Clinical trial · Interventional
PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy to Prevent Neutropenia
A Multi-center, Open-label,Single Arm Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia in Patients With Breast Cancer Receiving Chemotherapy
NCT02805205CI-TRIAL-00022636completedPhase 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 estimate 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-rhG-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 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
Primary outcomes (2)
- measure
- the occurrence rate of the adverse events that are related to treatment during four consecutive cycles chemotherapy
- timeFrame
- up to 30 days after the patient study completion
- measure
- the severity of the adverse events that are related to treatment during four consecutive cycles chemotherapy
- timeFrame
- up to 30 days after the patient study completion
Secondary outcomes (1)
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 who need to receive multi-cycle chemotherapy * grade III/IV neutropenia after chemotherapy * KPS score≥70 * life expectancy of at least 3 months * Written informed consent are acquired Exclusion Criteria: * Have accepted any other drug related clinical trial within 4 weeks before anticipated * uncontrolled infection * 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.