The trial is to compare the antitumor effect and safety of the study drug and the comparator drug. This study will be conducted in Russia, Ukraine and Latvia. OCT has recruited 200 patients with locally advanced or metastatic breast cancer after failure with previous anthracycline-containing chemotherapy.
According to the World Health Organization, from 800 thousand to 1 million of new cases of breast cancer are reported annually. In Russia, as of 2010, breast cancer had the highest rates of malignant neoplasms both in morbidity (20.5 %) and mortality (17.2 %) in women; apart from that, the number of newly diagnosed cases of breast cancer has increased to 57,241. Cancer remains a significant public health problem requiring continuous development of new anti-tumor drugs to address unmet medical needs in this life-threatening disease.
This is a full-service clinical project in which OCT provides full regulatory and investigational support.