Kolaric 1985.

Study characteristics
Methods	Randomised controlled trial Method of randomisation and allocation concealment not reported. Stratification by dominant metastatic site. Slight imbalance with 56% of postmenopausal women in CMFVP arm vs 44% in CAP arm.
Participants	128 pts (123 evaluable) Metastatic breast cancer. No prior cytotoxic chemotherapy. Age range was 30‐70 yrs.
Interventions	CA + CDDP vs CMFVP Arm A: CA + CDDP cisplantin, 30mg/m2 daily as an iv days 1, 3, 5; doxorubicin 40mg/m2 on day 1; cyclophosphamide 200mg/m2 iv daily on days 1, 3, 5. 3‐4 week cycles x 10 cycles Arm B: CMFVP cyclophosphamide 200mg/m2 iv daily 1,2,3,4 and 4; methotrexate 20mg/m2 iv days 2, 4; 5‐fluorouracil 500mg/m2 ivdaily days 1, 3, 5, vincristine 1mg/m2 iv days 1 and 5 and prednisolone 40mg po daily days 1, 2, 3, 4, 5. 3‐4 week cycles x 10 cycles.
Outcomes	Response Progression Toxicity (WHO/UICC)
Notes	123/128 pts considered to be evaluable (received more than 2 chemotherapy cycles. Minimum reported f/up = 6 months, maximum reported f/up=33 months. Overall response and complete remission rate favoured the CAP regimen (p<0.01) All pts who had no response with CAP underwent treatment with FIVB + P
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear