Clinical Trial

Real World Study of Biosimilar Trastuzumab in Her2 Positive Breast Cancer

Study acronym: LB1802
Active, Not Recruiting
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Summary
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.
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2019-03-26; most recent amendment 2025-12-17.
Status change: Recruiting → Active, Not Recruiting 2023-10-10
Status change: Not Yet Recruiting → Recruiting 2019-07-23
Trial Details
NCT Number NCT03892655
Lead Sponsor Libbs Farmacêutica LTDA
Conditions Breast Cancer
Enrollment 170 participants
Start Date 2019-10-07
Primary Completion 2022-12-30 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2025-12-24