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Table 2 List of some selected ongoing trials with different immune checkpoint blockers in different subtypes of breast cancer

From: Advancements in clinical aspects of targeted therapy and immunotherapy in breast cancer

S. no

Phases

Breast cancer subtypes

Immuno-therapeutic agents

Estimated participants

Co-treatment

Recruitment status

Identifiers

Anti-PD-1/PD-L1 therapy

 1

I

Advanced TNBC

Pembrolizumab

57

ZEN003694, nab-paclitaxel

Recruiting

NCT05422794

 2

I

HLA-A2 + metastatic TNBC

Pembrolizumab

20

PVX-410 vaccine

Active, not recruiting

NCT03362060

 3

I

TNBC

Pembrolizumab

Not clearly mentioned

CPI-006

Active, not recruiting

NCT03454451

 4

I

Early-Stage TNBC

Pembrolizumab

12

Lenvatinib

Recruiting

NCT04427293

 5

I

Metastatic TNBC

Pembrolizumab

11

TTAC-0001

Active, not recruiting

NCT03720431

 6

I

TNBC

Pembrolizumab

15

Intraoperative radiation

Recruiting

NCT02977468

 7

I (early)

Metastatic TNBC

Pembrolizumab

20

Bortezomib plus cisplatin injections; bortezomib followed by pembro/cis

Recruiting

NCT04265872

 8

I

Advanced BC

Pembrolizumab

150

LY3475070

Recruiting

NCT04148937

 9

I/II

Locally recurrent or metastatic TNBC

Pembrolizumab

211

Ladiratuzumab vedotin

Recruiting

NCT03310957

 10

II

HER-2 − metastatic TNBC

Pembrolizumab

70

Nab-paclitaxel

Active, not recruiting

NCT02752685

 11

II

TNBC

Pembrolizumab

26

Paclitaxel, cyclophosphamide, epirubicin

Recruiting

NCT05681728

 12

II

TNBC or HR + /HER2 − BC

Pembrolizumab

23

Olaparib

Recruiting

NCT05203445

 13

II

HR + localized inflammatory BC

Pembrolizumab

37

Hormonal therapy, radiation

Active, not recruiting

NCT02971748

 14

II

HER2 − inflammatory BC

Pembrolizumab

81

EC-paclitaxel

Recruiting

NCT03515798

 15

II

HER2 − BC and TNBC

Pembrolizumab

47

Decitabine followed by chemotherapy with cyclophosphamide, paclitaxel, carboplatin

Active, not recruiting

NCT02957968

 16

II

TNBC or HR + /HER2 − BC

Pembrolizumab

56

Olaparib, Radiation

Recruiting

NCT04683679

 17

II

Anthracycline- refractory TNBC

Pembrolizumab

30

Docetaxel, IL-12 gene therapy

Recruiting

NCT04095689

 18

II

Early-stage TNBC

Pembrolizumab

29

AE37 Peptide vaccine

Recruiting

NCT04427293

 19

II

TNBC

Pembrolizumab

460

Olaparib, carboplatin, gemcitabine

Active, not recruiting

NCT04191135

 20

II

Metastatic TNBC

Pembrolizumab

40

Cyclophosphamide

Active, not recruiting

NCT02768701

 21

II

Metastatic TNBC

Pembrolizumab

30

Nac-paclitaxel, carboplatin

Active, not recruiting

NCT03121352

 22

II

Inoperable locally recurrent or metastatic TNBC

Pembrolizumab

65

Tavokinogene telseplasmid, immunopulse, nab-paclitaxel

Recruiting

NCT03567720

 23

II

TNBC, PD-L1 − 

Pembrolizumab

110

Sacituzumab govitecan

Recruiting

NCT04468061

 24

II

Metastatic TNBC

Pembrolizumab

87

Carboplatin, Gemcitabine

Recruiting

NCT02755272

 25

II

TNBC, BC

Pembrolizumab

12

IRX 2

Active, not recruiting

NCT04373031

 26

II

TNBC, ER − , PR − , HER2 − , invasive BC

Pembrolizumab

51

Sacituzumab govitecan

Active, not recruiting

NCT04230109

 27

II

TNBC, HR + , HER2 − , LN + BC

Pembrolizumab

120

Radiation Therapy Boost, Paclitaxel, Carboplatin, Cyclophosphamide, Doxorubicin, Capecitabine

