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
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;
• Life expectancy is not less than 6 months.
• Adequate function of major organs.