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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDK4/6i Cohort | Adult HR+/HER2- mBC patients treated with 1L ribociclib, palbociclib, or abemaciclib. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Patients Treated With 1L Ribociclib by Demographic Category | Demographics included:
| Baseline |
| Age at 1L Ribociclib Treatment Initiation | Baseline | |
| Among 1L Ribociclib Patients, Age at mBC Diagnosis | Baseline | |
| Among 1L Ribociclib Patients, Age at Initial BC Diagnosis | Baseline | |
| Interval Between mBC Diagnosis and 1L Ribociclib Initiation | Baseline | |
| Number and Percentage of 1L Ribociclib Patients by Clinical Characteristic Category | Clinical characteristics included:
| Baseline |
| Among 1L Ribociclib Patients, Body Mass Index (BMI) | Baseline | |
| Follow-up Time From 1L Ribociclib Treatment Initiation | Up to approximately 7 years and 6 months | |
| Among 1L Ribociclib Patients, Number of Metastatic Sites per Patient at Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of 1L Ribociclib Patients by Type of First Dose Adjustment | Dose adjustments included up titration and down titration. | Up to approximately 7 years and 6 months |
| Among 1L Ribociclib Patients, Number of Total Dose Adjustments |
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Inclusion criteria:
Exclusion criteria:
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HR+/HER2- mBC patients who received 1L CDK4/6i treatment and have a medical record in the real-world evidence database.
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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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| Label | URL |
|---|---|
| Link to study results | View source |
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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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| Baseline |
| Among 1L Ribociclib Patients, Number of Metastatic Sites per Patient any Time During Study | Up to approximately 7 years and 6 months |
| Number and Percentage of 1L Ribociclib Patients by Sites of Metastasis During Follow-up | Up to approximately 7 years and 6 months |
| Number and Percentage of 1L Ribociclib Patients by Type of Medical Procedures Received | Baseline |
| Number and Percentage of 1L Ribociclib Patients With ESR1 Mutation at Baseline | Baseline |
| Number and Percentage of 1L Ribociclib Patients With ESR1 Mutation any Time During Study | Up to approximately 7 years and 6 months |
| Among 1L Ribociclib Patients, Red Blood Cell (RBC) Count | Baseline |
| Among 1L Ribociclib Patients, Hemoglobin Level | Baseline |
| Among 1L Ribociclib Patients, Hematocrit Level | Baseline |
| Among 1L Ribociclib Patients, White Blood Cell Count | Baseline |
| Among 1L Ribociclib Patients, Platelet Count | Baseline |
| Number and Percentage of 1L Ribociclib Patients With Neutropenia | Baseline |
| Among 1L Ribociclib Patients, Serum Creatinine Level | Baseline |
| Among 1L Ribociclib Patients, Aspartate Aminotransferase (AST) Level | Baseline |
| Among 1L Ribociclib Patients, Alanine Aminotransferase (ALT) Level | Baseline |
| Among 1L Ribociclib Patients, Alkaline Phosphatase (ALP) Level | Baseline |
| Among 1L Ribociclib Patients, Bilirubin Level | Baseline |
| Number and Percentage of 1L Ribociclib Patients by Type of Other Medications in 1L Treatment | Baseline |
| Interval Between Treatment Initiation and Ribociclib Initiation | Baseline |
| Number and Percentage of Patients by Type of Treatment Received per Line of Treatment | Up to approximately 7 years and 6 months |
| Up to approximately 7 years and 6 months |
| Number and Percentage of 1L Ribociclib Patients by Starting Dose of Ribociclib | Baseline |
| Relative Dose Intensity (RDI) of Ribociclib | RDI was calculated by dividing the actual average daily dose by the recommended daily dose. | Up to approximately 7 years and 6 months |
| Ribociclib Dose at First Dose Adjustment | Up to approximately 7 years and 6 months |
| Among 1L Ribociclib Patients, Time to First Dose Adjustment | Up to approximately 7 years and 6 months |
| Number and Percentage of Patients by Ribociclib Dosage Received per Dose Adjustment | Up to approximately 7 years and 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |