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

Phase 3

Completed

• Conditions: Breast Cancer; Neutropenia; Febrile Neutropenia
• Interventions: Drug: rhG-CSF 5ug/kg/day

• Registration Number: NCT01611051
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-05-31
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-04
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Last Update Submitted: 2013-01-05
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rhG-CSF 5ug/kg/day	rhG-CSF 5ug/kg/day	Chemtherapy naive patients receiving chemotherapy and rhG-CSF 5ug/kg/day

Primary Outcome Measures

Name	Time	Method
Rate and the duration of grade 3/4 neutropenia in cycle 1	21 days	Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L.

Secondary Outcome Measures

Name	Time	Method
Rate and the duration of grade 3/4 neutropenia in cycle 2-4	Through cycle 2 to cycle 4	Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L from cycle 2 to cycle 4.
Rate of the febrile neutropenia in cycle 1	Through 4 cycles	Rate of ANC\<0.5×109/L and auxiliary temperature\>38.5℃.

Trial Locations

Locations (1)

Hospital Affiliated to Academy Military Medical Science; 🇨🇳 Beijing, Beijing, China