Table 2.

Randomized Clinical Trials of Neoadjuvant / Adjuvant Immunotherapy for Breast Cancer.

Study	Patient Population	Sample Size	Treatment	pCR Rate	Comment
NCT03036488 KEYNOTE-522 Phase 3 Double-blind Placebo-controlled	T1cN1–2 or T2–4N0–2	n = 784 n = 390	Paclitaxel + Carboplatin + Pembrolizumab → AC/EC + Pembrolizumab → Surgery → Pembrolizumab Paclitaxel + Carboplatin + Placebo → AC/EC + Placebo → Surgery → Placebo	63.0% 55.6% (not formally tested)	Results listed for IA3. Significant pCR difference at IA1 (p = 0.00055) and IA2 (p = 0.00221), not tested at IA3. At IA4, 3-year EFS 84.5% vs 76.8% (p = 0.00031)
NCT03197935 IMpassion031 Phase 3 Double-blind Placebo-controlled	Unilateral tumor >2cm	n = 165 n = 168	nab-paclitaxel + Atezolizumab → EC + Atezolizumab nab-paclitaxel + Placebo → EC + Placebo	58% 41% (p = 0.0044)	PD-L1+ pCR rates: 69% vs 49% (p = 0.021)
NCT03726879 IMpassion050 Phase 3 Double-blind Placebo-controlled	T2–4N1–3 disease HER2+	n = 226 n = 228	AC + Atezolizumbab → Paclitaxel + HP + Atezolizumab → Surgery → HP + Atezolizumab AC + Placebo → Paclitaxel + HP + Placebo → Surgery → HP + Placebo	62.4% 62.7% (p = 1.0)	PD-L1+ pCR rates: 64.2% vs 72.5% (p = 0.2)
NCT02620280 NeoTRIPaPDL1 Phase 3 Open label	T1cN1+ or T3N0+ Unilateral IDC High Ki-67 or Grade	n = 142 n = 138	nab-paclitaxel + Carboplatin + Atezolizumab → Surgery → AC/EC/FEC nab-paclitaxel + Carboplatin → Surgery → AC/EC/FEC	43.5% 40.8% (p = 0.66)	Difference in pCR not significant
NCT01042379 I-SPY2 Phase 2 Adaptively randomized Open label	HER2- Tumor > 2cm on imaging / 2.5cm on exam MammaPrint low-risk excluded	n = 69 n = 181	Paclitaxel + Pembrolizumab → AC Paclitaxel → AC	44% 17% (not formally tested)	TNBC pCR rates: 60% vs 22% HR+ pCR rates: 30% vs 13%
		n = 73 n = 295	Paclitaxel + Pembrolizumab → Pembrolizumab Paclitaxel → AC	15% 15% (not formally tested)	Protocol amended so patients no longer received pembro monotherapy due to 3 progressions
		n = 73 n = 299	Paclitaxel + Olaparib + Durvalumab → AC Paclitaxel → AC	37% 20% (not formally tested)	TNBC pCR rates: 47% vs 27% HR+ pCR rates: 28% vs 14%
		n = 73 n = 299	Paclitaxel + SD-101 + Pembrolizumab → AC Paclitaxel → AC	34% 20% (not formally tested)	TNBC pCR rates: 44% vs 28% HR+ pCR rates: 26% vs 14%
NCT02685059 GeparNuevo Phase 2 Double-blind Placebo-controlled	Tumor ≥ 2cm	n = 88 n = 86	nab-paclitaxel + Durvalumab → EC + Durvalumab nab-paclitaxel + Placebo → EC + Placebo	53.4% 44.2% (p = 0.224)	Improvement seen in DDFS (HR 0.37, p = 0.0148) and OS (HR 0.26, p = 0.0076) with addition of durvalumab

Outcomes listed for immunotherapy containing arm vs non-immunotherapy arm.

pCR = pathologic complete response. HER2 = human epidermal growth factor receptor 2. HR = hormone receptor. TNBC = triple negative breast cancer. A = adriamycin. C = cyclophosphamide. E = epirubicin. F = 5-fluorouracil. PD-L1 = programmed death ligand-1. IDC = invasive ductal carcinoma. IA = interim analysis. HP = trastuzumab + pertuzumab