Optimal Timing and Duration of Daily G-CSF With Adjuvant TAC Chemotherapy in Node-positive Breast Cancer;Multicenter, Randomized, Open Label, Clinically IV Phase
20 Years
70 Years
Female
Neutropenia
Trial Information
Optimal Timing and Duration of Daily G-CSF With Adjuvant TAC Chemotherapy in Node-positive Breast Cancer;Multicenter, Randomized, Open Label, Clinically IV Phase
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
frequency of neutropenia
Outcome Description:
during the 1 cycle (21days) of ajuvant chemotherapy with TAC, record the frequency of neutropenia aftr using G-CSF (Leucostim)
Outcome Time Frame:
Change from Baseline in neutrophil count at 21days
Safety Issue:
Yes
Principal Investigator
Chul Wan Lim, MD,PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Soonchunhyang U Puchun Hospital
Authority:
Korea: Food and Drug Administration
Study ID:
2011-91
NCT ID:
NCT01571518
Start Date:
April 2012
Completion Date:
October 2013
Related Keywords:
- Neutropenia
- G-CSF
- neutropenia
- TAC
- Neutropenia
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