Skip to main content
OpenTrials
Completed

NCT Number: NCT02119715

A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF in 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 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 2

Primary location

307 Hospital Affiliated to Academy Military Medical Science

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pegylated rhG-CSF 100μg/kg

Drug

Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy).

Other names: HHPG-19K 100µg/kg

Pegylated rhG-CSF:150 μg/kg

Drug

Patients were administered pegylated rhG-CSF 150 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy).

Other names: HHPG-19K 150μg/kg

rhG-CSF 5 μg/kg/day

Drug

Patients were administered rhG-CSF 5 ug/kg daily during chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy) until (1)continuous injection for 14 days (2)two successive ANC counts exceed 5.0×109/L（3）ANC counts exceed 15×109/L at anytime.

Other names: Jie Xin 5 μg/kg/day

Primary outcomes

  1. Incidence and the duration of grade 3/4 neutropenia in cycle 2 and the time frame of ANC recovery to 2.0×109/L

    Time frame: 6 weeks

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

Secondary outcomes

  1. Incidence of the febrile neutropenia in cycle 1 and cycle 2

    Time frame: 6 weeks

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

  2. ANC alteration in cycle 1 and cycle 2

    Time frame: 6 weeks

    Weekly laboratory ANC value alteration

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF as Supportive Therapy to Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 22, 2014
Registry last updated
Apr 22, 2014

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.