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

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.484 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

484

Conditions

Breast Cancer

Interventions

PEG-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 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

Outcomes

Primary Outcomes

the occurrence rate of the adverse events that are related to treatment during four consecutive cycles chemotherapy

Time frame: up to 30 days after the patient study completion

the severity of the adverse events that are related to treatment during four consecutive cycles chemotherapy

Time frame: up to 30 days after the patient study completion

Secondary Outcomes

the occurrence rate of III/ IV neutropenia during the whole chemotherapy process

Time frame: through the study completion,an average of 5 months

Data from ClinicalTrials.gov

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