A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF in Breast Cancer Patients Receiving Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF as Supportive Therapy to Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy

Conditions
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Breast Cancer, Neutropenia, Febrile Neutropenia

Intervention / Treatment
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* Drug: Pegylated rhG-CSF 100μg/kg
* Drug: Pegylated rhG-CSF:150 μg/kg
* Drug: rhG-CSF 5 μg/kg/day


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pegylated rhG-CSF 100μg/kg<br>Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K） 100µg/kg in cycle 2 to 4 | Drug: Pegylated rhG-CSF 100μg/kg<br>* Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy).<br>* Other names: HHPG-19K 100µg/kg;|
| Experimental: Pegylated rhG-CSF 150μg/kg<br>Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K)150 μg/kg in cycle 2 to 4 | Drug: Pegylated rhG-CSF:150 μg/kg<br>* Patients were administered pegylated rhG-CSF 150 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy).<br>* Other names: HHPG-19K 150μg/kg;|
| Active Comparator: G-CSF 5 μg/kg/d<br>Chemotherapy naive patients receiving chemotherapy and rhG-CSF 5μg/kg/day in cycle 2 to 4 | Drug: rhG-CSF 5 μg/kg/day<br>* Patients were administered rhG-CSF 5 ug/kg daily during chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy) until (1)continuous injection for 14 days (2)two successive ANC counts exceed 5.0×109/L（3）ANC counts exceed 15×109/L at anytime.<br>* Other names: Jie Xin 5 μg/kg/day;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and the duration of grade 3/4 neutropenia in cycle 2 and the time frame of ANC recovery to 2.0×109/L | Proportion and the duration of subjects developing ANC lower than 1.0×109/L | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of the febrile neutropenia in cycle 1 and cycle 2 | Rate of ANC<0.5×109/L and auxiliary temperature>38.5℃ | 6 weeks | 
| ANC alteration in cycle 1 and cycle 2 | Weekly laboratory ANC value alteration | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Neutropenia, Febrile Neutropenia