Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT03575520
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2018-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
A Phase II Study to Evaluate the Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients Receiving Dose-dense Doxorubicin/Cyclophosphamide
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with pegteograstim support in Korean early breast cancer.
Detailed Description:
Pegteograstim is a novel monoPEGylated recombinant human G-CSF. In this prospective study, the incidence of febrile neutropenia during four cycles of dose dense (DD) doxorubicin/cyclophosphamide (AC) with pegtoegrastim support is being investigated.
The primary objective of this study is to determine the incidence of febrile neutropenia during four cycles of DD AC with pegteograstim support (8 weeks).
Patients received four cycles of DD-AC (60 mg/m² doxorubicin and 600 mg/m² cyclophosphamide administered intravenously on day 1 every two weeks).
A fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy).
Clinical, hematological, and biochemical assessments were done before the start of each cycle.
Adverse events (AEs) were graded using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE version 4.03).
The primary objective of this study is to determine the incidence of febrile neutropenia during four cycles of DD AC with pegteograstim support (8 weeks).
Patients received four cycles of DD-AC (60 mg/m² doxorubicin and 600 mg/m² cyclophosphamide administered intravenously on day 1 every two weeks).
A fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy).
Clinical, hematological, and biochemical assessments were done before the start of each cycle.
Adverse events (AEs) were graded using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE version 4.03).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: