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).
Females ≥18 yrs old;
Pathologically confirmed HER2-positive advanced breast cancer;
At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;
Subjects with leptomeningeal metastasis
CNS complications requiring emergency neurosurgical intervention
Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;
Suffering from heart disease that is not well controlled or having clinical symptoms
Parallel
Trastuzumab Rezetecan
DrugTrastuzumab Rezetecan：4.8mg/kg Q3W
FSRT or WBRT
RadiationFSRT （8Gy/3-5 fx）or WBRT（30Gy/10fx）
PFS
CNS-ORR
ORR by investigator using RECIST Guideline
CNS-PFS
Adverse events
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