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Biosimilar breast cancer drug tested in everyday clinics

NCT ID NCT03892655

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

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.

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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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