The aim of this study, using a Fleming single-stage design, was to explore the 
efficacy and safety of Taxotere 100 x mg x m(-2) docetaxel and FEC 75 
cyclophosphamide 500 mg x m(-2), fluorouracil 500 x mg x m(-2) and epirubicin 75 
mg x m(-2), in alternating and sequential schedules for the first-line treatment 
of metastatic breast cancer. One hundred and thirty-six women were randomly 
allocated, to one of three treatment regimens: DTX 100 plus FEC 75, alternated 
for eight courses (ALT); four courses of DTX 100 followed by four courses of FEC 
75 (SEQ T); or four courses of FEC 75 followed by four courses of DTX 100 (SEQ 
F). One hundred and thirty-one women were evaluable for tumour response. 
Although the treatment outcome was equivalent in the two sequential arms and the 
alternating regimen (P=0.110, not significant), the response rate was less 
encouraging in the SEQ F arm (52.3%) than in the other two arms (71.1% for ALT 
and 70.5% for SEQ T), in which docetaxel was administered first. Time to 
progression was similar in the ALT, SEQ T and SEQ F arms (9.5, 9.3 and 10.4 
months respectively). Grade 3-4 neutropenia was observed in nearly all patients; 
febrile neutropenia occurred in 9% (ALT), 16% (SEQ T) and 2% (SEQ F) of 
patients. Few patients (< or =9%) developed grade 3-4 non-haematological 
toxicities. Relative dose intensity was 97-99% for all regimens. All treatment 
regimens were active and well tolerated.