Table 1 Demographics and baseline characteristics
Characteristic | Elacestrant dose cohort | ||
|---|---|---|---|
200/400 mg (N = 8) | 400 mg (N = 8) | Overall (N = 16) | |
Median age (range), years | 57.0 (49, 74) | 53.0 (43, 84) | 53.5 (43, 84) |
Female, n (%) | 8 (100) | 8 (100) | 16 (100) |
ECOG performance status, n (%) | |||
0 | 3 (37.5) | 3 (37.5) | 6 (37.5) |
1 | 5 (62.5) | 4 (50.0) | 9 (56.3) |
2 | 0 | 1 (12.5) | 1 (6.3) |
Ductal carcinoma, n (%) | 8 (100) | 8 (100) | 16 (100) |
Median time since breast cancer diagnosis (Q1, Q3), yearsa | 12.5 (5.8, 16.7) | 6.0 (4.2, 11.0) | 8.5 (5.2, 13.7) |
Stage IV, n (%) | 8 (100) | 8 (100) | 16 (100) |
Visceral diseaseb, n (%) | 5 (62.5) | 5 (62.5) | 10 (62.5) |
Bone-only disease, n (%) | 1 (12.5) | 1 (12.5) | 2 (12.5) |
ESR1 mutationc, n (%) | 4 (50.0) | 5 (62.5) | 9 (56.3) |
Median number of lines of prior anticancer therapy (Q1, Q3), n | |||
Total, for ABC | 3.0 (1.5, 3.0) | 3.0 (2.0, 3.0) | 3.0 (2.0, 3.0) |
Endocrine therapy, for ABC | 3.0 (1.5, 3.0) | 2.0 (2.0, 3.0) | 2.5 (2.0, 3.0) |
Chemotherapy, for ABC | 0 (0, 1.0) | 0.5 (0, 1.0) | 0 (0, 1.0) |
Adjuvant endocrine therapy, n (%) | 7 (87.5) | 6 (75.0) | 13 (81.3) |
Prior fulvestrant, n (%) | 4 (50.0) | 2 (25.0) | 6 (37.5) |
Prior mTOR inhibitor, n (%) | 3 (37.5) | 3 (37.5) | 6 (37.5) |
Prior CDK4/6 inhibitor, n (%) | 0 | 0 | 0 |