Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06367088
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-10
Brief Title:
Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
Cancer Center Union Hospital Tongji Medical College Huazhong University of Science and Technology
Status:
RECRUITING
Status Verified Date:
2024-03
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 prognosis of recurrent and metastatic triple negative breast cancer TNBC is poor and chemotherapy is still the main treatment for TNBC Some studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 CTLA-4 and programmed cell death-1 PD-1 significantly improves clinical benefit over PD-1 antibody alone However broad application of this combination has been limited by toxicities Cadonilimab is a humanized immunoglobulin G1 bispecific antibody targeting PD-1 and CTLA-4 It mutates to eliminate Fc receptor and complement-mediated cytotoxic effects The purpose of this study is to evaluate the efficacy and safety of Cadonilimab combined with chemotherapy as a first or second-line treatment of recurrent and metastatic TNBC This study is a multicenter single arm phase II non randomized open label Simon two-stage design It is planned to enroll 27 late stage TNBC patients
Detailed Description:
None
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