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AzTrials

Breast CancerLB1802NCT03892655

Real World Study of Biosimilar Trastuzumab in Her2 Positive Breast Cancer

An observational study of Breast Cancer, run by Libbs Farmacêutica LTDA at 22 sites in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
How many people
170 participants
Where
22 sitesBrazil
Study dates
7 Oct 2019to Jul 2028
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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].

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Brazil22 sites

  • Sâmio Pimentel Ferreira

    Belém, Pará, 66035265

  • Raphael Luzorio Fernandes

    Cachoeiro de Itapemirim, Espírito Santo

  • Sabina Bandeira Aleixo

    Cachoeiro de Itapemirim, Espírito Santo

  • Cristina de Deus Anjos Tavares Sampaio

    Campo Grande, Mato Grosso

  • Tomas Reinert

    Caxias do Sul, Rio Grande do Sul

  • Karina Costa Maia Vianna

    Curitiba, Paraná

  • Sérgio Lunardon Padilha

    Curitiba, Paraná

  • Márcia Cristina Colares Régis de Araújo

    Fortaleza, Ceará, 60135285

  • Ruffo de Freitas Junior

    Goiânia, Goiás

  • Rafaela Kirchner Piccoli

    Ijuí, Rio Grande do Sul

  • Charles Alain Cordova Pinto

    Lages, Santa Catarina

  • William Hiromi Fuzita

    Manaus, Amazonas, 69057205

  • Daniel Grabarz

    Mogi das Cruzes, São Paulo, 08730500

  • Micheline Campos Rezende

    Muriaé, Minas Gerais

  • Andrea Juliana Pereira de Santana Gomes

    Natal, Rio Grande do Norte, 59075740

  • Mateus Bongers Alessandretti

    Porto Alegre, Rio Grande do Sul

  • Daniel Fontes Santos de Teive e Argolo

    Salvador, Estado de Bahia, 41810570

  • Monique Celeste Tavares

    São Paulo, São Paulo, 01509-900

  • Kaique Almeida

    São Paulo, São Paulo

  • Mariana Scaranti

    São Paulo, São Paulo

  • Cláudio Rocha

    Teresina, Piauí, 64049-200

  • Luis Eduardo Rosa Zucca

    Três Lagoas, Mato Grosso do Sul

Other trials in Brazil

About this study

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

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.

Read the 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).

Conditions
Breast Cancer
Keywords
breast carcinoma, receptors 2 (HER2), biosimilar, trastuzumab, Zedora
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Invasive disease relapse-free survival rate

    Measured: 18 months

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

    Invasive disease relapse-free survival rate

    Measured: 24 months

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

    Invasive disease relapse-free survival rate

    Measured: 30 months

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

    Invasive disease relapse-free survival rate

    Measured: 36 months

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

    Invasive disease relapse-free survival after curative-intent surgery

    Measured: 5 years

  6. Efficacy endpoints: Overall survival after curative intent surgery

    Overall survival after curative intent surgery

    Measured: 5 years

  7. Safety endpoints: Incidence of Related Adverse Events

    Incidence of Related Adverse Events

    Measured: 5 years

  8. Safety endpoints: Total cycles per patient

    Total cycles per patient

    Measured: 5 years

  9. Safety endpoints: Incidence of dose interruption

    Incidence of dose interruption

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2019
  2. Study start7 Oct 2019
  3. Primary completion30 Dec 2022
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
170 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03892655
Sponsor's protocol ID
LB1802
Acronym
LB1802
Status last verified
Dec 2025
First submitted
12 Feb 2019
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38836997

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Libbs Farmacêutica LTDA at 22 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy endpoints: Invasive disease relapse-free survival rate (time frame: 18 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03892655, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.

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