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

NCT03618810 | Unknown DMC

• 1 other identifier: RWS-PEGCSF
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Febrile Neutropenia

Keywords

breast cancer; chemotherapy; PEG-rhG-CSF; prophylactic; febrile neutropenia

Outcome Measures

Primary Outcomes (1)

• FN rate

  rate of febrile neutropenia during all cycles of chemotherapy

  assessment at 1 month after the last cycle chemotherapy complete

Secondary Outcomes (4)

• rate of 3-4 grade neutropenia

  During all cycles of chemotherapy, through study completion, an average of half year

• FN-caused hospitalization

  During all cycles of chemotherapy, through study completion, an average of half year

• FN-caused antibiotic use rate

  During all cycles of chemotherapy, through study completion, an average of half year

• rate of dose reduction

  During all cycles of chemotherapy, through study completion, an average of half year

Study Arms (2)

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

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

Interventions

PEGCSF first level prophylactic use DRUG

6mg (≥45kg) or 3mg (\<45kg) i.h. once 24h after chemotherapy in all cycles of chemotherapy

Also known as: Xin Rui Bai

PEGCSF first level prophylactic use

PEGCSF second level prophylactic use DRUG

6mg (≥45kg) or 3mg (\<45kg) i.h. once 24h after chemotherapy in next cycle if FN or 4 grade neutropenia happened

Also known as: Xin Rui Bai

PEGCSF second level prophylactic use

Eligibility Criteria

• Age: 13 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

MeSH Terms

Conditions

Febrile Neutropenia; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hongjian Yang, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongjian Yang, MD

CONTACT

057188122001; yhjzlyy@163.com

Haiyan Xu, MD

CONTACT

xuhy@zjcc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 7, 2018
• Study Start: January 20, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: December 27, 2018

Record last verified: 2018-12