Table 1 Baseline characteristics
Overall population (n = 51) | Dose level 1 (n = 10) | Dose level 2 (n = 11) | Dose level 3 (n = 26) | Dose level 4 (n = 4) | |
|---|---|---|---|---|---|
Median age, years (range) | 53 (32-67) | 49 (37-64) | 49 (32-64) | 55 (35-67) | 56 (49-56) |
ECOG performance status (%) | |||||
0 | 80 | 80 | 82 | 88 | 25 |
1 | 20 | 20 | 18 | 12 | 75 |
Tumour stage (%) | |||||
1 | 25 | 40 | 18 | 23 | 25 |
2 | 67 | 60 | 82 | 62 | 75 |
3 | 6 | 0 | 0 | 12 | 0 |
4 | 2 | 0 | 0 | 4 | 0 |
Nodal stage (%) | |||||
1 | 10 | 0 | 18 | 12 | 0 |
2 | 53 | 60 | 45 | 54 | 50 |
3 | 37 | 40 | 36 | 35 | 50 |
Involved lymph nodes | |||||
Median number | 9 | 10 | 9 | 7.5 | 7.5 |
3-6* (%) | 39 | 20 | 45 | 42 | 50 |
7-9 (%) | 20 | 30 | 9 | 23 | 0 |
10-14 (%) | 20 | 10 | 27 | 19 | 25 |
15-19 (%) | 12 | 20 | 9 | 8 | 25 |
≥20 (%) | 10 | 20 | 9 | 8 | 0 |
Hormone receptor status (%) | |||||
ER or PgR positive | 76 | 80 | 64 | 77 | 100 |
ER and PgR negative | 24 | 20 | 36 | 23 | 0 |
HER2 status (%) | |||||
Positive | 33 | 40 | 27 | 27 | 75 |
Negative | 63 | 60 | 64 | 69 | 25 |
Unknown | 4 | 0 | 9 | 4 | 0 |