The Efficacy and Safety of PEG-rhG-CSF（Pegylated Recombinant Human Granulocyte Colony Stimulating Factor)in Patients With Breast Cancer Who Were Treated With Intensive Chemotherapy

Phase 4

Completed

• Conditions: Breastcancer
• Interventions: Drug: PEG-rhG-CSF

• Registration Number: NCT02944604
• Lead Sponsor: Peking University

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer who were treated with intensive chemotherapy for prevention of neutrophil reduction.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-08
• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-26
• Primary Completion: 2017-09-29
• Study Completion: 2017-09-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1.18-65 years old, gender no limited.

2.Breast cancer diagnosed by pathology.

3.Did not receive chemotherapy previously and plans to receive 4 cycles intensive EC (epirubicin, cyclophosphamide) treatment.

4.No obvious blood system disease, ANC(absolute neutrophil count)≥ 1.5 × 10^9/L, PLT（Platelet）≥80×10^9 /L, Hb（hemoglobin）≥75g/L, WBC（White blood cell ）≥3×109/L, and no bleeding tendency.

5.KPS (Karnofsky performance status) score≥70.

6.Expected survival≥3 months.

7.Written informed consent are acquired.

Exclusion Criteria

1. Severe or uncontrolled infection.
2. Sensitive to the product or other genetically engineered biological products from Escherichia coli strains.
3. Mental or nervous system disorders.
4. Severe heart, lung and central nervous system disorders.
5. Pregnant or lactating women.
6. TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） > 2.5×ULN（upper limit of normal）; if it were caused by liver metastases, TBIL, ALT,AST >5×ULN.
7. Cr（creatinine） >1.5×ULN.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEG-rhG-CSF	PEG-rhG-CSF	Patients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF.

Primary Outcome Measures

Name	Time	Method
Incidence of chemotherapy delay	60 days after the first chemotherapy

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China