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

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: Breast Cancer

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 (Estimated): 170

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01509-900
    • Monique Celeste Tavares
  • São Paulo, Brazil
    • Kaique Almeida
  • São Paulo, Brazil
    • Mariana Scaranti
  • Amazonas
    • Manaus, Amazonas, Brazil, 69057205
      • William Hiromi Fuzita
  • Bahia
    • Salvador, Bahia, Brazil, 41810570
      • Daniel Fontes Santos de Teive e Argolo
  • 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
  • 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
  • Piaui
    • Teresina, Piaui, Brazil, 64049-200
      • Cláudio Rocha
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59075740
      • Danielli de Almeida Matias
  • 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

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Libbs Farmacêutica LTDA

Study record dates

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 (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: trastuzumab; biosimilar; breast carcinoma; receptors 2 (HER2); Zedora
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• 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