Ignite Creation Date:
2024-05-05 @ 11:24 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01328249
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2011-03-22
Brief Title:
Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Phase II Single-Arm Feasibility Study of Dose Dense Doxorubicin and Cyclophosphamide AC Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer
Status:
COMPLETED
Status Verified Date:
2018-03
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:
The purpose of this study is to assess the feasibility of dose-dense doxorubicin and cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast cancer
Detailed Description:
This is a multicenter single-arm Phase II trial to assess the feasibility of dose-dense adjuvant chemotherapy in subjects with early stage I-III HER-2 normal breast cancer A total of 80 adult subjects will be enrolled in order to have 73 subjects who start the eribulin portion of the adjuvant study regimen After completion of 4 cycles of AC each subject will begin 4 cycles of eribulin mesylate 14 mgm2 intravenously over 2 to 5 minutes on Days 1 and 8 of every 21 day cycle
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