OCT is happy to announce that the approval of a phase III multinational clinical trial of a drug aimed at treating patients with locally advanced or metastatic breast cancer after failure of previous anthracycline-containing chemotherapy has been obtained.
This is a prospective, multinational, multicenter, open-label, third party-blinded, randomized, active-controlled, parallel-group study conducted in order 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. The supposed period for the study is 1,5 years. It will cover about 15 sites. It is planned to screen and recruit over 200 patients.
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 to be 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 will provide full regulatory and investigational support including site selection, medical writing, performance of all necessary regulatory activities, making submissions to local ethics committees, execution of CTAs with investigational sites and principal investigators, as well as all activities related to project management, development of project plans, monitoring, logistics and submission for Marketing Approval in Russia.
OCT’s in-depth expertise in oncology clinical trials is verified by over a dozen of successfully finished trials with patients with breast cancer. Such a background ensures a required selection of trial sites capable of providing fast recruitment and high quality of the research.