Gagliato, Debora http://orcid.org/0000-0001-7480-0674
Reinert, Tomás http://orcid.org/0000-0003-4715-1415
Rocha, Cláudio http://orcid.org/0009-0004-6619-8723
Tavares, Monique http://orcid.org/0000-0001-9284-6318
Pimentel, Sâmio http://orcid.org/0009-0004-9851-5156
Fuzita, William http://orcid.org/0000-0002-4662-704X
Araújo, Márcia http://orcid.org/0009-0000-9176-9912
Matias, Danielli http://orcid.org/0009-0005-1557-0166
Aleixo, Sabina http://orcid.org/0000-0003-0034-2716
França, Bruno http://orcid.org/0000-0001-9252-4845
Magaton, Érida http://orcid.org/0000-0001-7256-2828
Brito, Natália http://orcid.org/0000-0003-4301-5942
Cardoso, Ana Carolina http://orcid.org/0000-0002-9612-2285
Castilho, Vivienne http://orcid.org/0000-0003-0784-6642
Clinical trials referenced in this document:
Documents that mention this clinical trial
A prospective real-world study to assess the effectiveness and safety of trastuzumab biosimilar in the adjuvant treatment of HER2-positive breast cancer: Preliminary safety results.
https://doi.org/10.1200/jco.2023.41.16_suppl.e12532
Real-World Study of Adjuvant Biosimilar Trastuzumab-dkst for HER2-Positive Breast Cancer Treatment in a Brazilian Population
https://doi.org/10.1007/s40487-024-00284-5
Funding for this research was provided by:
Libbs Farmacêutica Ltda.
Article History
Received: 29 February 2024
Accepted: 21 May 2024
First Online: 5 June 2024
Declarations
:
: Debora Gagliato reports receiving consulting honoraries from Libbs Farmacêutica, AstraZeneca, Daichii-Sankyo, Lilly, Novartis, Gilead, and Roche. Tomás Reinert reports receiving consulting honoraries from AstraZeneca, Daichii-Sankyo, Lilly, Novartis, MSD, and Pfizer; speaker honoraries from AstraZeneca, Daichii-Sankyo, Lilly, Novartis, MSD, Pfizer, and Libbs Farmacêutica; and research funding from AstraZeneca and Libbs Farmacêutica. William Fuzita reported having received honoraries for participation in clinical trials in the name of Instituto Sensumed de Ensino e Pesquisa—Ruy França. Danielli Matias declared receiving speaker honoraries from MSD, Janssen, AstraZeneca, and BMS; manuscript honoraries from MSD and Libbs Farmacêutica; consultory honoraries from MSD, Daichii-Sankyo, and AstraZeneca; event supporting fees from Janssen, MSD, and AstraZeneca; being a member of committees in Grupo Brasileiro de Oncologia Torácica (GBOT) and Sociedade Brasileira de Oncologia Clínica (SBOC). Cláudio Rocha, Monique Tavares, Sâmio Pimentel, Sabina Aleixo, Marcia Araujo and Bruno França declared that they have no conflicts of interest. Érida Magaton, Natália Brito, Ana Carolina Cardoso, and Vivienne Castilho report being current full-time employees of Libbs Farmacêutica.
: This study was conducted in accordance with Good Clinical Practice Guidelines and the provisions of the Declaration of Helsinki and its later amendments. Protocol approval was obtained at Fundação Antônio Prudente—A.C. Camargo Cancer Center number 5432 (CAAE: 11576919.0.1001.5432) and from an independent ethics committee at each site. All participants signed informed consent.