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Translational and real-world evidence of trastuzumab biosimilar CT-P6 plus pertuzumab in neoadjuvant HER2-positive early breast cancer

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dc.contributor.authorAlonso Romero, José Luis
dc.contributor.authorMartínez-García, Jerónimo
dc.contributor.authorCarrillo-Vicente, Raúl
dc.contributor.authorFernández Aramburo, Antonio
dc.contributor.authorFerrando Díez, Angélica
dc.contributor.authorSánchez Henarejos, Pilar
dc.contributor.authorde la Morena Barrio, Pilar
dc.contributor.authorPuertes Boix, Ana
dc.contributor.authorJiménez, Mª Dolores
dc.contributor.authorPeña Siles, Joaquín
dc.contributor.authorParejo Maestre, José Antonio
dc.contributor.authorde las Heras Rubio, Antonio
dc.contributor.authorRuiz Carreño, Paula
dc.contributor.departmentMedicina
dc.contributor.otherFacultades de la UMU::Facultad de Medicina
dc.date.accessioned2026-03-25T12:14:20Z
dc.date.available2026-03-25T12:14:20Z
dc.date.copyright© The Authors 2026
dc.date.issued2026-01-20
dc.description.abstractBackground Data on neoadjuvant treatment with trastuzumab biosimilars, particularly CT-P6, in combination with pertuzumab, are limited. This study evaluates the efficacy, tolerability, and immunogenicity of CT-P6 plus pertuzumab and chemotherapy, in routine clinical practice for HER2-positive early breast cancer, including translational biomarker analyses related to pathologic complete response (pCR). Methods Prospective, multicenter, observational study in 102 patients with HER2-positive early breast cancer. Patients received hospital-preferred neoadjuvant regimens protocols, with (scheme 1 and 3) or without anthracyclines (scheme 2). The primary endpoint was pCR, defined as the absence of invasive tumor in both the breast and axillary lymph nodes (ypT0/ypTis and ypN0). Translational endpoints included soluble HER2, anti-trastuzumab CT-P6 antibodies, and exploratory response-related modeling approaches supported by machine learning techniques. Results Among patients who underwent surgery, pCR (ypT0/ypTis and ypN0) was achieved in 57.43% of cases, with no significant differences between anthracycline-based and non-anthracycline-based regimens. Soluble HER2 and anti-trastuzumab CT-P6 antibodies were not significantly associated with pCR. Treatment was well-tolerated; the most relevant Grade 3–4 treatment-related adverse events were diarrhea (2.25%) and asthenia (0.50%). No immunogenicity or clinically relevant cardiotoxicity was observed. Conclusions Trastuzumab CT-P6 combined with pertuzumab and chemotherapy can be used in neoadjuvant treatment for HER2-positive early breast cancer, showing pCR rates comparable to the reference trastuzumab and without evidence of immunogenicity. Exploratory analyses of soluble HER2 and anti-trastuzumab CT-P6 antibodies did not demonstrate a significant association with pCR, although this possibility cannot be excluded. Their assessment contributes to the translational understanding of biosimilar integration into curative regimens.
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dc.identifier.citationAlonso-Romero, J.L., Martínez-García, J., Carrillo-Vicente, R. et al. Translational and real-world evidence of trastuzumab biosimilar CT-P6 plus pertuzumab in neoadjuvant HER2-positive early breast cancer. Breast Cancer Res Treat 215, 60 (2026).
dc.identifier.doihttps://doi.org/10.1007/s10549-026-07895-8
dc.identifier.eissn1573-7217
dc.identifier.issn0167-6806
dc.identifier.urihttp://hdl.handle.net/10201/222881
dc.languageeng
dc.publisherSpringer
dc.relationThis work was supported by Kern Pharma, S.L. under its Program Grants for Research Program. The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and the decision to submit the manuscript for publication
dc.relation.publisherversionhttps://link.springer.com/article/10.1007/s10549-026-07895-8
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International*
dc.rights.accessRightsinfo:eu-repo/semantics/openAccess
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectRoutine clinical practice
dc.subjectTrastuzumab biosimilar
dc.subjectTrastuzumab CT-P6
dc.subjectHER2-positive early breast cancer
dc.subjectNeoadjuvant treatment
dc.subject.odsObjetivo 3: Salud
dc.titleTranslational and real-world evidence of trastuzumab biosimilar CT-P6 plus pertuzumab in neoadjuvant HER2-positive early breast cancer
dc.typeinfo:eu-repo/semantics/article
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dspace.entity.typePublicationes
relation.isAuthorOfPublication79c9c691-9c36-4057-91b8-cf928d76847b
relation.isAuthorOfPublication097791fe-3ca8-4deb-bac3-7e8a7a10ffa8
relation.isAuthorOfPublication.latestForDiscovery79c9c691-9c36-4057-91b8-cf928d76847b
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