Breast Cancer
Conditions
Keywords
Ribociclib, CDK4/6i, Metastatic breast cancer
Brief summary
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Patients Treated With 1L Ribociclib by Demographic Category | Baseline | Demographics included: * Age group * Sex * Race * Ethnicity * Geographical region * Payer type * Year of 1L treatment initiation * De novo or recurrent mBC |
| 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 | Baseline | 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 |
| 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 | 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of 1L Ribociclib Patients by Type of First Dose Adjustment | Up to approximately 7 years and 6 months | Dose adjustments included up titration and down titration. |
| Among 1L Ribociclib Patients, Number of Total Dose Adjustments | 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 | Up to approximately 7 years and 6 months | RDI was calculated by dividing the actual average daily dose by the recommended daily dose. |
| 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 | — |
Countries
United States
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed