Study 211 is a Phase II, open-label, single-arm study evaluating the efficacy and safety of eribulin mesylate in patients with locally advanced or metastatic breast cancer who had received an as anthracycline, a taxane and capecitabine prior therapy, and who were refractory to their last chemotherapy regimen, as documented by progression on or within six months of that therapy.
Of 299 patients enrolled in the study, 291 were treated with eribulin mesylate. Eribulin mesylate was administered at a dose of 1.4mg/m2 as a two- to five-minute intravenous infusion on days one and eight of a 21-day cycle. Patients received a median of four cycles of eribulin mesylate (range 1-27).
Approximately 269 patients met the key inclusion criteria. In patients who received a median of four cycles of eribulin mesylate, overall response rate (ORR) by independent review (IR) was 9.3% (all partial responses (PR); 95% confidence interval (CI): 6.1%-13.4%). Investigator-assessed ORR was 14.1% (1 CR; 95% CI: 10.2%-18.9%). Nearly half (46.5%) the patients had stable disease (SD) after treatment with eribulin mesylate. The clinical benefit rate (CBR, defined as CR+PR+SD equal to or more than six months) was 17.1% (95% CI: 12.8%-22.1%).
The study also suggests that eribulin mesylate has a manageable tolerability profile, with a low incidence of Grade 3 (severe) and no Grade 4 (disabling or life-threatening) neuropathy.
Linda Vahdat, managing director of Weill Cornell Medical College in New York, said: “The anti-tumor activity of eribulin mesylate, as observed in this study, is encouraging, given the limited treatment options for women with advanced breast cancer who have previously received multiple lines of therapy.”