NCT07111832

A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer

A Phase III, Multicenter, Randomized, Open-label, Active-controlled Study of SHR-A1811 Plus SHR-1316 Versus Toripalimab Plus Nab-paclitaxel in PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the progression-free survival (PFS) of SHR-A1811 combined with SHR-1316 in the first-line treatment of PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer with Toripalimab combined with Nab-paclitaxel, as assessed by blinded independent central review (BICR).

Conditions

• PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	SHR-A1811 for Injection	SHR-A1811 for injection.
DRUG	SHR-1316 Injection	SHR-1316 injection.
DRUG	Toripalimab Injection	Toripalimab injection.
DRUG	Paclitaxel for Injection	Paclitaxel for injection.

Timeline

• Start date: 2025-08-20
• Primary completion: 2028-03-01
• Completion: 2028-12-01
• First posted: 2025-08-08
• Last updated: 2025-12-18

Locations

2 sites across 1 country: China