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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Biological: Leucostim 5µg/kg/day; Biological: Neupogen 5µg/kg/day

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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Bandung, Indonesia
    • RSUP Dr. Hasan Sadikin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Drug Group; Leucostim 5µg/kg/day	Biological: Leucostim 5µg/kg/day; 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
Active Comparator: Reference Drug Group; Neupogen 5µg/kg/day	Biological: Neupogen 5µg/kg/day; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
Anti-rhG-CSF antibody formation	180±14d

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2017
• Primary Completion (Actual): January 28, 2019
• Study Completion (Actual): July 29, 2019

Study Registration Dates

• First Submitted: November 10, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): December 28, 2020
• Last Update Submitted That Met QC Criteria: December 24, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Neutropenia
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: DAGCSF_NP_III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No