Clinical trial · Observational
Prophylactic Use of PEG-rhG-CSF in Medium-high Risk of FN in Chemotherapy of Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Febrile Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEGCSF first level prophylactic use | Drug | — | UNRESOLVED |
| PEGCSF second level prophylactic use | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- PEGCSF first level prophylactic use
- description
- The first level prophylactic use of PEG-rhG-CSF. The Prophylactic use of PEG-rhG-CSF in all cycles of chemotherapy.
- interventionNames
- Drug: PEGCSF first level prophylactic use
- label
- PEGCSF second level prophylactic use
- description
- 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.
- interventionNames
- Drug: PEGCSF second level prophylactic use
Primary outcomes (1)
- measure
- FN rate
- timeFrame
- assessment at 1 month after the last cycle chemotherapy complete
- description
- rate of febrile neutropenia during all cycles of chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 13 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available