Recruiting

NCT04443348

 28

III

Inoperable locally recurrent or metastatic TNBC

Pembrolizumab

882

Nab-Paclitaxel, Paclitaxel, Gemcitabine, Carboplatin

Active, not recruiting

NCT02819518

 29

I/II

Metastatic TNBC

Nivolumab

51

Romidepsin, cisplatin

Active, not recruiting

NCT02393794

 30

I/II

Localized TNBC

Nivolumab

50

Paclitaxel, carboplatin, cabiralizumab

Active, not recruiting

NCT04331067

 31

I/II

HER2 + 

Nivolumab

390

BDC-1001

Recruiting

NCT04278144

 32

II

TNBC

Nivolumab

45

Capecitabine

Active, not recruiting

NCT03487666

 33

II

HR − , HER2 − , early stage/resectable BC

Nivolumab

80

Ipilimumab, core biopsy/cryoablation, breast surgery

Recruiting

NCT03546686

 34

II

Metastatic TNBC

Nivolumab

52

Cisplatin, doxorubicin (low-dose)

Recruiting

NCT04159818

 35

II

TNBC

Nivolumab

84

Radiation, doxorubicin (low-dose), cyclophosphamide, cisplatin

Active, not recruiting

NCT02499367

 36

II

Metastatic TNBC

Nivolumab

78

Carboplatin

Active, not recruiting

NCT03414684

 37

II

First-line metastatic TNBC

Nivolumab

114

Ipilimumab, capecitabine

Active, not recruiting

NCT03818685

 38

II

HR + , HER2 − or TNBC

Cemiplimab

36

Paclitaxel, carboplatin (not mandatory), doxorubicin, cyclophosphamide

Recruiting

NCT04243616

 39

II

Different BC subtypes

Cemiplimab

5000

AMG 386 with/without trastuzumab, AMG 479 plus metformin, AMG 386 plus trastuzumab, MK-2206 with/without trastuzumab, T-DM1 and pertuzumab, pertuzumab and trastuzumab, ganetespib ABT-888, neratinib, PLX3397, pembrolizumab (4 cycle), talazoparib plus irinotecan, patritumab and trastuzumab, pembrolizumab (8 cycle), SGN-LIV1A, durvalumab plus olaparib, SD-101 plus Pembrolizumab, tucatinib plus trastuzumab and pertuzumab, cemiplimab, cemiplimab plus REGN3767, trilaciclib with/without trastuzumab plus pertuzumab, SYD985, paclitaxel + dostarlimab encequidar + carboplatin with/ without trastuzumab, paclitaxel + encequidar + dostarlimab with/without trastuzumab, amcenestrant, amcenestrant plus abemaciclib, amcenestrant plus letrozole, ARX788, ARX788 plus cemiplimab, VV1 plus cemiplimab, datopotamab deruxtecan, datopotamab deruxtecan plus durvalumab, zanidatamab, lasofoxifene, Z-endoxifen

Recruiting

NCT01042379

 40

I

Different BC subtypes

Avelumab

45

Palbociclib

Recruiting

NCT04360941

 41

I/II

TNBC

Avelumab

197

Cyclophosphamide plus JX-594 dose escalation, cyclophosphamide plus JX-594, cyclophosphamide, avelumab plus JX-594 and cyclophosphamide

Recruiting

NCT02630368

 42

II

TNBC

Avelumab

150

PF-04518600, utomilumab, binimetinib, sacituzumab govitecan, doxorubicin,

Recruiting

NCT03971409

 43

II

BC, metastatic TNBC

Atezolizumab

75

Doxorubicin plus cyclophosphamide, placebo for atezolizumab

Active, not recruiting

NCT03164993

 44

II

BC, metastatic TNBC

Atezolizumab

23

Talazoparib, radiation

Active, not recruiting

NCT04690855

 45

II

TNBC

Atezolizumab

458

Carboplatin, paclitaxel, epirubicin, cyclophosphamide, surgery

Active, not recruiting

NCT04770272

 46

II

TNBC and IV, HER2 − and invasive BC

Atezolizumab

106

Carboplatin

Active, not recruiting

NCT03206203

 47

II

TNBC, invasive BC, breast adenocarcinoma

Atezolizumab

37

Nab-Paclitaxel

Active, not recruiting

NCT02530489

 48

II

Advanced or metastatic TNBC

Atezolizumab

100

Paclitaxel, bevacizumab

 

NCT04408118

 49

II

TNBC

Atezolizumab

284

Capecitabine or capecitabine (monotherapy)

