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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03343145 |
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Date of registration:
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10/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients
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Scientific 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 |
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Date of first enrolment:
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January 12, 2017 |
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Target sample size:
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143 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03343145 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Indonesia
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Willing to provide a written informed consent
2. Men or women = 18 and = 70 years of age
3. Histologically or cytologically confirmed breast cancer (Stage II to Stage IV)
4. Be scheduled to receive TAC regimen as adjuvant therapy
5. 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
6. Adequate renal function (Creatinine = 1.5 x ULN at screening test)
7. Adequate hepatic function at screening test (Total bilirubin/AST/ALT = 1.5 x ULN, ALP
= 2.5 x ULN at screening test)
Exclusion Criteria:
1. Prior chemotherapy experiences
2. Prior bone marrow or stem cell transplantation
3. History of treatment with hematopoietic growth factors (e.g. G-CSF, peg-G-CSF,
erythropoietin)
4. History of prior malignancy other than breast cancer or surgically cured malignancies
within 5 years of informed consent date
5. Participation in any other clinical study within 4 weeks of informed consent date or
planning to simultaneously participate in another clinical study
6. Currently receiving radiation therapy or having completed radiation therapy within 4
weeks of informed consent date
7. 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))
8. History of systemic antibiotic use within 72 hours prior to chemotherapy
9. History of hypersensitivity to the investigational product, components or similar
products
10. HIV positive
11. 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
12. Any other cases that is considered by the investigator as an exclusion
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Biological: Leucostim 5µg/kg/day
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Biological: Neupogen 5µg/kg/day
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Primary Outcome(s)
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Mean duration of Grade 4 Neutropenia (i.e. ANC < 500/mm3) in Cycle 1
[Time Frame: Maximum of 14 Days]
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Secondary Outcome(s)
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Depth of ANC nadir after chemotherapy in Cycle 1
[Time Frame: Maximum of 14 Days]
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Incidence of febrile neutropenia in Cycle 1;
[Time Frame: Maximum of 14 Days]
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Time to ANC recovery in Cycle 1
[Time Frame: Maximum of 14 Days]
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Secondary ID(s)
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DAGCSF_NP_III
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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