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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

373 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-24

Study Completion Date

2024-11-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ribociclib Cohort

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

No interventions assigned to this group

Ribociclib Cohort: 65+ Years Age Group

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

No interventions assigned to this group

Ribociclib Cohort: 75+ Years Age Group

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

No interventions assigned to this group

Eligibility Criteria

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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.