Real World Study of Biosimilar Trastuzumab in Her2 Positive Breast Cancer
NCT ID: NCT03892655
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
170 participants
OBSERVATIONAL
2019-10-07
2028-07-31
Brief Summary
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This will be an observational study of patients receiving adjuvant Zedora at several Brazilian institutions for the purpose of describing its efficacy and safety.
Detailed Description
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Adult patients with early HER2+ breast cancer receiving adjuvant biosimilar trastuzumab (Zedora) at the participating sites after the start of the study and meeting the eligibility criteria will be invited to participate. Demographics, comorbidities, disease history, extent of exposure to biosimilar trastuzumab (Zedora), adverse events and LVEF values will be collected.
Data collection will be performed using a case report form (CRF) specifically designed for the study.
Study Treatment:
Biosimilar trastuzumab (Zedora) must be prescribed at the dosage described in the product label.
Treatment duration will be 12 months for patients starting upfront with biosimilar trastuzumab (Zedora). Patients switching at any time to biosimilar trastuzumab (Zedora) after a period of adjuvant or neoadjuvant Herceptin® use will also be included in the overall analysis and subsequently assessed in a subgroup analysis.
Sample Size:
Number of patients = 170 Given the inexistence of a specific hypothesis to be tested, the statistical analysis will be basically descriptive.
Sample size is based on the two-sided 95% confidence interval (95% CI) for the invasive disease relapse-free survival rate.
The table below shows the 95% CIs for different rates in a sample of 170 patients, with an interval size ranging between 9% and 15%.
Based on literature, a 3-year relapse-free survival between 88 and 96% is expected. According to the table above, a sample of 170 patients allows assessing this endpoint with +/- 6.0% accuracy.
Study duration:
The estimated time for patient enrollment in the study is one year and may be extended in case the sample size is not reached in this period. Biosimilar trastuzumab (Zedora) must be prescribed according to the product label and treatment duration will be up to one year. The patient will be maintained in the study for 5 years (from start of treatment), unless there is tumor recurrence (local or distant).
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* patients enrolled in and followed up by Programa Vida Plena \[Full Life Program\].
18 Years
FEMALE
No
Sponsors
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Libbs Farmacêutica LTDA
INDUSTRY
Responsible Party
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Locations
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William Hiromi Fuzita
Manaus, Amazonas, Brazil
Márcia Cristina Colares Régis de Araújo
Fortaleza, Ceará, Brazil
Raphael Luzorio Fernandes
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Sabina Bandeira Aleixo
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Daniel Fontes Santos de Teive e Argolo
Salvador, Estado de Bahia, Brazil
Ruffo de Freitas Junior
Goiânia, Goiás, Brazil
Cristina de Deus Anjos Tavares Sampaio
Campo Grande, Mato Grosso, Brazil
Luis Eduardo Rosa Zucca
Três Lagoas, Mato Grosso do Sul, Brazil
Micheline Campos Rezende
Muriaé, Minas Gerais, Brazil
Karina Costa Maia Vianna
Curitiba, Paraná, Brazil
Sérgio Lunardon Padilha
Curitiba, Paraná, Brazil
Sâmio Pimentel Ferreira
Belém, Pará, Brazil
Cláudio Rocha
Teresina, Piauí, Brazil
Andrea Juliana Pereira de Santana Gomes
Natal, Rio Grande do Norte, Brazil
Tomas Reinert
Caxias do Sul, Rio Grande do Sul, Brazil
Rafaela Kirchner Piccoli
Ijuí, Rio Grande do Sul, Brazil
Mateus Bongers Alessandretti
Porto Alegre, Rio Grande do Sul, Brazil
Charles Alain Cordova Pinto
Lages, Santa Catarina, Brazil
Daniel Grabarz
Mogi das Cruzes, São Paulo, Brazil
Monique Celeste Tavares
São Paulo, São Paulo, Brazil
Kaique Almeida
São Paulo, São Paulo, Brazil
Mariana Scaranti
São Paulo, São Paulo, Brazil
Countries
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References
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Gagliato 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.
Other Identifiers
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LB1802
Identifier Type: -
Identifier Source: org_study_id