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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03343145
• Other study ID #: DAGCSF_NP_III
• Status: Completed
• Phase: Phase 3
• Start date: January 12, 2017
• Est. completion date: July 29, 2019

Study information

• Verified date: December 2020
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: July 29, 2019
• Est. primary completion date: January 28, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Indonesia	RSUP Dr. Hasan Sadikin	Bandung

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anti-rhG-CSF antibody formation		180±14d
Primary	Mean duration of Grade 4 Neutropenia (i.e. ANC < 500/mm3) in Cycle 1		Maximum of 14 Days
Secondary	Depth of ANC nadir after chemotherapy in Cycle 1		Maximum of 14 Days
Secondary	Time to ANC recovery in Cycle 1		Maximum of 14 Days
Secondary	Incidence of febrile neutropenia in Cycle 1;		Maximum of 14 Days