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Prevention of Neutropenia After Using G-CSF With TAC 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. Read our disclaimer for details. Identifier: NCT01571518
Recruitment Status : Unknown
Verified April 2012 by Hyuk moon Kim, Sunchonhang University.
Recruitment status was:  Not yet recruiting
First Posted : April 5, 2012
Last Update Posted : April 5, 2012
Dong-A Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Hyuk moon Kim, Sunchonhang University

Brief Summary:
After resection of lymph node positive breast cancer, the injection duration and timing of Granulocyte-colony stimulating factor (G-CSF) could affect the neutropenia with TAC (Taxotere, Adriamycin, cyclophosphamide) chemotherapy.

Condition or disease Intervention/treatment Phase
Neutropenia Drug: late leukostim Drug: early leukostim Phase 4

Detailed Description:
The duration and the injection timing of G-CSF are effective in the prevention of neutropenia, incidence of infection and non hematologic toxicity. With the TAC chemotherapy after resection of breast cancer, the G-CSF early injection versus late injection could change the frequency of neutropenia.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimal Timing and Duration of Daily G-CSF With Adjuvant TAC Chemotherapy in Node-positive Breast Cancer;Multicenter, Randomized, Open Label, Clinically IV Phase
Study Start Date : April 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: early injection
injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy
Drug: late leukostim
injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy
Other Name: 5leuko
Sham Comparator: late injection
injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy
Drug: early leukostim
injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy
Other Name: 2leuko

Primary Outcome Measures :
  1. frequency of neutropenia [ Time Frame: Change from Baseline in neutrophil count at 21days ]
    during the 1 cycle (21days) of ajuvant chemotherapy with TAC, record the frequency of neutropenia aftr using G-CSF (Leucostim)

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • primary invasive breast carcinoma with lymph node positive with curative surgery with TAC chemotherapy

Exclusion Criteria:

  • pregnancy,
  • cardiovascualr disease,
  • abnormal renal function,
  • hematologic disorder

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): NCT01571518

Contact: Chul Wan Lim, M.D., Ph.D 82-32-621-5114

Korea, Republic of
Soonchunhyang university Puchun Hospital Not yet recruiting
Puchun, Korea, Republic of
Contact: Hyuk moon Kim, MD    82-32-621-5114   
Principal Investigator: ChulWan Lim, MD.PhD         
Sponsors and Collaborators
Hyuk moon Kim
Dong-A Pharmaceutical Co., Ltd.
Study Chair: Chul Wan Lim, MD,PhD Soonchunhyang U Puchun Hospital

Publications of Results:
Responsible Party: Hyuk moon Kim, Assistant professor, Sunchonhang University Identifier: NCT01571518     History of Changes
Other Study ID Numbers: 2011-91
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: April 5, 2012
Last Verified: April 2012

Keywords provided by Hyuk moon Kim, Sunchonhang University:

Additional relevant MeSH terms:
Leukocyte Disorders
Hematologic Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs