Table 1 Ongoing phase II/III randomized immunotherapy trials in triple-negative breast cancer
From: Recent advances in triple negative breast cancer: the immunotherapy era
Setting | Trial | Phase | Regimen | Patients | Status |
|---|---|---|---|---|---|
Neoadjuvant | NCT03639948 (NeoPACT) | II | Carboplatin + docetaxel + pembrolizumab | 100 | R |
NCT03289819 | II | Pembrolizumab + Nab-paclitaxel âž” pembrolizumab + epirubicin and cyclophosphamide | 50 | R | |
NCT03356860 (B-IMMUNE) | II | Paclitaxel + epirubicin + cyclophosphamide ± durvalumab | 57 | R | |
NCT02685059 (GeparNuevo) | II | Epirubicin + nab-paclitaxel + cyclophosphamide ± durvalumab | 174 | ANR | |
Neoadjuvant/Adjuvant | NCT03036488 (KEYNOTE-522) | III | Carboplatin + paclitaxel + (anthracycline) + cyclophosphamide ± pembrolizumab➔ pembrolizumab | 1174 | ANR |
NCT03281954 | III | Doxorubicin + cyclophosphamide + paclitaxel + carboplatin ± atezolizumab ➔ atezolizumab | 1520 | R | |
NCT03197935 (IMpassion031) | III | Doxorubicin + cyclophosphamide + nab-paclitaxel ± atezolizumab ➔ atezolizumab | 204 | ANR | |
Adjuvant only for patients with residual disease after neoadjuvant chemotherapy | NCT02954874 | III | Pembrolizumab vs. observation | 1000 | R |
NCT03756298 | II | Capecitabine ± atezolizumab | 284 | R | |
Adjuvant | NCT03498716 (IMpassion030) | III | Paclitaxel ➔ dose-dense doxorubicin/epirubicin + cyclophosphamide ± atezolizumab | 2300 | R |
NCT02926196 (A-Brave) | III | Avelumab vs. observation | 335 | R | |
Locally advanced or metastatic TNBC | NCT02768701 | II | Cyclophosphamide + pembrolizumab | 40 | ANR |
NCT03121352 | II | Carboplatin, nab-paclitaxel and pembrolizumab | 30 | R | |
NCT02819518 (KEYNOTE-355) | III | Abraxane or paclitaxel or carboplatin/gemcitabine ± pembrolizumab | 858 | ANR | |
NCT02555657 (KEYNOTE-119) | III | Capecitabine, eribulin, gemcitabine, or vinorelbine as TPC vs. pembrolizumab | 600 | ANR | |
NCT03644589 | II | Cisplatin + pembrolizumab | 60 | NYR | |
NCT02755272 | II | Carboplatin + gemcitabine ± pembrolizumab | 87 | R | |
NCT02447003 (KEYNOTE-086) | II | Pembrolizumab monotherapy | 285 | ANR | |
NCT03125902 (IMpassion131) | III | Paclitaxel ± atezolizumab | 540 | R | |
NCT03164993 (ALICE) | II | Pegylated liposomal doxorubicin + cyclophosphamide ± atezolizumab | 75 | R | |
NCT03206203 | II | Carboplatin + gemcitabine | 185 | R | |
NCT03606967 | II | Nab-paclitaxel + durvalumab ± neoantigen vaccine | 70 | NYR | |
NCT03616886 (SYNERGY) | II | Paclitaxel, carboplatin, durvalumab ± oleclumab | 171 | R | |
|  | NCT03371017 (IMpassion132) (early recurrent) | III | Carboplatin + gemcitabine or capecitabine ± atezolizumab | 350 | R |
NCT03167619 (DORA) | II | Durvalumab + olaparib | 60 | R |