A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results.

Fiche publication


Date publication

avril 2018

Journal

European journal of cancer (Oxford, England : 1990)

Auteurs

Membres identifiés du Cancéropôle Est :
Pr PIVOT Xavier


Tous les auteurs :
Pivot X, Bondarenko I, Nowecki Z, Dvorkin M, Trishkina E, Ahn JH, Im SA, Sarosiek T, Chatterjee S, Wojtukiewicz MZ, Shparyk Y, Moiseyenko V, Bello M, Semiglazov V, Lee Y, Lim J

Résumé

The equivalent efficacy between SB3, a proposed trastuzumab biosimilar, and the trastuzumab reference product (TRZ) in terms of the breast pathologic complete response rate after neoadjuvant therapy in patients with early or locally advanced human epidermal growth factor receptor 2-positive breast cancer was demonstrated in the previous report. Here, we report the final safety, immunogenicity and survival results after neoadjuvant-adjuvant treatment.

Mots clés

Biosimilar, Early breast cancer, Event-free survival, HER2, Safety, Trastuzumab

Référence

Eur. J. Cancer. 2018 Apr;93:19-27