NCT07132242

SHR-A1811 Combine With Pyrotinib for Locally Advanced/Metastatic HER2 Positive Breast Cancer

Safety and Efficacy of SHR-A1811 Combine With Pyrotinib for the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer, a Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if SHR-A1811 combine with Pyrotinib is safe and tolerable for patients with HER2 positive breast cancer. It will also learn about the anti-tumor efficacy of this combination therapy. Participants will take SHR-A1811 and pyrotinib every three weeks, until disease progression or intolerable toxicity.

Conditions

• Metastatic Breast Cancer With HER2 Positive

Interventions

Type	Name	Description
DRUG	SHR-A1811 4.0mg/kg	SHR-A1811 4.0mg/kg, IV, Day 1, Q3W
DRUG	Pyrotinib 240mg	Pyrotinib 240mg, po, QD, from Day 8 to Day 21,Q3W
DRUG	SHR-A1811 4.8mg/kg	SHR-A1811 4.8mg/kg, IV, D1, Q3W
DRUG	Pyrotinib 320mg	Pyrotinib 320mg, po, QD, from Day 8 to Day 21, Q3W

Timeline

• Start date: 2025-08-30
• Primary completion: 2028-08-30
• Completion: 2028-12-31
• First posted: 2025-08-20
• Last updated: 2025-08-20