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

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). Tra

SUBMITTER: Alonso-Romero JL 

PROVIDER: S-EPMC12819485 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature