SRT Versus WBRT Combined With Pyrrotinib and Capecitabine in the Treatment of HER2-positive Advanced Breast Cancer Patients With Brain Metastases: A Randomized Controlled, Prospective Clinical Study
This study evaluates the efficacy and safety of SRT combined with pyrotinib and capecitabine in the treatment of patients with HER2-positive advanced breast cancer patients with brain metastases.
• Age\> 18 years old, female
• KPS≥70
• HER2-positive breast cancer is confirmed by the pathology laboratory with an immunohistochemical (IHC) score of 3+ and/or 2+ and a positive in situ hybridization (ISH) test (ISH amplification rate ≥ 2.0)
• Brain metastasis confirmed by MRI, in line with the indications for whole brain radiotherapy
• At least one measurable brain lesion exists according to the RECIST 1.1 standard
• Unlimited number of previous chemotherapy lines
• Have not used capecitabine in the past, or progressed 6 months after capecitabine stopped, or progressed after capecitabine as adjuvant therapy stopped for one year
• The expected survival period is more than 12 weeks
• Patients must have adequate organ function, criteria as follows.
∙ Blood routine examination:Absolute Neutrophil Count (ANC)≥1.5×109/L;PLT ≥100×109/L; Hb ≥90g/L
‣ Blood chemistry test:TBIL ≤1.5 times the upper limit of normal (ULN); ALT and AST≤3 times ULN; For patients with liver metastases, ALT and AST≤5×ULN; BUN and Cr≤1×ULN and creatinine clearance ≥50mL/min (CockcroftGault formula);
‣ Ultrasonic cardiogram: LVEF≥50%
‣ 12-lead ECG: The QT interval (QTcF) corrected by Fridericia's method is \< 470 ms
⁃ Patients with known hormone receptor status
⁃ Patients need to voluntarily join this study after they fully understand and sign the informed consent form. Patients need to have good compliance and be willing to cooperate with follow-up.