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Real World Study of Biosimilar Trastuzumab in Her2 Positive Breast Cancer
Sponsor: Libbs Farmacêutica LTDA
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.
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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
170
Start Date
2019-10-07
Completion Date
2028-07
Last Updated
2025-12-24
Healthy Volunteers
No
Conditions
Locations (22)
William Hiromi Fuzita
Manaus, Amazonas, Brazil
Márcia Cristina Colares Régis de Araújo
Fortaleza, Ceará, Brazil
Raphael Luzorio Fernandes
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Sabina Bandeira Aleixo
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Daniel Fontes Santos de Teive e Argolo
Salvador, Estado de Bahia, Brazil
Ruffo de Freitas Junior
Goiânia, Goiás, Brazil
Cristina de Deus Anjos Tavares Sampaio
Campo Grande, Mato Grosso, Brazil
Luis Eduardo Rosa Zucca
Três Lagoas, Mato Grosso do Sul, Brazil
Micheline Campos Rezende
Muriaé, Minas Gerais, Brazil
Karina Costa Maia Vianna
Curitiba, Paraná, Brazil
Sérgio Lunardon Padilha
Curitiba, Paraná, Brazil
Sâmio Pimentel Ferreira
Belém, Pará, Brazil
Cláudio Rocha
Teresina, Piauí, Brazil
Andrea Juliana Pereira de Santana Gomes
Natal, Rio Grande do Norte, Brazil
Tomas Reinert
Caxias do Sul, Rio Grande do Sul, Brazil
Rafaela Kirchner Piccoli
Ijuí, Rio Grande do Sul, Brazil
Mateus Bongers Alessandretti
Porto Alegre, Rio Grande do Sul, Brazil
Charles Alain Cordova Pinto
Lages, Santa Catarina, Brazil
Daniel Grabarz
Mogi das Cruzes, São Paulo, Brazil
Monique Celeste Tavares
São Paulo, São Paulo, Brazil
Kaique Almeida
São Paulo, São Paulo, Brazil
Mariana Scaranti
São Paulo, São Paulo, Brazil