Clinical trial · Interventional
PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy
The Multi-center, Open-label,Randomized Comparison Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia in Patients With Breast Cancer Receiving Chemotherapy
NCT02805153CI-TRIAL-00022641completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-rhG-CSF | Drug | — | UNRESOLVED |
| rhG-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental/PEG-rhG-CSF
- description
- patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy.
- interventionNames
- Drug: PEG-rhG-CSF
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator/rhG-CSF
- description
- patients received daily subcutaneous injections of rhG-CSF(filgrastim) 5 ug/ kg/day. Injections on day 3 after chemotherapy and continued daily until an ANC of at least 10.0 X 10\^9/L was documented after the expected nadir, or for a maximum of 14 days
- interventionNames
- Drug: rhG-CSF
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with age between 18 and 70 years * diagnosis of breast cancer patients * chemotherapy naive * Karnofsky Performance Status ≥ 70 * Written informed consent are acquired Exclusion Criteria: * uncontrolled infection * Have accepted radiotherapy within 4 weeks before anticipated the study * pregnancy * Other situations that investigators consider as contra-indication for this study
References
Publications (0)
Data not yet available
No reference posted for this study.