Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06279364
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-02-19
Brief Title:
A Study of SKB264 Versus Investigators Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
Sponsor:
Sichuan Kelun-Biotech Biopharmaceutical Co Ltd
Organization:
Sichuan Kelun Pharmaceutical Research Institute Co Ltd
Study Overview
Official Title:
A Randomized Open-Label Multicenter Phase 3 Study of SKB264 Versus Investigators Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-02
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 aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer TNBC whose tumors do not express programmed cell death ligand 1 PD-L1 or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 PD-1PD-L1 inhibitor in early setting
Detailed Description:
This is a randomized open-label multicenter Phase 3 study to evaluate the efficacy and safety of SKB264 versus investigators choice chemotherapy as first-line treatment for patients with unresectable recurrent or metastatic TNBC whose tumors do not express PD-L1 or in patients with PD-L1 positive tumors who received prior anti-PD-1PD-L1 inhibitor in early setting
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