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http://dx.doi.org/10.1001/jamanetworkopen.2024.57495 | DOI Listing |
JAMA Netw Open
January 2025
Division of New Drugs and Early Drug Development for Innovative Therapies, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy.
JAMA
January 2017
Mylan Inc, Canonsburg, Pennsylvania.
Importance: Treatment with the anti-ERBB2 humanized monoclonal antibody trastuzumab and chemotherapy significantly improves outcome in patients with ERBB2 (HER2)-positive metastatic breast cancer; a clinically effective biosimilar may help increase access to this therapy.
Objective: To compare the overall response rate and assess the safety of a proposed trastuzumab biosimilar plus a taxane or trastuzumab plus a taxane in patients without prior treatment for ERBB2-positive metastatic breast cancer.
Design, Setting, And Participants: Multicenter, double-blind, randomized, parallel-group, phase 3 equivalence study in patients with metastatic breast cancer.