Table 1 Phases I and II – patient characteristics
Phase I | Phase II | |
|---|---|---|
No. of patients | No. of patients | |
(N =23) | (N =40) | |
Enrolled | 23 | 40 |
Median age (years) | 52 (range 34–69) | 55 (range 37–73) |
Performance status (ECOG) a | ||
0–1 | 20 | 40 |
2 | 3 | |
Estrogen receptors | ||
Positive | 8 | 22 |
Negative | 15 | 7 |
Unknown | 11 | |
Menopausal status | ||
Pre | 6 | 13 |
Post | 17 | 27 |
Median disease-free interval (months) | ||
0–12 | 6 | 10 |
12–24 | 12 | 21 |
24 | 5 | 9 |
Previous anthracyclines | 23 | 40 |
Adjuvant setting | 5 | 9 |
Advanced disease setting | 18 | 31 |
Previous taxanes | 16 | 25 |
Previous chemotherapy lines | ||
One | 11 | 18 |
Two | 6 | 9 |
Three | 6 | 13 |
Metastatic sites | ||
Viscera | 11 | 19 |
Bone | 6 | 8 |
Nodes and soft tissues | 6 | 13 |
