Severodvinsk

Researchers are conducting a national, multi-center, prospective study to collect real-world data on patients in the Russian Federation with advanced and aggressive endometrial cancer, specifically stage III-IV disease. The study focuses on molecular profiling markers such as POLE mutations, dMMRpMMR, p53 abnormalities, HER2 expression, and PD-L1 status, alongside demographic and clinical characteristics. It aims to understand first-line postoperative treatment approaches in these patients. The study involves no additional procedures beyond routine clinical practice. Patients provide archival tumor tissue samples obtained from biopsy or post-operative formalin-fixed paraffin-embedded FFPE blocks for molecular testing. Testing uses immunohistochemistry IHC for certain markers and next-generation sequencing NGS or polymerase chain reaction PCR for POLE mutations. Data will be collected at two visits a baseline visit to gather clinical and demographic information and tissue testing results, and a final visit 6 months later or at disease progression to collect follow-up treatment and progression data. Participants data and outcomes will be recorded in an electronic case report form. The study measures include rates of positive molecular markers and various clinical and treatment-related outcomes over 24 to 33 months. Approximately 500 patients will be enrolled across about 30 sites. The overall study duration is about 27 months or until data collection for all patients is complete.

Researchers are evaluating the effectiveness, safety, how the body processes, and immune response to BCD-236 combined with chemotherapy in women with relapsed or metastatic triple negative breast cancer TNBC who have received previous treatments. This is a Phase 2 study that compares BCD-236 plus chemotherapy versus chemotherapy alone in patients whose cancer has returned or progressed after earlier therapies. Participants will be randomly assigned to one of two groups one receiving BCD-236 by intravenous infusion plus chemotherapy chosen by the investigator, and the other receiving chemotherapy alone. Treatment continues until the cancer worsens, side effects become intolerable, or the study ends. During the study, participants will undergo regular assessments including tumor measurements and health evaluations to monitor response and side effects. The main outcome measured is the overall response rate at 24 weeks, with secondary outcomes including progression-free survival, overall survival, disease control rate, time to response, and duration of response assessed at various times up to 102 weeks. Participants will be monitored closely throughout their treatment and follow-up periods.