NCT07203729

The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis

Trastuzumab Rezetecan (SHR-A1811) Versus Chemotherapy of Physician's Choice in Patients With HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis：A Randomized, Prospective, Open-Label Phase II Trial.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if Trastuzumab Rezetecan (SHR-A1811) is safe and tolerable for patients with HER2-Low unresectable/metastatic breast cancer complicated with visceral crisis. Participants will take Trastuzumab Rezetecan every three weeks, until disease progression or intolerable toxicity.

Conditions

• HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis

Interventions

Type	Name	Description
DRUG	Trastuzumab Rezetecan	Trastuzumab Rezetecan 4.8mg/kg, IV, Day 1, Q3W
DRUG	Chemotherapy of Physician's Choice	Chemotherapy of Physician's Choice, including nab-paclitaxel, Eribulin, Capecitabine, Vinorelbine, Gemcitabine.

Timeline

• Start date: 2026-03-01
• Primary completion: 2030-06-15
• Completion: 2030-12-30
• First posted: 2025-10-02
• Last updated: 2026-03-16

Locations

1 site across 1 country: China