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

C

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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