Real World Study of Biosimilar Trastuzumab in Her2 Positive Breast Cancer (LB1802)

December 17, 2025 updated by: Libbs Farmacêutica LTDA

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

An observational, multicenter, prospective, real-world study at Brazilian institutions.

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).

Study Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Amazonas
      • Manaus, Amazonas, Brazil, 69057205
        • William Hiromi Fuzita
    • Ceará
      • Fortaleza, Ceará, Brazil, 60135285
        • Márcia Cristina Colares Régis de Araújo
    • Espírito Santo
      • Cachoeiro de Itapemirim, Espírito Santo, Brazil
        • Raphael Luzorio Fernandes
      • Cachoeiro de Itapemirim, Espírito Santo, Brazil
        • Sabina Bandeira Aleixo
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41810570
        • Daniel Fontes Santos de Teive e Argolo
    • Goiás
      • Goiânia, Goiás, Brazil
        • Ruffo de Freitas Junior
    • Mato Grosso
      • Campo Grande, Mato Grosso, Brazil
        • Cristina de Deus Anjos Tavares Sampaio
    • Mato Grosso do Sul
      • Três Lagoas, Mato Grosso do Sul, Brazil
        • Luis Eduardo Rosa Zucca
    • Minas Gerais
      • Muriaé, Minas Gerais, Brazil
        • Micheline Campos Rezende
    • Paraná
      • Curitiba, Paraná, Brazil
        • Karina Costa Maia Vianna
      • Curitiba, Paraná, Brazil
        • Sérgio Lunardon Padilha
    • Pará
      • Belém, Pará, Brazil, 66035265
        • Sâmio Pimentel Ferreira
    • Piauí
      • Teresina, Piauí, Brazil, 64049-200
        • Cláudio Rocha
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59075740
        • Andrea Juliana Pereira de Santana Gomes
    • Rio Grande do Sul
      • Caxias do Sul, Rio Grande do Sul, Brazil
        • Tomas Reinert
      • Ijuí, Rio Grande do Sul, Brazil
        • Rafaela Kirchner Piccoli
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Mateus Bongers Alessandretti
    • Santa Catarina
      • Lages, Santa Catarina, Brazil
        • Charles Alain Cordova Pinto
    • São Paulo
      • Mogi das Cruzes, São Paulo, Brazil, 08730500
        • Daniel Grabarz
      • São Paulo, São Paulo, Brazil, 01509-900
        • Monique Celeste Tavares
      • São Paulo, São Paulo, Brazil
        • Kaique Almeida
      • São Paulo, São Paulo, Brazil
        • Mariana Scaranti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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].

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy endpoints: Invasive disease relapse-free survival rate
Time Frame: 18 months
Invasive disease relapse-free survival rate
18 months
Efficacy endpoints: Invasive disease relapse-free survival rate
Time Frame: 24 months
Invasive disease relapse-free survival rate
24 months
Efficacy endpoints: Invasive disease relapse-free survival rate
Time Frame: 30 months
Invasive disease relapse-free survival rate
30 months
Efficacy endpoints: Invasive disease relapse-free survival rate
Time Frame: 36 months
Invasive disease relapse-free survival rate
36 months
Efficacy endpoints: Invasive disease relapse-free survival after curative-intent surgery
Time Frame: 5 years
Invasive disease relapse-free survival after curative-intent surgery
5 years
Efficacy endpoints: Overall survival after curative intent surgery
Time Frame: 5 years
Overall survival after curative intent surgery
5 years
Safety endpoints: Incidence of Related Adverse Events
Time Frame: 5 years
Incidence of Related Adverse Events
5 years
Safety endpoints: Total cycles per patient
Time Frame: 5 years
Total cycles per patient
5 years
Safety endpoints: Incidence of dose interruption
Time Frame: 5 years
Incidence of dose interruption
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Libbs Farmacêutica LTDA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2019

Primary Completion (Actual)

December 30, 2022

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Estimated)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB1802

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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