Table 4.
Main ongoing neoadjuvant trials in triple-negative breast cancer
| Trial | Phase | n | Schedule | Endpoint |
|---|---|---|---|---|
| KEYNOTE-522 | III | 855 |
neoadjuvant phase arm 1: pembrolizumab q3W + CTa arm 2: placebo q3W+ CTa adjuvant phase arm 1: pembrolizumab ×9 C arm 2: placebo ×9 C |
pCR EFS |
| NeoTRIPaPDL1 | III | 272 |
neoadjuvant phase control arm: carboplatin + nab-paclitaxelb experimental arm: carboplatin+nab-paclitaxelb + atezolizumab 1,200 mg q3W ×8 C adjuvant phase: AC/EC/FEC ×4 C |
EFS |
| GeparNUEVO | II | 174 | arm 1: durvalumab 0.75 g → durvalumab 1.5 g q4w + CTc arm 2: placebo → placebo + CTc |
pCR |
| NCT02954874 | III | 1,000 | no intervention: observation experimental: pembrolizumab 200 mg iv days 1 and 22 & q42 days for 52 weeks |
IDFS |
| NCT02926196 | III | 335 | no intervention: observation experimental: avelumab 10 mg/kg iv q2w for 52 weeks |
DFS |
a
CT: paclitaxel weekly + carboplatin q3w or weekly × 4 cycles followed by doxorubicin or epirubicin + cyclophosphamide (AC or EC) q3w × 4 cycles.
b
Carboplatin area under the curve 2 on days 1 and 8 q3w, nab-paclitaxel 125 mg/m2 on days 1 and 8 q3w.
c
CT: nab-paclitaxel 125 mg weekly × 12 cycles → EC q2w × 4 cycles.
CT = Chemotherapy; pCR = pathologic complete response; EFS = event-free survival; IDFS = invasive disease-free survival; DFS = disease-free survival; q3/2w = every 2/3 weeks; iv = intravenous; C = cycles; FEC = 5-fluorouracil, epirubicin, cyclophosphamide.