drugset / Trial / NCT05188313
TRAstuzumab and Pertuzumab for HER2+ Resectable Oesophageal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
Despite treatment according to the CROSS-regimen, median overall survival is less than four years (2.3 QALYs). The burden of disease is within the highest category (0.71 to 1.0). Also, no targeted treatment options are currently available, hampering personalized treatment for this patient population. TRAP-2 aims to address these needs by investigating whether addition of trastuzumab and pertuzumab to standard of care improves survival of patients with resectable HER2 positive esophageal adenocarcinoma (HER2+ EAC). Patients with HER2+ EAC will be randomised to neoadjuvant chemoradiation according to the CROSS regimen or CROSS + TRAstuzumab and Pertuzumab. Primary outcome is overall survival.
Timeline
- Start
- 2022-03-09
- Primary completion
- 2027-07
- Completion
- 2037-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pertuzumab | Monoclonal antibody | 840 mg | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | Carboplatin | Small molecule | 2 unknown | Intravenous |
| Background | Paclitaxel | Small molecule | 50 mg/m2 | Intravenous |