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Real World Study of Biosimilar Trastuzumab in Her2 Positive Breast Cancer

NCT03892655 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2025-12-24

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Libbs Farmacêutica LTDA

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2022-12-30
Completion
2028-07-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03892655 on ClinicalTrials.gov