Methods |
Design: 2‐arm parallel trial with a no‐treatment control group
No. of centres: 1
Recruitment and setting: Department of Radiotherapy and Oncology, Clinica Platon, Barcelona, Spain
Recruitment period: 06/92‐12/93
Observation period: one cycle of chemotherapy
Ethical approval: unclear |
Participants |
No. of patients: 54 randomised, 54 evaluated
Condition: metastatic breast cancer
Demographics: median age (range): IG: 46 (38‐54), CG: 46 (32‐54) years
Informed consent: yes |
Interventions |
Interventional treatment: thymostimulin; dose/schedule: 50 mg/day i.m.; every cycle (d2‐16)
Control treatment: no treatment
Basic treatment: mitoxantrone 28 mg/m² i.v., supportive treatment: G‐CSF 5 µg/kg s.c. (d2‐16) |
Outcomes |
Outcome measures: response, toxicity (AEs of chemo‐/radiotherapy) |
Notes |
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