Recruiting

NCT03756298

 50

II

TNBC and Brain Metastasis

Atezolizumab

45

Stereotactic radiosurgery

Active, not recruiting

NCT03483012

 51

II

Advanced TNBC

Atezolizumab

52

Stereotactic radiosurgery

Active, not recruiting

NCT03464942

 52

III

Inoperable locally advanced or metastatic TNBC

Atezolizumab

180

Nab-paclitaxel

Active, not recruiting

NCT04148911

 53

III

TNBC

Atezolizumab

1550

Atezolizumab, paclitaxel (neoadjuvant chemotherapy) carboplatin, doxorubicin, cyclophosphamide, epirubicin, (adjuvant continuation), surgery

Active, not recruiting

NCT03281954

 54

III

TNBC

Atezolizumab

2300

Paclitaxel, doxorubicin/epirubicin, cyclophosphamide

Active, not recruiting

NCT03498716

 55

III

Recurrent, inoperable locally advanced or metastatic TNBC

Atezolizumab

572

Gemcitabine, capecitabine, carboplatin

Recruiting

NCT03371017

 56

III

TNBC

Atezolizumab

278

Carboplatin, nab-paclitaxel, anthracycline chemotherapeutic drug, cyclophosphamide or fluorouracil, epirubicin and cyclophosphamide

Active, not recruiting

NCT02620280

 57

I

TNBC

Durvalumab

18

Neoantigen DNA vaccine

Active, not recruiting

NCT03199040

 58

I

Stage 2/3 TNBC

Durvalumab

22

PVX-410,

Hiltonol

Active, not recruiting

NCT02826434

 59

I/II

TNBC

Durvalumab

171

Paclitaxel, carboplatin, oleclumab

Active, not recruiting

NCT02489448

 60

I/II

Locally advanced luminal B HER2 − 

Durvalumab

57

Paclitaxel, epirubicin, cyclophosphamide

Active, not recruiting

NCT03356860

 61

I/II

TNBC

Durvalumab

200

Capivasertib, oleclumab paclitaxel, trastuzumab deruxtecan, datopotamab deruxtecan

Active, not recruiting

NCT03742102

 62

II

Advanced and metastatic TNBC

Durvalumab

28

CFI-400945

Active, not recruiting

NCT04176848

 63

II

Stage 4 BC AJCC v8, TNBC

Durvalumab

28

Olaparib

Recruiting

NCT03801369

 64

II

Stage 4 BC AJCC v8, invasive TNBC

Durvalumab

70

Carboplatin, gemcitabine hydrochloride, nab-paclitaxel, peptide vaccine, poly ICLC, tremelimumab

Recruiting

NCT03606967

 65

II

Breast neoplasm

Durvalumab

81

AZD6738, olaparib

Recruiting

NCT03740893

 66

II

Different BC subtypes

Durvalumab

5000

Olaparib

Recruiting

NCT01042379

Anti-CTLA-4 therapy

 67

II

Stage 4 BC AJCC v8, invasive BC, metastatic TNBC

Tremelimumab

70

Carboplatin, gemcitabine hydrochloride, nab-paclitaxel, peptide vaccine, poly ICLC, durvalumab

Recruiting

NCT03606967

 68

I

Different types of cancers including ER − , PR − , HER2 − BC

Ipilimumab

234

XmAb®23,104

Recruiting

NCT03752398

 69

I/II

Advanced solid tumors including BC

Ipilimumab

100

Pembrolizumab plus durvalumab

Recruiting

NCT05187338

 70

I/II

Advanced solid tumors including metastatic BC

Ipilimumab

914

ONC-392

Recruiting

NCT04140526

 71

II

HR − , HER2 − , early stage/resectable BC

Ipilimumab

80

Nivolumab, core biopsy/cryoablation, breast surgery

Recruiting

NCT03546686

 72

II

HER2 − metastatic or inoperable BC

Ipilimumab

138

Nivolumab, bicalutamide

Recruiting

NCT03650894

 73

I

Advanced solid tumors including TNBC

SI-B003 (a CTLA-4/PD-1 bispecific antibody)

159

-

Recruiting

NCT04606472

 74

I/II

Inoperable locally advanced or metastatic cancers including BC

JK08 (CTLA-4 targeting IL-15 antibody fusion protein)

149

-

Recruiting

NCT05620134

  1. BC Breast cancer, CTLA-4 cytotoxic T-lymphocyte-associated antigen-4, HER2 human epidermal growth factor receptor 2, HR Hormone receptor, PD-1 Programmed death receptor 1, PD-L1 Programmed death-ligand 1, PR progesterone receptor, TNBC Triple-negative breast cancer