Study to Evaluate the Efficacy and Safety of Neoadjuvant Treatment Based on Dual Blockade With Pertuzumab and the Trastuzumab Biosimilar CT-P6 (Herzuma®) in Early HER2-positive Breast Cancer in Routine Clinical Practice

Summary

The study hypothesis is to evaluate whether the pCR rate of neoadjuvant chemotherapy and dual blockade with pertuzumab and the trastuzumab biosimilar CT-P6 (Herzuma®) in HER2-positive early breast cancer in PCH is similar to that reported in clinical trials. Other aspects to be analyzed include the safety of the combination in PCH, as well as the clinical and tumor characteristics of the study population, assessment of radiological and pathological response, and the role of treatment-induced immunogenicity and the value of plasma HER2 determination.

Timeline

Start

2020-12-28

Primary completion

2024-03-14

Completion

2024-03-14

Publications

• Alonso-Romero JL, Martinez-Garcia J, Carrillo-Vicente R, Aramburo AF, Diez AF, Henarejos PS, de la Morena Barrio P, Boix AP, Jimenez MD, Siles JP, Maestre JAP, de Las Heras-Rubio A, Carreno PR. Translational and real-world evidence of trastuzumab biosimilar CT-P6 plus pertuzumab in neoadjuvant HER2-positive early breast cancer. Breast Cancer Res Treat. 2026 Jan 20;215(2):60. doi: 10.1007/s10549-026-07895-8.

Drugs

Indications