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

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.215 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

215

Conditions

Breast Cancer

Interventions

PEG-rhG-CSFDRUG

rhG-CSFDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

the occurrence rate of grade IV neutropenia during the first chemotherapy cycle

Time frame: through first cycle of chemotherapy,an average of 1 month

Secondary Outcomes

the non-occurrence rate of grade IV neutropenia (ANC < 0.5 x 10^9/L)during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)

Time frame: through the next three consecutive cycles chemotherapy,an average of 3 months

the duration of grade IV neutropenia (ANC < 0.5 x 10^9/L) during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)

Time frame: through the next three consecutive cycles chemotherapy,an average of 3 months

Data from ClinicalTrials.gov

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