Table 3.

Randomized clinical trials of neoadjuvant/adjuvant immunotherapy for triple-negative breast cancer

Trial	Patient population	Treatment arms	Subgroups	Sample size		pCR rate (%)
				IN	CT	IN	CT
NCT01042379a I-SPY2	Tumor ≥ 2.5 cm	T + pembro × 4 → AC × 4	ITT	29	85	60	22
		T × 4 → AC × 4
		T + pembro × 4 → pembro × 4	ITT	73b	295b	27	27
		T × 4 → AC × 4
		olaparib + durvalumab + T × 4 → AC × 4	ITT	22	142	47	27
		T × 4 → AC × 4
		T + pembro × 4 + SD-101 → AC × 4	ITT	29	147	44	28
		T × 4 → AC × 4
NCT03036488	T1cN1-2 or	T + carbo + pembro → AC/EC +	ITT	784	390	63.0	55.6
		pembro × 4 → surgery → pembro	PD-L1 CPS ≥ 1	560c	158c	67.1	58.3
KEYNOTE-522	T2-4N0-2		PD-L1 CPS < 1	109c	56c	47.7	37.3
		T + carbo + placebo → AC/EC +	Lymph Node +	349c	167c	62.8	49.7
		placebo × 4 → surgery → placebo	Lymph Node –	320c	166c	65.3	59.6
NCT02685059	Tumor ≥ 2 cm	nab-T + durvalumab × 4	ITT	88	86	53.4	44.2
GeparNuevo		→ EC + durvalumab × 4	PD-L1 IC/TC ≥ 1%	69	69	58.0	50.7
			PD-L1 IC/TC < 1%	9	11	44.4	18.2
		nab-T × 4 + placebo × 4	Window	59	58	61.0	41.4
		→ EC × 4 + placebo × 4	Concurrent	29	28	37.9	50.0
NCT02620280	T1cN1 + or T3N0 +	nab-T + carboplatin + atezolizumab × 8	ITT	142	138	43.5	40.8
	Unilateral IDC	→ surgery → AC/EC/FEC × 4	PD-L1 IC ≥ 1%	77	79	51.9	48.0
		nab-T + carboplatin × 8	PD-L1 IC < 1%	65	59	32.2	32.3
NeoTRIPaPD-L1
	High Ki-67 or Grade	→ surgery → AC/EC/FEC × 4
NCT03197935	Unilateral	nab-T × 12 + atezolizumab × 6	ITT	165	168	58	41
		→ EC × 4 + atezolizumab × 4	PD-L1 IC ≥ 1%	77	75	69	49
			PD-L1 IC < 1%	88	93	48	34
		nab-T × 12 + placebo × 6	Lymph Node +	56	72	57	31
IMpassion031	tumor > 2 cm	→ EC × 4 + placebo × 4	Lymph Node –	109	96	58	49

Intervention arm regimen listed followed by control arm for each trial

pCR pathologic complete response, IN intervention, CT Control, T paclitaxel, A doxorubicin, C cyclophosphamide, E epirubicin, F 5-fluorouracil, ITT intention to treat, PD-L1 programmed death-ligand 1, IDC invasive ductal carcinoma

^aData from the triple-negative subgroup of included patients is listed

^bSample size listed for overall population as breakdown of population by HR + /HER2- status not published

^cWhereas the ITT pCR rates are reported for all patients as from the third interim analysis, responses in subgroups were only available from the second interim analysis of 1002 patients