Table 1.
Summary of ongoing trials on cancer vaccines enrolling HER2-positive breast cancer patients, as of 23rd June 2021.
| ID | Ph | Platform | Setting | # pts | Intervention | Patient cohort | Target/Moiety | Outcome |
|---|---|---|---|---|---|---|---|---|
| NCT02061423a | 1 | Cell-based | eBC | 7 | 6 HER2 pulsed dendritic cell vaccines injections followed by 3 booster vaccines | Stage I–III HER2-positive BC with residual disease post-neoadjuvant CT | HER2 | Safety (compliance, AEs) |
| NCT00880464a | 1 | Cell-based | eBC | 8 | Irradiated, autologous BC cells engineered by adenoviral mediated gene transfer to secrete GM-CSF | Stage II–III (any subtype) BC who have at least 2 cm of disease after neoadjuvant CT or 4 cm without neoadjuvant CT | GM-CSF release | Safety (DLT) |
| NCT03384914c | 2 | Cell-based and gene-based | eBC | 110 | 9 dendritic cells vaccine injections or 6 WOKVAC vaccine injections | Stage I–III HER2-positive BC treated with neoadjuvant CT without pCR | HER2 | Immune response |
| NCT02297698a | 2 | Peptide-based | eBC | 100 | 6 Nelipepimut-S vaccine injections followed by 4 booster vaccine injections + trastuzumab for one year | HLA-A2+/A3+/A24+/A26+ HER2+ BC at high risk of relapse (no pCR, >3 LNs, 1–3 LNs with ER-/PR-) | HER2 E75 (369–377) | 5-year iDFS |
| NCT04329065c | 2 | Gene-based | eBC | 16 | 3 polyepitope plasmid–based WOKVAC vaccine injections and 3 infusions of paclitaxel + trastuzumab and pertuzumab | Stage I–III ER-/HER2-positive BC before surgery | pUMVC3-IGFBP2-HER2-IGF1R | Immune response |
| NCT04197687c | 2 | Peptide-based | eBC | 480 | 6 TPIV100 vaccine injections + T-DM1 as maintenance therapy, followed by 2 booster vaccine injections | Stage II–III HER2-positive BC who did not achieve pCR after NACT | HER2 | 5-year iDFS |
| NCT00317603a | 1 | Cell-based | mBC | 20 | Irradiated, autologous BC cells engineered by adenoviral mediated gene transfer to secrete GM-CSF | Stage IV BC (any subtype) in II line of treatment | GM-CSF release | Safety (DLT) |
| NCT00393783a | 1 | Gene-based (xenogenic) | mBC | 12 | 5 HER2 ECD DNA vaccine injections ± ET ± trastuzumab (as per local practice) | Stage III–IV HER2-positive BC | HER2 (ECD) | Safety (DLT) |
| (BrEAsT) NCT04296942c |
1 | Viral-based | mBC | 65 | MVA-BN-Brachyury vaccine injections followed by boosters with FPV-BN-Brachyury until disease progression + M7824 + TDM-1 (for HER2+ BC) | Stage IV TNBC and ER-/HER2-positive | Brachyury | ORR |
| NCT00436254a | 1 | Gene-based | mBC | 66 | 3 pNGVL3-hICD vaccine injections | Stage III–IV HER2-positive BC | HER2 | Safety (AEs) Immune response |
| NCT04521764c | 1 | Viral-based | mBC | 33 | 4 MV-s-NAP administered intratumorally | Stage IV BC (any subtype) | Pylori neutrophil activating protein (NAP) | Safety (DLT) |
| NCT01376505c | 1 | Peptide-based | mBC | 100 | 3 MVF-HER-2 (597–626 and 266–296) vaccine injections followed by 6 booster shots | Stage IV HER2-positive BC | HER2 (597–626, 266–296) | Immune response Clinical benefit (tumour markers, RECIST criteria) |
