Trial | NCT01571518  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    sargramostim ...

  • Study Participants

    60
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 Started
Apr 30
2012
Primary Completion
Oct 31
2013
Anticipated
Study Completion
Oct 31
2013
Anticipated
Last Update
Apr 05
2012
Estimate

Drug late leukostim

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

  • Other names: 5leuko

Drug early leukostim

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

  • Other names: 2leuko

early injection Experimental

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

late injection Sham Comparator

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

Criteria 

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
No Results Posted