Real-World Outcomes of Patients With Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i
- Conditions
- Advanced/Metastatic HER2-negative Breast Cancer
- Registration Number
- NCT06975371
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2200
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Real-world progression-free survival (rwPFS) 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.
- Secondary Outcome Measures
Name Time Method Real-world overall survival (rwOS) 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.
Real-world time to discontinuation or death (rwTTD/D) 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.
Real-world time to next treatment or death (rwTTNT/D) 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.
Trial Locations
- Locations (1)
Flatiron Health, Inc
🇺🇸New York, New York, United States
Flatiron Health, Inc🇺🇸New York, New York, United StatesSite CoordinatorContact