| advanced breast cancer (metastatic) | superior to capecitabine in terms of overall survival in EMBRACE (Cortes), 2011 | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Trial 301 (Kaufman), 2015 | vs capecitabine | | | overall survival 0.88 [0.77; 1.00] median 15.9 mo vs. 14.5 mo PFS 1.08 [0.93; 1.25] median 4.1 mo vs. 4.2 mo | | Vahdat, 2013 | vs capecitabine | | | | | EMBRACE (Cortes), 2011 | vs capecitabine | overall survival 0.81 [0.66; 0.99] median 13.1 mo vs. 10.6 mo Demonstrated | | PFS 0.87 [0.72; 1.06] |
| Trial | Treatments | Patients | Method |
|---|
| Trial 301 (Kaufman), 2015 | eribulin
mesylate 1.4 mg/m2 (equivalent to eribulin 1.23 mg/m2 [expressed as free
base]) intravenously over 2 to 5 minutes on days 1 and 8
until disease progression, unacceptable toxicity, or
patient/investigator request to discontinue (n=554) vs. capecitabine
1.25 g/m2 orally twice per day on days 1 to 14, both in 21-day cycles (n=548) | patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane | open-label Sample size: 554/548 Primary endpoint: Co-primary OS, PFS FU duration: | | Vahdat, 2013 | eribulin mesylate (1.4 mg/m2, 2–5 min
intravenous on days 1 and 8) (n=52) vs. ixabepilone (40 mg/m2,
3 h intravenous on day 1) on a 21-day cycle (n=52) | patients with metastatic breast cancer | open-label Parallel groups Sample size: 52/52 Primary endpoint: incidence of neuropathy FU duration: phase 2 | | EMBRACE (Cortes), 2011 | eribulin mesilate (1·4 mg/m² administered intravenously during 2–5 min on days 1 and 8 of a 21-day
cycle) (n=508) vs. treatment of physician’s choice (n=254) | patients with metastatic breast cancer who had received between two and fi ve previous chemotherapy
regimens (two or more for advanced disease), including an anthracycline and a taxane, unless contraindicated. | open-label Sample size: 508/254 Primary endpoint: overall survival FU duration: |
|
