Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00117910
Status:
COMPLETED
Last Update Posted:
2008-05-16
First Post:
2005-06-30
Brief Title:
Treatment for Elderly Patients With High Risk Breast Cancer
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
An Open Label Randomised Multicentre Study of Pegfilgrastim in Primary Versus Secondary Prophylaxis of Neutropenia as an Adjunct to Chemotherapy in Elderly Subjects With High Risk Breast Cancer
Status:
COMPLETED
Status Verified Date:
2008-05
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 open-label multicenter study explored primary and secondary prophylaxis treatment with a single fixed-dose subcutaneous SC injection of pegfilgrastim in elderly subjects with high-risk breast cancer receiving myelosuppressive chemotherapy The primary objective was to provide preliminary information on the incidence of protocol defined neutropenic events in chemotherapy cycle 1
Detailed Description:
None
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