Table 1 Patient demographic and baseline characteristics

From: Novel CDK2/4/6 inhibitor culmerciclib (TQB3616) plus fulvestrant in previously treated, HR-positive, HER2-negative advanced breast cancer: a randomized, double-blind, phase 3 trial

Variables

Culmerciclib plus fulvestrant N = 194

Placebo plus fulvestrant N = 99

Age, years

 Median (Q1,Q3)

53.0 (47.0, 61.0)

52.0 (46.0, 59.0)

Age distribution

 <65 years

165 (85.1)

87 (87.9)

 ≥65 years

29 (15.0)

12 (12.1)

Ethnicities

 Han Chinese

178 (91.8)

96 (97.0)

 Others

16 (8.3)

3 (3.0)

Menopausal status at study entrya

 Postmenopausal

112 (57.7)

57 (57.6)

 Premenopausal or perimenopausal

82 (42.3)

42 (42.4)

ECOG performance status scoreb

 0

103 (53.1)

44 (44.4)

 1

91 (46.9)

54 (54.6)

Hormone receptor status, n (%)

 ER-positive

192 (99.0)

98 (99.0)

 PR-positive

152 (78.4)

72 (72.7)

HER2 statusc

 0

60 (30.9)

31 (31.3)

 1+

71 (36.6)

29 (29.3)

 2+

63 (32.5)

39 (39.4)

Measurable target lesions

 Yes

168 (86.6)

85 (85.9)

 No

26 (13.4)

14 (14.1)

No. of metastatic organs

 <3

127 (65.5)

58 (58.6)

 ≥3

67 (34.5)

41 (41.4)

Visceral metastasisa, d

 Noe

79 (40.7)

41 (41.4)

 Yes

115 (59.3)

58 (58.6)

 Lung

70 (36.1)

34 (34.3)

 Liver

59 (30.4)

28 (28.3)

Bone metastasis

 No

71 (36.6)

31 (31.3)

 Yes

123 (63.4)

68 (68.7)

 Bone only

37(19.1)

18(18.2)

Sensitivity to previous endocrine therapiesa,f

 No

41(21.1)

22(22.2)

 Yes

153 (78.9)

77 (77.8)

 As (neo)adjuvant endocrine therapy and endocrine therapy for recurrent/metastatic disease

12 (6.2)

11 (11.1)

 As (neo)adjuvant endocrine therapy

138 (71.1)

72 (72.7)

 As endocrine therapy for recurrent/metastatic disease

44 (22.7)

16 (16.2)

Previous endocrine therapy drugs

 Aromatase inhibitors

115 (59.3)

57 (57.6)

 Selective estrogen receptor modulators

60 (31.0)

30 (30.3)

 Aromatase inhibitors plus selective estrogen receptor modulators

19 (9.8)

12 (12.1)

Aromatase inhibitors as adjuvant endocrine therapy

96 (49.5)

53 (53.5)

Aromatase inhibitors as rescue endocrine therapy

49 (25.3)

26 (26.3)

Selective estrogen receptor modulators as adjuvant endocrine therapy

72 (37.1)

42 (42.4)

Selective estrogen receptor modulators as rescue endocrine therapy

17 (8.8)

10 (10.1)

Previous chemotherapy for recurrent/metastatic disease

 No

148 (76.3)

77 (77.8)

 Yes

46 (23.7)

22 (22.2)

  1. Data are expressed as number (%) unless otherwise specified
  2. aStratification factors
  3. bEastern Cooperative Oncology Group (ECOG) performance-status scores range from 0 (no disability) to 5 (death)
  4. cHER2-negative status was defined as 0 or 1+ intensity on immunohistochemical testing, 2+ intensity on immunohistochemical testing and in-situ hybridization-negative, or in-situ hybridization-negative in the absence of immunohistochemical testing. Both HR and HER2 status were assessed centrally. Samples for assessing HR/HER2 status were primary tumors (123 patients), recurrent/metastatic lesions (151 patients) and both primary and recurrent/metastatic lesions (19 patients)
  5. dVisceral metastasis refers to metastasis to organs in the thorax, abdomen or pelvis
  6. eIncludes metastasis to lymph nodes, breast, and cutaneous and soft tissues
  7. fPatients were considered sensitive to prior endocrine therapy if they had a relapse after 24 months of adjuvant endocrine therapy or had a relapse after 6 months of first line endocrine therapy
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