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

Hengrui Medicine

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Febrile Neutropenia; Neutropenia

Treatments: Drug: Drug: Pegylated rhG-CSF: 100µg/kg; Drug: rhG-CSF 5ug/kg/day; Drug: Pegylated rhG-CSF: 6mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01611051

HHPG-19K -III-01

Details and patient eligibility

About

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.

Enrollment: 330 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 3 patient groups

Pegylated rhG-CSF: 100µg/kg

Experimental group

Description:

Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg

Treatment:

Drug: Drug: Pegylated rhG-CSF: 100µg/kg

Pegylated rhG-CSF: 6mg

Experimental group

Description:

Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 6mg

Treatment:

Drug: Pegylated rhG-CSF: 6mg

rhG-CSF 5ug/kg/day

Active Comparator group

Description:

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

Treatment:

Drug: rhG-CSF 5ug/kg/day