Metastatic Breast Cancer
Conditions
Keywords
Hormone receptor-positive, Human epidermal growth factor receptor-2 negative, CDK4/6i, Real-world, Adverse Events
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Clinical Characteristic: Duration of Follow-up | Up to approximately 5 years and 5 months | — |
| Clinical Characteristic: Number of Patients by Patient Disposition at Data Cutoff | Up to approximately 5 years and 5 months | Patient disposition included patients who died and discontinued treatment early. |
| Number of Patients by Year of Treatment Initiation for Each Line of Treatment | Up to approximately 5 years and 5 months | Lines of treatment included 1L, second-line (2L), and third-line (3L). |
| Duration of Each Line of Treatment | Up to approximately 5 years and 5 months | Lines of treatment included 1L, 2L, and 3L. |
| Number of Patients Still on 2L Treatment at Last EHR Activity | Up to approximately 5 years and 5 months | — |
| Number of Patients Still on 3L Treatment at Last EHR Activity | Up to approximately 5 years and 5 months | — |
| Number of Patients by Type of ET Partner During 1L Treatment | Up to approximately 5 years and 5 months | — |
| Number of Patients Still on 1L Treatment at Last EHR Activity | Up to approximately 5 years and 5 months | — |
| Number of Patients by Type of CDK4/6 Inhibitor Based Treatment During Each Line of Treatment | Up to approximately 5 years and 5 months | Lines of treatment included 1L, 2L, and 3L. CDK4/6 inhibitor-based treatments included: * Ribociclib * Abemaciclib * Palbociclib |
| Number of Patients by Total Number of Ribocicilib Dose Reduction Episodes During 1L Treatment | Up to approximately 5 years and 5 months | — |
| Number of Patients by Ribociclib Dose at Each Dose Reduction Episode During 1L Treatment | Up to approximately 5 years and 5 months | — |
| Number of Patients by Ribociclib Dosing Schedule at Each Dose Reduction Episode During 1L Treatment | 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 | Up to approximately 5 years and 5 months | Status included continuing, discontinued, dose change, held, not documented, and unknown, patient sent to hospice. |
| Number of Patients by Reason for Change in Ribociclib Dose During 1L Treatment | Up to approximately 5 years and 5 months | — |
| Number of Patients by Reason for Stopping Ribociclib 1L Treatment | Up to approximately 5 years and 5 months | — |
| Number of Patients by Type of Real-world Adverse Event (AE) During 1L Treatment | Up to approximately 5 years and 5 months | — |
| Number of Patients by Action Following or in Response to Real-world AE During 1L Treatment | Up to approximately 5 years and 5 months | Actions included: * Hospitalization * Treatment for AE * Therapy discontinuation * Therapy dose or schedule change * Therapy hold |
| Number of Patients by Treatment Category During Each Line of Treatment | Up to approximately 5 years and 5 months | 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 |
| Number of Patients by Demographic Category | Baseline | Demographics included: * Age at start of 1L treatment (18-64, 65 years or older) * Gender * Race * Ethnicity |
| Number of Patients by Clinical Characteristic Category | Baseline | 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). |
Countries
United States
Outcome results
None listed