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A randomized controlled clinical research of the safety and efficacy of prophylactic PEG-rhG-CSF 24 hours after chemotherapy in breast cancer patients

A randomized controlled clinical research of the safety and efficacy of prophylactic PEG-rhG-CSF 24 hours after chemotherapy in breast cancer patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054095
Enrollment
Unknown
Registered
2021-12-08
Start date
2021-12-09
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

24 hours after chemotherapy group:Subcutaneous injection of PEG-rhG-CSF 24 hours after chemotherapy
48 hours after chemotherapy group:Subcutaneous injection of PEG-rhG-CSF 48 hours after chemotherapy

Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Female patients, pathologically diagnosed female patients with breast cancer; no disease progression or recurrence or distant metastasis has occurred in the standard treatment of breast cancer; 3. The detection values of white blood cells and granulocytes before chemotherapy were normal; 4. The expected survival period is more than 3 months; there are indications for chemotherapy in the treatment plan, and chemotherapy is planned; 5. The main organs of the subjects including heart, liver, lung and kidney function well. Liver function: ALT/AST 60 %; ECOG score less than 2 points; 6. The subjects have not received any radiotherapy, targeted therapy, or endocrine therapy before enrollment.

Exclusion criteria

Exclusion criteria: 1. Those who used granulocyte stimulating factor within 2 weeks before enrollment; 2. Suffering from severe autoimmune disease or immunodeficiency disease; 3. Those suffering from uncontrollable infectious diseases within 2 weeks before enrollment; 4. The investigator believes that there may be any situation that may increase the risk of the subject or interfere with the results of the clinical trial.

Design outcomes

Primary

MeasureTime frame
The incidence of grade 3/4 neutropenia;

Secondary

MeasureTime frame
The incidence of adverse events;

Countries

China

Contacts

Public ContactShi Fujun

Zhujiang Hospital of Southern Medical University

drshifujun@163.com+86 15918720060

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026