3 results
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
Main objective• To determine the safety and tolerability of multiple dosing of SPC3649Secondary objectives• To assess the pharmacokinetics (PK) of multiple dosing of SPC3649 administered by i.v. and s.c. route in healthy volunteers• To evaluate the…
In this feasibility study, we will validate the value of the preoperative [89Zr]trastuzumab PET/CT imaging to identify HER2 positive primary breast cancer and the possibility to predict pathological complete response.