Trial name Phase Primary endpoint Population enrolled Regimen pCR outcome Survival outcomes Ref
KEYNOTE-522 III pCR and EFS in ITT Untreated stage II–III TNBC patients (n=1,174) Neoadjuvant TCb → AC ± pembro, followed by pembro (or placebo) for 1 year after surgery 64.8% vs 51.2%; p<0.001
  • 3-year EFS: 84.5% vs 76.8% (HR: 0.63 [95% CI: 0.48–0.82]; p=0.0003)
  • 3-year DDFS: 87% vs 80.7% (HR: 0.61 [95% CI: 0.46–0.82])
  • 3-year OS: 89.7% vs 86.9% (HR: 0.72 [95% CI: 0.51–1.02]; p=0.032)
[@111734]
IMpassion031 III pCR in ITT and in PD-L1+ patients Untreated stage II–III TNBC patients (n=333) Neoadjuvant nabT → AC ± atezo, followed by atezo (or placebo) for 1 year after surgery (capecitabine also allowed) 58% vs 41%; p=0.0044
  • EFS HR: 0.76 (95% CI: 0.40–1.40)
  • DFS HR: 0.74 (95% CI: 0.32–1.70)
  • OS HR: 0.69 (95% CI: 0.25–1.87)
[@111770]
NeoTRIPaPDL1 III EFS Untreated stage II–III TNBC patients (n=280) Neoadjuvant nabTCb ± atezo, followed by adjuvant anthracyclines after surgery 43.5% vs 40.8% (OR: 1.11 [95% CI: 0.69–1.79]; p=0.66) Pending [@111771]
GeparNuevo II pCR in ITT Untreated stage I–III TNBC patients (n=174) Neoadjuvant nabT → AC ± durva, followed by physician’s choice of adjuvant treatment after surgery 53.4% vs 44.2% (OR: 1.45 [95% CI: 0.80–2.63]; p=0.287)
  • 3-year iDFS: 84.9% vs 76.9% (HR: 0.54 [95% CI: 0.27–1.09]; p=0.0559)
  • 3-year DDFS: 91.4% vs 79.5% (HR: 0.37 [95% CI: 0.15–0.87]; p=0.0148)
  • 3-year OS: 95.1% vs 83.1% (HR: 0.26 [95% CI: 0.09–0.79]; p=0.0076)
[@111772]
I-SPY2 II pCR in ITT Untreated stage II–III TNBC and HR+/HER2- BC patients (n=107) Neoadjuvant T → AC ± pembro, followed by physician’s choice of adjuvant treatment after surgery 60% vs 22% (TNBC patients)
  • EFS HR: 0.60 (TNBC patients)
[@111773]