Table 1.

Cancer vaccines currently evaluated in TNBC for safety/efficacy, based on included results. Non-randomized trials are marked with asterisks.

Vaccine Name	Trial ID	Phase	Platform	Target Antigen	Adjuvant	Co-Therapies	Population	Outcomes	Reference
AE37	NCT00524277	2	Peptide	HER2 1	GM-CSF 2	-	Node positive, high-risk node-negative BC 3	DFS 4, safety	Full-text [25,26] Abstract [27,28,29,30,31]
GP2	NCT00524277	2	Peptide	HER2	GM-CSF	-	Node positive, high-risk node-negative BC	DFS, safety	Full-text [26] Abstract [32]
Nelipepimut-S	NCT01570036	2	Peptide	HER2	GM-CSF	Trastuzumab	Invasive BC, HER2-low	DFS, safety, IR 5	Full-text [33,34] Abstract [35,36,37,38]
Tecemotide	EudraCT2011-004822-85	2	Peptide	MUC1 6	Monophosphoryl lipid A	Chemotherapy (E 7 C 8 + D 9)	Early invasive BC	RCB 10, pCR 11, safety, QoL 12	Full-text [39]
AS/OBI-821	NCT01516307	2	Peptide	Globo-H	OBI-821	Cyclophosphamide	m 13 BC	PFS 14, OS 15, IR, safety	Full-text [40]
PVX-410	NCT02826434 *	1	Peptide	XBP1 16, CD138, CS-1	Poly-ICLC, montanide	Durvalumab	e 17 TNBC	Safety, IR	Abstract [41]
	NCT03362060 *	1	Peptide	XBP1, CD138, CS-1	Poly-ICLC, montanide	Pembrolizumab	mTNBC	Safety, IR, CBR 18, DCR 19, DoR 20, PFS, OS	Abstract [42]
H/K-HELP	UMIN000003489 *	1	Peptide	Survivn	OK-432, montanide	-	Advanced solid tumors, including mTNBC	IR, safety	Full-text [43] Abstract [44]
Personalized peptide vaccination (PPV)	UMIN000001844 *	2	Peptide	Up to 4 antigens	Montanide ISA 51	SoC 21 chemotherapy/RT 22	mBC	IR, safety, PFS, OS	Full-text [45] Abstract [46,47,48]
KRM-19	UMIN000014616 *	2	Peptide	Combination 19 antigens	Montanide ISA 51	-	mTNBC	Safety, PFS, IR	Full-text [49] Abstract [50]
Multipeptide active immunotherapy	N/S *	1	Peptide	Combination 22 antigens	N/S	Chemotherapy (Oxaliplatin, doxorubicin)	Ovarian cancer, soft sarcoma, pancreatic cancer, TNBC	Safety, IR	Abstract [51]
Tumor lysate-pulsed DC 23 vaccine	NCT01431196 * EudraCT 2009-017402-36	2	Dendritic Cell	Whole tumor cells	-	NAC 24 (dd 25 EC+ D)	eBC, HER2-negative	Safety, pCR, OS, IR	Full-text [52] Abstract [53,54]
Antigen-loaded DC vaccine	NCT02018458	1	Dendritic Cell	Cyclin B1, WT1 26, CEF	-	dd A 27 C + T 28 Cb 29	Locally advanced TNBC	Safety, local pCR, IR	Abstract [55,56,57]
RO7198457 (iNEST)	NCT03289962 *	1	RNA	Personalized neoantigens	-	Atezolizumab	Locally advanced/m solid tumors	Safety, IR, ORR 30	Abstract [58]
p53MVA	NCT02432963 *	1	DNA (MVA 31)	p53	-	Pembrolizumab	Advanced breast, pancreatic, hepatocellular, H&N 32 tumors	Safety, IR, RR 33	Full-text [59,60] Abstract [61]
NANT cancer vaccine (NCV)	NCT03387085 *	1	DNA (Adenovirus/yeast)	CEA 34, MUC1, brachyury, HER2, and RAS	-	Low dose chemo, SBRT 35, N-803, avelumab, haNK cells 36	mTNBC	Safety, ORR, DCR 37, PFS, OS	Abstract [62,63,64]
Elenagen	trial #506, Protocol E001 *	1/2	DNA (Plasmid)	p62	-	SoC chemo (C/M 38/F 39)	Metastatic breast, colon, renal, lung, and ovarian cancers, and melanoma	Safety, RR	Full-text [65,66]

¹ HER2: human epidermal growth factor receptor 2; ² GM-CSF: granulocyte-macrophage colony-stimulating factor; ³ BC: breast cancer; ⁴ DFS: disease-free survival; ⁵ IR: immune response; ⁶ MUC1: mucin 1; ⁷ E: epirubicin; ⁸ C: cyclophosphamide; ⁹ D: docetaxel; ¹⁰ RCB: residual cancer burden; ¹¹ pCR: pathological complete response; ¹² QoL: quality of life; ¹³ m: metastatic; ¹⁴ PFS: progression-free survival; ¹⁵ OS: overall survival; ¹⁶ XBP1: X-box binding protein 1; ¹⁷ e: early; ¹⁸ CBR: clinical benefit rate; ¹⁹ DCR: disease control rate; ²⁰ DoR: duration of response; ²¹ SoC: standard of care; ²² RT: radiotherapy; ²³ DC: dendritic cell; ²⁴ NAC: neoadjuvant chemotherapy; ²⁵ dd: dose-dense; ²⁶ WT1: Wilm’s tumor 1; ²⁷ A: doxorubicin; ²⁸ T: paclitaxel, ²⁹ Cb: carboplatin; ³⁰ ORR: objective response rate; ³¹ MVA: modified vaccinia virus Ankara; ³² H&N: head and neck; ³³ RR: response rate; ³⁴ CEA: carcinoembryonic antigen; ³⁵ SBRT: stereotactic body radiation therapy; ³⁶ haNK cells: high-affinity natural killer cells; ³⁷ DCR: disease control rate; ³⁸ M: methotrexate; ³⁹ F: fluorouracil.