Vinflunine plus capecitabine for advanced breast cancer previously treated with or resistant to anthracycline and resistant to taxane: A phase III study versus capecitabine.

1013^ Background: Vinflunine (VFL) is a microtubule inhibitor with single-agent activity in advanced breast cancer (ABC) pretreated with anthracycline (A) and resistant to taxane (T). Synergy with capecitabine (CAPE) was demonstrated in this setting. This phase 3 study compared VFL plus CAPE with CAPE alone in A pretreated or resistant and T-resistant ABC. Methods: Open-label, multicenter study, in which 770 ABC patients with up to 3 prior chemotherapy (CT) regimens were randomised to VFL 280 mg/m² on day 1 plus CAPE 1,650 mg/m² (N = 384) or to CAPE alone at 2,500 mg/m² (N = 386) on days 1 to 14 every 3 weeks. Randomization was stratified by resistance to anthracycline, performance status, disease measurability and number of prior lines of CT for ABC. Primary endpoint was PFS assessed by a blinded independent review committee (IRC) in the ITT population. Results: Patients had a median age of 54 years (range: 27 - 81); metastatic disease for 97%; anthracycline resistance for 63%; received study treatment a...