Breast Cancer
Conditions
Keywords
Early breast cancer, HR+/HER2-
Brief summary
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).
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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: 1. Nodal stage (N) N2 or N3 disease. 2. 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. 3. Node-negative with the following high-risk criteria: 1. Tumor size is T3, T4 2. Tumor size is T2 and Grade 3 3. Tumor size is T2 with Grade 2 and either Ki-67 score ≥ 20% or genomic high risk based on Oncotype Dx/Mammaprint/Endopredict/Prosigna
Exclusion criteria
* Use of any prior CDK4/6i before the index date. * Missing T or N values for both clinical and surgical stage. * Diagnosis of cancer other than breast cancer. * Evidence of participation in a clinical trial at any time during the study observation period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eligible Population that Received Genetic Testing | Baseline, up to approximately 1 year, 7 months | Testing includes germline mutation testing, Oncotype DX testing, Ki-67 scoring, and other breast cancer specific genetic tests (breast cancer index, Mammaprint, Endopredict, Prosigna). |
| Number and Percentage of Patients by Treatment Regimen | Baseline, up to approximately 1 year, 7 months | 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. |
| Number and Percentage of Patients With Treatment Switches | Baseline, up to approximately 1 year, 7 months | 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 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 | Up to approximately 1 year, 4 months | Time from initial adjuvant Chemotherapy to the start of CDK4/6i treatment, stratified by presence of adverse events prior to CDK4/6i initiation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Demographics | Baseline | — |
| Height | Baseline | — |
| Weight | Baseline | — |
| Body Mass Index (BMI) | Baseline | — |
| Number and Percentage of Patients by Patient Characteristics | Baseline | Patient characteristics include: * Menopausal status * Geographic location * Payer type * Index year * Vital status |
| 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 | Baseline | 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 |
| 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 | * Aspartate aminotransferase (AST) * Alanine aminotransferase (ALT) * Alkaline phosphatase (ALP) |
| 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 | Up to approximately 1 year, 7 months | 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). |
| Persistence of CDK4/6i Use | Up to approximately 1 year, 7 months | Persistence is defined as the number of days patients were taking a CDK4/6i during a pre-defined time-interval. |
| 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 | Up to approximately 1 year, 7 months | Cumulative dose is defined as the sum of individual doses during the initial adjuvant regimen. |
| Dose Intensity | Up to approximately 1 year, 7 months | Dose intensity is defined as the cumulative dose / total time period of treatment. |
| Relative Dose Intensity (RDI) | Up to approximately 1 year, 7 months | RDI is defined as the observed dose intensity / expected dose intensity x 100. |
| 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 | — |
Countries
United States
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed