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

• Conditions: Febrile Neutropenia
• Interventions: Drug: PEGCSF first level prophylactic use; Drug: PEGCSF second level prophylactic use

• Registration Number: NCT03618810
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Study Timeline

• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-07
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-26
• Last Update Posted: 2018-12-27
• Study Start: 2019-01-20
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PEGCSF first level prophylactic use	PEGCSF first level prophylactic use	The first level prophylactic use of PEG-rhG-CSF. The Prophylactic use of PEG-rhG-CSF in all cycles of chemotherapy.
PEGCSF second level prophylactic use	PEGCSF second level prophylactic use	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.

Primary Outcome Measures

Name	Time	Method
FN rate	assessment at 1 month after the last cycle chemotherapy complete	rate of febrile neutropenia during all cycles of chemotherapy

Secondary Outcome Measures

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