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

Phase 2

Completed

• Conditions: Febrile Neutropenia; Breast Cancer; Neutropenia
• Interventions: Drug: Pegylated rhG-CSF 100μg/kg; Drug: rhG-CSF 5 μg/kg/day

• Registration Number: NCT02119715
• 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 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: 2011-02
• Primary Completion: 2012-08
• Study Completion: 2012-12
• Status Verified: 2014-04
• Study First Submitted: 2014-04-17
• Study First Submitted QC: 2014-04-17
• Last Update Submitted: 2014-04-17
• Study First Posted: 2014-04-22
• Last Update Posted: 2014-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pegylated rhG-CSF 100μg/kg	Pegylated rhG-CSF 100μg/kg	Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K） 100µg/kg in cycle 2 to 4
G-CSF 5 μg/kg/d	rhG-CSF 5 μg/kg/day	Chemotherapy naive patients receiving chemotherapy and rhG-CSF 5μg/kg/day in cycle 2 to 4

Primary Outcome Measures

Name	Time	Method
Incidence and the duration of grade 3/4 neutropenia in cycle 2 and the time frame of ANC recovery to 2.0×109/L	6 weeks	Proportion and the duration of subjects developing ANC lower than 1.0×109/L

Secondary Outcome Measures

Name	Time	Method
Incidence of the febrile neutropenia in cycle 1 and cycle 2	6 weeks	Rate of ANC\<0.5×109/L and auxiliary temperature\>38.5℃
ANC alteration in cycle 1 and cycle 2	6 weeks	Weekly laboratory ANC value alteration

Trial Locations

Locations (1)

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