Table 3.
Summary of ongoing trials on cancer vaccines enrolling patients with HR-positive BC, as of 23rd June 2021.
| ID | Ph | Platform | Setting | # of pts | Intervention | Patient cohort | Target/Moiety | Outcome |
|---|---|---|---|---|---|---|---|---|
| NCT04270149c | 1 | Peptide-based | eBC | 18 | 6 ESR1 peptides vaccine injections | HLA-A0201+ with at least pT3 (any N) ER+ (any HER2) BC following standard treatment | ESR1 | Safety (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) who have at least 2 cm of disease after neoadjuvant CT or 4 cm without neoadjuvant CTd | GM-CSF release | Safety (DLT) |
| NCT02204098c | 1 | Gene-based | eBC | 56 | 3 Mammaglobin-A DNA vaccine injections + CT/ET | cT2-T4 (any N) ER+/HER2-negative BC undergoing neoadjuvant therapy | Mammaglobin-A | Safety (AEs) |
| NCT02780401a | 1 | Gene-based | eBC | 24 | 3 polyepitope plasmid–based WOKVAC vaccine injections | Stage I–III HER2-negative and node-positive BC after standard treatment | pUMVC3-IGFBP2-HER2-IGF1R | Safety (AEs) |
| NCT02364492a | 1 | Peptide-based | eBC | 20 | 6 MAG-Tn3 vaccine injections | TNBC (any T/N) or ER+/HER2- (with at least one lymph node), following standard treatment | Tn carbohydrate antigen | Safety (DLT) |
| NCT02229084c | 2 | Peptide-based | eBC | 61 | 3 P10s-PADRE injections + neoadjuvant CT with different schedules | Stage I–III ER+/HER2-negative BC who undergo neoadjuvant CT | Carbohydrate mimetic peptide P10s | Safety Immune response Clinical response (pCR) |
| NCT03804944c | 2 | Peptide-based | eBC | 100 | CDX-301 + pembrolizumab + radiotherapy | Post-menopausal stage II–III ER+/HER2− BC before surgery | Ftl-3 (binds to CD135) | Safety (AEs) Clinical response rate pCR |
| NCT02157051c | 1 | Gene-based | mBC | 40 | 3/6/9 polyepitope plasmid DNA vaccine injections followed by 1 or 2 booster vaccine injections | Stage III–IV HER2-negative BC | CD105/Yb-1/SOX2/CDH3/MDM2 | Safety (AEs) Immune efficacy |
| 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 treatmentd | GM-CSF | Safety (DLT) |
| NCT04521764c | 1 | Viral-based | mBC | 33 | 4 MV-s-NAP administered intratumorally | Stage IV BC (any subtype)e | Pylori NAP | Safety (DLT) |
| 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)e | GM-CSF release | Safety (AEs) ORR (RECIST 1.1) |
| 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)e | GM-CSF release PD-L1 IDO |
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)e | Cytokine-induced killer cells agonist | 1-year OS |
| NCT00722228c | 2 | Cell-based | mBC | 50 | 5 modified autologous or allogenic tumour cells vaccine injections | Stage IV BC (any subtype) | N/A | N/A |
Abbreviations: ID, identifier; ph, phase; #, number; mBC, metastatic breast cancer; eBC, early breast cancer; pCR, pathologic complete response; OS, overall survival; TNBC, triple-negative breast cancer; AE, adverse events; DLT, dose-limiting toxicity; GM-CSF, granulocyte-macrophage colony-stimulating factor; DNA, deoxyribonucleic acid; CT, chemotherapy; ET, endocrine therapy; ER, oestrogen receptor; HER2, human epidermal growth factor receptor 2; SoC, standard of care; IGF1R, insulin-like growth factor receptor 1; IV, intravenous; ORR, objective response rate; XBP1, X-box–binding protein 1; SLAMF7, SLAM family member 7; SOX2, (sex determining region Y)-box 2; CDH3, cadherin-3; PD-L1, programmed-death ligand 1; IDO, indoleamine-pyrrole 2,3-dioxygenase; WT1, Wilms' tumour protein; DC, dendritic cell; CIK, cytokine-induced killer; NAP, neutrophil-activating protein; 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 already been described in the section dedicated to vaccines targeting HER2 in breast cancer.
This trial has been described in the section dedicated to clinical trials open to BC patients, irrespective of the biological subtype.