This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Hyuk moon Kim, Sunchonhang University.
Recruitment status was:  Not yet recruiting
Dong-A Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Hyuk moon Kim, Sunchonhang University Identifier:
First received: March 29, 2012
Last updated: April 3, 2012
Last verified: April 2012
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 Intervention Phase
Neutropenia Drug: late leukostim Drug: early leukostim Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hyuk moon Kim, Sunchonhang University:

Primary Outcome Measures:
  • 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)

Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Hyuk moon Kim, Assistant professor, Sunchonhang University Identifier: NCT01571518     History of Changes
Other Study ID Numbers: 2011-91
Study First Received: March 29, 2012
Last Updated: April 3, 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 processed this record on September 21, 2017