Amsterdam

Researchers are evaluating the effectiveness and safety of sacituzumab govitecan-hziy (SG) combined with pembrolizumab compared to the treatment chosen by a doctor, which may be pembrolizumab alone or pembrolizumab with capecitabine. This study focuses on patients with triple negative breast cancer who still have invasive cancer remaining after surgery and pre-surgical treatment. The study is a phase 3, randomized, open-label trial designed to assess outcomes in this patient group. Participants receive sacituzumab govitecan-hziy and pembrolizumab through intravenous infusion as the experimental treatment. The comparison group receives the physician's choice of treatment, which involves either pembrolizumab alone intravenously or pembrolizumab combined with oral capecitabine tablets. Both treatment options follow surgery and prior therapy, targeting residual invasive disease. Throughout the study, participants are monitored up to 60 months to measure invasive disease-free survival, which indicates the time without cancer recurrence or progression. Researchers will track treatment safety and effectiveness through regular assessments. The study involves tissue sample submissions from before and after neoadjuvant therapy and surgery, performance status evaluations, organ function tests, and recovery status from surgery and radiotherapy.