| Study characteristics |
| Methods |
Accrual dates: September 1974 to July 1976
Sample size: 42 randomised (+15 on pilot)
Number of centres: unknown (USA)
Randomisation method: not reported
Baseline comparability: more patients in AC group had prior chemotherapy and endocrine therapy, although this is based on all patients not just randomised patients |
| Participants |
Female
Age range: median 58 (AC) and 54 (ACMF)
100% MBC
100% not first line |
| Interventions |
AC vs ACMF
Arm I: (AC) doxorubicin + cyclophosphamide
Arm II: (ACMF) doxorubicin + cyclophosphamide + methotrexate + 5‐fluorouracil |
| Outcomes |
Response
Toxicity |
| Notes |
Not possible to distinguish between randomised and non‐randomised patients (on pilot) therefore study outcomes not included in this review |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
C ‐ Inadequate, 15 patients not randomised |
| Allocation concealment (selection bias) |
High risk |
C ‐ Inadequate |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
B ‐ Unclear |
| Incomplete outcome data (attrition bias)
Response |
Low risk |
A ‐ Adequate |
| Incomplete outcome data (attrition bias)
Toxicity |
Low risk |
A ‐ Adequate |
| Selective reporting (reporting bias) |
Low risk |
A ‐ Adequate, outcomes reported |
| Other bias |
High risk |
C ‐ 15/48 patients were not randomised, more patients in AC group (21/26) had prior hormonal therapy compared to ACMF (13/22) |
