Back to resultsA Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Leucostim 5µg/kg/day
Neupogen 5µg/kg/day
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Neutropenia
Eligibility Criteria
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
Sites / Locations
- RSUP Dr. Hasan Sadikin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test Drug Group
Reference Drug Group
Arm Description
Leucostim 5µg/kg/day
Neupogen 5µg/kg/day
Outcomes
Primary Outcome Measures
Mean duration of Grade 4 Neutropenia (i.e. ANC < 500/mm3) in Cycle 1
Secondary Outcome Measures
Depth of ANC nadir after chemotherapy in Cycle 1
Time to ANC recovery in Cycle 1
Incidence of febrile neutropenia in Cycle 1;
Full Information
NCT ID
NCT03343145
First Posted
November 10, 2017
Last Updated
December 24, 2020
Sponsor
Dong-A ST Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03343145
Brief Title
A Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 12, 2017 (Actual)
Primary Completion Date
January 28, 2019 (Actual)
Study Completion Date
July 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Neutropenia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Drug Group
Arm Type
Experimental
Arm Description
Leucostim 5µg/kg/day
Arm Title
Reference Drug Group
Arm Type
Active Comparator
Arm Description
Neupogen 5µg/kg/day
Intervention Type
Biological
Intervention Name(s)
Leucostim 5µg/kg/day
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Neupogen 5µg/kg/day
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean duration of Grade 4 Neutropenia (i.e. ANC < 500/mm3) in Cycle 1
Time Frame
Maximum of 14 Days
Secondary Outcome Measure Information:
Title
Depth of ANC nadir after chemotherapy in Cycle 1
Time Frame
Maximum of 14 Days
Title
Time to ANC recovery in Cycle 1
Time Frame
Maximum of 14 Days
Title
Incidence of febrile neutropenia in Cycle 1;
Time Frame
Maximum of 14 Days
Other Pre-specified Outcome Measures:
Title
Anti-rhG-CSF antibody formation
Time Frame
180±14d
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
RSUP Dr. Hasan Sadikin
City
Bandung
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients
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