Table 1 Clinical trials of immunotherapy in TNBC

NCT02447003

Pembrolizumab

Metastatic TNBC

ORR in ITT: 5.3%; ORR in patients with PD-L1+: 5.7%; mPFSb : 2.0 m; mOSb : 9.0 m

[54]

KEYNOTE-012

Pembrolizumab

Metastatic TNBC

ORR: 18.5%; mPFS: 1.9 m; mOS: 11.2 m

[53]

NCT01375842

Atezolizumab

Metastatic TNBC

ORR in ITT: 10.0%; ORR in patients with PD-L1+: 12.0%;

mPFSb: 1.4 m; mOSb : 8.9 m

[58]

NCT01772004

Avelumab

Metastatic TNBC

ORR in ITT: 5.2%; ORR in patients with PD-L1+: 44.0%; mPFSb : 1.4 m; mOSb : 9.2 m

[59]

NCT02838823

JS001

Metastatic TNBC

ORR in ITT: 5.0%; ORR in patients with PD-L1+: 11.1%; ORR in patients with PD-L1– tumours: 0%; mPFSb : 1.8 m

[57]

NCT02447003

Pembrolizumab

Metastatic TNBC

ORR: 21.4%; mPFS: 2.1 mo; mOS: 18 m

[162]

Durvalumab + Tremelimumab

Metastatic TNBC

Induce plasma cells to produce specific antibodies, Activated and Increased T cell

[66]

NCT02657889

Pembrolizumab + Niraparib

Advanced/metastatic TNBC

ORR 21%, DCR 49%

[94]

NCT03330405

ICIs + Avelumab + Talazoparib

Advanced TNBC

ORR = 18.2%

[95]

NCT0265788

Niraparib + Pembrolizumab

Advanced/Metastatic TNBC

ORR in ITT: 29.0%; ORR in patients with

PD-L1 + tumors 32%

[94]

NCT03394287

Camrelizumab + VEGFR2 inhibitors

Advanced TNBC

shown good efficacy in patients with PD-L1 negative tumors or those receiving advanced lines of chemotherapy

[100]

NCT02555657

Pembrolizumab vs. TPCe

Metastatic TNBC

ORR in patients with CPS ≥ 10: 17.7% vs. 9.2%; mPFS in patients with CPS ≥ 10: 2.1 mo vs. 3.4 m; mOS in patients with CPS ≥ 10: 12.7 m vs. 11.6 m (P = 0.06)

[163]

NCT03310957

Ladiratuzumab vedotin + Pembrolizumab

Metastatic TNBC

ORR: 54.0%

[164]

NCT03742102

Durvalumab + Trastuzumab deruxtecan

Metastatic TNBC

ORR: 66.7%

[165]

NCT02513472

Eribulin + Pembrolizumab

Metastatic TNBC

ORR overall: 23.4%; ORR in patients with

PD-L1 + tumors, first-line setting: 34.5%;

[166]

NCT02734004

Olaparib + Durvalumab

Metastatic TNBC

ORR: 58.8%; mPFS: 4.9 m; mOS: 20.5 m

[96]

NCT03752723

GX-I7 + Pembrolizumab

Metastatic TNBC

ORR: 13.3%

[167]

NCT02708680

Entinostat + Atezolizumab

Metastatic TNBC

ORR: 10.0%; mPFS: 1.68 m; mOS: 9.4 m

[107]

NCT03797326

Lenvatinib + Pembrolizumab

Metastatic TNBC

ORR: 29.0%

[168]

NCT02819518

TPCg + Pembrolizumab/Placebo

Metastatic TNBC

ORR (co-primary end point) in patients with CPS > 10: 53.2% vs. 39.8%

[81, 169]

NCT01042379

Paclitaxel with or without Pembrolizumab + adjuvant chemotherapy

Early-stage TNBC

pCR rate: 60% vs. 22%

[170]

