| Study characteristics |
| Methods |
UK, number of centres not given, N = 218
Randomised without stratification, performed centrally by phone over 24m |
| Participants |
Median age 64y
Actively progressive disease
Received hormonal therapy with tamoxifen
Received no anticancer therapy within preceding 4w |
| Interventions |
AG (250mg for 2w, increased to 500mg if not toxic effect plus 40mg HC) versus high dose MPA 1000mg
Numbers in each treatment arm: 106 versus 112
Patients evaluable for toxicity: 106 versus 112 |
| Outcomes |
Duration of response, survival, time to response |
| Notes |
FU duration: minumum 9m, median 55w for AG, 57w MPA
7 patients either violated protocol or did not meet entry criteria but included in analyses
Crossover on failure
No variation between groups in known prognostic variables |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
performed centrally by phone |
