Table 2.
Efficacy endpoints
| Endpoint | Results |
|---|---|
| Median time to progression second-line trastuzumab-based therapy (months) | 7 (95% CI 5.74-8.26) |
| Median time to progression first-line trastuzumab-based therapy (months) | 8 (95% CI 6.26-9.74) |
| Overall survival (months) | 43 (95% CI 37,92-48.09) |
| Response rate second-line trastuzumab-based therapy (%) | 30.9% |
| Complete response (%) | 7.2% |
| Partial response (%) | 23.7% |
| Response rate first-line trastuzumab-based therapy (%) | 44.3% |
| Complete response (%) | 9.3% |
| Partial response (%) | 35.1% |
| Clinical Benefit second-line trastuzumab-based therapy (%) | 66% |
| Clinical Benefit first-line trastuzumab-based therapy (%) | 83.5% |
| Time to development of brain metastases (months) | 21 (95% CI 13.86-28.14) |
| Overall survival after treatment for brain metastases (months) | 10 (95% CI 4.53-15.47) |
| Drop of left ventricular ejection fraction (LVEF) > 10% (n=) | 3 |
| Symptomatic congestive heart failure (n=) | 2 |