Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy

Optimal Timing and Duration of Daily G-CSF With Adjuvant TAC Chemotherapy in Node-positive Breast Cancer;Multicenter, Randomized, Open Label, Clinically IV Phase

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01571518

Enrollment

Registered

2012-04-05

Start date

2012-04-30

Completion date

2013-10-31

Last updated

2012-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neutropenia

Keywords

G-CSF, neutropenia, TAC

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.

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.

Interventions

DRUGlate leukostim

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

DRUGearly leukostim

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
frequency of neutropenia	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)

Countries

South Korea

Contacts

Primary ContactChul Wan Lim, M.D., Ph.D

cylim@soonchunhyang.com82-32-621-5114

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026