Ignite Creation Date:
2024-05-06 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05186545
Status:
RECRUITING
Last Update Posted:
2022-09-02
First Post:
2021-12-23
Brief Title:
An Exploratory Study of Surufatinib Combined With Chidamide and Fulvestrant in HR Positive Unresectable Metastatic Breast Cancer
Sponsor:
The First Affiliated Hospital of Zhengzhou University
Organization:
The First Affiliated Hospital of Zhengzhou University
Study Overview
Official Title:
An Exploratory Study of Surufatinib Combined With Chidamide and Fulvestrant in HR Positive Unresectable Metastatic Breast Cancer Refractory to Endocrine Therapy
Status:
RECRUITING
Status Verified Date:
2022-08
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 center single arm phase II study designed to explore the efficacy and safety of surufatinib fulvastrant chidamide combinational treatment in HR positive breast cancer refractory to endocrine therapy
Detailed Description:
This is a prospective single center single arm phase II study In the safety lead-in stage 6 subjects will be recruited and administered with surufatinib 250 mgd QD PO Fulvestrant 500mg im Q4W Chidamide 30mg PO BIW with four weeks as a cycle DLTs of the 6 subjects will be evaluated in the first cycle to determine the recommended dosage of combinational therapy Then 57 subjects will be recruited and administered with the triplet regimen to explore the efficacy and safety of combinational treatment
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