. 2022 May 19;8(7):1010–1018. doi: 10.1001/jamaoncol.2022.1059

Table. Comparison of Short-term Efficacy End Point pCR (ypT0 ypN0) Overall and in Predefined Subgroups.

pCR^a	No. (%) [90% CI]		P value, Dmab stratified^b	No. (%) [90% CI]		P value, nP stratified^c	Overall No. (%)
pCR^a	Dmab	No Dmab	P value, Dmab stratified^b	nP wk	nP d1,8 q3 wk	P value, nP stratified^c	Overall No. (%)
ypT0 ypN0 (primary definition)
No.	390	390		390	390		780
Yes	160 (41.0) [36.9-45.1]	167 (42.8) [38.7-46.9]	.58	175 (44.9) [40.7-49.0]	152 (39.0) [34.9-43.0]	.06	327 (41.9)
ypT0 ypN0 in predefined subgroups
ERBB2^–/HR⁺
No.	153	157		155	155		310
Yes	33 (21.6) [16.1-27.0]	35 (22.3) [16.8-27.8]	.96	35 (22.6) [17.1-28.1]	33 (21.3) [15.9-26.7]	.91	68 (21.9)
TNBC
No.	160	157		159	158		317
Yes	84 (52.5) [46.0-59.0]	91 (58.0) [51.5-64.4]	.31	96 (60.4) [54.0-66.8]	79 (50.0) [43.5-56.5]	.06	175 (55.2)
ERBB2 ⁺
No.	77	76		76	77		153
Yes	43 (55.8) [46.5-65.2]	41 (53.9) [44.5-63.4]	.82	44 (57.9) [48.6-67.2]	40 (51.9) [42.6-61.3]	.29	84 (54.9)
No LPBC
No.	359	359		359	359		718
Yes	138 (38.4) [34.2-42.7]	148 (41.2) [37.0-45.5]	.45	153 (42.6) [38.3-46.9]	133 (37.0) [32.9-41.2]	.13	286 (39.8)
LPBC
No.	31	31		31	31		62
Yes	22 (71.0) [57.6-84.4]	19 (61.3) [46.9-75.7]	.53	22 (71.0) [57.6-84.4]	19 (61.3) [46.9-75.7]	.14	41 (66.1)
EC every 2 wk
No.	206	208		207	207		414
Yes	83 (40.3) [34.7-45.9]	90 (43.3) [37.6-48.9]	.61	97 (46.9) [41.2-52.6]	76 (36.7) [31.2-42.2]	.04	173 (41.8)
EC every 3 wk
No.	184	192		183	183		366
Yes	77 (41.8) [35.9-47.8]	77 (42.3) [36.3-48.3]	.79	78 (42.6) [36.6-48.6]	76 (41.5) [35.5-47.5]	.60	154 (42.1)
With Dmab
No.	NA	NA		195	195		390
Yes	NA	NA	NA	94 (48.2) [42.3-54.1]	66 (33.8) [28.3-39.4]	.03	160 (41.0)
Without Dmab
No.	NA	NA		195	195		390
Yes	NA	NA	NA	81 (41.5) [35.7-47.3]	86 (44.1) [38.3-50.0]	.67	167 (42.8)

Abbreviations: Dmab, denosumab; EC, epirubicin and cyclophosphamide; d1,8 q3 wk, days 1 and 8 every 3 wk; HR, hormone receptor; LPBC, lymphocyte-predominant breast cancer; NA, not applicable; nP, nab-paclitaxel; pCR, pathological complete response; TNBC, triple-negative breast cancer; wk, weekly.

^{^a}

Primary end point significant to the .10 level; significance level for all further analyses is set to a 2-sided α = .05.

^{^b}

Stratified test, primary analysis (stratified by 3 factors).

^{^c}

Stratified test, primary analysis (stratified by 4 factors including denosumab arm).