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Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy

Information source: Sunchonhang University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neutropenia

Intervention: late leukostim (Drug); early leukostim (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Hyuk moon Kim

Official(s) and/or principal investigator(s):
Chul Wan Lim, MD,PhD, Study Chair, Affiliation: Soonchunhyang U Puchun Hospital

Overall contact:
Chul Wan Lim, M.D., Ph.D, Phone: 82-32-621-5114, Email: cylim@soonchunhyang.com


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: frequency of neutropenia

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.


Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Female.


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

Locations and Contacts

Chul Wan Lim, M.D., Ph.D, Phone: 82-32-621-5114, Email: cylim@soonchunhyang.com

Soonchunhyang university Puchun Hospital, Puchun, Korea, Republic of; Not yet recruiting
Hyuk moon Kim, MD, Phone: 82-32-621-5114, Email: hmkim@soonchunhyang.com
ChulWan Lim, MD.PhD, Principal Investigator
Additional Information

Starting date: April 2012
Last updated: April 3, 2012

Page last updated: August 23, 2015

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