Table 1.
Patients' characteristics, Phases I-II.
| N = 34 | ||
| Median age | 72.5 (47–84) | |
| Median DFI (months) | 82 (0–120) | |
|
| ||
| N | % | |
|
| ||
| Performance status (ECOG) | ||
| 0–1 | 26 | 76.5 |
| 2 | 8 | 23.5 |
| Stage at enrolment | ||
| Locally advanced | 0 | |
| Metastatic | 34 | 100 |
| Histology | ||
| Ductal carcinoma | 28 | 82.5 |
| Lobular carcinoma | 5 | 14.7 |
| Other | 1 | 2.9 |
| Hormone receptor status | ||
| ER+/PgR+ | 25 | 73.5 |
| ER+/PgR− | 5 | 14.7 |
| ER−/PgR− | 4 | 11.7 |
| HER2 status | ||
| HER2−ve | 28 | 82.3 |
| HER2+ve | 3 | 8.8 |
| HER2 unknown | 3 | 8.8 |
| Number of metastatic site | ||
| 1 | 7 | 20.6 |
| ≥2 | 27 | 79.4 |
| Prior adjuvant therapy | ||
| None | 10 | 29.4 |
| Chemotherapy | 7 | 20.6 |
| Endocrine therapy | 7 | 20.6 |
| Both | 10 | 29.4 |
| Prior therapy for metastatic disease | ||
| None | 5 | 14.7 |
| Chemotherapy | 2 | 5.8 |
| Endocrine therapy | 8 | 23.5 |
| Both | 18 | 52.9 |
| Chemotherapy + trastuzumab | 1 | 2.9 |
| Number of previous chemotherapy treatments | ||
| 0 | 13 | 38.2 |
| 1 | 13 | 38.2 |
| ≥2 | 8 | 23.5 |
| Prior treatments | ||
| Anthracyclines | 23 | 67.6 |
| Taxanes | 22 | 64.7 |