NCT07476170Recruiting
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
Source: ClinicalTrials.gov · Last updated 2 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 14000 (estimated)
- First submitted
- 13 Mar 2026
- Start date
- Mar 2026
- Primary completion date
- Apr 2027
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07476170
What you commit to
- Study type: Observational
- Planned participants: 14000
- From Mar 2026 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- (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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Bingjie | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.