A study to compare the efficacy, safety and immunogenicity of Leucostim® to those of Neupogen® in patients with breast cancer intended to be treated with TAC regimen as a myelosuppressive chemotherapy.
TAC regimen (docetaxel, doxorubicin and cyclophosphamide) is recommended for the adjuvant treatment of breast cancer patients. The TAC regimen is known to lead to significant hematological toxicity and induces febrile neutropenia with a rate \> 20%. The use of primary G-CSF prophylaxis with the TAC regimen is recommended by guidelines. e.g., by the European Organisation for Research and Treatment of Cancer as well as by the guideline on myeloid growth factors of the National Comprehensive Cancer Network.6,7 This study is to compare the efficacy, safety and immunogenicity of Leucostim® to those of Neupogen® in patients with breast cancer intended to be treated with TAC regimen as a myelosuppressive chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
143
5µg/kg/day (based on actual body weight) Leucostim®, subcutaneously, once a day, for up to 14 days or until the target ANC of 10,000/mm3 following the expected chemotherapy-induced ANC nadir
5µg/kg/day (based on actual body weight) Neupogen®, subcutaneously, once a day, for up to 14 days or until the target ANC of 10,000/mm3 following the expected chemotherapy-induced ANC nadir
RSUP Dr. Hasan Sadikin
Bandung, Indonesia
Mean duration of Grade 4 Neutropenia (i.e. ANC < 500/mm3) in Cycle 1
Time frame: Maximum of 14 Days
Depth of ANC nadir after chemotherapy in Cycle 1
Time frame: Maximum of 14 Days
Time to ANC recovery in Cycle 1
Time frame: Maximum of 14 Days
Incidence of febrile neutropenia in Cycle 1;
Time frame: Maximum of 14 Days
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