Table 1 Selected ongoing phase II or III clinical trials in TNBC.

From: Practical classification of triple-negative breast cancer: intratumoral heterogeneity, mechanisms of drug resistance, and novel therapies

Agent(s)

Target(s)/pathway(s)

Phase

Setting

Sample size

Estimated study completion

ClinicalTrials.gov Identifier

Immunotherapy

Pembrolizumab

IL-12 gene therapy

L-NMMA

Chemotherapy#

PD-1

IL-12

II

(Neo)-adjuvant

43

Aug 2020

NCT04095689

HLX10

Chemotherapy##

PD-1

III

(Neo)-adjuvant

522

Apr 2027

NCT04301739

Atezolizumab

Ipatasertib

Paclitaxel

PD-L1

AKT

III

Advanced/metastatic

1155

Oct 2025

NCT04177108

Spartalizumab

LAG525

Carboplatin

PD-1

LAG-3

II

Advanced/metastatic

88

Jan 2021

NCT03499899

Toripalimab

Nab- paclitaxel

PD-1

III

Advanced/metastatic

660

Feb 2022

NCT04085276

Camrelizumab

Famitinib

Carboplatin

PD-1

II

Advanced/metastatic

46

Jan 2021

NCT04129996

(FUTURE-C-PLUS)

Lacnotuzumab

Gemcitabine

Carboplatin

M-CSF

II

Advanced/metastatic

50

Mar 2020

NCT02435680

Nivolumab

Capecitabine

PD-1

II

Post-neoadjuvant without pCR

45

Dec 2022

NCT03487666 (OXEL)

Pembrolizumab

Imprime PGG

PD-1

Dectin

II

Advanced/metastatic

64

Nov 2021

NCT02981303

Avelumab

PD-L1

III

Adjuvant

335

June 2023

NCT02926196

(A-BRAVE)

Pembrolizumab

Tavokinogene telseplasmid (intratumoral)

PD-1

II

Advanced/metastatic

25

Jan 2020

NCT03567720 (KEYNOTE-890)

Nivolumab

Ipilimmumab

Capecitabine

Radiation therapy

PD-1

CTLA-4

II

Adjuvant

98

March 2022

NCT03818685

(BreastImmune03)

Durvalumab

CFI-400945

Pd-L1

Plk4

II

Advanced/metastatic

28

Dec 2022

NCT04176848

KN046

Nab-paclitaxel

PD-L1

CTLA-4

I/II

Advanced/metastatic

90

Sept 2021

NCT03872791

Atezolizumab

Ipatasertib Ladiratuzumab-Vedotin

Bevacizumab

Cobimetinib RO6874281

Selicrelumab

Chemotherapy

PD-L1

AKT

LIV-1

VEGF

MEK

IL-2

CD40

I/II

Advanced/metastatic

310

Aug 2021

NCT03424005** (MORPHEUS-TNBC)

PF-04518600

Avelumab

Binimetinib

Utomilumab

OX-40

PD-L1

MEK

4-1BB/CD137

II

Advanced/metastatic

150

June 2023

NCT03971409 (inCITe)

Atezolizumab

Cobimetinib

Nab-paclitaxel/paclitaxel

PD-L1

MEK

II

Advanced/metastatic

269

Apr 2020

NCT02322814

Durvalumab

Oleclumab

Paclitaxel

Carboplatin

PD-L1

CD73

I/II

Advanced/metastatic

171

Dec 2022

NCT03616886 (SYNERGY)

CAN04

Chemotherapy

IL1RAP

I/II

Advanced/metastatic

100

Oct 2020

NCT03267316 (CANFOUR)

Sarilumab

Capecitabine

IL-6

I/II

Advanced/metastatic

50

June 2020

NCT04333706 (EMPOWER)

NKTR-214

Nivolumab

Ipilimumab

CD122

PD-1

CTLA-4

I/II

Advanced/metastatic

780

Dec 2021

NCT02983045 (PIVOT 02)

Nivolumab

Ipilimumab

PD-1

CTLA-4

II

Advanced/metastatic

30

Oct 2022

NCT03789110 (NIMBUS)

PARP inhibitors and other DNA modulating agents

Niraparib

Pembrolizumab

PARP

PD-1

I/II

Advanced/metastatic

121

Mar 2020

NCT02657889

(TOPACIO)

Olaparib

PARP

III

Adjuvant

1836

Nov 2020

NCT02032823

(OlympiA)

Olaparib

AZD6738

AZD1775

PARP

ATR

WEE1

II

Advanced/metastatic

450

Nov 2020

NCT03330847

Olaparib

Durvalumab

PARP

PD-L1

II

Advanced/metastatic

28

Dec 2020

NCT03801369

Olaparib

Durvalumab

Bevacizumab

PARP

PD-L1

VEGF

I/II

Advanced/metastatic gBRCAm

427

Sep 2022

NCT02734004

(MEDIOLA)

Talazoparib

Avelumab

PARP

PD-L1

II

Advanced/metastatic

242

Aug 2020

NCT03330405

Olaparib

Durvalumab

PARP

PD-L1

II

Advanced/metastatic

60

Apr 2020

NCT03167619

(DORA)

Olaparib

Platinum-based CT

PARP

II/III

(Neo)-adjuvant

527

Jan 2032

NCT03150576

(PARTNER)

Olaparib

Durvalumab

AZD6738

PARP

PD-L1

ATR

II

(Neo)-adjuvant

81

Dec 2025

NCT03740893

(PHOENIX)

