Status:
COMPLETED
A Study to Evaluate the Efficacy, Safety and Immunogenicity of Leucostim® Versus Neupogen® in Breast Cancer Patients
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
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 an...
Eligibility Criteria
Inclusion
- Willing to provide a written informed consent
- Men or women ≥ 18 and ≤ 70 years of age
- Histologically or cytologically confirmed breast cancer (Stage II to Stage IV)
- Be scheduled to receive TAC regimen as adjuvant therapy
- 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
- Adequate renal function (Creatinine ≤ 1.5 x ULN at screening test)
- Adequate hepatic function at screening test (Total bilirubin/AST/ALT ≤ 1.5 x ULN, ALP ≤ 2.5 x ULN at screening test)
Exclusion
- Prior chemotherapy experiences
- Prior bone marrow or stem cell transplantation
- History of treatment with hematopoietic growth factors (e.g. G-CSF, peg-G-CSF, erythropoietin)
- History of prior malignancy other than breast cancer or surgically cured malignancies within 5 years of informed consent date
- Participation in any other clinical study within 4 weeks of informed consent date or planning to simultaneously participate in another clinical study
- Currently receiving radiation therapy or having completed radiation therapy within 4 weeks of informed consent date
- 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))
- History of systemic antibiotic use within 72 hours prior to chemotherapy
- History of hypersensitivity to the investigational product, components or similar products
- HIV positive
- 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
- Any other cases that is considered by the investigator as an exclusion
Key Trial Info
Start Date :
January 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2019
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT03343145
Start Date
January 12 2017
End Date
July 29 2019
Last Update
December 28 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
RSUP Dr. Hasan Sadikin
Bandung, Indonesia