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NCT02944604 Clinical Trial

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

Breastcancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02944604
Other study ID # CSPC-JYL-20160314
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 8, 2016
Est. completion date September 30, 2017

Study information
Verified date January 2019
Source Peking University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date September 30, 2017
Est. primary completion date September 29, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• PEG-rhG-CSF

Locations
Country Name City State
China Peking University Cancer Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of chemotherapy delay 60 days after the first chemotherapy
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