Olaparib

PARP

II

Advanced/metastatic

91

Dec 2020

NCT00679783

Olaparib

Durvalumab

PARP

PD-L1

I/II

(Neo)-adjuvant

25

Apr 2020

NCT03594396

Talazoparib

ZEN003694

PARP

Bromodomain

II

Advanced/metastatic

29

Jan 2021

NCT03901469

Talazoparib

PARP

II

Advanced/metastatic

40

Aug 2021

NCT02401347

Veliparib

Cisplatin

PARP

II

Advanced metastatic

333

Oct 2021

NCT02595905

Pembrolizumab

Olaparib

Gemcitabine Carboplatin

PD-1

PARP

II/III

Advanced/metastatic

932

Jan 2026

NCT04191135

Olaparib

PARP

II

Advanced/metastatic

39

Nov 2021

NCT03367689

PI3K/mTOR/AKT/PTEN pathway

Tak-228

Tak-117

Cisplatin

Nab-paclitaxel

TORC 1/2

PI3Kα

II

Advanced/metastatic

20

June 2022

NCT03193853

LY3023414

Prexasertib

PI3K/mTOR

CHEK1

II

Advanced/metastatic

10

Aug 2021

NCT04032080

(ExIST)

Everolimus

Carboplatin

mTOR

II

Advanced/metastatic

72

June 2021

NCT02531932

Ipatasertib

Paclitaxel

AKT

II/III

Advanced/metastatic

450

Dec 2021

NCT03337724

(IPATunity130)

Alpelisib

Nab-paclitaxel

PIK3CA

II

Advanced/metastatic

62

Dec 2021

NCT04216472

Capivasertib

Paclitaxel

AKT

III

Advanced/metastatic

800

Sept 2021

NCT03997123 (CapItello290)

IPI-549

Atezolizumab

Bevacizumab

Nab-paclitaxel

PI3K-gamma

PD-L1

VEGF

II

Advanced/metastatic

90

Aug 2022

NCT03961698 (MARIO-3)

Gedatolisib

Talazoparib

PI3K/mTOR

PARP

II

Advanced/metastatic

54

May 2022

NCT03911973

Vistusertib

Selumetinib

mTORC1/2

MEK

II

Advanced/metastatic

118

Mar 2020

NCT02583542 (TORCMEK)

Capivasertib

Ceralasertib

Adavosertib

Olaparib

AKT

ATR

WEE1

PARP

II

Advanced/metastatic

64

Mar 2020

NCT02576444 (OLAPCO)

RAS/MAPK/ERK

ONC 201

ERK

AKT

II

Advanced/metastatic

90

Dec 2027

NCT03394027

Antibody-drug conjugates

      

Sacituzumab govitecan

Chemotherapy

Trop2

III

Advanced/metastatic

529

July 2020

NCT02574455 (ASCENT)

CAB-ROR2-ADC BA3021

ROR2

I/II

Advanced/metastatic

120

May 2022

NCT03504488

SKB264

Trop2

I/II

Advanced/metastatic

78

Dec 2022

NCT04152499

(A264)

EnfortuMab Vedotin

Nectin-4

II

Advanced/metastatic

240

Apr 2023

NCT04225117

(EV-202)

Androgen pathway

Orteronel

17α-hydroxylase

II

Advanced/metastatic

71

Feb 2020

NCT01990209

Enobosarm

Pembrolizumab

AR

PD-1

II

Advanced/metastatic

29

Nov 2020

NCT02971761

Bicalutamide

Palbociclib

AR

PARP

II

Advanced/metastatic

51

Nov 2020

NCT02605486

Enzalutamide

Taselisib

AR

PI3K

I/II

Advanced/metastatic

73

Dec 2021

NCT02457910

Enzalutamide

Alpelisib

AR

PIK3CA

II

Advanced/metastatic

28

Dec 2020

NCT03207529

Bicalutamide

AR

II

Advanced/metastatic

262

Dec 2020

NCT03055312 (SYSUCC-007)

Enzalutamide

AR

II

Adjuvant

50

May 2020

NCT02750358

Enzalutamide

Paclitaxel

AR

II

Neoadjuvant

37

Sept 2021

NCT02689427

Bicalutamide

Ribociclib

AR

PARP

I/II

Advanced/metastatic

11

Sept 2021

NCT03090165

Darolutamide

Capecitabine

AR

II

Advanced/metastatic

90

Sept 2021

NCT03383679 (START)

Orteronel

17α-hydroxylase

II

Advanced/metastatic

71

Feb 2020

NCT01990209

  1. IL-2 gene therapy refers to Adenoviral-mediated IL-12. L-NMMA, NG-monomethyl-L-arginine, inhibitor of the nitric oxide synthetase. Famitinib, inhibitor of multiple tyrosine kinase receptor anti c-Kit, vascular endothelial growth factor receptor 2 and 3, platelet-derived growth factor receptor and FMS-like tyrosine kinases Flt1 and Flt3. M-CSF, macrophage colony-stimulating factor. pCR, pathological complete response. Tavokinogene telseplasmid is aDNA plasmid that encodes genes for both the p35 and p40 subunits of the heterodimeric human interleukin 12 (hIL-12) protein.
  2. PLK4 Polo-like kinase 4, IL1RAP Interleukin 1 Receptor Accessory Protein, pCR pathological complete response, DDR DNA damage repair.
  3. #standard neoadjuvant regimen with anthracyclines and taxanes.
  4. ##nab-paclitaxel, carboplatin, doxorubicin/epirubicin and cyclophosphamide.
  5. **umbrella study evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations.
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