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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
Trastuzumab Rezetecan:4.8mg/kg Q3W
FSRT (8Gy/3-5 fx)or WBRT(30Gy/10fx)
Professor
Zhengzhou, Henan, China
RECRUITINGPFS
Time frame: up to 1.5 years
CNS-ORR
Time frame: 2 months
ORR by investigator using RECIST Guideline
Time frame: 2 months
CNS-PFS
Time frame: 1.5 year
Adverse events
Time frame: up to 1.5 years
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