A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611051
• Other study ID #: HHPG-19K -III-01
• Status: Completed
• Phase: Phase 3
• First received: May 31, 2012
• Last updated: January 5, 2013
• Start date: March 2012

Study information

• Verified date: January 2013
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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 and phase 2 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Investigator diagnosis of breast cancer

• Age 18 to 70 years

• ECOG performance status = 1

• Chemotherapy naïve

• Body weight = 45kg

• Hemoglobin = 90g/L; white blood cell = 4.0×109/L; absolute neutrophil count =1.5 × 109/L; platelet count = 100 × 109/L

• Alanine transarninase =1.5×ULN; aspartate aminotransferase =1.5×ULN; serum creatinine =1.5×ULN; total bilirubin =1.5×ULN

Exclusion Criteria:

• Prior bone marrow or stem cell transplantation

• Received systemic antibiotics treatment within 72 h of chemotherapy

• Radiation therapy within 4 weeks of randomization into this study

• Pregnancy, lactation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Febrile Neutropenia
• Neutropenia

Intervention

Drug:
• Drug: Pegylated rhG-CSF: 100µg/kg
Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
• Pegylated rhG-CSF: 6mg
Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
• rhG-CSF 5ug/kg/day
Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).

Locations

Country	Name	City	State
China	Hospital Affiliated to Academy Military Medical Science	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate and the duration of grade 3/4 neutropenia in cycle 1	Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L.	21 days	No
Secondary	Rate and the duration of grade 3/4 neutropenia in cycle 2-4	Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L from cycle 2 to cycle 4.	Through cycle 2 to cycle 4	No
Secondary	Rate of the febrile neutropenia in cycle 1	Rate of ANC<0.5×109/L and auxiliary temperature>38.5?.	Through 4 cycles	No