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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: Leucostim 5µg/kg/day
* Biological: Neupogen 5µg/kg/day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to provide a written informed consent Men or women ≥ 18 and ≤ 70 years of age Histologically or cytologically confirmed breast cancer (Stage II to Stage IV) Be scheduled to receive TAC regimen as adjuvant therapy Subjects who meet the conditions at screening test as follows; Absolute Neutrophil Count (ANC) ≥ 1,500/mm3 Platelet Count ≥ 100,000/mm3 ECOG Performance Status : 0 2 Adequate renal function (Creatinine ≤ 1.5 x ULN at screening test) Adequate hepatic function at screening test (Total bilirubin/AST/ALT ≤ 1.5 x ULN, ALP ≤ 2.5 x ULN at screening test) Exclusion Criteria: Prior chemotherapy experiences Prior bone marrow or stem cell transplantation History of treatment with hematopoietic growth factors (e.g. G-CSF, peg-G-CSF, erythropoietin) History of prior malignancy other than breast cancer or surgically cured malignancies within 5 years of informed consent date Participation in any other clinical study within 4 weeks of informed consent date or planning to simultaneously participate in another clinical study Currently receiving radiation therapy or having completed radiation therapy within 4 weeks of informed consent date Active infection which may require systemic antimicrobial or antiviral therapy during the study (e.g. ANC ≥ 12,000/mm3 or Body Temperature > 38.2 degrees C (100.8 degrees F)) History of systemic antibiotic use within 72 hours prior to chemotherapy History of hypersensitivity to the investigational product, components or similar products HIV positive Pregnant or lactating women, or women of child-bearing potential who are not willing to follow a reliable and effective contraceptive measure during the course of the study and for at least one month after the completion of the study Any other cases that is considered by the investigator as an exclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Drug Group<br>Leucostim 5µg/kg/day | Biological: Leucostim 5µg/kg/day<br>* 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<br>|
| Active Comparator: Reference Drug Group<br>Neupogen 5µg/kg/day | Biological: Neupogen 5µg/kg/day<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean duration of Grade 4 Neutropenia (i.e. ANC < 500/mm3) in Cycle 1 |  | Maximum of 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth of ANC nadir after chemotherapy in Cycle 1 |  | Maximum of 14 Days | 
| Time to ANC recovery in Cycle 1 |  | Maximum of 14 Days | 
| Incidence of febrile neutropenia in Cycle 1; |  | Maximum of 14 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neutropenia