Table 1.
Clinical trials testing immunotherapies in patients with breast cancer
| Disease setting | Phase | Clinical trial reference number | Breast cancer | Immunotherapies (alone or in combination) | Control arm treatment |
|---|---|---|---|---|---|
| Trials including only patients with TNBC | |||||
| Metastatic | I/II | NCT02513472 | TNBC | Pembrolizumab*/eribulin mesylate | NA |
| II | NCT02499367 | TNBC | Nivolumab*/doxorubicin (low dose) or cyclophosphamide metronomic or radiation therapy or cisplatin | NA | |
| NCT02447003 | TNBC | Pembrolizumab | NA | ||
| III | NCT02555657 | TNBC | Pembrolizumab | Single-agent CT (capecitabine, eribulin, gemcitabine or vinorelbine) | |
| NCT02425891 | TNBC | Atezolizumab‡/nab-paclitaxel | Nab-paclitaxel | ||
| NCT02819518 | TNBC | Pembrolizumab + chemo | Pembrolizumab + placebo | ||
| Adjuvant | II | NCT02539017 | TNBC | Vaccine (DC-CIK)/EC followed by docetaxel | EC followed by docetaxel |
| Neoadjuvant | II | NCT02685059 | TNBC | Durvalumab‡/nab-paclitaxel followed by EC | Nab-paclitaxel followed by EC |
| II | NCT02530489 | TNBC | Atezolizumab/nab-paclitaxel | NA | |
| II | KEYNOTE 173 | TNBC | Pembrolizumab/nab-paclitaxel followed by AC | six-cohorts (see text above) | |
| III | NCT02620280 (NeoTRIP) | TNBC (LABC only) | Atezolizumab/nab-paclitaxel/carboplatin | Nab-paclitaxel/carboplatin | |
| Trials including patients with breast cancer | |||||
| Metastatic | I | NCT02303366 | All | Pembrolizumab/stereotactic ablative body radiosurgery | NA |
| I/II | NCT00003432 | All (CEA- positive only) | Vaccine (CEA RNA-pulsed DC) | NA | |
| NCT01421017 | All with skin metastasis | Imiquimod (TLR7 agonist)/radiotherapy or cyclophosphamide | NA | ||
| II | NCT02536794 | HER2- negative | Durvalumab/tremelimumab¦ | NA | |
| NCT02411656 | HER2- negative | Pembrolizumab | NA | ||
| NCT02563925 | All with brain metastasis | Tremelimumab/brain radiotherapy or stereotactic | NA | ||
| NCT00083278 | All | Ipilimumab¦ | NA | ||
| NCT01792050 | HER2- negative | Indoximod (IDO inhibitor)/paclitaxel or docetaxel | Paclitaxel or docetaxel | ||
| NCT02491697 | All | Vaccine (DC-CIK)/capecitabine | Capecitabine | ||
*Anti-programmed cell death PD-1 mAbs: Nivolumab and pembrolizumab (anti-PD1), ‡Anti PD L1 mAbs: Atezolizumab and durvalumab, §Anti cytotoxic T lymphocyte protein 4 (CTLA 4) mAbs: Ipilimumab and tremelimumab. BC: Breast cancer, CEA: Carcinoembryonic antigen, CT: Chemotherapy, DC: Dendritic cells, DC-CIK: Dendritic cells co-cultured with cytokine-induced killer cells, AC: Doxorubicin and cyclophosphamide, EC: Epirubicin and cyclophosphamide, LABC: Locally advanced breast cancer, TLR7: Tool like receptor 7, NA: Not applicable, TNBC: Triple negative breast cancer, PD-1: Programmed cell death-1, mAbs: Monoclonal antibodies, CTLA-4: Cytotoxic T-lymphocyte-associated antigen-4, IDO: Indoleamine2,3-dioxygenase pathway, HER2: Human epidermal growth factor receptor-2, PD L1: Programmed cell death 1 ligand 1