Trial | NCT | First author | Year | Phase | No. of TNBC patients | Median age | Cancer stage | ICI used | Treatment arm | Control arm | Dose of ICI used | Duration of ICI used | Median follow-up time | PD-L1 expression positivity |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
SAFIR02-BREAST [38] | NCT02299999 | Bachelot | 2021 | II | 82 | 56Â years | Metastatic treated TNBC for maintenance | Durvalumab | Durvalumab | Continuation of induction Chemotherapy | 10Â mg/kg q2wk | 7 cycles | 19.7Â months | 52% |
KEYNOTE-355 [35] | NCT02819518 | Cortes | 2020 | III | 847 | 53.5 years | Untreated locally recurrent inoperable or metastatic TNBC | Pembrolizumab | Pembrolizumab + Investigator’s choice chemotherapy | Placebo + Investigator’s choice chemotherapy | 200 mg q3wk | Up to 35 administrations or disease progression | 26 months | 75% |
Garrido-Castro [43] | NCT03414684 | Garrido-Castro | 2022 | II | 78 | 59.1 years | Metastatic TNBC | Nivolumab | Nivolumab + Carboplatin | Carboplatin | 360 mg IV q3wk | Not mentioned | 23.5 months | 39% |
NeoTRIPaPDL1 [36] | NCT02620280 | Gianni | 2022 | III | 280 | 50 years | Invasive TNBC | Atezolizumab | Atezolizumab + Carboplatin + Nab-paclitaxel | Carboplatin + Nab-paclitaxel | 1200 mg IV q3wk | 8 cycles | On-going | 56% |
GeparNuevo [37] | NCT02685059 | Loibl | 2022 | II | 174 | 49.5 years | Primary, non-metastatic invasive TNBC | Durvalumab | Durvalumab + Nab-paclitaxel then epirubicin/cyclophosphamide | Placebo + Nab-paclitaxel then epirubicin/cyclophosphamide | First dose 0.75 g then 1.5 g q4wk | 6 cycles | 43.7 months | 87% |
IMpassion131 [33] | NCT03125902 | Miles | 2021 | III | 651 | 54 years | Unresectable locally or metastatic TNBC | Atezolizumab | Atezolizumab + Paclitaxel | Placebo + Paclitaxel | 840 mg day 1,15 q4wk | 6 cycles | 14.5 months | 45% |
IMpassion031 [39] | NCT03197935 | Mittendorf | 2020 | III | 333 | 51 years | Early-stage TNBC | Atezolizumab | Atezolizumab + Nab-paclitaxel/Doxorubicin/Cyclophosphamide | Placebo + Nab-paclitaxel + Doxorubicin/Cyclophosphamide | 840 mg IV q2wk | 6 cycles | 20 months | 46% |
IMpassion130 [40] | NCT02425891 | Schmid | 2022 | III | 902 | 55 years | Advanced TNBC | Atezolizumab | Atezolizumab + Nab-paclitaxel | Placebo + Nab-paclitaxel | 840 mg day 1,15 q4wk | 6 cycles | 12.9 months | 41% |
Nci 10,013 [44] | NCT02883062 | Ademuyiwa | 2021 | II | 67 | 52 years | Stage II-III TNBC | Atezolizumab | Carboplatin + Paclitaxel | Atezolizumab + Carboplatin + Paclitaxel | 1200 mg q3wk | 4 cycles | 6 months | Not done yet |
KEYNOTE-522 [41] | NCT03036488 | Schmid | 2020 | III | 1174 | 48–49 years | Primary, non-metastatic TNBC (Stage II and III) | Pembrolizumab | Pembrolizumab + Paclitaxel/Carboplatin + Doxorubicin OR Epirubicin/Cyclophosphamide | Placebo + Paclitaxel/Carboplatin + Doxorubicin OR Epirubicin/Cyclophosphamide | 200 mg IV q3wk | Neoadjuvant up to 8 cycles | 15.5 months | 84% |
KEYNOTE-119 [34] | NCT02555657 | Winer | 2021 | III | 622 | 52 years | Metastatic treated TNBC | Pembrolizumab | Pembrolizumab | Investigator’s choice mono-chemotherapy | 200 mg IV q3wk | Up to 35 administrations | 31.5 months | 65% |
I-SPY2 Trial [42] | NCT01042379 | Nanda | 2020 | II | 114 | 50 years | Stage II-III TNBC | Pembrolizumab | Pembrolizumab + Paclitaxel + Doxorubicin/Cyclophosphamide | Paclitaxel + Doxorubicin/Cyclophosphamide | 200 mg IV q3wk | 4 cycles | 3 yrs | Not done yet |