A phase III trial to evaluate oral chemotherapy with capecitabine versus standard chemotherapy with CMF for advanced breast cancer (ANZ 0001 Capecitebine)

Full description

323 eligible women were randomly assigned to capecitabine adminis-tered intermittently (1,000 mg/m2 twice daily for 14 of every 21 days; n = 107) or continuously (650 mg/m2 twice daily for 21 of every 21 days; n = 107), or to classical CMF (oral cyclophos-phamide 100 mg/m2 days 1 to 14 with intravenous methotrexate 40 mg/m2 and fluorouracil 600 mg/m2 on days 1 and 8 every 28 days; n = 109). The primary end point was quality-adjusted progression-free survival (PFS); secondary end points included PFS, overall survival (OS), objective tumor response, and adverse events. Intermittent and continuous capecitabine were to be compared first and, if similar (P >.05), combined for definitive comparisons versus CMF.

Notes

HeSANDA 1.0.0