Nemoto 1982a.

Study characteristics
Methods	Multi‐centre national randomised controlled trial. Dates of accrual; July 1974 ‐ Oct 1975. 4 arm study Randomisation by closed‐envelope at one institution. Pts stratified by menopausal status, DFI and dominant site of metastasis. Baseliine comparability achieved.
Participants	126 pts. Postmenopausal women with metastatic breast cancer. No prior cytotoxic chemotherapy. Age distribution: 80% pts 50yrs +
Interventions	Comparison 1: CFP‐CA vs CFP Arm A: CFP‐CA alternating regimens: Cyclophosphamide 150mg/m2 iv, days 1‐5; 5‐fluorouracil 300mg/m2 iv, days 1‐5; prednisone 30mg/d po for 1 week, then 10mg/d po. 5 week cycle then cyclophosphamide 500mg/m2 iv and doxorubicin 40mg/m2 iv every nine weeks. Arm B: CFP cyclophosphamide 150mg/m2 iv, days 1‐5; 5‐fluorouracil 300mg/m2 iv, days 1‐5; prednisone 30mg/d po for 1 week, then 10mg/d po. 5 week cycles.
Outcomes	Survival Response Toxicity
Notes	ITT analysis. 9 pts were nonevaluable due to early deaths or withdrawal from study. Cumulative dose of adriamycin did not exceed 500mg/m2. Pts rerandomised to tamoxifen or adrenalectomy at progression. One pt on CA arm developed moderate cardiotoxicity. Treatment‐related deaths not reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear