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Biosimilar breast cancer drug tested in everyday clinics

NCT ID NCT03892655

Disease control Sponsor: Libbs Farmacêutica LTDA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 170 women with early-stage HER2+ breast cancer who are receiving the biosimilar drug Zedora after surgery. Researchers want to see how well it prevents the cancer from coming back and how safe it is in real-world settings, where patients may have other health issues or trouble sticking to treatment. The goal is to confirm that Zedora works as well in practice as it did in earlier trials for advanced cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
biosimilar trastuzumab (Zedora)
What this could lead to
If successful, this study could confirm that Zedora is a safe and effective option for treating early-stage HER2+ breast cancer in everyday clinical practice.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It is also relatively small (170 patients) and only includes Brazilian women, which may limit how well the findings apply to other groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

170 people

The number who actually took part.

Started

Oct 2019

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \[Full Life Program\].

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Andrea Juliana Pereira de Santana Gomes

    Natal, Rio Grande do Norte, 59075740, Brazil

  • Charles Alain Cordova Pinto

    Lages, Santa Catarina, Brazil

  • Cláudio Rocha

    Teresina, Piauí, 64049-200, Brazil

  • Cristina de Deus Anjos Tavares Sampaio

    Campo Grande, Mato Grosso, Brazil

  • Daniel Fontes Santos de Teive e Argolo

    Salvador, Estado de Bahia, 41810570, Brazil

  • Daniel Grabarz

    Mogi das Cruzes, São Paulo, 08730500, Brazil

  • Kaique Almeida

    São Paulo, São Paulo, Brazil

  • Karina Costa Maia Vianna

    Curitiba, Paraná, Brazil

  • Luis Eduardo Rosa Zucca

    Três Lagoas, Mato Grosso do Sul, Brazil

  • Mariana Scaranti

    São Paulo, São Paulo, Brazil

  • Mateus Bongers Alessandretti

    Porto Alegre, Rio Grande do Sul, Brazil

  • Micheline Campos Rezende

    Muriaé, Minas Gerais, Brazil

  • Monique Celeste Tavares

    São Paulo, São Paulo, 01509-900, Brazil

  • Márcia Cristina Colares Régis de Araújo

    Fortaleza, Ceará, 60135285, Brazil

  • Rafaela Kirchner Piccoli

    Ijuí, Rio Grande do Sul, Brazil

  • Raphael Luzorio Fernandes

    Cachoeiro de Itapemirim, Espírito Santo, Brazil

  • Ruffo de Freitas Junior

    Goiânia, Goiás, Brazil

  • Sabina Bandeira Aleixo

    Cachoeiro de Itapemirim, Espírito Santo, Brazil

  • Sâmio Pimentel Ferreira

    Belém, Pará, 66035265, Brazil

  • Sérgio Lunardon Padilha

    Curitiba, Paraná, Brazil

  • Tomas Reinert

    Caxias do Sul, Rio Grande do Sul, Brazil

  • William Hiromi Fuzita

    Manaus, Amazonas, 69057205, Brazil

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