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NCT Number: NCT03892655

Real World Study of Biosimilar Trastuzumab in 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

William Hiromi Fuzita, Manaus, Amazonas, Brazil

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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].

Treatment and study plan

Primary outcomes

  1. Efficacy endpoints: Invasive disease relapse-free survival rate

    Time frame: 18 months

    Invasive disease relapse-free survival rate

  2. Efficacy endpoints: Invasive disease relapse-free survival rate

    Time frame: 24 months

    Invasive disease relapse-free survival rate

  3. Efficacy endpoints: Invasive disease relapse-free survival rate

    Time frame: 30 months

    Invasive disease relapse-free survival rate

  4. Efficacy endpoints: Invasive disease relapse-free survival rate

    Time frame: 36 months

    Invasive disease relapse-free survival rate

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

    Time frame: 5 years

    Invasive disease relapse-free survival after curative-intent surgery

  6. Efficacy endpoints: Overall survival after curative intent surgery

    Time frame: 5 years

    Overall survival after curative intent surgery

  7. Safety endpoints: Incidence of Related Adverse Events

    Time frame: 5 years

    Incidence of Related Adverse Events

  8. Safety endpoints: Total cycles per patient

    Time frame: 5 years

    Total cycles per patient

  9. Safety endpoints: Incidence of dose interruption

    Time frame: 5 years

    Incidence of dose interruption

Sponsors and collaborators

Lead sponsor

Libbs Farmacêutica LTDA

Industry

Registry information

Official study 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

Acronym: LB1802

Important dates

Study start
2019
Primary completion
2022
Study completion
2028
First posted
Mar 27, 2019
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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