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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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Date
2026-01-20
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Alonso Romero, José Luis ; Martínez-García, Jerónimo ; Carrillo-Vicente, Raúl ; Fernández Aramburo, Antonio ; Ferrando Díez, Angélica ; Sánchez Henarejos, Pilar ; de la Morena Barrio, Pilar ; Puertes Boix, Ana ; Jiménez, Mª Dolores ; Peña Siles, Joaquín ; Parejo Maestre, José Antonio ; de las Heras Rubio, Antonio ; Ruiz Carreño, Paula
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Facultades de la UMU::Facultad de Medicina
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Publisher
Springer
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Medicina
DOI
https://doi.org/10.1007/s10549-026-07895-8
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info:eu-repo/semantics/article
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Abstract
Background 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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Routine clinical practice , Trastuzumab biosimilar , Trastuzumab CT-P6 , HER2-positive early breast cancer , Neoadjuvant treatment
Citation
Alonso-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).
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http://hdl.handle.net/10201/222881
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