Real-world first-line treatments and outcomes for HR+/HER2- advanced breast cancer 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 project will look at real-world first-line treatment patterns and outcomes for adults in China with HR+/HER2- advanced or metastatic breast cancer, with a focus on use of CDK4/6 inhibitors such as ribociclib.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 14000 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 1 site (Bingjie, Beijing Municipality) |
| Trial ID | NCT07476170 on ClinicalTrials.gov |
What this trial studies
This is a longitudinal, retrospective, non-interventional observational analysis using routinely collected electronic health records and secondary data from the National Anti-Tumor Drug Surveillance System (NATDSS). The study will include adults diagnosed with HR+/HER2- advanced or metastatic breast cancer who began first-line systemic therapy between January 1, 2024 and January 1, 2027. Analyses will describe real-world treatment patterns, clinical outcomes, and influential factors associated with outcomes, with particular attention to the uptake and performance of CDK4/6 inhibitors and recent entrants like ribociclib. No active interventions, randomization, or control groups will be involved.
Who should consider this trial
Good fit: Adults (age 18 or older) in China with documented HR+/HER2- advanced or metastatic breast cancer who initiated first-line systemic anti-cancer treatment between Jan 1, 2024 and Jan 1, 2027 and have records in the NATDSS/EHR data sources.
Not a fit: Patients without records in the NATDSS or participating EHR systems, those treated outside the specified 2024–2027 window, patients with HER2-positive disease, or those with insufficient clinical data are unlikely to benefit from the study findings directly.
Why it matters
Potential benefit: If successful, the findings could help clinicians and patients in China make more informed first-line treatment choices and clarify the real-world role of CDK4/6 inhibitors including ribociclib.
How similar studies have performed: Real-world studies worldwide have described treatment patterns and benefits of CDK4/6 inhibitors, but real-world evidence specifically for ribociclib in China remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bingjie, Beijing Municipality
- Novartis Investigative SIte — Bingjie, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.