Clinical trial · Interventional
Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
Study on the Efficacy and Safety of 4.5mg Pegylated Recombinant Human Granulocyte Colony Stimulating Factor Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
NCT04009941CI-TRIAL-00047959completedPhase 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)
This is a prospective, single-center, single-arm clinical study, to evaluate the clinical efficacy, safety and tolerance of patients with early breast cancer receiving ddEC adjuvant chemotherapy, accepting PEG-rhG-CSF as primary prevention of neutropenia.
Conditions
Conditions (2)
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 |
| Neutropenia | — | UNRESOLVED | — |
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 with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF.
- interventionNames
- Drug: PEG-rhG-CSF
Primary outcomes (3)
- measure
- RDI for each EC chemotherapy
- timeFrame
- 60 days after the first chemotherapy
- description
- Ratio of actual dose intensity to standard dose intensity
- measure
- Chemotherapeutic dose adjustment due to neutropenia
- timeFrame
- 60 days after the first chemotherapy
- description
- percentage of dose decreasing due to neutropenia
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer patients in need for adjuvant chemotherapy confirmed by histopathology, whom should accept ddEC regimen. * ECOG\<=1 * Expected survival is greater than 6 months * Qualified for chemotherapy，WBC\>=3\*109/L, ANC\>=1.5\*109/L, Hb\>=80g/L, PLT\>=80\*109/L. With no bleeding tendency or systemic hematology disorder symptoms. * No obvious EKG abnormality, no obvious cardiac dysfunction, and normal left ventricular ejection fraction. * Liver function, ALT and AST should less than 2.5 times of the upper limit. * Renal function, Cr and BUN should less than 1.5 times of the upper limit. * Subjects voluntarily participate in this study and sign informed consent. Exclusion Criteria: * Total amount of doxorubicin used in previous chemotherapy\>240mg/m2, or epirubicin\>360mg/m2 * Has received hematopoietic stem cell transplantation or bone marrow transplantation * Other drugs are currently in clinical trials * There are currently hard-to-control infections, body temperature is higher than 38 degrees. * Received PEG-rhG-CSF treatment before enrollment * Received chemotherapy in 4 weeks before enrollment * Patients with any visceral metastasis * Patients with severe heart, kidney, liver or any other important organs chronic diseases * Patients with severe uncontrolled diabetes * Patients with allergic diseases, or allergies to this product or other biological products derived from genetically engineered e. coli * Suspected or real drug users, substance abusers, alcoholics * Pregnant or lactating women * Severe mental or neurological disorders that affect informed consent and adverse reactions described or observed
References
Publications (0)
Data not yet available
No reference posted for this study.