Clinical trial · Interventional
A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF in Breast Cancer Patients Receiving Chemotherapy
A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF as Supportive Therapy to Breast Cancer Patients Receiving Neoadjuvant/Adjuvant 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)
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.
Conditions
Conditions (3)
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 |
| Febrile Neutropenia | — | UNRESOLVED | — |
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegylated rhG-CSF 100μg/kg | Drug | — | UNRESOLVED |
| Pegylated rhG-CSF:150 μg/kg | Drug | — | UNRESOLVED |
| rhG-CSF 5 μg/kg/day | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Pegylated rhG-CSF 100μg/kg
- description
- Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K） 100µg/kg in cycle 2 to 4
- interventionNames
- Drug: Pegylated rhG-CSF 100μg/kg
- type
- EXPERIMENTAL
- label
- Pegylated rhG-CSF 150μg/kg
- description
- Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K)150 μg/kg in cycle 2 to 4
- interventionNames
- Drug: Pegylated rhG-CSF:150 μg/kg
- type
- ACTIVE_COMPARATOR
- label
- G-CSF 5 μg/kg/d
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathology diagnosis of breast cancer,Chemotherapy naïve * ECOG performance status 0-1 * Age 18 to 70 years * Available for at least 2 cycles of consistent neoadjuvant/adjuvant therapy * White blood cell ≥ 4.0×109/L; absolute neutrophil count ≥2.0 × 109/L; platelet count ≥ 100 × 109/L * Alanine aminotransferase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN * No obvious cardiac dysfunction Exclusion Criteria: * Prior bone marrow or stem cell transplantation * Received systemic antibiotics treatment within 72 h of chemotherapy * Other disease might have influence on bone marrow function * Radiation therapy within 4 weeks of randomization into this study * Previous exposure or or allergic to Pegylated rhG-CSF * Pregnancy, lactation
References
Publications (0)
Data not yet available