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

NCT ID: NCT03618810

Last Updated: 2018-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-20

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Febrile Neutropenia

Keywords

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breast cancer chemotherapy PEG-rhG-CSF prophylactic febrile neutropenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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 first level prophylactic use

Intervention Type DRUG

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

PEGCSF second level prophylactic use

Intervention Type DRUG

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

Interventions

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PEGCSF first level prophylactic use

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Xin Rui Bai Xin Rui Bai

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongjian Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Central Contacts

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Hongjian Yang, MD

Role: CONTACT

Phone: 057188122001

Email: [email protected]

Haiyan Xu, MD

Role: CONTACT

Email: [email protected]

Other Identifiers

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RWS-PEGCSF

Identifier Type: -

Identifier Source: org_study_id