Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-28 @ 8:39 PM
Study NCT ID:
NCT05347134
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2022-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer
Sponsor:
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Controlled, Open-label, Multi-center Phase III Clinical Trial of SKB264 for Injection Versus Investigator Selected Regimens in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer Who Have Failed Second-line or Above Prior Standard of Care
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
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 evaluate the efficacy of SKB264 in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer who have failed second-line or above prior standard of care
Detailed Description:
The 2021 CSCO guidelines recommend treatment for patients with advanced TNBC as follows: Taxoides are generally preferred for patients who have failed anthracycline therapy in the past; For patients with anthracycline and taxane treatment failure, there is no standard therapy. Previously unused chemotherapy alone or in combination can be considered. However, the toxicity of combination chemotherapy is high and the survival benefit is limited, therefore, in consideration of the quality of life of advanced patients, single-agent chemotherapy is recommended as a priority.
Study Oversight
Has Oversight DMC:
True
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?: