Clinical Trial: NCT05347134
SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Information Provided By: | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Last Update Posted: | 2026-05-08 |
Study Overview
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
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
Conditions
Triple Negative Breast Cancer
Intervention / Treatment
- Drug: SKB264
Other Study ID Numbers
- SKB264-Ⅲ-03
Start Date (Actual)
2022-06-10
Primary Completion Date (Actual)
2023-11-30
Study Completion Date (Estimated)
2027-06-30
Enrollment (Estimated)
254
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Information Provided By: | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Last Update Posted: | 2026-05-08 |
Study Overview
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
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
Conditions
Triple Negative Breast Cancer
Intervention / Treatment
- Drug: SKB264
Other Study ID Numbers
- SKB264-Ⅲ-03
Start Date (Actual)
2022-06-10
Primary Completion Date (Actual)
2023-11-30
Study Completion Date (Estimated)
2027-06-30
Enrollment (Estimated)
254
Study Type
Interventional
Phase
Phase 3