Retrospective Analysis of Real-World Outcomes of Ribociclib in First-Line Treatment for Metastatic HR+/HER2- Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Number Patients by Demographic Category
Study Overview
Brief Summary
The main aim of this study was to describe the profile of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC) patients who received first-line (1L) current treatment options with ribociclib in the United States (US) clinical practice.
This study used administrative claims data. De-identified patient-level data of adult patients with HR+/HER2- mBC who initiated 1L treatment with a cyclin dependant kinase 4/6 inhibitor (CDK4/6i) i.e., ribociclib from the Komodo Health Solutions Research Database (KRD; data from 1 January 2016 to 30 June 2023) was used. Data included medical and pharmacy claims for insured patients, which had already been collected (i.e., secondary use of data).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number Patients by Demographic Category
Time Frame: Baseline
Demographics included: * Age (≥ 65 years, ≥ 75 years) * Gender * Race * Index year (year of the first paid pharmacy claim for ribociclib)
Number of Patients by Clinical Characteristic Category
Time Frame: Baseline
Clinical characteristic categories included: * Menopausal status * Comorbidity * Metastatic site * Eastern Cooperative Oncology Group (ECOG) performance score less than 2 ECOG performance score measures a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased).
Clinical Characteristic: National Cancer Institute (NCI) Comorbidity Index Score
Time Frame: Baseline
The NCI comorbidity index is a tool used to measure the risk of non-cancer deaths for cancer patients based on the presence and severity of other health conditions. It includes 14 conditions identified using administrative data diagnosis and procedure codes. The index excludes solid tumors, leukemias, and lymphomas as comorbid conditions. Each condition is assigned a score based on how serious it is and patient scores are summed to give a final overall score. A high score indicates a higher burden of comorbid conditions and possible higher risk of death.
Clinical Characteristic: Number of Metastatic Sites
Time Frame: Baseline
Treatment Characteristic: Number of Patients by Type of Treatment Received While on 1L mBC Treatment
Time Frame: Up to approximately 3 years and 4 months
Treatments included: * Endocrine therapy partner (AI, Fulvestrant, or AI and Fulvestrant) * Gonadotropin-releasing hormone (GNRH) * Cytochrome P450, family 3, subfamily A (CYP3A) inhibitors and inducers * P-inhibitors and inducers * Medications potentially associated with an increased risk of torsade de pointes
Treatment Characteristic: Time from mBC diagnosis to 1L Initiation
Time Frame: Baseline
Treatment Characteristic: Duration of Follow-up From 1L Initiation
Time Frame: Up to approximately 3 years and 4 months
Treatment Characteristic: Duration of 1L mBC Treatment
Time Frame: Up to approximately 3 years and 4 months
Secondary Outcomes
- Number of Patients by Tolerability-related Medical Events Experienced While on 1L Treatment With Ribociclib(Up to approximately 3 years and 4 months)
- Number of Patients by Cardiovascular-related Medical Events Experienced While on 1L Treatment With Ribociclib(Up to approximately 3 years and 4 months)