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

Novartis

Status: Completed

Conditions: Metastatic Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT07148505

CLEE011AUS73

Details and patient eligibility

About

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.

Enrollment: 373 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

373 participants in 3 patient groups

Ribociclib Cohort

Description:

Adult patients with mBC who received 1L treatment with ribociclib in combination with endocrine therapy (ET).

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.

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.