Table 3.

Current randomized neoadjuvant endocrine therapy trials

TrialProfileTreatmentPrimary endpoint(s)
With PI3K inhibitors
NCT01923168Phase II (n = 360)6 monthspCR
 NEO-ORBT1–3A: Letrozole + placebo
Stratification:B: Letrozole + alpelisib
PIK3CA MUT: Ki67 low vs. highC: Letrozole + buparlisib
PIK3CA WT: Ki67 low vs. high
NCT02273973Phase II (n = 330)4 months1. pCR
 LORELEIStage I–IIIA: Letrozole + placebo2. OR by MRI
T >2 cm by MRIB: Letrozole + taselisib
Available PIK3CA mut status
With CDK4/6 inhibitors
NCT02712723Phase II (n = 120)6 monthsPEPI 0
 FELINIStage II–IIIA: Letrozole + placebo
ER Allred: 6–8B: Letrozole + ribociclib
NCT02296801Phase II (n = 306)2 weeks → 3 monthsKi67 at 2 weeks
 PALLETT >2 cmA: Letrozole + placebo
B: Letrozole → letrozole + palbociclib
C: Palbociclib → letrozole + palbociclib
D: Letrozole + palbociclib → letrozole + palbociclib
NCT02764541Phase II (n = 180)2 weeks → 6 months1. pCR
 PELOPSStage I–IIIA: Tamoxifen2. Ki67 at 2 weeks
Invasive lobular cancerB: Letrozole3. RCB 0–1
C: Tamoxifen → tamoxifen + palbociclib
D: Letrozole → letrozole + palbociclib
NCT02400567Phase II (n = 132)5 monthsRCB 0–1
 NEOPALStage II–IIIA: FEC × 3 → docetaxel × 3
ER Allred > 4B: Letrozole + palbociclib
PAM50 Luminal B or Luminal A/N1
NCT02441946 NEO-MONARCHPhase II (n = 148)T >1 cmKi67 >5%2 weeks → 4 monthsKi67 at 2 weeks
A: Anastrozole → anastrozole + abemaciclib
B: Anastrozole + abemaciclib → anastrozole + abemaciclib
C: Abemaciclib → anastrozole + abemaciclib
  • Abbreviations: FEC, 5-fluorouracil, Epirubicin, Cyclophosphamide; OR, objective response; RCB, residual cancer burden; T, tumor size; WT, wild-type.