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. 2011 Feb 16;2011(2):CD003993. doi: 10.1002/14651858.CD003993.pub3

Sanchiz 1996.

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