Real World Study of Biosimilar Trastuzumab in Her2 Positive Breast Cancer

Breast Cancer Clinical Trial

— LB1802  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03892655
• Other study ID #: LB1802
• Status: Active, not recruiting
• Start date: October 7, 2019
• Est. completion date: July 2028

Study information

• Verified date: October 2023
• Source: Libbs Farmacêutica LTDA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 170
• Est. completion date: July 2028
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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].

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Brazil	Sâmio Pimentel Ferreira	Belém	Pará
Brazil	Raphael Luzorio Fernandes	Cachoeiro De Itapemirim	Espírito Santo
Brazil	Sabina Bandeira Aleixo	Cachoeiro De Itapemirim	Espírito Santo
Brazil	Cristina de Deus Anjos Tavares Sampaio	Campo Grande	Mato Grosso
Brazil	Tomas Reinert	Caxias Do Sul	Rio Grande Do Sul
Brazil	Karina Costa Maia Vianna	Curitiba	Paraná
Brazil	Sérgio Lunardon Padilha	Curitiba	Paraná
Brazil	Márcia Cristina Colares Régis de Araújo	Fortaleza	Ceará
Brazil	Ruffo de Freitas Junior	Goiânia	Goiás
Brazil	Rafaela Kirchner Piccoli	Ijuí	Rio Grande Do Sul
Brazil	Charles Alain Cordova Pinto	Lages	Santa Catarina
Brazil	William Hiromi Fuzita	Manaus	Amazonas
Brazil	Daniel Grabarz	Mogi Das Cruzes	São Paulo
Brazil	Micheline Campos Rezende	Muriaé	Minas Gerais
Brazil	Danielli de Almeida Matias	Natal	Rio Grande Do Norte
Brazil	Mateus Bongers Alessandretti	Porto Alegre	Rio Grande Do Sul
Brazil	Daniel Fontes Santos de Teive e Argolo	Salvador	Bahia
Brazil	Kaique Almeida	São Paulo
Brazil	Mariana Scaranti	São Paulo
Brazil	Monique Celeste Tavares	São Paulo
Brazil	Cláudio Rocha	Teresina	Piaui
Brazil	Luis Eduardo Rosa Zucca	Três Lagoas	Mato Grosso Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Libbs Farmacêutica LTDA

Country where clinical trial is conducted

Brazil, 

Outcome

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