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Completed

NCT Number: NCT02805153

PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy

The purpose of this study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with age between 18 and 70 years
  • diagnosis of breast cancer patients
  • chemotherapy naive
  • Karnofsky Performance Status ≥ 70
  • Written informed consent are acquired

Exclusion criteria

  • uncontrolled infection
  • Have accepted radiotherapy within 4 weeks before anticipated the study
  • pregnancy
  • Other situations that investigators consider as contra-indication for this study

Treatment and study plan

PEG-rhG-CSF

Drug

Other names: pegfilgrastim

rhG-CSF

Drug

Other names: filgrastim

Primary outcomes

  1. the occurrence rate of grade IV neutropenia during the first chemotherapy cycle

    Time frame: through first cycle of chemotherapy,an average of 1 month

Secondary outcomes

  1. the non-occurrence rate of grade IV neutropenia (ANC < 0.5 x 10^9/L)during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)

    Time frame: through the next three consecutive cycles chemotherapy,an average of 3 months

  2. the duration of grade IV neutropenia (ANC < 0.5 x 10^9/L) during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)

    Time frame: through the next three consecutive cycles chemotherapy,an average of 3 months

Sponsors and collaborators

Lead sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

The Multi-center, Open-label,Randomized Comparison Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia in Patients With Breast Cancer Receiving Chemotherapy

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2016
Registry last updated
Jun 20, 2016

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.

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