Clinical trial · Observational
Real World Study of Biosimilar Trastuzumab in Her2 Positive Breast Cancer
A Multicenter, Prospective, Real World, National Study to Assess the Efficacy and Safety of Adjuvant Biosimilar Tratuzumab (Zedora) Treatment in Patients With Localized Her2 Positive Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (9)
- measure
- Efficacy endpoints: Invasive disease relapse-free survival rate
- timeFrame
- 18 months
- description
- Invasive disease relapse-free survival rate
- measure
- Efficacy endpoints: Invasive disease relapse-free survival rate
- timeFrame
- 24 months
- description
- Invasive disease relapse-free survival rate
- measure
- Efficacy endpoints: Invasive disease relapse-free survival rate
- timeFrame
- 30 months
- description
- Invasive disease relapse-free survival rate
- measure
- Efficacy endpoints: Invasive disease relapse-free survival rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 \[Full Life Program\].
References
Publications (1)
- DERIVEDGagliato D, Reinert T, Rocha C, Tavares M, Pimentel S, Fuzita W, Araujo M, Matias D, Aleixo S, Franca B, Magaton E, Brito N, Cardoso AC, Castilho V. Real-World Study of Adjuvant Biosimilar Trastuzumab-dkst for HER2-Positive Breast Cancer Treatment in a Brazilian Population. Oncol Ther. 2024 Sep;12(3):437-449. doi: 10.1007/s40487-024-00284-5. Epub 2024 Jun 5. PMID 38836997