ECOG E1193a.

Study characteristics
Methods	Multi‐centre randomised controlled trial. 3 arm trial. Accrual dates: Feb 1993 ‐ Sept 1995. Pts stratified by institution. Randomisation method not described. Baseline comparability of pt pre‐treatment characteristics achieved..
Participants	739 pts (683 evaluable) Women with histologically confirmed breast adenocarcinoma with progressing regional (13‐19%) or metastatic disease No prior cyctotoxic chemotherapy for metastatic disease. Prior adjuvent chemotherapy eligible if ceased >=6 months prior and the regimen did not include anthracyclines or taxanes. Age range: 25‐79 yrs in doxorubicin arm; 27‐78yrs in combined agent arm; 27‐76 yrs in paclitaxel arm. Median age: 58 yrs in doxorubicin arm; 56 yrs in paclitaxel and combined agent arms.
Interventions	Comparison 1: A vs T Arm A: A doxorubicin 60mg/m2 iv day 1. 3 week cycle x 8. Arm B: T paclitaxel 175mg/m2 iv day 1. 3 week cycle until disease progression.
Outcomes	Response Survival Time to treatment failure Toxicity QoL
Notes	Pts on single agent arms were crossed over to the alternate single agent at progression. ITT not followed, data on 683 pts included in time‐to‐event analyses. 41 pts cancelled or excluded from analysis due to ineligibility (reasons stated), additonal 15 pts excluded with reasons not given. Estimated min follow‐up = 6 months (3 week cycle x 8), estimated max f/up = 75 months from curve. Treatment‐related deaths were reported in 2.5% of pts assigned to doxorubicin and 1.6% of pts assigned to the other 2 arms. Moderate‐severe cardiac complications were reported in 8.6‐8.7% of pts assigned to the 2 doxorubicin‐containing arms and 3.7% of pts assigned to paclitaxel.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear