NCT07100600

Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases

An Open-label, Randomized, Controlled Trial of Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A total of 224 subjects of HER2-positive advanced breast cancer with brain metastases are planned to be enrolled. Eligible subjects will be randomly assigned in a 1:1 ratio to the group receiving Trastuzumab Rezetecan combined with radiotherapy or the group receiving Trastuzumab Rezetecan monotherapy until disease progression, intolerable toxicity, withdrawal of informed consent, or the study determines that treatment must be terminated (whichever occurs first).

Conditions

• HER2-positive Advanced Breast Cancer
• Brain Metastases
• Radiotherapy

Interventions

Type	Name	Description
DRUG	Trastuzumab Rezetecan	Trastuzumab Rezetecan：4.8mg/kg Q3W
RADIATION	FSRT or WBRT	FSRT （8Gy/3-5 fx）or WBRT（30Gy/10fx）

Timeline

• Start date: 2025-08-30
• Primary completion: 2030-07-30
• Completion: 2032-12-30
• First posted: 2025-08-03
• Last updated: 2025-08-11

Locations

1 site across 1 country: China