Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Ribociclib Cohort
- description
- Adult patients with mBC who received 1L treatment with ribociclib in combination with endocrine therapy (ET).
- label
- Ribociclib Cohort: 65+ Years Age Group
- description
- Patients aged 65 years or older with mBC who received 1L treatment with ribociclib in combination with ET.
- label
- Ribociclib Cohort: 75+ Years Age Group
- description
- Patients aged 75 years or older with mBC who received 1L treatment with ribociclib in combination with ET.
Primary outcomes (3)
- measure
- Number of Patients by Type of Real-world Adverse Event (AE) of Interest During 1L Treatment
- timeFrame
- Up to approximately 5 years and 5 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * 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. Exclusion criteria: None identified.
References
Publications (0)
Data not yet available