Table 2 Published clinical trials of HER2 + breast cancer patients treated with immunotherapy, early setting
From: Immunotherapy in HER2-positive breast cancer: state of the art and future perspectives
Name | Drug | Phase | Setting | Number of HER2-positive patients | Type of intervention | Mechanism of action | Outcomes |
|---|---|---|---|---|---|---|---|
Benavides et al. [168] | NA | I | Adjuvant | 151* | Vaccine | Peptide-based vaccine (E75) | -Immune response (p = 0.02) -DFS (p = 0.4 LE; p = 0.7 OE) -Mortality (p = 0.08 LE; p = 0.6 OE) |
Carmicheal et al. [169] | NA | I | Adjuvant | 18 | Vaccine | Peptide-based vaccine (GP2) | -Safety -Immune response (p = 0.000004) |
Holmes et al. [170] | NA | I | Adjuvant | 15 | Vaccine | Peptide-based vaccine (AE37) | Immunological response |
Limentani et al. [171] | NA | I | Adjuvant | 61 | Vaccine | Recombinant HER2 protein + immunostimulant | Immunological response |
Peoples et al. [172] | NA | NA | Adjuvant | 53 | Vaccine | Peptide-based vaccine (E75) | DFS (p < 0.19) |
Mittendorf et al. [173] | Nelipepimut-S | I/II | Adjuvant | 187 | Vaccine | Peptide-based vaccine (E75) | DFS (p = 0.08) |
Patil et al. [174] | NA | I/II | Adjuvant | 52 (28% of all patients) | Vaccine | Peptide-based vaccine (E75) | -Immunological response -DFS (0.52) |
NA | NA | Adjuvant | 186 | Vaccine | Peptide-based vaccine (E75) | -Immunological response -DFS (p = 0.04 20 months; p = 0.08 24 months) | |
Mittendorf et al. [177] | NA | II | Adjuvant | 101 | Vaccine | Peptide-based vaccine (GP2) | DFS (p = 0.43) |
Clifton et al. [178] | NA | I | Adjuvant | 17 | Vaccine | Peptide-based vaccine (GP2) | Immunological response |
Mittendorf et al. [179] | NA | II | Adjuvant | 144 | Vaccine | Peptide-based vaccine (AE37) | -DFS (p = 0.45) -Immunological response |
Higgins et al. [180] | NA | I | Neoadjuvant | 15 (25% of total patients) | Vaccine | Wilms’ tumor 1 (WM1) immunotherapeutic | -Objective response rate -Immunogenicity |
Valdes-Zayas et al. [181] | NA | III | Adjuvant | 22 (25% of total evaluated patients) | Vaccine | Anti-ganglyoside vaccine (NeuGcGM3) | Immunological response |
Czerniecki et al. [182] | NA | I | Neoadjuvant | 13 | Vaccine | Dendritic cell based vaccine | Immunological response |
Koski et al. [183] | NA | I | Neoadjuvant | 27 | Vaccine | Dendritic cell-based vaccine | -Immunological response |
Lowenfeld et al. [184] | NA | I | Neoadjuvant | 54 | Vaccine | Dendritic cell-based vaccine | -Immunological response -pCR |