Ignite Creation Date:
2024-05-06 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03575520
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2018-06-06
Brief Title:
Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
A Phase II Study to Evaluate the Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients Receiving Dose-dense DoxorubicinCyclophosphamide
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 doxorubicincyclophosphamide 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 mgm² doxorubicin and 600 mgm² cyclophosphamide administered intravenously on day 1 every two weeks
A fixed dose of 60 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 403
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 mgm² doxorubicin and 600 mgm² cyclophosphamide administered intravenously on day 1 every two weeks
A fixed dose of 60 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 403
Study Oversight
Has Oversight DMC:
None
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?:
None