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OCT has successfully initiated patient recruitment for the clinical trial in a cardio-oncology study in Russia and Ukraine.
A long-term follow-up study for cardiac safety in patients with HER2 positive early or locally-advanced breast cancer was carried out. The patients participated in the core trial and were treated with IMP (proposed trastuzumab biosimilar) or Herceptin as neoadjuvant and adjuvant treatment. The primary objective is to observe the incidence of symptomatic congestive heart failure (CHF) New York Heart Association (NYHA) class II, III, and IV and asymptomatic significant left ventricular ejection fraction (LVEF) decrease in subjects who participated in the core trial.
FU period is 5 years after the last subject will have received the last investigational product. The enrollment target is 193 patients in the Cardiac Safety cohort in Russia and Ukraine; up to 81 patients are to be enrolled in additional Survival Only cohort. The study participants include women who participated in the core trial.
Within this project, the OCT team is responsible for project management, and monitoring and obtaining approval from Local Ethics Committees.
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