Phase III study of vinflunine plus gemcitabine versus paclitaxel plus gemcitabine in the first-line treatment of anthracycline pretreated advanced breast cancer.

1011 Background: Paclitaxel (PTX), plus gemcitabine (GEM) showed survival advantage over paclitaxel in advanced breast cancer (ABC) patients who relapsed after adjuvant anthracycline. This was associated with increased toxicity, especially neurotoxicity. Vinflunine (VFL) plus GEM was confronted to PTX- GEM in this clinical setting. Methods: This open-label phase 3 study enrolled 1004 Her-2 negative ABC patients who had received neo- or adjuvant anthracycline more than 12 months prior to study entry. Patients were randomised to VFL 320 mg/m² on day 1 plus GEM 1000 mg/m² on days 1 and 8 every 3 weeks (N = 503) or PTX 175 mg/m² on day 1 plus GEM 1250 mg/m² on days 1 and 8 every 3 weeks (N = 501). Randomisation was stratified by PS, (neo)adjuvant taxane, disease measurability and visceral lesions. The primary objective was to test the non-inferiority of VFL-GEM vs PTX-GEM in terms of PFS assessed by a blinded independent review committee in the intent-to-treat population assuming a median PFS of 5.2 months in...