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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* female patients aged 18 years and over
* diagnosis of early stage I to III breast cancer confirmed by histopathology test according to local guidelines.
* human epidermal growth factor receptor 2 (HER2)-positive tumor by immunohistochemistry or FISH (Fluorescence In Situ Hybridization), as per the 2018 ASCO assessment guideline \[J Clin Oncol 36:2105, 2018\].
* use of at least one dose of biosimilar trastuzumab (Zedora) as adjuvant therapy, regardless of previous neoadjuvant trastuzumab or Zedora use or the type of chemotherapy combined with the antibody.
* Signing of the informed consent form (ICF).
Exclusion Criteria:
* use of biosimilar trastuzumab (Zedora) differently from the provisions in the label.
* patients enrolled in and followed up by Programa Vida Plena \[Full Life Program\].
Efficacy endpoints: Invasive disease relapse-free survival after curative-intent surgery — 5 years Invasive disease relapse-free survival after curative-intent surgery
Efficacy endpoints: Overall survival after curative intent surgery — 5 years Overall survival after curative intent surgery
Safety endpoints: Incidence of Related Adverse Events — 5 years Incidence of Related Adverse Events
Safety endpoints: Total cycles per patient — 5 years Total cycles per patient
Safety endpoints: Incidence of dose interruption — 5 years Incidence of dose interruption
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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