More than 15 women aged 18-75 with histologically or cytologically confirmed HER2-positive metastatic breast cancer, who had not received prior therapy for their metastatic disease, were randomized in two investigational sites. Despite the fact that inclusion criteria were difficult to achieve and enrollment was in summer, OCT managed to successfully complete it in 4 months. The total duration of subjects’ participation in the study will be approximately 28 weeks including screening, treatment period and end of study visit. The safety extension phase is expected to follow the active phase of the study.
In this project, OCT is responsible for review of medical documentation (clinical study protocol, investigator’s brochure, ICF) and its translation, most part of site administration-related activities (site selection, paperwork, negotiations, remote monitoring, etc.), full project and regulatory support, arrangement of monitoring visits, pharmacovigilance, preparation and approval of quality assurance plan.