Novartis
East Hanover, New Jersey, 07936, United States
NCT Number: NCT07086196
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).
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Notify Me18 year and older
All sexes
Observational
East Hanover, New Jersey, 07936, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Demographics included:
Time frame: Baseline
Clinical characteristic categories included:
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).
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.
Time frame: Baseline
Time frame: Up to approximately 3 years and 4 months
Treatments included:
Time frame: Baseline
Time frame: Up to approximately 3 years and 4 months
Time frame: Up to approximately 3 years and 4 months
Time frame: Up to approximately 3 years and 4 months
Medical events were assessed among patients who did not have the selected condition during the baseline period and were described based on the presence of 2 or more medical claims on distinct dates.
Time frame: Up to approximately 3 years and 4 months
Medical events were assessed among patients who did not have the selected condition during the baseline period and were described based on the presence of 2 or more medical claims on distinct dates.
Novartis Pharmaceuticals
Industry
Retrospective Analysis of Real-World Outcomes of Ribociclib in First-Line Treatment for Metastatic HR+/HER2- Breast Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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