NCT07497386

A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer

A Randomized, Open-Label, Multicenter Phase II Clinical Study of Different Doses of Trastuzumab Rezetecan for Injection or Trastuzumab Deruxtecan for Injection in the Treatment of Unresectable Locally Recurrent/Metastatic Breast Cancer With HR-Positive and HER2-Low Expression

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to compare the efficacy and safety of different dose groups of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in patients with HR-positive, HER2-low unresectable locally recurrent/metastatic breast cancer. It will also exploratively evaluate the pharmacokinetic profile and immunogenicity of Trastuzumab Rezetecan.

Conditions

• Unresectable Locally Recurrent Breast Cancer
• Unresectable Locally Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab Rezetecan for Injection	Trastuzumab Rezetecan for injection.
DRUG	Trastuzumab Deruxtecan for Injection	Trastuzumab Deruxtecan for injection.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-06-01
• Completion: 2028-12-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China