Table 1.

Patient and tumor characteristics of the HR+/HER2- analysis population, overall and according to cohort.

Characteristic	Cohort								Overall HR+/HER2-Population
	No chemo SOFT		No chemo TEXT		Chemo TEXT		Prior chemo SOFT
	N	%	N	%	N	%	N	%	N	%
N Patients	1135	100.0	844	100.0	1073	100.0	1063	100.0	4115	100.0
Age at randomization	15	1.3	35	4.1	116	10.8	190	17.9	356	8.7
<35
35-39	86	7.6	89	10.5	188	17.5	307	28.9	670	16.3
40-44	302	26.6	296	35.1	364	33.9	345	32.5	1307	31.8
45-49	515	45.4	322	38.2	341	31.8	183	17.2	1361	33.1
50+	217	19.1	102	12.1	64	6.0	38	3.6	421	10.2
No. nodes positive	1039	91.5	661	78.3	353	32.9	444	41.8	2497	60.7
N0
N 1-3	95	8.4	181	21.4	451	42.0	429	40.4	1156	28.1
N 4+	1	0.1	2	0.2	269	25.1	190	17.9	462	11.2
Tumor size (path.; cm)
≤2 cm	975	85.9	670	79.4	487	45.4	532	50.0	2664	64.7
>2 cm	154	13.6	174	20.6	576	53.7	499	46.9	1403	34.1
Unknown	6	0.5	-	-	10	0.9	32	3.0	48	1.2
Centrally-assessed
Tumor grade
1	420	37.0	210	24.9	143	13.3	156	14.7	929	22.6
2	602	53.0	496	58.8	603	56.2	619	58.2	2320	56.4
3	108	9.5	135	16.0	320	29.8	282	26.5	845	20.5
Not determined	5	0.4	3	0.4	7	0.7	6	0.6	21	0.5
Vessel invasion (lymphatics and/or blood vessels)
No	1013	89.3	682	80.8	695	64.8	792	74.5	3182	77.3
Yes	120	10.6	161	19.1	374	34.9	268	25.2	923	22.4
Not determined	2	0.2	1	0.1	4	0.4	3	0.3	10	0.2
Estrogen receptor (ER)
<10%	1	0.1	-	-	6	0.6	11	1.0	18	0.4
10-49%	13	1.1	12	1.4	35	3.3	22	2.1	82	2.0
≥50%	1103	97.2	826	97.9	1020	95.1	1011	95.1	3960	96.2
Not determined	18	1.6	6	0.7	12	1.1	19	1.8	55	1.3
Median and IQR	95	90-99	95	90-99	90	85-99	95	90-99	95	90-99
Progesterone receptor (PgR)
<10%	28	2.5	36	4.3	92	8.6	131	12.3	287	7.0
10-19%	13	1.1	10	1.2	36	3.4	47	4.4	106	2.6
20-49%	42	3.7	50	5.9	110	10.3	105	9.9	307	7.5
≥50%	1034	91.1	735	87.1	822	76.6	761	71.6	3352	81.5
Not determined	18	1.6	13	1.5	13	1.2	19	1.8	63	1.5
Median and IQR	95	90-99	90	80-99	90	60-95	90	40-95	90	70-99
Ki-67 expression
<14%	505	44.5	269	31.9	198	18.5	247	23.2	1219	29.6
14-19%	324	28.5	261	30.9	293	27.3	302	28.4	1180	28.7
20-25%	152	13.4	135	16.0	234	21.8	216	20.3	737	17.9
>26%	101	8.9	135	16.0	310	28.9	236	22.2	782	19.0
Not determined	53	4.7	44	5.2	38	3.5	62	5.8	197	4.8
Median and IQR	14	9-19	16	11-22	20	15-27	18	14-25	18	12-24
Luminal A/B-likea
A-like	796	70.1	507	60.1	448	41.8	480	45.2	2231	54.2
B-like	279	24.6	291	34.5	585	54.5	519	48.8	1674	40.7
Not determined	60	5.3	46	5.5	40	3.7	64	6.0	210	5.1

Abbreviations: IQR=interquartile range; SOFT=Suppression of Ovarian Function Trial; TEXT=Tamoxifen and Exemestane Trial.

a: Defined according to 2013 St. Gallen Consensus: in HR+/HER2-negative disease, Luminal A-like is PgR≥20% and Ki-67<20%; B-like is either PgR<20% or Ki-67≥20%.