This is a phase IV non-interventional clinical study to observe the use of the investigational drug in postmenopausal women with ER+ advanced breast cancer after failure of previous endocrine therapy (ET) in routine clinical practice.
The main objectivel of this study is to collect data in a standardized way in order to prospectively assess Russian trends on current and evolving diagnostic, treatment, and outcome measures in patients with advanced breast cancer treated with the observational drug in country routine practice. Since this is a noninterventional and observational study, there are no mandated visits or treatment regimens, as well as there is no formal hypothesis or sample size calculation. OCT will be preparing descriptive statistical analyses at the end of the study.
The secondary goal of the trial include collection of the safety data of the observational drug and data on drug effectiveness based on patients’ treatment outcomes in the routine clinical practice.
The exploratory objective of the current study is to evaluate the impact of the treatment from the patients’ perspective.
The current clinical trial will be performed in 600 postmenopausal women with ER-positive advanced breast cancer receiving observational medicinal product after previous endocrine therapy. Approximately 100 sites in the Russian Federation will be involved in the current study in order to enroll the necessary number of patients within 36 months. The study has been initiated several months ago and is planned to last for 4 years.
Statistics shows that breast cancer is the most common form of malignancy occurring in women all over the world, and the Russian Federation is not an exception – during the past 5 years a 13,4% increase of morbidity has been noticed. In Russian Federation 10,4% of all newly diagnosed cases of breast cancer are metastatic and 24,3% are locally advanced forms of breast cancer. According to the facts and figures of World Health Organization, treatment for MBC is palliative and median life expectancy after recurrence is between 24 to 30 months or less.
OCT proven track record contains 28 post-marketing (phase IV) studies: we have formed close and trust relationships with a number of principal investigators in a number of medicinal sites all over Russia, Europe and US, in different therapeutic areas.
Oncology is an area OCT has major expertise in (more than 45 trials since 2005), including 10 trials in breast cancer (three of them were post-marketing studies).