A randomized phase III study of vinflunine versus an alkylating agent of physician's choice in metastatic breast cancer (MBC) previously treated with or resistant to an anthracycline, a taxane, an antimetabolite and a vinca-alkaloid.

1031 Background: There is currently no consensus on the efficacy of chemotherapy (CT) beyond 3rd line in MBC and only eribulin (which has been recently approved) has shown to improve survival. No proven treatment options are available. VFL was tested in comparison with an AA of physician’s choice in MBC treated in > 3rdline. Methods: This open-label phase 3 study enrolled 594 MBC pts who have received at least 2 prior CT regimens for MBC including an anthracycline (A), a taxane (T), an antimetabolite (AM) and a vinca-alkaloid (VA). Pts were no longer candidate for those CT because of resistance and/or intolerance. Pts were randomised to VFL 280 mg/m² every 3 w (N=298) or to an AA used as a single agent every 3 w (N=296). Randomization was stratified by performance status (PS), number of prior CT lines for MBC and disease measurability. Primary endpoint was OS population assuming a median OS of 6.5 m for AA and a 2 m difference between arms. Results: Pts had a median age of 58 y [range: 28-79]; visceral me...