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Table 2 Best overall response in the premenopausal population of the MONARCH 2 trial

From: Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial

Overall population Abemaciclib + fulvestrant
N = 72
Placebo + fulvestrant
N = 42
P value
n (%) 95% CI n (%) 95% CI
CR 2 (2.8) − 1.0, 6.6 0 (0)  
PR 29 (40.3) 28.9, 51.6 8 (19.0) 7.2, 30.9  
SD 30 (41.7) 30.3, 53.1 27 (64.3) 49.8, 78.8  
≥ 6 months 25 (34.7) 23.7, 45.7 21 (50.0) 34.9, 65.1  
Progressive disease 8 (11.1) 3.9, 18.4 6 (14.3) 3.7, 24.9  
Not evaluable 3 (4.2) − 0.4, 8.8 1 (2.4) − 2.2, 7.0  
Overall response rate (CR + PR) 31 (43.1) 31.6, 54.5 8 (19.0) 7.2, 30.9 .009
Disease control rate (CR + PR + SD) 61 (84.7) 76.4, 93.0 35 (83.3) 72.1, 94.6 .845
Clinical benefit rate (CR + PR + SD ≥ 6 months) 56 (77.8) 68.2, 87.4 29 (69.0) 55.1, 83.0 .304
Measurable disease population Abemaciclib + fulvestrant
N = 51
Placebo + fulvestrant
N = 28
P value
n (%) 95% CI n (%) 95% CI  
CR 2 (3.9) − 1.4, 9.2 0 (0.0)  
PR 29 (56.9) 43.3, 70.5 8 (28.6) 11.8, 45.3  
SD 11 (21.6) 10.3, 32.9 16 (57.1) 38.8, 75.5  
 ≥ 6 months 7 (13.7) 4.3, 23.2 12 (42.9) 24.5, 61.2  
Progressive disease 7(13.7) 4.3, 23.2 4 (14.3) 1.3, 27.2  
Not evaluable 2 (3.9) − 1.4, 9.2 0 (0.0)  
Overall response rate (CR + PR) 31 (60.8) 47.4, 74.2 8 (28.6) 11.8, 45.3 .006
Disease control rate (CR + PR + SD) 42 (82.4) 71.9, 92.8 24 (85.7) 72.8, 98.7 .702
Clinical benefit rate (CR + PR + SD ≥ 6 months) 38 (74.5) 62.5, 86.5 20 (71.4) 54.7, 88.2 .768
  1. CI, confidence interval; CR, complete response; ITT, intent-to-treat; N, number of patients in the arm; n, number of patients in each subgroup; PR, partial response; SD, stable disease
  2. *Using RECIST version 1.1