OCT is happy to announce that the important 75% enrollment milestone has been reached in metastatic breast cancer study conducted in the USA and Russia. This study is FDA controlled. OCT is responsible for enrollment of 150 patients in 15 sites in Russia. The trial, designed to enroll 150 patients to achieve 130 evaluable patients, was initiated in October 2011. As its primary objective, the study will assess whether the study drug extends progression-free survival, and it will also evaluate overall response rate, survival, and safety.
OCT has a broad experience in conducting all kinds of oncology trials including 6 successfully completed breast cancer trials.
Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute. In 2010, NCI estimated that 207,090 women were diagnosed with breast cancer, while 39,840 women likely died from the disease.
According to official sources, worldwide, breast cancer comprises 22.9% of all cancers (excluding non-melanoma skin cancers) in women. In 2008, breast cancer caused 458,503 deaths worldwide (13.7% of cancer deaths in women).
OCT client is sponsoring a controlled Phase II trial in metastatic breast cancer (MBC) subjects who have been previously treated with a taxane and an anthracycline.
This is a full-service support clinical project, including project management, site selection, clinical monitoring, warehousing, study materials purchase and other logistics assistance, safety management, regulatory activities within the clinical trial approval and export/import licenses obtainment, final report preparation, investigator’s meeting organization, others. In addition OCT provides data management and final statistical report preparation services in this study. The leading international laboratory will be used for biosamples assessment. Total study duration will be 20 months.