A randomized, double-blind, phase III study comparing SB3 (trastuzumab biosimilar) with originator trastuzumab in patients treated by neoadjuvant therapy for HER2-positive early breast cancer

Pivot, Xavier B and Bondarenko, Igor and Dvorkin, Mikhail and Trishkina, Ekaterina and Ahn, Jin-Hee and Im, Seock-Ah and Sarosiek, Tomasz and Chattopadhyay, Sanjay and Wojtukiewicz, Marek and Moiseyenko, Vladimir and Shparyk, Yaroslav V and Bello, Maximino De Guzman and Semiglazov, Vladimir and Song, Sujeong and Lim, Jae Yun (2017) A randomized, double-blind, phase III study comparing SB3 (trastuzumab biosimilar) with originator trastuzumab in patients treated by neoadjuvant therapy for HER2-positive early breast cancer. Journal of Clinical Oncology, 35 (15). p. 509. ISSN 0732-183X (Print) ; 1527-7755 (Electronic) ; 0732-183X (Linking)

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Abstract

Background: SB3, a proposed biosimilar to the originator trastuzumab (TRZ), demonstrated similarity to its originator in terms of biological activities and pharmacokinetic (PK) equivalence. This study compared SB3 to TRZ in terms of efficacy, safety, PK, and immunogenicity in patients treated by neoadjuvant therapy for HER2 positive early breast cancer (NCT02149524). Methods: Phase III, randomized, double blind, multicenter study compared neoadjuvant SB3 or TRZ for 8 cycles concurrently given with chemotherapy ( ...

Item Type:	Article
Additional Information:	Дата публикации 2017/5/20 Clinical trial information: NCT02149524. https://clinicaltrials.gov/show/NCT02149524
Subjects:	Oncology
Depositing User:	Елена Шрамко
Date Deposited:	07 Sep 2017 08:53
Last Modified:	07 Sep 2017 08:53
URI:	http://repo.dma.dp.ua/id/eprint/1922

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