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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2020

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • FN rate
    • Time Frame: assessment at 1 month after the last cycle chemotherapy complete
    • rate of febrile neutropenia during all cycles of chemotherapy

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 13 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhejiang Cancer Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hongjian Yang, MD, Principal Investigator, Zhejiang Cancer Hospital
  • Overall Contact(s)
    • Hongjian Yang, MD, 057188122001, yhjzlyy@163.com

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