Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy

Hyuk moon Kim

Status and phase: Unknown; Phase 4

Conditions: Neutropenia

Treatments: Drug: early leukostim; Drug: late leukostim

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01571518

2011-91

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

early injection

Experimental group

Description:

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

Treatment:

Drug: late leukostim

late injection

Sham Comparator group

Description:

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

Treatment:

Drug: early leukostim