Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy

Hyuk moon Kim60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Neutropenia

Interventions

late leukostimDRUG

injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy

early leukostimDRUG

injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 (1)

Soonchunhyang university Puchun Hospital

Puchun, South Korea

Outcomes

Primary Outcomes

frequency of neutropenia

during the 1 cycle (21days) of ajuvant chemotherapy with TAC, record the frequency of neutropenia aftr using G-CSF (Leucostim)

Time frame: Change from Baseline in neutrophil count at 21days

Central Contacts

Chul Wan Lim, M.D., Ph.D

CONTACT

82-32-621-5114 cylim@soonchunhyang.com

Data from ClinicalTrials.gov

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