Exploration of the Safety and Efficacy of T-DXd Concurrent With Brain Radiotherapy in Patients With Brain Metastases HER2-positive/HER2-low Advanced Breast Cancer
A study on the safety and efficacy of T-DXd in combination with local radiotherapy for brain metastases in HER2-Positive and HER2-Low breast cancer patients.
• Female patients aged ≥18 and ≤75 years with histologically confirmed breast cancer.
• ECOG performance status of 0 to 2.
• HER2-positive or HER2-low invasive breast cancer, defined as:
• HER2-positive: IHC 3+ or IHC 2+ with FISH amplification; HER2-low: IHC 2+ without FISH amplification, or IHC 1+.
• Confirmed diagnosis of breast cancer brain metastases.
• Patients may have received prior chemotherapy (from first-line to multiple lines), HER2-targeted therapy (monoclonal antibodies), endocrine therapy, and immunotherapy.
• Adequate organ function as defined below:
• Hematology:
• Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 80 × 10⁹/L (no blood transfusion within 14 days prior to first dose); Hemoglobin (Hb) ≥ 80 g/L;
• Serum biochemistry:
• Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN; Blood urea nitrogen (BUN) and serum creatinine ≤ 1.5 × ULN;
• Cardiac function:
• Echocardiography: Left ventricular ejection fraction (LVEF) ≥ 45%.
• Subjects must voluntarily participate in the study and provide signed informed consent.