Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer

This study is a multicenter phase II trial planning to enroll 40 patients with primary triple-negative breast cancer (tumor size ≥2 cm, clinical lymph node stage cN0-3, M0). Participants will receive the combination therapy of Sac-TMT and KL-A167 during the neoadjuvant treatment phase. The study aims to evaluate the efficacy and safety of Sac-TMT combined with KL-A167 as neoadjuvant treatment for triple-negative breast cancer.

NCT Number	NCT07371208
Lead Sponsor	Shanghai Jiao Tong University School of Medicine
Conditions	Breast Cancer
Enrollment	40 participants
Start Date	2025-12-24
Primary Completion	2028-08 (estimated)
Study Completion	2030-08 (estimated)
Updated on ClinicalTrials.gov	2026-01-27