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Table 3 Clinical trials testing the association of checkpoint inhibitors and HER2-targeted treatment in HER2 + BC

From: Interaction of host immunity with HER2-targeted treatment and tumor heterogeneity in HER2-positive breast cancer

Study Phase Setting Treatment N. Patients Primary outcome evaluated
NCT02605915 Cohort 2A Ib Neoadjuvant
Atezolizumab/Trastuzumab/Pertuzumab followed by docetaxel + carboplatin + trastuzumab + pertuzumab 98 entire trial (recruiting) Safety
NCT02605915 Cohort 2B Ib Neoadjuvant
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: Safety
Phase 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+Avelumab +Utomilumab
100 (recruiting) PFS
NCT03199885 III mHER2 + BC Randomized:
-Paclitaxel/Trastuzumab/Pertuzumab + Pembrolizumab
480 (not yet recruiting) PFS
  1. BC breast cancer, mBC metastatic breast cancer, N number, PFS progression-free survival, RANO-BM response assessment in neuro-oncology – brain metastases