Table 2 Pharmacodynamic results (mITT population, n = 95)

Ki67 (%)

 Baseline^a

29.7

28.6

29.4

 Day 15^a

7.1

9.1

6.6

 Relative change (95% CI)^b

− 75.9 (− 81.9 to − 67.9)

− 68.2 (− 75.7 to − 58.4)

− 77.7 (− 83.4 to − 70.0)

Patients with ≥ 50% reduction in Ki67 from baseline, % (95% CI)

74.2 (55.4 to 88.1)

68.6 (50.7 to 83.1)

89.7 (72.6 to 97.8)

Patients with post-treatment Ki67 ≤ 2.7%, % (95% CI)^c

16.1 (5.5 to 33.7)

8.6 (1.8 to 23.1)

13.8 (3.9 to 31.7)

ER H-score

 Baseline^d

286.6 (38.1)

276.8 (37.9)

289.5 (15.1)

 Day 15^d

103.7 (80.2)

84.8 (67.0)

248.8 (54.3)

 Absolute change (95% CI)^e

− 176.7 (− 201.4 to − 152.0)

− 202.9 (− 226.1 to − 179.7)

− 32.5 (− 57.2 to − 7.7)

 Relative change (%)^f

− 65.3 (− 100, 216)

− 68.3 (− 100, 3)

− 9.5 (− 81, 15)

PgR H-score

 Baseline^d

109.4 (90.1)

121.6 (93.5)

138.1 (102.2)

 Day 15^d

56.6 (70.7)

55.1 (63.4)

38.7 (51.1)

 Absolute change (95% CI)^e

− 58.2 (− 78.4 to − 38.1)

− 68.3 (− 87.4 to − 49.2)

− 88.4 (− 110.1 to − 66.6)

 Relative change (%)^f

− 70.0 (− 100, 5233)

− 74.4 (− 100, 3)

− 75.3 (− 100, 13)