Skip to main content
OpenTrials
Completed

NCT Number: NCT01611051

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Agranulocytosis Breast Diseases Breast Neoplasms Cytopenia Febrile Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Site Neutropenia Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Affiliated to Academy Military Medical Science

Beijing, Beijing Municipality, 100071, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug: Pegylated rhG-CSF: 100µg/kg

Drug

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

Drug

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

Drug

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).

Primary outcomes

  1. Rate and the duration of grade 3/4 neutropenia in cycle 1

    Time frame: 21 days

    Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L.

Secondary outcomes

  1. Rate and the duration of grade 3/4 neutropenia in cycle 2-4

    Time frame: 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.

  2. Rate of the febrile neutropenia in cycle 1

    Time frame: Through 4 cycles

    Rate of ANC<0.5×109/L and auxiliary temperature>38.5℃.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
First posted
Jun 4, 2012
Registry last updated
Jan 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.