The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile neutropenia among patients with breast cancer, treated with chemotherapy and presenting with a low to moderate risk of developing febrile neutropenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
142
Institut Jules Bordet
Brussels, Belgium
RECRUITINGOccurrence of a febrile neutropenic episode defined as fever (>=38.5°C once or >=38°C twice within 12 hours interval) and neutropenia (ANC < 0.5 IU)
Time frame: At the beginning of 2nd chemotherapy cycle, no more than 30 days after randomization
Need for unplanned hospitalization
Unplanned hospitalization is defined as the need to admit a patient outside of the schedule that was planned for chemotherapy administration
Time frame: At the beginning of second chemotherapy cycle, no more than 30 days after randomization
Complicated febrile neutropenic episode
A complicated febrile neutropenic episode is defined as a febrile neutropenic episode (see above) that does not resolve without the occurrence of serious medical complication as defined in Klasterky J et al; JCO 2000 : 3038-3051
Time frame: At the beginning of the second chemotherapy cycle, no more than 30 days after randomization
Mortality any cause
Time frame: 30 days from randomization
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