This is a prospective, multicenter, noninterventional, observational study in postmenopausal women with ER+ advanced breast cancer (ABC) receiving the observational drug in combination with aromatase inhibitor (AI) after failure of previous endocrine therapy (ET) in routine practice.
The main goal 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 ABC treated with the observational drug in combination with AI in an early line of their treatment path for ABC 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. The statistical analyses for such kinds of studies, including this one, are usually mainly descriptive.
The secondary objectives include collecting of the safety data of the observational drug and data on patients’ treatment outcomes (drug effectiveness) in the routine clinical practice.
The exploratory objective of the current study is to evaluate the impact of the treatment from the patients’ perspective.
This registry will be performed in 600 postmenopausal women with ER-positive advanced breast cancer receiving observational medicinal product in combination with AI after previous endocrine therapy. This number of patients is planned to be recruited from approximately 100 sites in the Russian Federation within the enrollment period of 36 months. The foreseen total duration of the study is 4 years.
OCT has serious experience in conducting post-marketing clinical trials – 28 phase IV studies has been conducted by OCT during the last 8 years, and 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 40 trials since 2005), including 10 trials in breast cancer (three of them were post-marketing studies).
Breast cancer is the most common form of malignancy occurring in women. In Russian Federation approximately 20% (57,241) of all new cases of cancer that were diagnosed in 2010 were breast cancer. An increase of morbidity is 13,4% as compared with 2005. 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. Treatment for MBC is palliative and median life expectancy after recurrence is between 24 to 30 months or less (World Health Organization Facts and Figures).