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OpenTrials
Completed

NCT Number: NCT02805205

PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy to Prevent Neutropenia

The purpose of this study is to estimate 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 who need to receive multi-cycle chemotherapy
  • grade III/IV neutropenia after chemotherapy
  • KPS score≥70
  • life expectancy of at least 3 months
  • Written informed consent are acquired

Exclusion criteria

  • Have accepted any other drug related clinical trial within 4 weeks before anticipated
  • uncontrolled infection
  • pregnancy
  • Other situations that investigators consider as contra-indication for this study

Treatment and study plan

PEG-rhG-CSF

Drug

Other names: pegfilgrastim

Primary outcomes

  1. the occurrence rate of the adverse events that are related to treatment during four consecutive cycles chemotherapy

    Time frame: up to 30 days after the patient study completion

  2. the severity of the adverse events that are related to treatment during four consecutive cycles chemotherapy

    Time frame: up to 30 days after the patient study completion

Secondary outcomes

  1. the occurrence rate of III/ IV neutropenia during the whole chemotherapy process

    Time frame: through the study completion,an average of 5 months

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Sponsors and collaborators

Lead sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multi-center, Open-label,Single Arm 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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