Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04502680
Status:
UNKNOWN
Last Update Posted:
2020-08-11
First Post:
2020-08-04
Brief Title:
Maintenance Treatment With Eribulin Mesylate Versus Observation in Triple Negative Breast Cancer Patients
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
A Multicenter Randomized Open-Label Phase II Study to Evaluate the Efficacy and Safety of Maintenance Treatment With Eribulin Mesylate Following Standard Adjuvant Chemotherapy in Triple Negative Breast Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
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:
EMBRAVE-001
Brief Summary:
This clinical trial is a multicenter randomized open-label phase-II study to evaluate the efficacy and safety of maintenance treatment with eribulin mesylate following standard adjuvant chemotherapy in triple negative breast cancer patients
Detailed Description:
Triple negative breast cancer TNBC is an aggressive disease with high relapse rates and poor overall survival This study explores the role of maintenance treatment with eribulin following standard adjuvant chemotherapy in TNBC Patients will be randomized to receive eribulin mesylate maintenance treatment or observation after standard adjuvant chemotherapy
The primary objective is to evaluate the disease free survival DFS The secondary objective is to evaluate the overall survival OS objective response rate ORR and the safety of eribulin mesylate maintenance treatment
The primary objective is to evaluate the disease free survival DFS The secondary objective is to evaluate the overall survival OS objective response rate ORR and the safety of eribulin mesylate maintenance treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None