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The aim of this study was to describe treatment patterns, patient characteristics and clinical outcomes among hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) early breast cancer (eBC) patients who became eligible for treatment with cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) in the real-world setting after the FDA approval of ribociclib treatment for eBC.
The study used data abstracted from structured and unstructured patient electronic health records from sites available in the Integra Connect PrecisionQ database (secondary data use).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR+/HER2- eBC Cohort | Adult HR+/HER2- eBC patients eligible for treatment with CDK4/6i (ribociclib and abemaciclib) since the approval of ribociclib in the real-world setting. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eligible Population that Received Genetic Testing | Testing includes germline mutation testing, Oncotype DX testing, Ki-67 scoring, and other breast cancer specific genetic tests (breast cancer index, Mammaprint, Endopredict, Prosigna). | Baseline, up to approximately 1 year, 7 months |
| Number and Percentage of Patients by Treatment Regimen | Number and percentage of patients by treatment regimen in the neo-adjuvant and adjuvant setting, stratified by patient and provider characteristics, and CDK4/6i eligibility. | Baseline, up to approximately 1 year, 7 months |
| Number and Percentage of Patients With Treatment Switches | Number and percentage of patients with treatment switches within the CDK4/6i and aromatase inhibitor (AI) drug classes, classified as switch due to toxicity vs. other reason. | Baseline, up to approximately 1 year, 7 months |
| Time From Surgery to Start of Adjuvant ET | Up to 1 year | |
| Time From Surgery to Start of CDK4/6i Treatment | Up to 1 year | |
| Time From ET to Start of CDK4/6i Treatment | Up to approximately 1 year, 7 months | |
| Time From Adjuvant Chemotherapy to Start of CDK4/6i Treatment | Time from initial adjuvant Chemotherapy to the start of CDK4/6i treatment, stratified by presence of adverse events prior to CDK4/6i initiation. | Up to approximately 1 year, 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Demographics | Baseline | |
| Height | Baseline | |
| Weight |
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Inclusion criteria:
Diagnosed with HR+/HER2- breast cancer.
No evidence of distant metastatic spread.
Underwent primary breast cancer surgery (mastectomy/lumpectomy) during the study period.
Initiated adjuvant ET within 12 months of surgery date and after September 17, 2024, to the period up to 3 months prior to the data cutoff date.
Had at least one visit during the baseline period and at least one visit one day after the index date.
Patients included must have met one of the following conditions at the time of diagnosis or surgery:
Nodal stage (N) N2 or N3 disease.
N1 any anatomic tumor size (T), including micrometastatic patients except T0 N1mi and T1 N1mi; For T0 N1mi and T1 N1mi patients with Grade 3 disease alone will be selected.
Node-negative with the following high-risk criteria:
Exclusion criteria:
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HR+/HER2- eBC patients who initiated adjuvant endocrine therapy (ET) on or after 17 September 2024 up to three months prior to data cut off.
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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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| Baseline |
| Body Mass Index (BMI) | Baseline |
| Number and Percentage of Patients by Patient Characteristics | Patient characteristics include:
| Baseline |
| Age at Initial Diagnosis of BC | Baseline |
| Duration Between Diagnosis of BC and Initiation of Adjuvant ET | Baseline |
| Number and Percentage of Patients by Clinical Characteristics | Clinical characteristics include:
| Baseline |
| Red Blood Cell Count | Basline |
| Hemoglobin Level | Baseline |
| Hematocrit Level | Baseline |
| White Blood Cell Count | Baseline |
| Platelet Count | Baseline |
| Absolute Neutrophil Count (ANC) | Baseline |
| Serum Creatinine Level | Baseline |
| Liver Enzyme Levels |
| Baseline |
| Bilirubin Level | Baseline |
| Number and Percentage of Patients by Medications Used and Procedures | Baseline, up to approximately 1 year, 7 months |
| Time to Discontinuation or Death | Time to all-cause discontinuation or death (TTD-all cause), TTD-all cause but recurrence, and time to adverse event-related discontinuation or death (TTD from AE). | Up to approximately 1 year, 7 months |
| Persistence of CDK4/6i Use | Persistence is defined as the number of days patients were taking a CDK4/6i during a pre-defined time-interval. | Up to approximately 1 year, 7 months |
| Number and Percentage of Patients who Discontinued Adjuvant Treatment | Up to approximately 1 year, 7 months |
| Number of Patients by Reason for CDK4/6i Treatment Discontinuation | Up to approximately 1 year, 7 months |
| Duration of Treatment | Up to approximately 1 year, 7 months |
| Percentage of Patients by Dose of Treatment | Up to approximately 1 year, 7 months |
| Cumulative Dose | Cumulative dose is defined as the sum of individual doses during the initial adjuvant regimen. | Up to approximately 1 year, 7 months |
| Dose Intensity | Dose intensity is defined as the cumulative dose / total time period of treatment. | Up to approximately 1 year, 7 months |
| Relative Dose Intensity (RDI) | RDI is defined as the observed dose intensity / expected dose intensity x 100. | Up to approximately 1 year, 7 months |
| Number and Percentage of Patients With Dose Reductions During Follow-up | Up to approximately 1 year, 7 months |
| Time to First and Subsequent Dose Reductions of CDK4/6is | Up to approximately 1 year, 7 months |
| Number and Percentage of Patients With Drug Interruptions | Up to approximately 1 year, 7 months |
| D017437 |
| Skin and Connective Tissue Diseases |