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

Breast Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805205
• Other study ID #: CSPC-PGC-IV-02
• Status: Completed
• Phase: Phase 4
• First received: June 13, 2016
• Last updated: June 17, 2016
• Start date: April 2013
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neutropenia

Intervention

Drug:
• PEG-rhG-CSF

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the occurrence rate of the adverse events that are related to treatment during four consecutive cycles chemotherapy		up to 30 days after the patient study completion	No
Primary	the severity of the adverse events that are related to treatment during four consecutive cycles chemotherapy		up to 30 days after the patient study completion	No
Secondary	the occurrence rate of III/ IV neutropenia during the whole chemotherapy process		through the study completion,an average of 5 months	No