The study Sponsor is a startup biotechnology company based in Moscow, Russia. The trial is located in the six largest Russian oncology sites. OCT’s great relations with all oncology sites in our region will allow us to enroll 70 patients within a 7-month timeline. The first patient was randomized at a large oncology center in Krasnodar headed by a highly experienced principal investigator.
The population of patients enrolled in this study will be comprised of women, between 18 and 75 years of age that have been diagnosed with metatstatic breast cancer and are scheduled to undergo AC (cyclophosphamide, doxorubicin), a combination chemotherapy treatment. As its primary objective, the study will assess whether the study drug is safe and effective in primary prophylactics of neutropenia in chemotherapy patients.
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).
his 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. OCT’s self-developed CTMS is used as a data management platform in this trial.