A Study of Real-world Outcomes Among Patients Treated With Ribociclib

Completed

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT07148505

Run by

Novartis Pharmaceuticals

People needed

373

Starts

2024-04-24

Expected to finish

2024-11-07

Last updated by the study team

2025-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• None identified.

Where it is running

• Novartis — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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