Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients

Gligorov, KAZIM; Ataseven, B.; Verrill, M.; De laurentiis, M.; Jung, K.; Azim, H.; Al-Sakaff, N.; Lauer, S.; Shing, M.; Pivot, X.

doi:10.1016/j.ejca.2017.05.010

Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients

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Gligorov J., Ataseven B., Verrill M., De laurentiis M., Jung K. H., Azim H. A., ...More

EUROPEAN JOURNAL OF CANCER, vol.82, pp.237-246, 2017 (SCI-Expanded)

Publication Type: Article / Article
Volume: 82
Publication Date: 2017
Doi Number: 10.1016/j.ejca.2017.05.010
Journal Name: EUROPEAN JOURNAL OF CANCER
Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
Page Numbers: pp.237-246
Keywords: Adjuvant, Breast cancer, HER2/neu, Herceptin, Subcutaneous, Trastuzumab, OPEN-LABEL, CHEMOTHERAPY, DOXORUBICIN, PACLITAXEL, PREFHER, HANNAH
Kocaeli University Affiliated: Yes

Abstract

Aim: To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin (R) SC, H SC), delivered from an H SC Vial via hand-held syringe (Cohort A) or single-use injection device (Cohort B), with or without chemotherapy, for human epidermal growth factor receptor 2 (HER2)-positive stage I to IIIC early breast cancer (EBC) in the phase III SafeHer study (NCT01566721).