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

NCT07148505 | Completed

• 1 other identifier: CLEE011AUS73
• Study Type: observational
• Target: 373
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metastatic Breast Cancer

Keywords

Hormone receptor-positive; Human epidermal growth factor receptor-2 negative; CDK4/6i; Real-world; Adverse Events

Outcome Measures

Primary Outcomes (3)

• Number of Patients by Type of Real-world Adverse Event (AE) of Interest During 1L Treatment

  Up to approximately 5 years and 5 months

• Number of Patients by Real-world AE of Interest at Baseline

  Baseline

• Number of Patients by Type of Real-world AE of Interest During 1L Treatment Among Those Without the Specific Real-world AE at Baseline

  Up to approximately 5 years and 5 months

Secondary Outcomes (23)

• Number of Patients by Demographic Category

  Baseline

• Number of Patients by Clinical Characteristic Category

  Baseline

• Clinical Characteristic: Body Mass Index (BMI)

  Baseline

• Clinical Characteristic: Time Between Initial Diagnosis and Metastatic Diagnosis

  Baseline

• Clinical Characteristic: Time Between Metastatic Diagnosis and Initiation of 1L Treatment

  Baseline

Study Arms (3)

Ribociclib Cohort

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

Ribociclib Cohort: 65+ Years Age Group

Patients aged 65 years or older with mBC who received 1L treatment with ribociclib in combination with ET.

Ribociclib Cohort: 75+ Years Age Group

Patients aged 75 years or older with mBC who received 1L treatment with ribociclib in combination with ET.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a restrospective, noninterventional cohort study.

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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 29, 2025
• Study Start: April 24, 2024
• Primary Completion: November 7, 2024
• Study Completion: November 7, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

US (1)