From: nab-Paclitaxel for the treatment of breast cancer: an update across treatment settings
Study, ClinicalTrials.gov identifier | Phase | Planned N | Patient population or stage of disease | Regimen | Primary endpoint |
---|---|---|---|---|---|
Early-stage (n = 4) | |||||
 GAIN-2, NCT01690702 [66] | III | 2886 | High risk, after R0 resection | Adjuvant epirubicin 150 mg/m2 q2w × 3 cycles → nab-P 260-330 mg/m2 × 3 cycles (TBD in run-in-phase) q2w → cyclophosphamide 2000 mg/m2 q2w × 4 cycles | iDFS |
EC q2w → docetaxel q2w | |||||
 ETNA, NCT01822314 | III | 632 | High risk HER2− | Neoadjuvant nab-P 125 mg/m2 qw 3/4 × 4 cycles → AC, EC, or FEC × 4 cycles | pCR |
Neoadjuvant paclitaxel 90 mg/m2 qw 3/4 × 4 cycles → AC, EC, or FEC × 4 cycles | |||||
 NCT00618657 | II | 120 | Stage I–III | Neoadjuvant nab-P + carbo + trastuz for HER2+ qw × 12 weeks | PFS |
Neoadjuvant nab-P + carbo qw × 12 cycles + bev q2w × 5 cycles for HER2− | |||||
 NCT02530489 | II | 37 | TNBC nonmetastatic | Neoadjuvant nab-P 100 mg/m2 + atezolizumab | pCR |
 NCT02489448 | I/II | 61 | Stage I–III TNBC | Neoadjuvant durvalumab + nab-P qw × 12 cycles → ddAC × 4 cycles | pCR (ypT0/Tis, ypN0) |
Metastatic or advanced stage (n = 12) | |||||
 PERUSE, NCT01572038 [43] | III | 1500 | HER2+ | Trastuz + pertuzumab + taxane of choice | Safety |
 IMpassion130, NCT02425891 | III | 350 | Untreated locally advanced or metastatic TNBC | nab-P + atezolizumab | PFS |
nab-PÂ +Â placebo | |||||
 tnAcity, NCT01881230 [48] | II/III | 790 | TNBC | Selected nab-P regimen from phase II portion (either nab-P 125 mg/m2 + gem 1000 mg/m2 d1, 8 q3w or nab-P 125 mg/m2 + carbo AUC 2 d1, 8 q3w) | PFS |
Gem 1000Â mg/m2Â +Â carbo AUC 2 d1, 8 q3w | |||||
 SNAP, NCT01746225 [48] | II | 258 | HER2− MBC | Induction nab-P 125 mg/m2 qw 3/4 × 3 cycles in all patients → randomization into 3 arms: nab-P 150 mg/m2 q2w | ORR by RECIST v1.1 |
nab-P 100Â mg/m2 qw 3/4 | |||||
nab-P 75Â mg/m2 qw | |||||
 NCT00733408 | II | 63 | MBC | Induction nab-P qw 3/4 + bev q2w → maintenance with bev q2w or q3w + erlotinib qd | PFS |
 NCT01730833 | II | 50 | Stage II–IV HER2+ LABC and MBC | Pertuzumab q3w + trastuz qw + nab-P qw | PFS |
 NCT01463072 | II | 40 | LABC or MBC in ≥65-year-old patients | nab-P qw 3/4 | Tolerability |
 PembroPlus, NCT02331251 | I/II | 90 | MBC and other solid tumor types | Pembrolizumab + chemotherapy, including nab-P | RP2D |
 NCT02379247 | I/II | 54 | Locally recurrent BC or MBC | PI3K inhibitor BYL719 + nab-P 100 mg/m2 qw 3/4 | Phase I, RP2D; phase II, ORR |
 NCT01938833 | I/II | 47 | Metastatic inflammatory BC | nab-P + romidepsin qw 3/4 | MTD, PFS |
 STELA, NCT02073916 [46] | I/II | 45 | HER2+ MBC | T-DM1 + lapatinib + nab-P | MTD |
 NCT02309177 | I | 138a | Recurrent MBC and other solid tumor types | Nivolumab + nab-P 100 mg/m2 qw 3/4a | DLTs, safety |
Nivolumab + nab-P 260 mg/m2 q3wa |