NCT03618810

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: Female
• Age: 13 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Febrile Neutropenia

Interventions

Type	Name	Description
DRUG	PEGCSF first level prophylactic use	6mg (≥45kg) or 3mg (\<45kg) i.h. once 24h after chemotherapy in all cycles of chemotherapy
DRUG	PEGCSF second level prophylactic use	6mg (≥45kg) or 3mg (\<45kg) i.h. once 24h after chemotherapy in next cycle if FN or 4 grade neutropenia happened

Timeline

• Start date: 2019-01-20
• Primary completion: 2020-12-31
• Completion: 2021-12-31
• First posted: 2018-08-07
• Last updated: 2018-12-27