Clinical trial · Interventional
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
NCT03343145CI-TRIAL-00049140completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leucostim 5µg/kg/day | Biological | — | UNRESOLVED |
| Neupogen 5µg/kg/day | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Test Drug Group
- description
- Leucostim 5µg/kg/day
- interventionNames
- Biological: Leucostim 5µg/kg/day
- type
- ACTIVE_COMPARATOR
- label
- Reference Drug Group
- description
- Neupogen 5µg/kg/day
- interventionNames
- Biological: Neupogen 5µg/kg/day
Primary outcomes (1)
- measure
- Mean duration of Grade 4 Neutropenia (i.e. ANC < 500/mm3) in Cycle 1
- timeFrame
- Maximum of 14 Days
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.