This clinical study is a multiple center, registering and real-world conditional research. The breast cancer patients planning for chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of PEG-rhG-CSF in at least two cycles of chemotherapy according to real-world clinical judgement and choice by physicians in local cancer center. Comparing real conditional-FN rate, FN-caused hospitalization rate and antibiotic use rate, direct/indirect medical cost.
The breast cancer patients planning for neo-adjuvant/adjuvant chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) according to NCCN and ASCO guideline are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of PEG-rhG-CSF according to real-world clinical judgement and choice by physicians in local cancer center for at least two cycles of chemotherapy. The primary outcome is FN rate, the second outcomes are rate of 3-4 grade decrease of ANC, FN-caused hospitalization, FN-caused antibiotic use rate, rate of reduction of chemotherapy dose, delay of chemotherapy, safety and pharmacoeconomics.
Study Type
OBSERVATIONAL
Enrollment
2,000
6mg (≥45kg) or 3mg (\<45kg) i.h. once 24h after chemotherapy in all cycles of chemotherapy
6mg (≥45kg) or 3mg (\<45kg) i.h. once 24h after chemotherapy in next cycle if FN or 4 grade neutropenia happened
FN rate
rate of febrile neutropenia during all cycles of chemotherapy
Time frame: assessment at 1 month after the last cycle chemotherapy complete
rate of 3-4 grade neutropenia
rate of 3-4 grade decrease of ANC
Time frame: During all cycles of chemotherapy, through study completion, an average of half year
FN-caused hospitalization
rate of FN-caused hospitalization
Time frame: During all cycles of chemotherapy, through study completion, an average of half year
FN-caused antibiotic use rate
rate of FN-caused antibiotic use
Time frame: During all cycles of chemotherapy, through study completion, an average of half year
rate of dose reduction
rate of reduction of chemotherapy dose
Time frame: During all cycles of chemotherapy, through study completion, an average of half year
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