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Trial Description
| Title | OPTimizing adjuvant prescription of PEMBROlizumab in patients with early-stage triple-negative breast cancer achieving pathologic complete response after standard neoadjuvant chemotherapy and pembrolizumab |
| Participants (P) | OPT-PEMBRO will enrol patients with early-stage, non-metastatic TNBC who experienced pCR after a neoadjuvant chemotherapy plus pembrolizumab regimen |
| Intervention (I) | Observation (suspension of current standard pembrolizumab adjuvant treatment [9 cycles in 6 months]). |
| Control (C) | Pembrolizumab, 200 mg, every 3 weeks for up to 6 months, 9 cycles. Or Pembrolizumab, 400 mg, every 6 weeks for up to 6 months, 4 cycles [standard of care]. |
| Outcome (O) | Determine the non-inferiority of observation compared to 6 months of adjuvant pembrolizumab after surgery in terms of event-free survival (EFS) in patients who experienced pCR after a course of treatment combining neoadjuvant chemotherapy and pembrolizumab |
| Trial Design | The OPT-PEMBRO trial is a pragmatic, international, prospective, randomised (1:1), non-inferiority, multicenter, open-label Phase III clinical trial, mapping onto standard practice in Europe |
| Sample Size | 2454 (200 in Belgium) |
| Trial duration | 174 months (Primary endpoint after 108 months) |
| Budget | 1.48 Mio € |
Trial team
| Sponsor | Unicancer |
| Chief Investigator | François Duhoux (UCL St Luc – Brussels) |
| External partners | France, Greece, Romania, Bulgaria, Germany, Spain, Switzerland, United Kingdom, Norway, Japan, Italy, Georgia, Argentina, Ireland, Canada |
| Number of participating sites | 10 (+2 optional) in Belgium |
