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Table 2 Active trials testing immune optimized anti-HER2 treatments for HER2+ BC

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

Strategy Tested Study Phase Setting Treatment N. Patients
Immune-optimized anti-HER2 antibodies SOPHIA NCT02492711 III HER2+ mBC progressed on HER2-targeted treatment Randomized:
-Chemotherapy+ Margetuximab
-Chemotherapy+ Trastuzumab
530 (active, not recruiting)
Bispecific antibodies NCT02829372 I Progressive HER2+ Solid Tumors GBR1302 (CD3/HER2 bispecific mAb) 60 (recruiting)
Vaccines NCT03387553 I During neoadjuvant treatment (HER2+ BC) HER-2 Pulsed Dendritic cell vaccine 24 (recruiting)
NCT02061423 I Post-neoadjuvant residual disease HER-2+ BC HER-2 Pulsed Dendritic cell vaccine 7 (active, not recruiting)
NCT02063724 I Adjuvant (High Risk HER2+ BC) HER-2 Pulsed Dendritic cell vaccine 15 (active, not recruiting)
NCT00436254 I Stage III-IV HER2+ BC or OC pNGVL3-hICD vaccine (plasmid-based DNA vaccine) + GM-CSF 66 (active, not recruiting)
NCT01730118 I Solid tumors with 1–3+ HER2/Neu Expression Adenoviral Transduced Autologous HER2/Neu Dendritic Cell Vaccine 65 (recruiting)
NCT01376505 I Advanced solid tumors Synthetic peptides of HER-2 comprising B cell epitopes with a Promiscuous T cell epitope of Measles Virus 36 (recruiting)
NCT01355393 I/II Stage II-IV HER2+ BC HER-2/neu peptide vaccine + rintatolimod and/or GM-CSF 50 (active, not recruiting)
NCT00194714 I/II Stage IV HLA-A2+ HER2+ BC or OC receiving Trastuzumab HER2 cytotoxic T-cell peptide-based vaccine 20 (enrolling by invitation)
NCT01922921 I/II Stage IV HER2+ BC receiving HER2-targeted mAb Randomized:
-HER2 ICD peptide-based vaccine+polysaccharide-K
-HER2 ICD peptide-based vaccine+Placebo
31 (active, not recruiting)
NCT00343109 II HER2+ stage IIIB- IV BC receiving trastuzumab HER-2/neu intracellular domain peptide-based vaccine mixed with GM-CSF 38(active, not recruiting)
NCT00266110 II HLA-A0201+ HER2+ mBC Dendritic cell Vaccine + GM-CSF + trastuzumab + vinorelbine 17(active, not recruiting)
NCT03384914 II Adjuvant HER2+ BC Randomized:
-Dendritic Cell (DC1) Vaccine
-pUMVC3-IGFBP2-HER2-IGF1R (WOKVAC)
110 (recruiting)
NCT00640861 NA Treated Stage II/III MUC1+ HLA-A2+ BC Randomized: combinations of MUC1/HER-2/Neu Peptide Based Immunotherapeutic Vaccines 45 (active, not recruitng)
NCT02297698 II Adjuvant (High Risk HER2+ BC) Randomized:
Trastuzumab/GM-CSF +/− nelipepimut-S
100 (recruiting)
Immune-stimulating agents concomitantly with trastuzumab NCT03571633 II Operable HER2+ BC Randomized:
Paclitaxel/trastuzumab +/− Pegfilgrastim
90 (not yet recruiting)
NCT03112590 I/II HER2+ BC IFN-γ + Paclitaxel+Pertuzumab+Trastuzumab 48 (recruiting)
Cellular immunotherapy NCT02843126 I/II Recurrent HER2 + BC Randomized:
Trastuzumab +/− NK immunotherapy
30 (recruiting)
NCT02713984 I/II Relapsed or refractory HER2+ solid tumors anti-HER2 CAR-modified T cells 60 (recruiting)
  1. BC breast cancer, CAR chimeric antigen receptor, GM-CSF granulocyte-macrophage colony-stimulating factor, HLA human leukocyte antigen, ICD intracellular domain, IFN- γ interferon gamma, mAb monoclonal antibody, mBC metastatic breast cancer, MUC1 mucin1, N number, NA not available, NK natural killer, OC ovarian cancer