Zedora registration was based on studies of women with metastatic breast cancer, but its approval includes adjuvant treatment. Thus, prospective data of drug use in localized disease are lacking, as well as are real-world safety and efficacy data, taking into consideration comorbidities and compliance difficulties. This will be an observational study of patients receiving adjuvant Zedora at several Brazilian institutions for the purpose of describing its efficacy and safety.
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Efficacy endpoints: Invasive disease relapse-free survival rate
Timeframe: 18 months
Efficacy endpoints: Invasive disease relapse-free survival rate
Timeframe: 24 months
Efficacy endpoints: Invasive disease relapse-free survival rate
Timeframe: 30 months
Efficacy endpoints: Invasive disease relapse-free survival rate
Timeframe: 36 months
Efficacy endpoints: Invasive disease relapse-free survival after curative-intent surgery
Timeframe: 5 years
Efficacy endpoints: Overall survival after curative intent surgery
Timeframe: 5 years
Safety endpoints: Incidence of Related Adverse Events
Timeframe: 5 years
Safety endpoints: Total cycles per patient
Timeframe: 5 years
Safety endpoints: Incidence of dose interruption
Timeframe: 5 years