Clinical trials testing the association of checkpoint inhibitors and HER2-targeted treatment in HER2 + BC
| Study | Phase | Setting | Treatment | N. Patients | Primary outcome evaluated |
|---|---|---|---|---|---|
| NCT02605915 Cohort 2A | Ib | NeoadjuvantHER2+ BC | Atezolizumab/Trastuzumab/Pertuzumab followed by docetaxel + carboplatin + trastuzumab + pertuzumab | 98 entire trial (recruiting) | Safety |
| NCT02605915 Cohort 2B | Ib | NeoadjuvantHER2+ BC | Atezolizumab + T-DM1 followed by docetaxel + carboplatin + trastuzumab + pertuzumab | ||
| NCT02605915 Cohort 1A | Ib | locally advanced or mHER2+ BC | Atezolizumab/Trastuzumab/Pertuzumab | ||
| NCT02605915 Cohort 1B-C-D | Ib | locally advanced or mHER2+ BC | Atezolizumab + T-DM1 | ||
| NCT02605915 Cohort 1F | Ib | locally advanced or mHER2 + BC | Atezolizumab/Trastuzumab/Pertuzumab/ Docetaxel | ||
| NCT03032107 | I | mHER2+ BC | T-DM1 + Pembrolizumab | 27 (recruiting) | Safety |
| NCT02649686 | Ib | mHER2+ BC | Trastuzumab + Durvalumab | 15 (active, not recruiting) | Safety |
| NCT03272334 | I/II | mHER2 + BC | Pembrolizumab + Anti-CD3 x Anti-HER2 Armed Activated T Cells | 33 (recruiting) | Safety |
| NCT02129556 (PANACEA) | Ib/II | Unresectable or mHER2+ BC | Pembrolizumab + Trastuzumab | 58 (active, not recruiting) | Phase I: SafetyPhase II: Response by RECIST |
| NCT03417544 | II | mHER2+ BC with brain mts | Atezolizumab + trastuzumab + pertuzumab | 33 (recruiting) | Overall Response Rate by RANO-BM criteria |
| NCT03125928 | II | Unresectable or mHER2+ BC | Atezolizumab + paclitaxel + trastuzumab + pertuzumab | 50 (recruiting) | Safety and Response by RECIST |
| NCT03414658 | II | mHER2 + BC progressed to prior trastuzumab and pertuzumab | Randomized:-Trastuzumab/Vinorelbine-Trastuzumab/Vinorelbine+Avelumab- Trastuzumab/Vinorelbine+Avelumab +Utomilumab | 100 (recruiting) | PFS |
| NCT03199885 | III | mHER2 + BC | Randomized:-Paclitaxel/Trastuzumab/Pertuzumab + Pembrolizumab-Paclitaxel/Trastuzumab/Pertuzumab | 480 (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