Characteristic | Total | Cohort 1 ENT 3 mg mono → EXE combo | Cohort 2 ENT 5 mg mono → EXE combo | Cohort 3 ENT 10 mg mono → EXE combo | Cohort 4 ENT 5 mg + EXE combo |
---|---|---|---|---|---|
N | 12 | 3 | 3 | 3 | 3 |
Age, median (range), years | 61.5 (48–72) | 56.0 (48–62) | 61.0 (59–62) | 64.0 (55–65) | 68.0 (55–72) |
Baseline BMI, mean (SD), kg/m2 | 22.82 (3.25) | 24.00 (4.30) | 22.53 (4.73) | 22.33 (3.08) | 22.40 (2.19) |
Baseline ECOG PS | |||||
 0 | 11 (91.7) | 3 (100.0) | 2 (66.7) | 3 (100.0) | 3 (100.0) |
 1 | 1 (8.3) | 0 | 1 (33.3) | 0 | 0 |
Histopathological description | |||||
 Invasive ductal carcinoma | 10 (83.3) | 3 (100.0) | 3 (100.0) | 3 (100.0) | 1 (33.3) |
 Other | 2 (16.7) | 0 | 0 | 0 | 2 (66.7) |
ER+/PgR+ | 10 (83.3) | 2 (66.7) | 3 (100.0) | 3 (100.0) | 2 (66.7) |
ER+/PgR− | 1 (8.3) | 0 | 0 | 0 | 1 (33.3) |
ER−/PgR+ | 1 (8.3) | 1 (33.3) | 0 | 0 | 0 |
Current metastatic site | 12 (100.0) | 3 (100.0) | 3 (100.0) | 3 (100.0) | 3 (100.0) |
Visceral disease (lung, liver metastasis) | 7 (58.3) | 2 (66.7) | 2 (66.7) | 2 (66.7) | 1 (33.3) |
Prior surgery | 11 (91.7) | 3 (100.0) | 3 (100.0) | 2 (66.7) | 3 (100.0) |
Prior systemic therapya | 11 (91.7) | 2 (66.7) | 3 (100.0) | 3 (100.0) | 3 (100.0) |
Prior chemotherapya | |||||
 0 | 8 (66.7) | 2 (66.7) | 3 (100.0) | 2 (66.7) | 1 (33.3) |
 1 | 2 (16.7) | 1 (33.3) | 0 | 1 (33.3) | 0 |
 2 | 2 (16.7) | 0 | 0 | 0 | 2 (66.7) |
Prior endocrine therapya | |||||
 0 | 1 (8.3) | 1 (33.3) | 0 | 0 | 0 |
 1 | 3 (25.0) | 1 (33.3) | 1 (33.3) | 1 (33.3) | 0 |
 2 | 3 (25.0) | 0 | 1 (33.3) | 1 (33.3) | 1 (33.3) |
 ≥ 3 | 5 (41.7) | 1 (33.3) | 1 (33.3) | 1 (33.3) | 2 (66.7) |