Evaluation of vinorelbine (N) and trastuzumab (H) as first-line therapy for patients (pts) with HER2- positive metastatic breast cancer (HER2+ MBC): Impact on clinical response and cardiac function

636 Background: Combination therapy of vinorelbine (N) and trastuzumab (H) has recently been shown to be an active and safe regimen for HER2 positive MBC patients (Burstein JCO 01, 19;2722–2730). Here we report results of a multinational phase II trial. Methods: HER2 positive MBC pts (IHC 3+ or FISH + by centralised testing), with measurable disease, KPS = 70%, no prior H or N were treated with N : 30mg/m2/week and H: 4 mg/kg on day1 as loading dose and then 2mg/kg /w. Patients were reassessed every 8 w. All pts were evaluated for the left ventricular ejection fraction (LVEF) at the baseline and every 6 months and more often if needed. Either ultrasonography or MUGA scan were used. Results: Between October 2000 and June 2002, 69 patients were included in the study, median age: 53 years (30–74), prior neo/adjuvant chemotherapy: 65.2%, prior hormonal therapy: 49.3%, visceral metastasis: 75.4%. Sixty-six patients were evaluable for response and 68 pts for toxicity. The overall response rate was 61%, disease ...