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

CSPC Pharmaceutical Group

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Drug: rhG-CSF; Drug: PEG-rhG-CSF

Study type: Interventional

Funder types: Industry

Identifiers

NCT02805153

CSPC-PGC-IV-01

Details and patient eligibility

About

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

Enrollment: 215 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
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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215 participants in 2 patient groups

Experimental/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

Active Comparator/rhG-CSF

Active Comparator group

Description:

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

Treatment:

Drug: rhG-CSF