Flatiron Health, Inc
New York, 10013, United States
NCT Number: NCT06975371
This study aims to assess the treatment patterns and real-world outcomes of HR+/HER- metastatic breast cancer patients who have progressed on 1L ET + CDK4/6i and started a second line (2L) treatment within a real-world cohort in the United States Flatiron Health Database.
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Notify Me18 year and older
All sexes
Observational
New York, 10013, United States
This analysis will assess real-world outcomes in HR+/HER2- mBC patients who initiated a subsequent line of therapy (LOT) (i.e., 2L) after progressing on 1L treatment with ET+CDK4/6i. This study will also characterize the treatment patterns, clinical characteristics, and outcomes in this patient population. No study drug was administered in this non-interventional study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No study drug was administered in this non-interventional study.
Time frame: Baseline up to end of observation period, approximately 7 years 9 months
Real-world progression-free survival (rwPFS) will be calculated as the time from the index treatment date to the date of the first documented rwP event occurring >14 days after the index treatment date or date of death, whichever occurs first.
Time frame: Baseline up to end of observation period, approximately 7 years 9 months
Real-world overall survival (rwOS) will be calculated as the time from the index treatment date to death. Patients who do not experience the event of interest (death) will be censored at their last confirmed activity date.
Time frame: Baseline up to end of observation period, approximately 7 years 9 months
Real-world time to treatment discontinuation or death (rwTTD/D) will be calculated for the index LOT. For the set of drugs contained in the index LOT, rwTTD/D will be calculated as the time from the first drug episode to the last drug episode or death, whichever comes first.
Time frame: Baseline up to end of observation period, approximately 7 years 9 months
Real-world time to next treatment or death (rwTTNT/D) will be calculated for the index LOT as the time from the start of the LOT to the initiation of next LOT or death, whichever comes first.
Daiichi Sankyo
Industry
Real-World Outcomes of Patients With HR-Positive HER2-Negative Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i in the United States
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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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