NCT07148505Completed
A Study of Real-world Outcomes Among Patients Treated With Ribociclib
Assessment of Real-world Outcomes Among Patients Treated With Kisqali (Ribociclib)
Source: ClinicalTrials.gov · Last updated 29 Aug 2025
Brief summary (registry, in English)
The main aim of the study was to evaluate the real-world tolerability and safety of ribociclib as a first-line (1L) treatment among adults with hormone receptor-positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer (mBC). This study used data from the Flatiron Health Research Database (FHRD). The FHRD is a longitudinal database derived from electronic health records (EHRs) and other real-world data (RWD) sources from cancer care providers across the United States. The dataset generated for this study included de-identified patient-level data for eligible individuals between 1 January 2015 up to the data cutoff date, 30 November 2022.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 373 (actual)
- First submitted
- 21 Aug 2025
- Start date
- 24 Apr 2024
- Primary completion date
- 7 Nov 2024
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07148505
What you commit to
- Study type: Observational
- Participants enrolled: 373
- From 24 Apr 2024 to the primary completion date, 7 Nov 2024
- 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.
Other
- None identified.
Who the study is looking for
- Diagnosed with mBC on or after 1 January 2015.
- Had HR+/HER2- test results.
- Received ribociclib and endocrine therapy in 1L treatment.
- Patients had a gap of 90 days or less between mBC diagnosis date and the first structured EHR activity (e.g., lab tests and prescriptions) after metastatic diagnosis date.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Coordinator of this site? Confirm its status | East Hanover | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.