Table 1 Baseline demographics and disease characteristics per local assessment
Parameter | Amcenestrant 400 mg | Amcenestrant 200 mg | Letrozole |
|---|---|---|---|
No. of study participants | 34 | 36 | 35 |
Age (years) | 59.5 (49, 85) | 63.5 (49, 86) | 64.0 (41, 83) |
Age categories (years) | |||
18–64 | 25 (73.5) | 19 (52.8) | 20 (57.1) |
65–84 | 8 (23.5) | 16 (44.4) | 15 (42.9) |
≥ 85 | 1 (2.9) | 1 (2.8) | 0 (0) |
Race | |||
Asian | 2 (5.9) | 3 (8.3) | 5 (14.3) |
Black/African-American | 1 (2.9) | 0 (0) | 0 (0) |
White | 23 (67.6) | 24 (66.7) | 25 (71.4) |
Multiple | 0 (0) | 1 (2.8) | 1 (2.9) |
Missing/not reported | 8 (23.5) | 8 (22.2) | 4 (11.4) |
Bodyweight (kg)a | 72.0 (45, 111) | 76.1 (51, 110) | 69.4 (48, 118) |
ECOG PSa | |||
0 | 29 (87.9) | 31 (86.1) | 32 (91.4) |
1 | 4 (12.1) | 5 (13.9) | 3 (8.6) |
Time from diagnosis to randomization (weeks) | 3.3 (0, 8) | 4.0 (1, 15) | 3.9 (1, 8) |
Histology | |||
Ductal adenocarcinoma | 25 (73.5) | 27 (75.0) | 24 (68.6) |
Lobular carcinoma | 2 (5.9) | 3 (8.3) | 2 (5.7) |
Other carcinoma | 6 (17.6) | 4 (11.1) | 6 (17.1) |
Other | 1 (2.9) | 2 (5.6) | 3 (8.6) |
Stage | |||
I | 11 (32.4) | 13 (36.1) | 14 (40.0) |
II | 22 (64.7) | 22 (61.1) | 20 (57.1) |
IIIA | 1 (2.9) | 1 (2.8) | 1 (2.9) |
PgR status | |||
Positive | 28 (82.4) | 34 (94.4) | 32 (91.4) |
Negative | 6 (17.6) | 2 (5.6) | 3 (8.6) |
Ki67 (%) | 20.0 (15, 80) | 25.0 (15, 80) | 25.0 (15, 80) |
Ki67 | |||
≥ 15% to < 20% | 9 (26.5) | 6 (16.7) | 10 (28.6) |
≥ 20% | 25 (73.5) | 30 (83.3) | 25 (71.4) |
Tumor size (mm) | 22.0 (10, 52) | 20.5 (10, 47) | 21.0 (10, 63) |
Tumor size (mm)b | |||
≥ 10 to < 20 | 14 (41.2) | 15 (41.7) | 13 (37.1) |
≥ 20 | 20 (58.8) | 21 (58.3) | 22 (62.9) |