Clinical trial NCT03343145: A Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Neutropenia
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Mean duration of Grade 4 Neutropenia (i.e. ANC < 500/mm3) in Cycle 1
timeFrame: Maximum of 14 Days
Secondary outcomes:
measure: Depth of ANC nadir after chemotherapy in Cycle 1
timeFrame: Maximum of 14 Days
measure: Time to ANC recovery in Cycle 1
timeFrame: Maximum of 14 Days
measure: Incidence of febrile neutropenia in Cycle 1;
timeFrame: Maximum of 14 Days
Other outcomes:
measure: Anti-rhG-CSF antibody formation
timeFrame: 180±14d
Locations:
city: Bandung
country: Indonesia
facility: RSUP Dr. Hasan Sadikin
Study officials:
References: