Real World Study of Biosimilar Trastuzumab in Her2 Positive Breast Cancer

NCT03892655 | Active Not Recruiting

• 1 other identifier: LB1802
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 22

Brief 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

Breast Cancer

Keywords

breast carcinoma; receptors 2 (HER2); biosimilar; trastuzumab; Zedora

Outcome Measures

Primary Outcomes (9)

• Efficacy endpoints: Invasive disease relapse-free survival rate

  Invasive disease relapse-free survival rate

  18 months

• Efficacy endpoints: Invasive disease relapse-free survival rate

  Invasive disease relapse-free survival rate

  24 months

• Efficacy endpoints: Invasive disease relapse-free survival rate

  Invasive disease relapse-free survival rate

  30 months

• Efficacy endpoints: Invasive disease relapse-free survival rate

  Invasive disease relapse-free survival rate

  36 months

• Efficacy endpoints: Invasive disease relapse-free survival after curative-intent surgery

  Invasive disease relapse-free survival after curative-intent surgery

  5 years

• Efficacy endpoints: Overall survival after curative intent surgery

  Overall survival after curative intent surgery

  5 years

• Safety endpoints: Incidence of Related Adverse Events

  Incidence of Related Adverse Events

  5 years

• Safety endpoints: Total cycles per patient

  Total cycles per patient

  5 years

• Safety endpoints: Incidence of dose interruption

  Incidence of dose interruption

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult female patients with diagnosis of early stage I to III HER2+ breast cancer confirmed by histopathology test, immunohistochemistry test and FISH, where required, according to local guidelines, and who have started biosimilar trastuzumab (Zedora) as neoadjuvant or adjuvant therapy according to the product label will be eligible for the study.

You may qualify if:

• 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).

You may not qualify if:

• use of biosimilar trastuzumab (Zedora) differently from the provisions in the label.
• patients enrolled in and followed up by Programa Vida Plena \[Full Life Program\].

Sponsors & Collaborators

• Libbs Farmacêutica LTDA: lead

Study Sites (22)

William Hiromi Fuzita

Manaus, Amazonas, 69057205, Brazil

Location

Márcia Cristina Colares Régis de Araújo

Fortaleza, Ceará, 60135285, Brazil

Location

Raphael Luzorio Fernandes

Cachoeiro de Itapemirim, Espírito Santo, Brazil

Location

Sabina Bandeira Aleixo

Cachoeiro de Itapemirim, Espírito Santo, Brazil

Location

Daniel Fontes Santos de Teive e Argolo

Salvador, Estado de Bahia, 41810570, Brazil

Location

Ruffo de Freitas Junior

Goiânia, Goiás, Brazil

Location

Cristina de Deus Anjos Tavares Sampaio

Campo Grande, Mato Grosso, Brazil

Location

Luis Eduardo Rosa Zucca

Três Lagoas, Mato Grosso do Sul, Brazil

Location

Micheline Campos Rezende

Muriaé, Minas Gerais, Brazil

Location

Karina Costa Maia Vianna

Curitiba, Paraná, Brazil

Location

Sérgio Lunardon Padilha

Curitiba, Paraná, Brazil

Location

Sâmio Pimentel Ferreira

Belém, Pará, 66035265, Brazil

Location

Cláudio Rocha

Teresina, Piauí, 64049-200, Brazil

Location

Andrea Juliana Pereira de Santana Gomes

Natal, Rio Grande do Norte, 59075740, Brazil

Location

Tomas Reinert

Caxias do Sul, Rio Grande do Sul, Brazil

Location

Rafaela Kirchner Piccoli

Ijuí, Rio Grande do Sul, Brazil

Location

Mateus Bongers Alessandretti

Porto Alegre, Rio Grande do Sul, Brazil

Location

Charles Alain Cordova Pinto

Lages, Santa Catarina, Brazil

Location

Daniel Grabarz

Mogi das Cruzes, São Paulo, 08730500, Brazil

Location

Monique Celeste Tavares

São Paulo, São Paulo, 01509-900, Brazil

Location

Kaique Almeida

São Paulo, São Paulo, Brazil

Location

Mariana Scaranti

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 38836997 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: March 27, 2019
• Study Start: October 7, 2019
• Primary Completion: December 30, 2022
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

BR (22)