Metastatic HER2-Overexpressing Breast Cancer
RemediumOne has partnered with global Sponsor and CRO to conduct this project in Sri Lanka at National Cancer Institute. Within 16 weeks both ERC and Regulatory approvals were obtained. Sri Lanka has achieved 100 % recruitment target within given recruitment period. Retention was also 100%. We succeeded this project with the leadership given by the Coordinating Principal Investigator and his team.
This project was an open-label, randomised phase III trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine in patients with metastatic HER2-overexpressing breast cancer failing one prior trastuzumab treatment. The objective was To investigate the efficacy and safety of afatinib in combination with vinorelbine with trastuzumab in combination with vinorelbine as treatment in patients with metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer failing 1 prior trastuzumab treatment.
Data from the trial have been published in the following article, based on the cut-off date for the primary analysis (08 Jun 2013 for RECIST-based efficacy endpoints; 03 Sep 2013 for survival and safety data): Harbeck N, Huang C-S, Hurvitz S, et al on behalf of the LUX-Breast 1 Study Group. Afatinib plus vinorelbine versus trastuzumab plus vinorelbine in patients with HER2-overexpressing metastatic breast cancer who had progressed on one previous trastuzumab treatment (LUX-Breast 1): an open-label, randomised, phase 3 trial. Lancet Oncol 2016;17:357-366.