Ignite Creation Date:
2024-05-06 @ 7:22 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02527317
Status:
COMPLETED
Last Update Posted:
2018-02-09
First Post:
2015-06-03
Brief Title:
Dose Dense Chemotherapy With Lipegfilgrastim Support in Early Breast Cancer
Sponsor:
Beaumont Hospital
Organization:
Beaumont Hospital
Study Overview
Official Title:
An Observational Study of Dose Dense Chemotherapy With Lipegfilgrastim Support
Status:
COMPLETED
Status Verified Date:
2018-02
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 non-interventional single arm study which is examining doxorubicin and cyclophosphamide AC once every 2 weeks with lipegfilgrastim support in early breast cancer
Detailed Description:
An important advance in the use of dose dense chemotherapy regimens for breast cancer was the development of pegylated form of G-CSF pegfilgrastim and lipegfilgrastim which offered the convenience of single subcutaneous injection rather than multiple daily injections
Lipegfilgrastim is a pegylated long-acting covalent conjugate of filgrastim G-CSF In a pivotal randomized phase III study in breast cancer lipegfilgrastim was shown to be non-inferior to pegfilgrastim
In this prospective observational study the incidence of treatment-related neutropenia following four cycles of dose dense every 2 week doxorubicin cyclophosphamide AC with lipegfilgrastim support is being investigated
Data will be collected on 40 consecutive patients treated with AC and lipegfilgrastim in Ireland
The primary objective of this study is to determine the incidence of treatment-related neutropenia following four cycles of dose dense doxorubicin cyclophosphamide AC with lipegfilgrastim support 8 weeks
Secondary Objectives
1 Determine the incidence of febrile neutropenia during 4 cycles 8 weeksof dose dense AC with lipegfilgrastim
2 Examine the incidence of treatment-related neutropenia during subsequent intravenous cancer therapy up to 1 year
Lipegfilgrastim is a pegylated long-acting covalent conjugate of filgrastim G-CSF In a pivotal randomized phase III study in breast cancer lipegfilgrastim was shown to be non-inferior to pegfilgrastim
In this prospective observational study the incidence of treatment-related neutropenia following four cycles of dose dense every 2 week doxorubicin cyclophosphamide AC with lipegfilgrastim support is being investigated
Data will be collected on 40 consecutive patients treated with AC and lipegfilgrastim in Ireland
The primary objective of this study is to determine the incidence of treatment-related neutropenia following four cycles of dose dense doxorubicin cyclophosphamide AC with lipegfilgrastim support 8 weeks
Secondary Objectives
1 Determine the incidence of febrile neutropenia during 4 cycles 8 weeksof dose dense AC with lipegfilgrastim
2 Examine the incidence of treatment-related neutropenia during subsequent intravenous cancer therapy up to 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None