We conducted a randomized controlled trial comparing oral regimen [doxiflur
idine, an intermediate metabolite of capecitabine, + medroxyprogesterone ac
etate (MPA) + cyclophosphamide (CPA)] (Method A) with a standard regimen (5
-fluorouracil + adriamycin + CPA) plus MPA (Method B) as first line chemoth
erapy for metastatic breast cancer. Overall response rate was 55.8% for Met
hod A, 46.3% for Method B. The total ratio of responder and long stable dis
ease was significantly higher with Method A (p=0.006). Median time to progr
ession and survival were not differences between Methods. Incidence of toxi
city was 56.3% with Method A and 80.0% with Method B (p=0.014). Oral regime
n is more useful than standard therapy.