Clinical Trial

Sac-TMT Plus KL-A167 in PD-L1+, HR+/HER2- Metastatic Breast Cancer After CDK4/6 Inhibitors

Recruiting Phase 2
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Summary
This is a Phase II single-arm study designed to evaluate the efficacy and safety of Sac-TMT + KL-A167 in 35 patients with PD-L1+, HR+/HER2- metastatic breast cancer who previously treated with CDK4/6 inhibitor. The primary endpoint is the 6-month PFS rate. Treatment will continue until disease progression or intolerable toxicity, with periodic imaging assessments and survival follow-up.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-20.
Status change: Not Yet Recruiting → Recruiting 2026-05-05
Trial Details
NCT Number NCT07258108
Lead Sponsor Sun Yat-sen University
Collaborators: Fifth Affiliated Hospital, Sun Yat-Sen University
Conditions Breast Cancer
Enrollment 35 participants
Start Date 2025-11-13
Primary Completion 2027-07-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-08