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

Phase 4

Completed

• Conditions: Breast Cancer
• Interventions: Drug: PEG-rhG-CSF; Drug: rhG-CSF

• Registration Number: NCT02805153
• Lead Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-06
• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-17
• Last Update Submitted: 2016-06-17
• Last Update Posted: 2016-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental/PEG-rhG-CSF	PEG-rhG-CSF	patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy.
Active Comparator/rhG-CSF	rhG-CSF	patients received daily subcutaneous injections of rhG-CSF(filgrastim) 5 ug/ kg/day. Injections on day 3 after chemotherapy and continued daily until an ANC of at least 10.0 X 10\^9/L was documented after the expected nadir, or for a maximum of 14 days

Primary Outcome Measures

Name	Time	Method
the occurrence rate of grade IV neutropenia during the first chemotherapy cycle	through first cycle of chemotherapy,an average of 1 month

Secondary Outcome Measures

Name	Time	Method
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
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