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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients by Demographic Category | Demographics included:
| Baseline |
| Number of Patients by Clinical Characteristic Category |
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Inclusion criteria:
Exclusion criteria:
None identified.
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This was a restrospective, noninterventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Clinical characteristics included:
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).
| 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 |
| 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 | Patient disposition included patients who died and discontinued treatment early. | 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). | Up to approximately 5 years and 5 months |
| Duration of Each Line of Treatment | Lines of treatment included 1L, 2L, and 3L. | 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 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 by Treatment Category During Each Line of Treatment | Lines of treatment included 1L, 2L, and 3L. Treatment categories included:
| 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:
| Up to approximately 5 years and 5 months |
| 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 | Status included continuing, discontinued, dose change, held, not documented, and unknown, patient sent to hospice. | Up to approximately 5 years and 5 months |
| 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 | Actions included:
| Up to approximately 5 years and 5 months |
| D017437 |
| Skin and Connective Tissue Diseases |