Efficacy and Safety of SHR-A1811 Followed by Dalpiciclib and Endocrine Therapy in HR+/HER2-Low/Ultra-Low Advanced Breast Cancer

• Status: NOT_YET_RECRUITING
• Trial end date: 2030-06-30

Summary

This multicenter, prospective phase II clinical trial evaluates the efficacy and safety of sequential SHR-A1811 followed by dalpiciclib plus endocrine therapy (fulvestrant or aromatase inhibitors) in 45 patients with HR+/HER2-low/ultra-low advanced breast cancer. Enrolled patients will receive SHR-A1811 monotherapy for 6-8 cycles until clinical benefit, then transition to dalpiciclib with endocrine therapy until disease progression or unacceptable toxicity. The primary endpoint is progression-free survival (PFS), with secondary endpoints including objective response rate (ORR), overall survival (OS), and treatment-related adverse events (TRAEs). The study will be conducted at Sun Yat-sen Memorial Hospital and collaborating centers.

• Phase: PHASE2

Details

• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University