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

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.

Study Overview

• Status: Unknown
• Conditions: Febrile Neutropenia
• Intervention / Treatment: Drug: PEGCSF first level prophylactic use; Drug: PEGCSF second level prophylactic use

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Hongjian Yang, MD; Phone Number: 057188122001; Email: yhjzlyy@163.com
• Study Contact Backup: Name: Haiyan Xu, MD; Email: xuhy@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients who undergoing chemotherapy given by prophylactic PEG-rhG-CSF using for preventing FN.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: PEGCSF first level prophylactic use; 6mg (≥45kg) or 3mg (<45kg) i.h. once 24h after chemotherapy in all cycles of chemotherapy; Other Names: Xin Rui Bai
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.	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; Other Names: Xin Rui Bai

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Hongjian Yang, MD, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 20, 2019
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (ACTUAL): August 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 27, 2018
• Last Update Submitted That Met QC Criteria: December 26, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: breast cancer; chemotherapy; febrile neutropenia; prophylactic; PEG-rhG-CSF
• Additional Relevant MeSH Terms: Wounds and Injuries; Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Body Temperature Changes; Heat Stress Disorders; Neutropenia; Hyperthermia; Fever; Febrile Neutropenia
• Other Study ID Numbers: RWS-PEGCSF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No