Table 2.
List of some selected ongoing trials with different immune checkpoint blockers in different subtypes of 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 |
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