Final results of a phase 2 study of ramucirumab (RAM) plus eribulin (E) versus E in advanced metastatic breast cancer (MBC).

1035 Background: RAM, a recombinant human IgG1 monoclonal antibody, targets VEGFR-2 and blocks the interaction of VEGF ligands and VEGFR-2. E is a microtubule inhibitor active in MBC. The primary goal of this multicenter US study was to identify if the addition of RAM to E would increase progression-free survival (PFS) in comparison to E alone as third- to fifth-line therapy in patients (pts) with MBC. Methods: Pts with locally recurrent or MBC and 2-4 prior chemotherapy regimens in the advanced setting were randomized 1:1 to receive RAM+E or E (E 1.4 mg/m2 days 1 and 8; RAM 10 mg/kg day 1; q21 days). Stratifications included prior antiangiogenic therapy and triple negative status. Prior anthracycline and taxane treatment, normal LVEF, and ECOG PS 0-1 were required. Treated, stable brain metastases were allowed. Results: 141 pts with a median age of 56 yrs were in the ITT population (RAM+E, n=71; E, n=70). Median PFS was 4.4 mo in RAM+E and 4.1 mo in E (HR=0.8: 95% CI 0.6-1.2; p=0.4) with a median overall...