Prophylactic Use of PEG-rhG-CSF in Medium-high Risk of FN in Chemotherapy of Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Febrile Neutropenia

Intervention / Treatment
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* Drug: PEGCSF first level prophylactic use
* Drug: PEGCSF second level prophylactic use


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: provision of informed consent stage I-III, invasive breast cancer accept at least 4 cycles of chemotherapy ECOG score 0-2 with medium-high risk of FN according to researchers Exclusion Criteria: accepted stem cell or bone marrow transplant undergoing any other clinical trial uncontrolled infection, temperature≥38℃ per-week scheme chemotherapy concurrent with radiotherapy allergic conditions sever organ dysfunction uncontrolled diabetes

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PEGCSF first level prophylactic use<br>The first level prophylactic use of PEG-rhG-CSF. The Prophylactic use of PEG-rhG-CSF in all cycles of chemotherapy. | Drug: PEGCSF first level prophylactic use<br>* 6mg (≥45kg) or 3mg (<45kg) i.h. once 24h after chemotherapy in all cycles of chemotherapy<br>* Other names: Xin Rui Bai;|
| PEGCSF second level prophylactic use<br>The second level prophylactic use of PEG-rhG-CSF. The Prophylactic use of PEG-rhG-CSF in the next cycle until FN or 4 grade neutropenia happened. | Drug: PEGCSF second level prophylactic use<br>* 6mg (≥45kg) or 3mg (<45kg) i.h. once 24h after chemotherapy in next cycle if FN or 4 grade neutropenia happened<br>* Other names: Xin Rui Bai;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FN rate | rate of febrile neutropenia during all cycles of chemotherapy | assessment at 1 month after the last cycle chemotherapy complete | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of 3-4 grade neutropenia | rate of 3-4 grade decrease of ANC | During all cycles of chemotherapy, through study completion, an average of half year | 
| FN-caused hospitalization | rate of FN-caused hospitalization | During all cycles of chemotherapy, through study completion, an average of half year | 
| FN-caused antibiotic use rate | rate of FN-caused antibiotic use | During all cycles of chemotherapy, through study completion, an average of half year | 
| rate of dose reduction | rate of reduction of chemotherapy dose | During all cycles of chemotherapy, through study completion, an average of half year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, chemotherapy, PEG-rhG-CSF, prophylactic, febrile neutropenia