Table 1 Baseline demographic and clinical characteristics of patientsa

From: Bireociclib plus fulvestrant for HR+/HER2- advanced female breast cancer progressed on or after endocrine therapy: phase 3 BRIGHT-2 study interim analysis

 

Bireociclib plus fulvestrant

(n = 204)

Placebo plus fulvestrant

(n = 101)

Median age, years (range)

54.5 (32, 73)

55.0 (31, 74)

 <65 years

161 (78.9)

85 (84.2)

 ≥65 years

43 (21.1)

16 (15.8)

ECOG score

  

 0

83 (40.7)

45 (44.6)

 1

121 (59.3)

56 (55.4)

Menopausal status

  

 Premenopausal or perimenopausal

75 (36.8)

38 (37.6)

 Postmenopausal

129 (63.2)

63 (62.4)

Hormone receptor status

  

 ER+PR+

156 (76.5)

72 (71.3)

 ER+PR−

48 (23.5)

29 (28.7)

Measurable disease

  

 Yes

185 (90.7)

90 (89.1)

 No

19 (9.3)

11 (10.9)

Visceral metastases

  

 Yes

140 (68.6)

68 (67.3)

     Liver

62 (30.4)

37 (36.6)

     Lung

79 (38.7)

45 (44.6)

 No

64 (31.4)

33 (32.7)

     Bone-only

26 (12.7)

14 (13.9)

No. of recurrent/metastatic sites

  

 1

62 (30.4)

33 (32.7)

 2

72 (35.3)

30 (29.7)

 ≥3

70 (34.3)

38 (37.6)

Disease setting

  

 Locoregionally recurrent

12 (5.9)

4 (4.0)

 Metastatic

192 (94.1)

97 (96.0)

Previous chemotherapy for ABC

46 (22.5)

27 (26.7)

ET resistance

  

 Primary

54 (26.5)

24 (23.8)

 Secondary

150 (73.5)

77 (76.2)

Previous endocrine therapy

  

 Letrozole/Anastrozole

123 (60.3)

68 (67.3)

 Exemestane

31 (15.2)

11 (10.9)

 Tamoxifen/Toremifene

99 (48.5)

45 (44.6)

  1. a Data are presented as number (percentage) of patients unless otherwise indicated.
  2. ABC advanced breast cancer, ECOG Eastern Cooperative Oncology Group, ER+ estrogen receptor positive; ET endocrine therapy, PR+ progesterone receptor positive.