| Study characteristics |
| Methods |
Spain, multicentre, N = 105, Dec 1982 ‐ Dec 1985
Three arm trial (only two arms included in review N = 70)
Randomisation method not given
Baseline characteristics balanced |
| Participants |
Age range 37 ‐ 75y
Proven metastatic breast cancer, measurable disease sites
No previous endocrine therapy |
| Interventions |
AG (500mg for 2w, then 100mg) versus TAM 40mg versus AG + TAM 40mg
Numbers in each treatment arm: 35 versus 35 versus 35
(AG+TAM arm data excluded from review N = 35)
Assessable patients (two included arms): 31 versus 34
Patients evaluable for toxicity (two included arms): 33 versus 34 |
| Outcomes |
Toxicity, TTP, response rate
Not survival |
| Notes |
11 not evaluable (4 AG, 6 TAM + AG, 1 TAM) due to: 4 died within 6w, 1 discontinued treatment, 5 toxicity, 1 lost to FU
FU duration not given
TTP not given by treatment arm |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
|
