The Efficacy and Safety of PEG-rhG-CSF(Pegylated Recombinant Human Granulocyte Colony Stimulating Factor)in Patients With Breast Cancer Who Were Treated With Intensive Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02944604
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : December 19, 2017
Information provided by (Responsible Party):
Tao OUYANG, Peking University

Brief Summary:
The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer who were treated with intensive chemotherapy for prevention of neutrophil reduction.

Condition or disease Intervention/treatment Phase
Breastcancer Drug: PEG-rhG-CSF Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: PEG-rhG-CSF
Patients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF.
Drug: PEG-rhG-CSF

Primary Outcome Measures :
  1. Incidence of chemotherapy delay [ Time Frame: 60 days after the first chemotherapy ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

1.18-65 years old, gender no limited.

2.Breast cancer diagnosed by pathology.

3.Did not receive chemotherapy previously and plans to receive 4 cycles intensive EC (epirubicin, cyclophosphamide) treatment.

4.No obvious blood system disease, ANC(absolute neutrophil count)≥ 1.5 × 10^9/L, PLT(Platelet)≥80×10^9 /L, Hb(hemoglobin)≥75g/L, WBC(White blood cell )≥3×109/L, and no bleeding tendency.

5.KPS (Karnofsky performance status) score≥70.

6.Expected survival≥3 months.

7.Written informed consent are acquired.

Exclusion Criteria:

  1. Severe or uncontrolled infection.
  2. Sensitive to the product or other genetically engineered biological products from Escherichia coli strains.
  3. Mental or nervous system disorders.
  4. Severe heart, lung and central nervous system disorders.
  5. Pregnant or lactating women.
  6. TBIL(total bilirubin ), ALT(alanine aminotransferase),AST(glutamic-oxalacetic transaminase) > 2.5×ULN(upper limit of normal); if it were caused by liver metastases, TBIL, ALT,AST >5×ULN.
  7. Cr(creatinine) >1.5×ULN.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02944604

Contact: Tao Ouyang, MD

China, Beijing
Peking University Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: TAO OUYANG, M.D.    0086-10-88196695   
Sponsors and Collaborators
Peking University
Study Chair: Tao Ouyang, MD Beijing Cancer Hospital

Responsible Party: Tao OUYANG, Chairman of Breast Center, Peking University Identifier: NCT02944604     History of Changes
Other Study ID Numbers: CSPC-JYL-20160314
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs