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

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ClinicalTrials.gov Identifier: NCT03618810
Recruitment Status : Not yet recruiting
First Posted : August 7, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

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.

Condition or disease Intervention/treatment
Febrile Neutropenia 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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : January 20, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

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 Name: 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 Name: Xin Rui Bai




Primary Outcome Measures :
  1. FN rate [ Time Frame: assessment at 1 month after the last cycle chemotherapy complete ]
    rate of febrile neutropenia during all cycles of chemotherapy


Secondary Outcome Measures :
  1. 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

  2. FN-caused hospitalization [ Time Frame: During all cycles of chemotherapy, through study completion, an average of half year ]
    rate of FN-caused hospitalization

  3. 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

  4. 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



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Ages Eligible for Study:   13 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who undergoing chemotherapy given by prophylactic PEG-rhG-CSF using for preventing FN.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618810


Contacts
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Contact: Hongjian Yang, MD 057188122001 yhjzlyy@163.com
Contact: Haiyan Xu, MD xuhy@zjcc.org.cn

Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
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Principal Investigator: Hongjian Yang, MD Zhejiang Cancer Hospital

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Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT03618810     History of Changes
Other Study ID Numbers: RWS-PEGCSF
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhejiang Cancer Hospital:
breast cancer
chemotherapy
PEG-rhG-CSF
prophylactic
febrile neutropenia

Additional relevant MeSH terms:
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Breast Neoplasms
Neutropenia
Fever
Febrile Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms