Table 3.

Current Randomized Neoadjuvant Endocrine Therapy Trials

Trial	Profile	Treatment	Primary Endpoint(s)
With PI3K inhibitors
NCT01923168 NEO-ORB	Phase II (n: 360) T1-3 Stratification: PIK3CA mut: Ki67 low vs high PIK3CA wt: Ki67 low vs high	6 months A: Letrozole + Placebo B: Letrozole + Alpelisib C: Letrozole + Buparlisib	pCR
NCT02273973 LORELEI	Phase II (n: 330) Stage I–III T >2 cm by MRI Available PIK3CA mut status	4 months A: Letrozole + Placebo B: Letrozole + Taselisib	1. pCR 2. OR by MRI
With CDK4/6 inhibitors
NCT02712723 FELINI	Phase II (n: 120) Stage II–III ER Allred: 6–8	6 months A: Letrozole + Placebo B: Letrozole + Ribociclib	PEPI 0
NCT02296801 PALLET	Phase II (n: 306) T >2 cm	2 weeks → 3 months A: Letrozole + Placebo B: Let → Let + Palbociclib C: Palbociclib → Let + Palbociclib D: Let + Palbociclib → Let + Palbociclib	Ki67 at 2 wks
NCT02764541 PELOPS	Phase II (n: 180) Stage I–III Invasive Lobular Cancer	2 weeks → 6 months A: Tamoxifen B: Letrozole C: Tam → Tam + Palbociclib D: Let → Let + Palbociclib	1. pCR 2. Ki67 at 2 wks 3. RCB 0–1
NCT02400567 NEOPAL	Phase II (n: 132) Stage II–III ER Allred>4 PAM50 Luminal B or Lum A/N1	5 months A: FEC x3 → Docetaxel x3 B: Letrozole + Palbociclib	RCB 0–1
NCT02441946 NEO-MONARCH	Phase II (n: 148) T >1 cm Ki67 >5%	2 weeks → 4 months A: Anastrozole → Ana + Abemaciclib B: Ana + Abema → Ana + Abema C: Abema → Ana + Abema	Ki67 at 2 wks

pCR: Pathologic Complete Response; OR:Objective Response; MRI: Magnetic Resonance Imaging; RCB: Residual Cancer Burden