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

NCT07100600 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2025-08-11

No results posted yet for this study

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

Interventions

DRUG

Trastuzumab Rezetecan

Trastuzumab Rezetecan：4.8mg/kg Q3W

RADIATION

FSRT or WBRT

FSRT （8Gy/3-5 fx）or WBRT（30Gy/10fx）

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-30
Primary Completion
2030-07-30
Completion
2032-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100600 on ClinicalTrials.gov