| NCT03689192c | 1 | Peptide-based | mBC | 10 | ARG1 vaccine injections every third week for 45 weeks | Stage IV BC (any subtype) | Arginase-1 | Safety (AEs) |
| NCT04418219b | 1/2 | Cell-based | mBC | 42 | SV-BR-1-GM + cyclophosphamide, pembrolizumab, interferon-alpha-2b for 2 years | Stage IV BC (any subtype)d | GM-CSF release | Safety (AEs) ORR (RECIST 1.1) |
| NCT03632941c | 2 | Viral-based | mBC | 39 | 3 VRP-HER2 vaccine injections + pembrolizumab | ER-/PR-/HER2-positive mBC | HER2 | Immune response (TILs and anti-HER2 Abs) |
| NCT04348747b | 2 | Cell-based | mBC | 23 | 3 anti-HER2/HER3 DCs vaccine injections + celecoxib, recombinant INFalfa-2b, rintatolimod followed by pembrolizumab | TNBC or HER2-positive BC with brain metastasis | HER2/HER3 | CNS ORR |
| NCT03328026c | 2 | Cell-based + TME modulator | mBC | 60 | 4 SV-BR-1-GM + 24 INCMGA00012 vaccine injections ± epacadostat (twice daily) | Stage IV BC (any subtype) | GM-CSF release PD-L1 IDO |
Safety (AEs) |
| NCT00194714b | 2 | Peptide-based | mBC | 26 | 6 HER2 peptide vaccine + trastuzumab | HLA-A2+, HER2-positive stage IV BC | HER2 | Immune response Safety (AEs) |
| NCT02491697a | 2 | Cell-based | mBC | 400 | 4 cycles of DC-CIK treatment (every 1 year) + capecitabine (2500 mg/m2 twice daily for 2 weeks followed by a 1-week rest period q21) | Stage IV BC (any subtype) | CIK cells agonist | 1-year OS |
| NCT04246671c | 2 | Viral-based | mBC | 45 | 3 TAEK-VAC-HerBy vaccine injections + trastuzumab/pertuzumab/T-DM1/anti-PD-L1 (not disclosed) | Stage IV HER2-positive BC (ER+/−) | HER2/neu | Safety (DLT) |
| NCT00722228c | 2 | Cell-based | mBC | 50 | 5 modified autologous or allogenic tumour cells vaccine injections | Stage IV BC (any subtype) | NA | NA |
Abbreviations: ID, identifier; #, number; pts, patients; BC, breast cancer; eBC, early breast cancer; mBC, metastatic breast cancer; DLT, dose-limiting toxicity; HER2, human epidermal growth factor receptor 2; CT, chemotherapy; NACT, neoadjuvant chemotherapy; ET, endocrine therapy; HR, hormone receptor; TPC, treatment of physician's choice; DCIS, ductal carcinoma in situ; TNBC, triple-negative breast cancer; AEs, adverse events; SoC, standard of care; ORR, objective response rate; CNS, central nervous system; PFS, progression-free survival; DFS, disease-free survival; pCR, pathologic complete response; IV, intravenous; LNs, lymph nodes; DCs, dendritic cells; GM-CSF, granulocyte-macrophage colony-stimulating factor; HLA, human leukocyte antigen; iDFS, invasive disease-free survival; MVA-BN, Modified Vaccinia Ankara-Bavarian Nordic; T-DM1, trastuzumab emtasine; MVF, measles virus fusion; ARG1, Arginase 1; VRP, Virus-like replicon particles; CIK, cytokine-induced killer cells; PD-L1, programmed-death ligand 1; IDO, indoleamine-pyrrole 2,3-dioxygenase; TME, tumour microenvironment; INF, interferon alpha; ECD, extracellular domain; IGF1R, insulin-like growth factor 1 receptor; IGFBP2, insulin-like growth factor binding protein 2. Source: clinicaltrials.gov.
Active, not recruiting.
Not yet recruiting.
Recruiting.
This trial has been described in the section dedicated to clinical trials open to BC patients, irrespective of the biological subtype.