An observational study in Breast Cancer, sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Novartis Pharmaceuticals · Observational
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).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 750 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Patients included must have met one of the following conditions at the time of diagnosis or surgery:
Node-negative with the following high-risk criteria:
Exclusion criteria:
Adult HR+/HER2- eBC patients eligible for treatment with CDK4/6i (ribociclib and abemaciclib) since the approval of ribociclib in the real-world setting.
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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline, up to approximately 1 year, 7 months
Time From Surgery to Start of Adjuvant ET
Time frame: Up to 1 year
Time From Surgery to Start of CDK4/6i Treatment
Time frame: Up to 1 year
Time From ET to Start of CDK4/6i Treatment
Time frame: 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.
Time frame: Up to approximately 1 year, 4 months
Baseline Demographics
Time frame: Baseline
Height
Time frame: Baseline
Weight
Time frame: Baseline
Body Mass Index (BMI)
Time frame: Baseline
Number and Percentage of Patients by Patient Characteristics
Patient characteristics include: * Menopausal status * Geographic location * Payer type * Index year * Vital status
Time frame: Baseline
Age at Initial Diagnosis of BC
Time frame: Baseline
Duration Between Diagnosis of BC and Initiation of Adjuvant ET
Time frame: Baseline
Number and Percentage of Patients by Clinical Characteristics
Clinical characteristics include: * Eastern Cooperative Oncology Group (ECOG) performance status grade * Tumor, Node, Metastasis (T.N.M) classification at BC diagnosis and after surgery * Anatomical staging at BC diagnosis * Tumor grade at BC diagnosis * HR+ and HER2- status * QT prolongation * Molecular subtype * Mutation status * Genomic scoring tests (where available) * Comorbidities * Adverse events
Time frame: Baseline
Red Blood Cell Count
Time frame: Basline
Hemoglobin Level
Time frame: Baseline
Hematocrit Level
Time frame: Baseline
White Blood Cell Count
Time frame: Baseline
Platelet Count
Time frame: Baseline
Absolute Neutrophil Count (ANC)
Time frame: Baseline
Serum Creatinine Level
Time frame: Baseline
Liver Enzyme Levels
* Aspartate aminotransferase (AST) * Alanine aminotransferase (ALT) * Alkaline phosphatase (ALP)
Time frame: Baseline
Bilirubin Level
Time frame: Baseline
Number and Percentage of Patients by Medications Used and Procedures
Time frame: 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).
Time frame: 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.
Time frame: Up to approximately 1 year, 7 months
Number and Percentage of Patients who Discontinued Adjuvant Treatment
Time frame: Up to approximately 1 year, 7 months
Number of Patients by Reason for CDK4/6i Treatment Discontinuation
Time frame: Up to approximately 1 year, 7 months
Duration of Treatment
Time frame: Up to approximately 1 year, 7 months
Percentage of Patients by Dose of Treatment
Time frame: Up to approximately 1 year, 7 months
Cumulative Dose
Cumulative dose is defined as the sum of individual doses during the initial adjuvant regimen.
Time frame: Up to approximately 1 year, 7 months
Dose Intensity
Dose intensity is defined as the cumulative dose / total time period of treatment.
Time frame: Up to approximately 1 year, 7 months
Relative Dose Intensity (RDI)
RDI is defined as the observed dose intensity / expected dose intensity x 100.
Time frame: Up to approximately 1 year, 7 months
Number and Percentage of Patients With Dose Reductions During Follow-up
Time frame: Up to approximately 1 year, 7 months
Time to First and Subsequent Dose Reductions of CDK4/6is
Time frame: Up to approximately 1 year, 7 months
Number and Percentage of Patients With Drug Interruptions
Time frame: Up to approximately 1 year, 7 months
Plan to share: No
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Novartis Pharmaceuticals