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

Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03343145
Collaborator
(none)
143
Enrollment
1
Location
2
Arms
30.5
Actual Duration (Months)
4.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Leucostim 5µg/kg/day
  • Biological: Neupogen 5µg/kg/day
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
143 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jan 12, 2017
Actual Primary Completion Date :
Jan 28, 2019
Actual Study Completion Date :
Jul 29, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Mean duration of Grade 4 Neutropenia (i.e. ANC < 500/mm3) in Cycle 1 [Maximum of 14 Days]

Secondary Outcome Measures

  1. Depth of ANC nadir after chemotherapy in Cycle 1 [Maximum of 14 Days]

  2. Time to ANC recovery in Cycle 1 [Maximum of 14 Days]

  3. Incidence of febrile neutropenia in Cycle 1; [Maximum of 14 Days]

Other Outcome Measures

  1. Anti-rhG-CSF antibody formation [180±14d]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

  1. Adequate renal function (Creatinine ≤ 1.5 x ULN at screening test)

  2. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 RSUP Dr. Hasan Sadikin Bandung Indonesia

Sponsors and Collaborators

  • Dong-A ST Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03343145
Other Study ID Numbers:
  • DAGCSF_NP_III
First Posted:
Nov 17, 2017
Last Update Posted:
Dec 28, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dong-A ST Co., Ltd.
Neutropenia
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Dec 28, 2020