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Completed

NCT Number: NCT02944604

The Efficacy and Safety of PEG-rhG-CSF(Pegylated Recombinant Human Granulocyte Colony Stimulating Factor)in Patients With Breast Cancer Who Were Treated With Intensive Chemotherapy

The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer who were treated with intensive chemotherapy for prevention of neutrophil reduction.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

1.18-65 years old, gender no limited.

2.Breast cancer diagnosed by pathology.

3.Did not receive chemotherapy previously and plans to receive 4 cycles intensive EC (epirubicin, cyclophosphamide) treatment.

4.No obvious blood system disease, ANC(absolute neutrophil count)≥ 1.5 × 10^9/L, PLT(Platelet)≥80×10^9 /L, Hb(hemoglobin)≥75g/L, WBC(White blood cell )≥3×109/L, and no bleeding tendency.

5.KPS (Karnofsky performance status) score≥70.

6.Expected survival≥3 months.

7.Written informed consent are acquired.

Exclusion criteria

  • Severe or uncontrolled infection.
  • Sensitive to the product or other genetically engineered biological products from Escherichia coli strains.
  • Mental or nervous system disorders.
  • Severe heart, lung and central nervous system disorders.
  • Pregnant or lactating women.
  • TBIL(total bilirubin ), ALT(alanine aminotransferase),AST(glutamic-oxalacetic transaminase) > 2.5×ULN(upper limit of normal); if it were caused by liver metastases, TBIL, ALT,AST >5×ULN.
  • Cr(creatinine) >1.5×ULN.

Treatment and study plan

PEG-rhG-CSF

Drug

Primary outcomes

  1. Incidence of chemotherapy delay

    Time frame: 60 days after the first chemotherapy

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 26, 2016
Registry last updated
Jan 18, 2019

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.

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