Novartis
East Hanover, New Jersey, 07936, United States
NCT Number: NCT07760714
The aim of this study was to assess real-world treatment patterns and tolerability of ribociclib among patient populations historically underrepresented in clinical trials - specifically older adults and Black/African American patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC).
The study was conducted using data from a nationwide database derived from electronic health record (EHR) data collected from oncology practices across the United States. The study population was drawn from community and academic oncology practices within the health research network.
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Notify Me18 year–120 year
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 and clinical characteristics included race/ethnicity, practice type, geographic region, insurance type, socioeconomic status (SES) quintile, stage at initial diagnosis, menopausal status at 1L start, sites of metastasis, endocrine sensitivity status, year of 1L initiation, and prior chemotherapy exposure.
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
ECOG performance status is a scale used to measure a patient's level of functioning in terms of self-care, 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
Time frame: Up to approximately 6 years, 10 months
Time frame: Up to approximately 6 years, 10 months
Dose modifications defined as a dose being held, increased, or decreased.
Time frame: Up to approximately 6 years, 10 months
Dose modifications defined as a dose being held, increased, or decreased.
Time frame: Up to approximately 6 years, 10 months
Time frame: Up to approximately 6 years, 10 months
Time frame: Baseline
Demographics and clinical characteristics included race/ethnicity, practice type, geographic region, insurance type, socioeconomic status (SES) quintile, stage at initial diagnosis, menopausal status at 1L start, sites of metastasis, endocrine sensitivity status, year of 1L initiation, and prior chemotherapy exposure.
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
ECOG performance status is a scale used to measure a patient's level of functioning in terms of self-care, 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
Time frame: Up to approximately 6 years, 10 months
Time frame: Up to approximately 6 years, 10 months
Dose modifications defined as a dose being held, increased, or decreased.
Time frame: Up to approximately 6 years, 10 months
Dose modifications defined as a dose being held, increased, or decreased.
Time frame: Up to approximately 6 years, 10 months
Time frame: Up to approximately 6 years, 10 months
Novartis Pharmaceuticals
Industry
Real-World, Retrospective Study of Treatment Patterns, Tolerability and Effectiveness of CDK4/6 Inhibition in HR+, HER2-negative Metastatic Breast Cancer, With a Focus on Patients 65 Years and Older, and Patients Who Self-identify as African American
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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