A Study of Real-World Treatment Patterns and Outcomes Among HR+/HER2- Metastatic Breast Cancer Patients Treated With First-Line CDK4/6 Inhibitors

N/ACompletedNCT07512063

Novartis Pharmaceuticals480 enrolled

Overview

The aim of this study was to evaluate patient profiles, treatment patterns, and outcomes of hormone receptor positive (HR+)/human epidermal growth factor receptor-2 negative (HER2-) metastatic breast cancer (mBC) patients treated with a 1L cyclin dependent kinase 4/6 inhibitor (CDK4/6i) in the real-world setting.

Study Type

OBSERVATIONAL

Enrollment

480

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * A diagnosis of mBC based on at least two diagnoses of breast cancer (International Classification of Diseases, 10th Revision, Clinical Modification \[ICD-10-CM\] code C50.xxx) along with a diagnosis of secondary malignant neoplasm (ICD-10-CM codes C77.xxx - C80.xxx except C79.8 or C79.81, reporting of a metastatic site by curation), in the period prior to or on the index date. * Patients with HR+/HER2- status. * Use of either ribociclib, palbociclib, or abemaciclib in 1L treatment for mBC. * Continuous care at the contributing practices. Patients with a minimum of two visits up to and including the index date. Exclusion criteria: * Use of any prior CDK4/6i before the index date. * Prior 1L treatment, other than CDK4/6i, in mBC including treatment with endocrine therapy (ET) either with tamoxifen, aromatase inhibitors (AI; anastrozole, exemestane, or letrozole) or fulvestrant. For it to be considered 1L in mBC, the diagnosis of mBC must have preceded treatment initiation, or was indicated so in unstructured data. * Diagnosis of cancer other than breast cancer and/or mBC on or prior to the index. * Evidence of participation in a clinical trial at any time during the study observation period.

Locations (1)

Novartis

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Number and Percentage of Patients Treated With 1L Ribociclib by Demographic Category

Demographics included: * Age group * Sex * Race * Ethnicity * Geographical region * Payer type * Year of 1L treatment initiation * De novo or recurrent mBC

Time frame: Baseline

Age at 1L Ribociclib Treatment Initiation

Time frame: Baseline

Among 1L Ribociclib Patients, Age at mBC Diagnosis

Time frame: Baseline

Among 1L Ribociclib Patients, Age at Initial BC Diagnosis

Time frame: Baseline

Interval Between mBC Diagnosis and 1L Ribociclib Initiation

Time frame: Baseline

Number and Percentage of 1L Ribociclib Patients by Clinical Characteristic Category

Clinical characteristics included: * Menopausal status * Eastern Cooperative Oncology Group (ECOG) performance status * Stage at initial breast cancer (BC) diagnosis * Comorbidities * QT prolongation diagnosis (yes/no) * Sites of metastasis

Time frame: Baseline

Among 1L Ribociclib Patients, Body Mass Index (BMI)

Time frame: Baseline

Follow-up Time From 1L Ribociclib Treatment Initiation

Time frame: Up to approximately 7 years and 6 months

Among 1L Ribociclib Patients, Number of Metastatic Sites per Patient at Baseline

Time frame: Baseline

Among 1L Ribociclib Patients, Number of Metastatic Sites per Patient any Time During Study

Data from ClinicalTrials.gov

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Time frame: Up to approximately 7 years and 6 months

Number and Percentage of 1L Ribociclib Patients by Sites of Metastasis During Follow-up

Time frame: Up to approximately 7 years and 6 months

Number and Percentage of 1L Ribociclib Patients by Type of Medical Procedures Received

Time frame: Baseline

Number and Percentage of 1L Ribociclib Patients With ESR1 Mutation at Baseline

Time frame: Baseline

Number and Percentage of 1L Ribociclib Patients With ESR1 Mutation any Time During Study

Time frame: Up to approximately 7 years and 6 months

Among 1L Ribociclib Patients, Red Blood Cell (RBC) Count

Time frame: Baseline

Among 1L Ribociclib Patients, Hemoglobin Level

Time frame: Baseline

Among 1L Ribociclib Patients, Hematocrit Level

Time frame: Baseline

Among 1L Ribociclib Patients, White Blood Cell Count

Time frame: Baseline

Among 1L Ribociclib Patients, Platelet Count

Time frame: Baseline

Number and Percentage of 1L Ribociclib Patients With Neutropenia

Time frame: Baseline

Among 1L Ribociclib Patients, Serum Creatinine Level

Time frame: Baseline

Among 1L Ribociclib Patients, Aspartate Aminotransferase (AST) Level

Time frame: Baseline

Among 1L Ribociclib Patients, Alanine Aminotransferase (ALT) Level

Time frame: Baseline

Among 1L Ribociclib Patients, Alkaline Phosphatase (ALP) Level

Time frame: Baseline

Among 1L Ribociclib Patients, Bilirubin Level

Time frame: Baseline

Number and Percentage of 1L Ribociclib Patients by Type of Other Medications in 1L Treatment

Time frame: Baseline

Interval Between Treatment Initiation and Ribociclib Initiation

Time frame: Baseline

Number and Percentage of Patients by Type of Treatment Received per Line of Treatment

Time frame: Up to approximately 7 years and 6 months

Secondary Outcomes

Number and Percentage of 1L Ribociclib Patients by Type of First Dose Adjustment

Dose adjustments included up titration and down titration.

Time frame: Up to approximately 7 years and 6 months

Among 1L Ribociclib Patients, Number of Total Dose Adjustments

Time frame: Up to approximately 7 years and 6 months

Number and Percentage of 1L Ribociclib Patients by Starting Dose of Ribociclib

Time frame: Baseline

Relative Dose Intensity (RDI) of Ribociclib

RDI was calculated by dividing the actual average daily dose by the recommended daily dose.

Time frame: Up to approximately 7 years and 6 months

Ribociclib Dose at First Dose Adjustment

Time frame: Up to approximately 7 years and 6 months

Among 1L Ribociclib Patients, Time to First Dose Adjustment

Time frame: Up to approximately 7 years and 6 months

Number and Percentage of Patients by Ribociclib Dosage Received per Dose Adjustment

Time frame: Up to approximately 7 years and 6 months