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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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ClinicalTrials.gov Identifier: NCT03343145
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

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
Breast Cancer 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 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 : January 12, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Filgrastim

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




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

Secondary Outcome Measures :
  1. Depth of ANC nadir after chemotherapy in Cycle 1 [ Time Frame: Maximum of 14 Days ]
  2. Time to ANC recovery in Cycle 1 [ Time Frame: Maximum of 14 Days ]
  3. Incidence of febrile neutropenia in Cycle 1; [ Time Frame: Maximum of 14 Days ]

Other Outcome Measures:
  1. Anti-rhG-CSF antibody formation [ Time Frame: 180±14d ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343145


Contacts
Contact: Jeong jyjeong@donga.co.kr

Locations
Indonesia
RSUP Dr. Hasan Sadikin Recruiting
Bandung, Indonesia
Contact: Trinugroho Heri Fadjari, dr.         
Sponsors and Collaborators
Dong-A ST Co., Ltd.

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT03343145     History of Changes
Other Study ID Numbers: DAGCSF_NP_III
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases