Table 2 Tumor response per investigator for the patients with intention-to-treat population or with measurable disease

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

Placebo plus fulvestrant

Odds ratio

p-value

ITT

n = 204

n = 101

  

Best overall response, n (%)

    

 CR

1 (0.5)

2 (2.0)

NA

NA

 PR

80 (39.2)

12 (11.9)

 SD

95 (46.6)

57 (56.4)

 PD

19 (9.3)

26 (25.7)

 Not evaluable

9 (4.4)

4 (4.0)

ORR (%) [95% CI]

39.7 [32.9, 46.8]

13.9 [7.8, 22.2]

4.1 [2.2, 7.8]

<0.0001

DCR (%) [95% CI]

86.3 [80.8, 90.7]

70.3 [60.4, 79.0]

2.9 [1.6, 5.2]

0.0007

CBR (%) [95% CI]

63.2 [56.2, 69.9]

40.6 [30.9, 50.8]

2.7 [1.6, 4.4]

0.0001

Measurable disease

n = 185

n = 90

  

Best overall response, n (%)

    

 CR

1 (0.5)

2 (2.2)

NA

NA

 PR

80 (43.2)

12 (13.3)

 SD

78 (42.2)

48 (53.3)

 PD

18 (9.7)

24 (26.7)

 Not evaluable

8 (4.3)

4 (4.4)

ORR (%) [95% CI]

43.8 [36.5, 51.3]

15.6 [8.8, 24.7]

4.3 [2.3, 8.1]

<0.0001

DCR (%) [95% CI]

85.9 [80.1, 90.6]

68.9 [58.3, 78.2]

3.0 [1.6, 5.6]

0.0007

CBR (%) [95% CI]

61.1 [53.7, 68.2]

37.8 [27.8, 48.6]

2.7 [1.6, 4.5]

0.0002

  1. Binary response outcomes (ORR, DCR, and CBR) were compared between treatment groups using odds ratios with corresponding 95% confidence intervals. The p-values were calculated using two-sided Fisher’s exact test. No adjustments were made for multiple comparisons across these secondary endpoints.
  2. CBR clinical benefit rate, CR complete response, DCR disease control rate, ITT intention-to-treat, NA not applicable, ORR objective response rate, PD disease progression, PR partial response, SD stable disease.
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