Pyrotinib Combined With Capecitabine and Bevacizumab for Patients With HER2 Positive Breast Cancer and Brain Metastases：a Single-arm,Prospective,Phase II Study
This study intends to conduct a small, prospective, single-center clinical study to explore and evaluate the efficacy and safety of pyrrotinib combined with capecitabine and bevacizumab in HER2-positive advanced breast cancer with brain metastases.The overall objective is to provide a new drug regimen for HER2 positive breast cancer patients with brain metastases by balancing survival benefits and patient quality of life.
• Age ≥18 years old
• ECOG PS score ≤2
• Pathologically confirmed advanced breast cancer with positive HER-2 expression;
• Patients with brain metastases identified by MRI/ enhanced CT with at least one measurable lesion of brain parenchyma according to RECIST 1.1 criteria. There are no requirements as to whether extracranial lesions can be measured.
• Patients with brain metastases who have not received local treatment in the past and have been treated more than two weeks since the end of the last systemic treatment。Patients with new brain lesions after craniotomy were allowed if they did not receive postoperative radiotherapy and were at least 2 weeks away from surgery.
• Previous treatment:
‣ Prior treatment with trastuzumab and other HER2-targeting macromolecular antibodies is permitted;
⁃ Prior chemotherapy was allowed with any line of chemotherapy. Prior use of endocrine therapy is permitted
⁃ Patients who had not previously used capecitabine or progressed after 6 months of discontinuation during metastatic disease or 12 months of discontinuation during adjuvant therapy were admitted.
⁃ Concomitant use of bisphosphonates, mannitol, and glucocorticoids was allowed, provided that the glucocorticoid dose was stable for at least a week before enrollment and that the hormone dose was less than 5mg/ day of dexamethasone or equivalent.
• The expected survival is not less than 6 months.
• Major organ function is normal, meet the following criteria:
‣ Blood routine: ANC ≥1.0×109/L;PLT ≥100×109/L;Hb ≥90g/L
⁃ Blood biochemistry: 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);
⁃ Heart color ultrasound: LVEF≥50%;
⁃ 12-lead electrocardiogram: Fridericia corrected QT interval (QTcF) \< 450ms for males and \< 470 ms for females.
• Voluntarily participate in this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.