Browsing by Subject "Routine clinical practice"

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    Translational and real-world evidence of trastuzumab biosimilar CT-P6 plus pertuzumab in neoadjuvant HER2-positive early breast cancer
    (Springer, 2026-01-20) 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; Medicina; Facultades de la UMU::Facultad de Medicina
    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.