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

Febrile Neutropenia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03618810
• Other study ID #: RWS-PEGCSF
• Status: Not yet recruiting
• Start date: January 20, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2018
• Source: Zhejiang Cancer Hospital
• Contact: Hongjian Yang, MD
• Phone: 057188122001
• Email: yhjzlyy[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Febrile Neutropenia
• Fever
• Neutropenia

Intervention

Drug:
• PEGCSF first level prophylactic use
6mg (=45kg) or 3mg (<45kg) i.h. once 24h after chemotherapy in all cycles of chemotherapy
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FN rate	rate of febrile neutropenia during all cycles of chemotherapy	assessment at 1 month after the last cycle chemotherapy complete
Secondary	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
Secondary	FN-caused hospitalization	rate of FN-caused hospitalization	During all cycles of chemotherapy, through study completion, an average of half year
Secondary	FN-caused antibiotic use rate	rate of FN-caused antibiotic use	During all cycles of chemotherapy, through study completion, an average of half year
Secondary	rate of dose reduction	rate of reduction of chemotherapy dose	During all cycles of chemotherapy, through study completion, an average of half year