Clinical trial NCT03618810: Prophylactic Use of PEG-rhG-CSF in Medium-high Risk of FN in Chemotherapy of Breast Cancer
Official title: The Effect, Safety and Pharmacoeconomics of First or Second Level-prophylactic Use of PEG-rhG-CSF in Breast Cancer Patients With Medium-high Risk of Febrile Neutropenia During Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Febrile Neutropenia
Keywords: breast cancer
chemotherapy
PEG-rhG-CSF
prophylactic
febrile neutropenia
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergoing chemotherapy given by prophylactic PEG-rhG-CSF using for preventing FN.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. provision of informed consent
2. stage I-III, invasive breast cancer
3. accept at least 4 cycles of chemotherapy
4. ECOG score 0-2
5. with medium-high risk of FN according to researchers

Exclusion Criteria:

1. accepted stem cell or bone marrow transplant
2. undergoing any other clinical trial
3. uncontrolled infection, temperature≥38℃
4. per-week scheme chemotherapy
5. concurrent with radiotherapy
6. allergic conditions
7. sever organ dysfunction
8. uncontrolled diabetes

Primary outcomes:
measure: FN rate
timeFrame: assessment at 1 month after the last cycle chemotherapy complete
Secondary outcomes:
measure: rate of 3-4 grade neutropenia
timeFrame: During all cycles of chemotherapy, through study completion, an average of half year
measure: FN-caused hospitalization
timeFrame: During all cycles of chemotherapy, through study completion, an average of half year
measure: FN-caused antibiotic use rate
timeFrame: During all cycles of chemotherapy, through study completion, an average of half year
measure: rate of dose reduction
timeFrame: During all cycles of chemotherapy, through study completion, an average of half year
Other outcomes:
Locations:
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Hongjian Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: