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

Novartis Pharmaceuticals373 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

373

Conditions

Metastatic Breast Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

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

Time frame: Up to approximately 5 years and 5 months

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

Time frame: 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

Time frame: Up to approximately 5 years and 5 months

Secondary Outcomes

Number of Patients by Demographic Category

Demographics included: * Age at start of 1L treatment (18-64, 65 years or older) * Gender * Race * Ethnicity

Time frame: Baseline

Number of Patients by Clinical Characteristic Category

Clinical characteristics included: * Type of medical practice (academic, community or both) * Geographic region * Type of health plan * Stage of cancer at initial diagnosis * Year of metastatic cancer diagnosis * Eastern Cooperative Oncology Group (ECOG) performance score * Received chemotherapy prior to ribociclib treatment initiation * Menopausal status ECOG performance score measures a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased).

Time frame: Baseline

Clinical Characteristic: Body Mass Index (BMI)

Time frame: Baseline

Clinical Characteristic: Time Between Initial Diagnosis and Metastatic Diagnosis

Time frame: Baseline

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

Time frame: Baseline

Clinical Characteristic: Duration of Follow-up

Time frame: Up to approximately 5 years and 5 months

Clinical Characteristic: Number of Patients by Patient Disposition at Data Cutoff

Patient disposition included patients who died and discontinued treatment early.

Time frame: Up to approximately 5 years and 5 months

Number of Patients by Year of Treatment Initiation for Each Line of Treatment

Lines of treatment included 1L, second-line (2L), and third-line (3L).

Time frame: Up to approximately 5 years and 5 months

Duration of Each Line of Treatment

Lines of treatment included 1L, 2L, and 3L.

Time frame: Up to approximately 5 years and 5 months

Number of Patients Still on 1L Treatment at Last EHR Activity

Time frame: Up to approximately 5 years and 5 months

Number of Patients Still on 2L Treatment at Last EHR Activity

Time frame: Up to approximately 5 years and 5 months

Number of Patients Still on 3L Treatment at Last EHR Activity

Time frame: Up to approximately 5 years and 5 months

Number of Patients by Type of ET Partner During 1L Treatment

Time frame: Up to approximately 5 years and 5 months

Number of Patients by Treatment Category During Each Line of Treatment

Lines of treatment included 1L, 2L, and 3L. Treatment categories included: * Cyclin dependent kinase 4/6 (CDK4/6) inhibitor based regimen * Chemotherapy based regimen * Clinical study drug * ET monotherapy * mTor based regimen * PI3K based regimen

Time frame: Up to approximately 5 years and 5 months

Number of Patients by Type of CDK4/6 Inhibitor Based Treatment During Each Line of Treatment

Lines of treatment included 1L, 2L, and 3L. CDK4/6 inhibitor-based treatments included: * Ribociclib * Abemaciclib * Palbociclib

Time frame: Up to approximately 5 years and 5 months

Number of Patients by Total Number of Ribocicilib Dose Reduction Episodes During 1L Treatment

Time frame: Up to approximately 5 years and 5 months

Number of Patients by Ribociclib Dose at Each Dose Reduction Episode During 1L Treatment

Time frame: Up to approximately 5 years and 5 months

Number of Patients by Ribociclib Dosing Schedule at Each Dose Reduction Episode During 1L Treatment

Time frame: Up to approximately 5 years and 5 months

Number of Patients by Status of Oral Therapy at the End of Each Dose Reduction Episode During 1L Treatment

Status included continuing, discontinued, dose change, held, not documented, and unknown, patient sent to hospice.

Time frame: Up to approximately 5 years and 5 months

Number of Patients by Reason for Change in Ribociclib Dose During 1L Treatment

Time frame: Up to approximately 5 years and 5 months

Number of Patients by Reason for Stopping Ribociclib 1L Treatment

Time frame: Up to approximately 5 years and 5 months

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

Time frame: Up to approximately 5 years and 5 months

Number of Patients by Action Following or in Response to Real-world AE During 1L Treatment

Actions included: * Hospitalization * Treatment for AE * Therapy discontinuation * Therapy dose or schedule change * Therapy hold

Time frame: Up to approximately 5 years and 5 months