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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