NCT02685059

Nab-paclitaxel + Durvalumab/Placebo

+Endocrine therapy

+Durvalumab/Placebo

Early-stage TNBC

pCR rate in ITT: 53.4% vs. 44.2% (P = 0.29); pCR rate in patients with PD-L1 + on IC: 58.0% vs. 50.7%

[75, 76]

NCT02622074

Pembrolizumab + Anthracycline

+ Taxane-based Chemotherapy with or without Carboplatin + Adjuvant chemotherapyc

Early-stage TNBC

pCR rate overall: 60%; pCR rate in patients with CPS > 1: 64%; pCR rate in patients with CPS > 30: 72%

[72]

NCT03197935

Nab-paclitaxel + Atezolizumab /Placebo + Adjuvant chemotherapy+

Atezolizumab/Placebo

Early-stage TNBC

pCR rate in ITT: 58% vs. 41% (P = 0.004); pCR rate in patients with PD-L1 + on IC: 69% vs. 49% (P = 0.02);

[78]

NCT03036488

Anthracycline, taxane and carboplatin-based chemotherapy +

Pembrolizumab/Placebo + Adjuvant Chemotherapy/Endocrine therapy

Early-stage TNBC

pCR rate: 63.0% vs. 55.6%

[73]

NCT02620280

Nab-paclitaxel + Carboplatin with or

without Atezolizumab

Early-stage TNBC

pCR rate in ITT: 43.5% vs. 40.8%; pCR rate in patients with PD-L1 + on IC: 51.9% vs. 48.0%

[77]

NCT02819518

Pembrolizumab + Chemotherapy

Advanced TNBC

mOS was higher than placebo-chemotherapy group

[80]

NCT01633970

Nab-paclitaxel

+Atezolizumab

Metastatic TNBC

ORR in ITT: 39.4%; mPFSb : 5.5 m; mOSb : 14.7 m

[171]

NCT03800836

Ipatasertib + Atezolizumab + Paclitaxel/ Nab-paclitaxel

Metastatic TNBC

ORR in ITT: 73.0%; ORR in patients with PD-L1 + tumors: 82%

[105]

NCT04129996

Angiogenesis inhibitor + Camrelizumab + Chemotherapy

Advanced immunomodulatory TNBC patients

objective response rate was 81.3%, mPFS was 13.6 m, PFS was higher in CD8 + than in CD8- patients

[101]

NCT02322814

Cobimetinib + Atezolizumab

+Paclitaxel/Nab-paclitaxel

Metastatic TNBC

ORR overall: 31.7%; ORR in patients with PD-L1 + tumors: 44% with paclitaxel, 33%

with nab-paclitaxel

[108]

NCT02425891

Nab-paclitaxel + Atezolizumab/Placebo

Metastatic TNBC

ORR in ITT: 56.0% vs. 45.9% (P = 0.002); ORR in patients with PD-L1 + tumors: 58.9%

vs. 42.6% (P = 0.002)

[172]

NCT03125902

Paclitaxel + Atezolizumab/Placebo

Metastatic TNBC

ORR in ITT: 53.6 vs. 47.5; ORR in patients with PD-L1 + tumors: 63.4% vs. 55.4%

[173]

NCT02299999

Durvalumab vs. Chemotherapy

Metastatic TNBC

mOS in all patients with TNBC: 21.2 m vs. 14 m (P = 0.04); mOS in patients with PD-L1 + tumors: 27.3 m vs. 12.1 m

(P = 0.07)

[174]

NCT04674306

α- lactalbumin engineered vaccine

TNBC

Ongoing

[121]

NCT03562637

Adagloxad Simolenin(OBI-822/OBI-821)

High risk early Globo-H positive TNBC

Longer PFS in vaccinated patients who developed anti-Globo H (anti-GH) IgG

[120]

NCT02427581

Personalized peptide vaccine

Metastatic and recurrent TNBC

1/18 patients developed a complete and partial immune response

[125]

NCT01395056

cytokine-induced killer cell (CIK) infusion + chemotherapy

Post-mastectomy TNBC/TNBC

Prevented disease recurrence and prolong survival,

[142]