Table 1.
Selected ongoing phase II or III clinical trials in TNBC.
| 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 |
(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 |
(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 |
(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 |
(TOPACIO) |
| Olaparib | PARP | III | Adjuvant | 1836 | Nov 2020 |
(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 |
(MEDIOLA) |
|
Talazoparib Avelumab |
PARP PD-L1 |
II | Advanced/metastatic | 242 | Aug 2020 | NCT03330405 |
|
Olaparib Durvalumab |
PARP PD-L1 |
II | Advanced/metastatic | 60 | Apr 2020 |
(DORA) |
|
Olaparib Platinum-based CT |
PARP | II/III | (Neo)-adjuvant | 527 | Jan 2032 |
(PARTNER) |
|
Olaparib Durvalumab AZD6738 |
PARP PD-L1 ATR |
II | (Neo)-adjuvant | 81 | Dec 2025 |
(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 |
(ExIST) |
|
Everolimus Carboplatin |
mTOR | II | Advanced/metastatic | 72 | June 2021 | NCT02531932 |
|
Ipatasertib Paclitaxel |
AKT | II/III | Advanced/metastatic | 450 | Dec 2021 |
(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 |
(A264) |
| EnfortuMab Vedotin | Nectin-4 | II | Advanced/metastatic | 240 | Apr 2023 |
(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 |
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.
PLK4 Polo-like kinase 4, IL1RAP Interleukin 1 Receptor Accessory Protein, pCR pathological complete response, DDR DNA damage repair.
#standard neoadjuvant regimen with anthracyclines and taxanes.
##nab-paclitaxel, carboplatin, doxorubicin/epirubicin and cyclophosphamide.
**umbrella study evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations.