NCT03343145

A Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients

A Randomized, Open-label, Active-controlled, Multi-center, Phase III Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Leucostim 5µg/kg/day	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
BIOLOGICAL	Neupogen 5µg/kg/day	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

Timeline

• Start date: 2017-01-12
• Primary completion: 2019-01-28
• Completion: 2019-07-29
• First posted: 2017-11-17
• Last updated: 2020-12-28

Locations

1 site across 1 country: Indonesia