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Patient demographics and baseline characteristics
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Characteristic*
Ribociclib + fulvestrant
n=484
Placebo + fulvestrant
n=242
Median age, years (range)
63 (31–89)
63 (34–86)
Race
Caucasian
406 (83.9)
213 (88.0)
Asian
45 (9.3)
18 (7.4)
Other
‡
33 (6.8)
11 (4.5)
ECOG PS
§
0
310 (64.0)
158 (65.3)
1
173 (35.7)
83 (34.3)
Metastatic sites
Visceral disease
293 (60.5)
146 (60.3)
Bone-only disease
103 (21.3)
51 (21.1)
Prior endocrine therapy status
ǁ
First line
¶
238 (49.2)
129 (53.3)
Second line + early relapsers**
236 (48.8)
109 (45.0)
Prior endocrine therapy setting
(Neo)adjuvant
289 (59.7)
142 (58.7)
Advanced
110 (22.7)
40 (16.5)
Prior (neo)adjuvant chemotherapy
261 (53.9)
126 (52.1)
*All values are n (%), unless stated otherwise;
‡
‘Other’ includes Black, Native American, other, and unknown; race unknown for 15 (3.1%) patients in the ribociclib arm and 5 (2.1%) patients in the placebo arm;
§
ECOG PS missing for 1 (0.2%) patient in the ribociclib arm and 1 (0.4%) patient in the placebo arm;
ǁ
14 patients were not included in the prior endocrine therapy status subgroup due to missing data or criteria not being met;
¶
Treatment naive for ABC; **Received up to 1 line of prior endocrine therapy for ABC.