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

Breast Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805153
• Other study ID #: CSPC-PGC-IV-01
• 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 evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• PEG-rhG-CSF

• 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 grade IV neutropenia during the first chemotherapy cycle		through first cycle of chemotherapy,an average of 1 month	No
Secondary	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)		through the next three consecutive cycles chemotherapy,an average of 3 months	No
Secondary	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)		through the next three consecutive cycles chemotherapy,an average of 3 months	No