Clinical trials testing the association of checkpoint inhibitors and HER2-targeted treatment in HER2 + BC

StudyPhaseSettingTreatmentN. PatientsPrimary outcome evaluated
NCT02605915 Cohort 2AIbNeoadjuvantHER2+ BCAtezolizumab/Trastuzumab/Pertuzumab followed by docetaxel + carboplatin + trastuzumab + pertuzumab98 entire trial (recruiting)Safety
NCT02605915 Cohort 2BIbNeoadjuvantHER2+ BCAtezolizumab + T-DM1 followed by docetaxel + carboplatin + trastuzumab + pertuzumab
NCT02605915 Cohort 1AIblocally advanced or mHER2+ BCAtezolizumab/Trastuzumab/Pertuzumab
NCT02605915 Cohort 1B-C-DIblocally advanced or mHER2+ BCAtezolizumab + T-DM1
NCT02605915 Cohort 1FIblocally advanced or mHER2 + BCAtezolizumab/Trastuzumab/Pertuzumab/ Docetaxel
NCT03032107ImHER2+ BCT-DM1 + Pembrolizumab27 (recruiting)Safety
NCT02649686IbmHER2+ BCTrastuzumab + Durvalumab15 (active, not recruiting)Safety
NCT03272334I/IImHER2 + BCPembrolizumab + Anti-CD3 x Anti-HER2 Armed Activated T Cells33 (recruiting)Safety
NCT02129556 (PANACEA)Ib/IIUnresectable or mHER2+ BCPembrolizumab + Trastuzumab58 (active, not recruiting)Phase I: SafetyPhase II: Response by RECIST
NCT03417544IImHER2+ BC with brain mtsAtezolizumab + trastuzumab + pertuzumab33 (recruiting)Overall Response Rate by RANO-BM criteria
NCT03125928IIUnresectable or mHER2+ BCAtezolizumab + paclitaxel + trastuzumab + pertuzumab50 (recruiting)Safety and Response by RECIST
NCT03414658IImHER2 + BC progressed to prior trastuzumab and pertuzumabRandomized:-Trastuzumab/Vinorelbine-Trastuzumab/Vinorelbine+Avelumab- Trastuzumab/Vinorelbine+Avelumab +Utomilumab100 (recruiting)PFS
NCT03199885IIImHER2 + BCRandomized:-Paclitaxel/Trastuzumab/Pertuzumab + Pembrolizumab-Paclitaxel/Trastuzumab/Pertuzumab480 (not yet recruiting)PFS

BC breast cancer, mBC metastatic breast cancer, N number, PFS progression-free survival, RANO-BM response assessment in neuro-oncology – brain metastases