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

NCT03343145 | Completed Phase 3

• 1 other identifier: DAGCSF_NP_III
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Neutropenia

Outcome Measures

Primary Outcomes (1)

• Mean duration of Grade 4 Neutropenia (i.e. ANC < 500/mm3) in Cycle 1

  Maximum of 14 Days

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• Anti-rhG-CSF antibody formation

  180±14d

Study Arms (2)

Test Drug Group

EXPERIMENTAL

Leucostim 5µg/kg/day

Biological: Leucostim 5µg/kg/day

Reference Drug Group

ACTIVE COMPARATOR

Neupogen 5µg/kg/day

Biological: Neupogen 5µg/kg/day

Interventions

Leucostim 5µg/kg/day BIOLOGICAL

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

Test Drug Group

Neupogen 5µg/kg/day BIOLOGICAL

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

Reference Drug Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

RSUP Dr. Hasan Sadikin

Bandung, Indonesia

Location

MeSH Terms

Conditions

Breast Neoplasms; Neutropenia

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 17, 2017
• Study Start: January 12, 2017
• Primary Completion: January 28, 2019
• Study Completion: July 29, 2019
• Last Updated: December 28, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)