PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy to Prevent Neutropenia

CSPC Pharmaceutical Group

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Drug: PEG-rhG-CSF

Study type: Interventional

Funder types: Industry

Identifiers

NCT02805205

CSPC-PGC-IV-02

Details and patient eligibility

About

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

Enrollment: 484 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with age between 18 and 70 years
• diagnosis of breast cancer patients who need to receive multi-cycle chemotherapy
• grade III/IV neutropenia after chemotherapy
• KPS score≥70
• life expectancy of at least 3 months
• Written informed consent are acquired

Exclusion criteria

• Have accepted any other drug related clinical trial within 4 weeks before anticipated
• uncontrolled infection
• pregnancy
• Other situations that investigators consider as contra-indication for this study

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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484 participants in 1 patient group

PEG-rhG-CSF

Experimental group

Description:

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

Treatment:

Drug: PEG-rhG-CSF