| Methods |
Design: 2‐arm parallel trial with a no‐treatment control group
No. of centres: 1
Recruitment and setting: Institute of Internal Medicine and Division of Medical Oncology, University of Siena, Italy
Recruitment period: unclear
Observation period: 6 months
Ethical approval: yes |
| Participants |
No. of patients: 40 randomised, 36 evaluated
Condition: breast cancer, patients with bone metastasis and at least one measurable osteolytic lesion
Demographics: median age (range): IG: 59 (47‐71), CG: 61 (43‐70) years
Informed consent: yes |
| Interventions |
Interventional treatment: thymostimulin; dose/schedule: 50 mg i.m. daily for 6 months
Control treatment: no treatment
Basic treatment: 5‐fluoruracil 500 mg/m² (d1), epirubicin 50 mg/m² (d1), cyclophosphamide 500 mg/m² (d1), or: 5‐fluoruracil 400 mg/m² (d1‐5), folinic acid 200 mg/m² (d1‐5); mitomycin C 5 mg/m² (d3‐5); every 3 weeks |
| Outcomes |
Outcome measures: response, toxicity (AEs of chemo‐/radiotherapy), other |
| Notes |
Method: according to a sample size calculation 60 patients would have been required, but accrual was finished earlier due to loss of funding
Funding: thymostimulin was supplied by Serono, Italy |
