects with AESIs	AESIs under different treatment patterns, including: Hematology: neutropenia, leukopenia, anemia, and thrombocytopenia;; Gastrointestinal tract: diarrhea, nausea, vomiting, stomatitis/mucositis;; QTc prolongation;; Hepatotoxicity: alanine transaminase (ALT)/aspartate transaminase (AST) increased, and total bilirubin increased.	Up to 39 months
Baseline demographics		Baseline

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: NIS; HR+/HER2- advanced or metastatic breast cancer; China,
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: CLEE011ACN01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO