UnknownNot Applicable

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

2,000 participantsStarted 2019-01-20

Plain-language 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.

Who can participate

Age range13 Years – 70 Years

SexFEMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

FN rate

Timeframe: assessment at 1 month after the last cycle chemotherapy complete

Trial details

NCT IDNCT03618810

SponsorZhejiang Cancer Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12-31

Contact for this trial

Hongjian Yang, MD

057188122001 yhjzlyy@163.com

View on ClinicalTrials.gov More Febrile Neutropenia trials