The study aims to compare the efficacy of the investigational and reference products in conjunction with protocol-directed chemotherapy.
Targeted therapies against tumor biological properties are an essential part of individualized therapy concepts in breast cancer. In an attempt to inhibit tumor growth caused, antibodies were developed against the extracellular domain of the HER2 receptor. Over the last decade a number of monoclonal antibodies have been approved in the US and Europe for treatment of a variety of primary cancers.
It is planned to randomize more than 150 female patients aged 18-75 with histologically or cytologically confirmed HER2-positive metastatic breast cancer, who had not received prior therapy for their metastatic disease. They will be randomized into two treatment arms in a 1:1 ratio. The total duration of subject participation will be approximately 28 weeks including a screening period, treatment period, and an end of study visit. The safety extension phase is supposed to follow the active phase of the study.
The study is planned to be conducted in up to 45 investigational sites in India. Investigational sites in other countries may also be included in the study.
In this clinical study, OCT is responsible for review of medical documentation (including CSP, 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.