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 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) identifier identifier identifier

  • 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: No

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).