A randomized trial of capecitabine (C) given intermittently (IC) rather than continuously (CC) compared to classical CMF as first-line chemotherapy for advanced breast cancer (ABC)

1031 Background: Intensive treatment is not indicated for many women having first line chemotherapy for ABC. We sought to determine for such women whether oral C was preferable to classical CMF, and whether C given continuously (CC) was preferable to the same total dose given intermittently for 14 of every 21 days (IC). Methods: 325 women were randomized between June 01 and July 05 to either IC (2,000mg/m2/d for 14 of every 21d), or CC (1,300mg/m2/d for 21 of every 21d), or CMF (cyclophosphamide 100mg/m2/d p.o. d1–14; methotrexate 40mg/m2 and 5-FU 600mg/m2, IV d1&8, every 28d). Treatment was continued until disease progression (PD), unacceptable toxicity, or intolerance. Clinical and quality of life (QOL) assessments were 3–4 wkly, and imaging was 3 monthly, both until PD. The primary endpoint was quality adjusted progression-free survival (QAPFS). Overall survival (OS), PFS, response rates (RR=CR+PR), QOL, acceptability of chemotherapy and adverse events (AE) were secondary endpoints. The analysis plan w...